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1

Pelletier, Sara Jeanne, Marie-Pierre Gagnon, Souleymane Diabaté, et al. "Pre-Exposure Prophylaxis (PrEP) in Men Who have Sex with Men in Bouaké, Côte d’Ivoire: A Qualitative Evaluation of Acceptability." Open AIDS Journal 13, no. 1 (2019): 49–58. http://dx.doi.org/10.2174/1874613601913010049.

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Background: HIV remains an important public health issue throughout the world. In Côte d’Ivoire, a high burden of HIV is observed in men who have sex with men (MSM). Objective: We assessed the acceptability of Pre-Exposure Prophylaxis (PrEP) among men who have sex with men (MSM) in Bouaké, Côte d’Ivoire. Methods: We conducted and analysed four focus groups with 31 HIV-negative MSM and eight in-depth individual interviews with participants recruited from the focus groups. Results: Four MSM (13%) were aware of PrEP before participating in the study. All the participants were interested in taking PrEP if available: 19 (61.3%) would prefer the daily regimen and 12 (38.7%) would opt for the on-demand regimen. Many advantages of PrEP were mentioned: protection in case of a condom break, protection in case of high-risk sexual behaviour, self-reliance, decreasing HIV fear and ease of use. Barriers to the use of PrEP included: it does not protect against other Sexually Transmitted Tnfections (STIs), taking a pill regularly is necessary, the size of the pill, possibility of side effects, the cost and accessibility. Six participants (19.3%) admitted that they would use condoms less if they take PrEP. Conclusion: Findings indicate that PrEP is acceptable within the MSM community. Implementation should be done rapidly, and PrEP should be part of a global prevention program which includes counselling, STI screening and promotion of safe sex practices. Health authorities should consider PrEP for all high-risk groups to avoid worsening stigmatization by targeting MSM only.
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Dimitrov, Dobromir, James R. Moore, Daniel Wood, et al. "Predicted Effectiveness of Daily and Nondaily Preexposure Prophylaxis for Men Who Have Sex With Men Based on Sex and Pill-taking Patterns From the Human Immuno Virus Prevention Trials Network 067/ADAPT Study." Clinical Infectious Diseases 71, no. 2 (2019): 249–55. http://dx.doi.org/10.1093/cid/ciz799.

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Abstract Background The HIV Prevention Trials Network (HPTN) 067/Alternative Dosing to Augment PrEP Pill Taking (ADAPT) Study evaluated the feasibility of daily and nondaily human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) regimens among high-risk populations, including men who have sex with men (MSM) and transgender women, in Bangkok, Thailand and Harlem, New York. We used a mathematical model to predict the efficacy and effectiveness of different dosing regimens. Methods An individual-based mathematical model was used to simulate annual HIV incidence among MSM cohorts. PrEP efficacy for covered sex acts, as defined in the HPTN 067/ADAPT protocol, was estimated using subgroup efficacy estimates from the preexposure prophylaxis initiative (iPrEx) trial. Effectiveness was estimated by comparison of the HIV incidence with and without PrEP use. Results We estimated that PrEP was highly protective (85%–96% efficacy across regimens and sites) for fully covered acts. PrEP was more protective for partially covered acts in Bangkok (71%–88% efficacy) than in Harlem (62%–81% efficacy). Our model projects 80%, 62%, and 68% effectiveness of daily, time-driven, and event-driven PrEP for MSM in Harlem compared with 90%, 85%, and 79% for MSM in Bangkok. Halving the efficacy for partially covered acts decreases effectiveness by 8–9 percentage points in Harlem and by 5–9 percentage points in Bangkok across regimens. Conclusions Our analysis suggests that PrEP was more effective among MSM in Thailand than in the United States as a result of more fully covered sex acts and more pills taken around partially covered acts. Overall, nondaily PrEP was less effective than daily PrEP, especially in the United States where the sex act coverage associated with daily use was substantially higher.
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Giovenco, Danielle, Caroline Kuo, Kristen Underhill, Jacqueline Hoare, and Don Operario. "“The Time Has Arrived”: Perceptions of Behavioral Adjustments in the Context of Pre-Exposure Prophylaxis Availability Among Adolescents in South Africa." AIDS Education and Prevention 30, no. 6 (2018): 463–73. http://dx.doi.org/10.1521/aeap.2018.30.6.463.

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Antiretroviral pre-exposure prophylaxis (PrEP) holds enormous potential to reduce HIV acquisition in key populations globally. We conducted an exploratory PrEP acceptability study using qualitative methodology among adolescents and service providers in the Western Cape Province of South Africa to inform future PrEP implementation challenges in South Africa and other high-prevalence African countries. Semistructured focus groups and in-depth individual interviews were conducted among 57 adolescents 16–17 years of age, living with and without HIV, and 25 clinical service providers. Adolescents and service providers expressed concerns that the availability of PrEP would lead to sexual disinhibition and a reduction in condom use among adolescents. Unexpected positive impacts included predictions that PrEP might encourage disclosure in serodiscordant partnerships and help normalize pill-taking in the community. Careful age, gender, and developmentally appropriate messaging will be needed to ensure adolescents understand partial efficacy and view PrEP as a component of combination prevention.
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Pines, HA, SA Strathdee, CW Hendrix, et al. "Oral and vaginal HIV pre-exposure prophylaxis product attribute preferences among female sex workers in the Mexico-US border region." International Journal of STD & AIDS 30, no. 1 (2018): 45–55. http://dx.doi.org/10.1177/0956462418793038.

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To assess the potential uptake of HIV pre-exposure prophylaxis (PrEP) products among female sex workers (FSWs) vulnerable to HIV infection, we examined the influence of product attributes on willingness to use products among 271 HIV-negative FSWs in Tijuana and Ciudad Juarez, Mexico (2016–2017). Via five-point Likert scale ratings, participants indicated their willingness to use hypothetical products with six attributes: formulation (pill, gel, liquid, or ring), frequency of use (daily, on-demand, or monthly), cost per use (10 or 200 pesos), effectiveness (40% or 80%), side effects (none or mild), and access point (healthcare clinic or non-governmental organization). Conjoint analysis was used to determine the impact of attributes on product ratings and identify preferred product attributes. Multinomial logistic regression was used to identify factors associated with formulation preferences. In both cities, formulation and frequency of use had the greatest impact on ratings. Participants in Ciudad Juarez indicated a strong preference for oral pills, whereas participants in Tijuana indicated roughly equal preferences for oral pills and vaginal gels. Monthly product use was preferred in both cities. Compared to preferring oral pills (38%), preferring vaginal gels (28%) was associated with practicing vaginal lubrication (adjusted odds ratio = 2.08; 95% confidence interval: 1.07–4.04). Oral PrEP may be acceptable to many FSWs in Tijuana and Ciudad Juarez; however, continued development of behaviorally-congruent vaginal PrEP products may also facilitate uptake and ensure sufficient coverage.
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Marsh, Ketzela Jacobowitz, and Meghan Rothenberger. "A Young Black MSM on PrEP Is Lost to Follow-Up and Acquires HIV Infection: A Case to Call for Improved Strategies to Support Youth Adherence and Engagement in HIV Prevention." Journal of the International Association of Providers of AIDS Care (JIAPAC) 18 (January 1, 2019): 232595821985383. http://dx.doi.org/10.1177/2325958219853834.

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Young men who have sex with men (YMSM) are disproportionately affected by HIV in the United States. High-risk sexual behaviors are difficult to modify; thus, HIV pre-exposure prophylaxis (PrEP) with a daily pill is a promising prevention tool for this vulnerable population. We present a case of a young black MSM who was able to successfully access PrEP with the help of a community program but was not able to adhere to the regimen or engage in care. He ultimately acquired HIV infection. We review the existing literature and advocate for increased services and research to support youth’s adherence to PrEP and engagement in HIV prevention programs, with a focus on YMSM of color.
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Wirtz, Andrea L., Brian Wilson Weir, Sandra Hsu Hnin Mon, et al. "Testing the Effectiveness and Cost-Effectiveness of a Combination HIV Prevention Intervention Among Young Cisgender Men Who Have Sex With Men and Transgender Women Who Sell or Exchange Sex in Thailand: Protocol for the Combination Prevention Effectiveness Study." JMIR Research Protocols 9, no. 1 (2020): e15354. http://dx.doi.org/10.2196/15354.

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Background Pre-exposure prophylaxis (PrEP) is highly effective in the prevention of HIV acquisition, particularly for men who have sex with men (MSM). Questions remain on the benefits of PrEP and implementation strategies for those at occupational risk of HIV acquisition in sex work, as well as on methods to support adherence among young people who initiate PrEP. Objective The Combination Prevention Effectiveness study for young cisgender MSM and transgender women (TGW) aims to assess the effectiveness and cost-effectiveness of a combination intervention among HIV-uninfected young MSM and TGW engaged in sex work in Thailand. Methods This open-label, nonrandomized assessment compares the relative effectiveness of a combination prevention intervention with and without daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada) PrEP with SMS-based adherence support. HIV-uninfected young MSM and TGW aged 18 to 26 years in Bangkok and Pattaya who self-report selling/exchanging sex at least once in the previous 12 months are recruited by convenience sampling and peer referral and are eligible regardless of their intent to initiate PrEP. At baseline, participants complete a standard assessment for PrEP eligibility and may initiate PrEP then or at any time during study participation. All participants complete a survey and HIV testing at baseline and every 3 months. Participants who initiate PrEP complete monthly pill pickups and may opt-in to SMS reminders. All participants are sent brief weekly SMS surveys to assess behavior with additional adherence questions for those who initiated PrEP. Adherence is defined as use of 4 or more pills within the last 7 days. The analytic plan uses a person-time approach to assess HIV incidence, comparing participant time on oral PrEP to participant time off oral PrEP for 12 to 24 months of follow-up, using a propensity score to control for confounders. Enrollment is based on the goal of observing 620 person-years (PY) on PrEP and 620 PY off PrEP. Results As of February 2019, 445 participants (417 MSM and 28 TGW) have contributed approximately 168 PY with 95% (73/77) retention at 12 months. 74.2% (330/445) of enrolled participants initiated PrEP at baseline, contributing to 134 PY of PrEP adherence, 1 PY nonadherence, and 33 PY PrEP nonuse/noninitiation. Some social harms, predominantly related to unintentional participant disclosure of PrEP use and peer stigmatization of PrEP and HIV, have been identified. Conclusions The majority of cisgender MSM and TGW who exchange sex and participate in this study are interested in PrEP, report taking sufficient PrEP, and stay on PrEP, though additional efforts are needed to address community misinformation and stigma. This novel multilevel, open-label study design and person-time approach will allow evaluation of the effectiveness and cost-effectiveness of combination prevention intervention in the contexts of both organized sex work and exchanged sex. International Registered Report Identifier (IRRID) RR1-10.2196/15354
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Giovenco, Danielle, Katherine Gill, Lauren Fynn, et al. "Experiences of oral pre-exposure prophylaxis (PrEP) use disclosure among South African adolescent girls and young women and its perceived impact on adherence." PLOS ONE 16, no. 3 (2021): e0248307. http://dx.doi.org/10.1371/journal.pone.0248307.

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Introduction There is limited understanding of how social dynamics impact pre-exposure prophylaxis (PrEP) adherence among adolescent girls and young women (AGYW) in generalized HIV-epidemic settings. We examined experiences of oral PrEP use disclosure to various social groups with the goal of identifying supportive relationships that can be leveraged to promote adherence. Methods We used qualitative methods to explore experiences disclosing PrEP use and the perceived impact of disclosure on adherence among 22 South African AGYW (16–25 years) taking daily oral PrEP. Serial in-depth-interviews (IDIs) were conducted 1-, 3-, and 12-months post-PrEP initiation. Respondents also self-reported their disclosures separately for various social groups and adherence was assessed using intracellular tenofovir-diphosphate levels. Results Qualitative respondents had a median age of 20.5 years and reported disclosing their PrEP use to friends (n = 36 total disclosures), partners, siblings, other family members (n = 24 disclosures each), and parents (n = 19 disclosures). IDI data revealed that parents and partners provided the most support to respondents and a lack of support from these groups was most often perceived as negatively affecting PrEP use. AGYW described difficulties explaining PrEP to their mothers, who believed PrEP was HIV treatment or would lead to HIV infection. Disclosure to household members was notably meaningful for AGYW (both positively and negatively). Respondents reported leveraging supportive relationships for pill reminders. For respondents who perceived a household member would be unsupportive, however, non-disclosure was less feasible and PrEP use was often stigmatized. To avoid stigma, several respondents hid or discontinued PrEP. Conclusions While supportive relationships may facilitate PrEP use, disclosure can also lead to stigma. Counselors should support AGYW in disclosing to key people in their social networks and provide AGYW with materials that lend credibility to explanations of PrEP. Community education is necessary to alleviate PrEP-related stigma and facilitate disclosure.
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Harling, Guy, Aisa Muya, Katrina F. Ortblad, et al. "HIV risk and pre-exposure prophylaxis interest among female bar workers in Dar es Salaam: cross-sectional survey." BMJ Open 9, no. 3 (2019): e023272. http://dx.doi.org/10.1136/bmjopen-2018-023272.

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ObjectiveFemale bar workers (FBW) in East Africa often conduct sex work to supplement their incomes, and may be vulnerable to HIV acquisition. Pre-exposure prophylaxis (PrEP) offers protection against HIV acquisition. However, there is little research on FBW’s sexual health. Our objective was to determine HIV risk behaviours and interest in PrEP among FBW in the largest city in East Africa.DesignCross-sectional survey covering respondents’ work and personal lives, including social and behavioural risk factors for HIV. The survey aimed to determine the feasibility of working with FBW and HIV prevalence estimates. Those who did not report being HIV positive were asked about their knowledge of and interest in PrEP. All women were offered free on-site HIV testing and counselling (HTC).SettingEight randomly selected workplaces, that is, bars, in Kinondoni district, Dar es Salaam (DSM).Participants66 FBW (≥18 years) selected at random from all women working in selected bars on the day of visit.ResultsHalf of respondents reported having had sex for money: 20% with bar clients only, 15% with other men only and 15% with both. Almost all (98%) reported ≥1 non-commercial partners in the past 12 months; only 30% reported using condoms with these partners. 85% of respondents had ever been pregnant; 44% had had an unintended pregnancy. Only 5% of respondents had ever heard of PrEP. However, 54% were somewhat/very interested in daily-pill PrEP and 79% were somewhat/very interested in long-acting injectable PrEP. When asked to rank modalities, long-acting injectable PrEP was the most preferred. Seven per cent of the 56 respondents who completed HTC tested HIV positive.ConclusionsFBW in DSM have elevated risk factors for HIV acquisition, and PrEP appears highly acceptable. Studies developing PrEP delivery models and assessing PrEP initiation and adherence in FBW appear warranted.
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Puppo, Costanza, Xavier Mabire, Laurent Cotte, et al. "Community-Based Care in the ANRS-IPERGAY Trial: The Challenges of Combination Prevention." AIDS Education and Prevention 31, no. 3 (2019): 259–72. http://dx.doi.org/10.1521/aeap.2019.31.3.259.

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ANRS-IPERGAY was a community-based randomized trial investigating the efficacy of sexual activity-based HIV pre-exposure prophylaxis (PrEP) in a population of males and transgender females who had sex with men and were at high risk of HIV infection. We qualitatively analyzed the support provided to participants by community-based health workers (CBHW) throughout the trial's double-blind and open-label extension phases. In particular, we showed that the relationship between participants and CBHW strongly influenced self-managed pill intake. The delicate construction of this relationship, balanced between trust and dependence, played an important role in PrEP adherence. CBHW had to deal with various issues surrounding participants' feelings of empowerment regarding their role in the trial, as well as related tensions between various logics and rationalities. They were essential to participants' continued involvement.
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Corneli, Amy, Brian Perry, Kawango Agot, Khatija Ahmed, Fulufhelo Malamatsho, and Lut Van Damme. "Facilitators of Adherence to the Study Pill in the FEM-PrEP Clinical Trial." PLOS ONE 10, no. 4 (2015): e0125458. http://dx.doi.org/10.1371/journal.pone.0125458.

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Goodman, Georgia, Conall O'Cleirigh, Kenneth H. Mayer, Edward W. Boyer, Rochelle K. Rosen, and Peter R. Chai. "Attitudes and Response to a Smartphone-Based Digital Pill Intervention to Enhance PrEP Adherence Among Men Who Have Sex With Men With Stimulant Use." Iproceedings 5, no. 1 (2019): e15273. http://dx.doi.org/10.2196/15273.

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Background Digital pills contain a radiofrequency emitter and gelatin capsule that over-encapsulate a study medication. The radiofrequency emitter, activated by the chloride ion gradient in the stomach, transmits a signal to a wearable Reader device following ingestion. The Reader relays ingestion data to a smartphone app and cloud-based server, allowing for real-time verification of ingestion events and adherence measurement. Digitized pre-exposure prophylaxis (PrEP) may improve outcomes in populations with suboptimal adherence related to substance use. Stimulant use is particularly prevalent among men who have sex with men (MSM) and is associated with increased HIV risk behavior and transmission. We conducted seven focus groups with MSM who use stimulants (N=16) to inform the development of PrEPsteps, a novel smartphone-based adherence intervention respondent to data from digitized PrEP and designed to augment adherence. Objective To inform the specification of the design, content, and delivery of the smartphone-based PrEPsteps adherence system via focus groups with HIV-negative MSM who use stimulants. Methods Seven focus groups were conducted with HIV-negative MSM reporting stimulant use (eg, cocaine, methamphetamine) in the past six months. Participants self-reported medical history, substance use and sexual activity. Focus groups explored responses to digital pill technology, willingness and barriers to use, content and timing of adherence messaging, and three intervention components: (1) abbreviated cognitive behavioral therapy (CBT) adherence counseling (LifeSteps); (2) contingent reinforcement/corrective feedback; and (3) substance use-related Screening, Brief Intervention and Referral to Treatment (SBIRT). Focus groups were transcribed and analyzed using applied thematic analysis. Results Sixteen individuals participated in focus groups. All were male; age ranged from 24 to 63 (mean 39.9, SD 14.1) and most self-identified as gay (N=13). Participants were primarily non-Hispanic or Latino (N=12); 10 identified as white, two as black, and four as multiracial. Most had at least a college degree (N=14). Twelve participants were taking PrEP, 5 of whom reported missed doses in the past two weeks. Number of sexual partners in the past three months ranged from 1 to 200 (M=28.1; SD=50.9). Fifteen participants reported using stimulants during the last 30 days. Participants viewed digital pills as a tool to enhance PrEP adherence and accountability. They expressed a willingness to use the digital pill and identified physicians, family members, and partners as people with whom they would share adherence data. The Reader was viewed as the most difficult technological component to use, although participants also described the device as itself an adherence reminder. Participants identified customizability as a valuable aspect of the technology; message and reminder content, structure, and scheduling were all considered customizable. With regard to the intervention, participants were accepting of and willing to interact with corrective feedback messages linked to a brief CBT LifeSteps booster session. Conclusions PrEPsteps, a smartphone-based adherence intervention, was viewed as acceptable by HIV-negative MSM who use stimulants. Individuals perceived corrective feedback notifications to be the most helpful component of the system, and expressed a strong preference for customizability across the intervention.
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Mowlabocus, Sharif. "‘What a skewed sense of values’: Discussing PreP in the British press." Sexualities 23, no. 8 (2019): 1343–61. http://dx.doi.org/10.1177/1363460719872726.

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In this article I examine the public discussion of pre-exposure prophylaxis (PrEP) in the UK and investigate how this treatment and its key beneficiaries were framed by the British press between 2012 and 2016. Drawing upon an archive of articles published in national newspapers, I identify the discursive transformation that PrEP underwent during this period, as it moved from being a ‘wonder drug’ that benefited the health of the general population, to a ‘promiscuity pill’ that threatened the lives of the most vulnerable. I illustrate how this transformation was accompanied by a shift in the representation of gay men – who were almost universally positioned as the future beneficiaries of PrEP in the UK. Utilizing critical discourse analysis methods, I explore how gay men went from being ‘upstanding citizens’ to ‘dangerous outsiders’, and how the British press mapped older stereotypes of the diseased gay male body onto newer homonormative representations of the ‘good gay’ and the ‘evil queer’. This analysis reveals the precarious status gay men occupy in ‘post-equalities’ Britain – a status that requires adherence to a particular code of sexual and moral conduct, and the disavowal of long-term health inequalities.
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Wang, Hongyi, Jing Zhang, Zhenxing Chu, et al. "Risk-Taking Behaviors and Adherence to HIV Pre-Exposure Prophylaxis in Users of Geosocial Networking Apps: Real-World, Multicenter Study." Journal of Medical Internet Research 22, no. 10 (2020): e22388. http://dx.doi.org/10.2196/22388.

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Background Over half of men who have sex with men (MSM) use geosocial networking (GSN) apps to encounter sex partners. GSN apps’ users have become a unique large subpopulation among MSM for interventions concerning HIV prevention and control. Pre-exposure prophylaxis (PrEP) is a promising measure for HIV prevention, especially for MSM, but its effectiveness largely depends on medication adherence. However, little is known about PrEP adherence among GSN apps’ users, which is critical to addressing the overall optimization of PrEP compliance outside of clinical trials in the context of large-scale implementation. Objective The objective of this study is to understand the correlation between GSN apps’ use and medication adherence among MSM receiving PrEP, with the aim to increase their awareness about PrEP use in order to increase adherence. Methods This study based on the China Real-world Oral intake of PrEP (CROPrEP) project, a multicenter, real-world study of Chinese MSM on daily and event-driven PrEP. Eligible participants completed a detailed computer-assisted self-interview on sociodemographic, GSN apps’ use, and sexual behavior. Then participants were followed up for 12 months and assessed for various characteristics (eg, PrEP delivery, adherence assessment, PrEP coverage of sexual activities, and regimens switch). A generalized estimation equation was used to analyze the predictors of medication adherence and regimen conversion among GSN apps’ users and nonusers. Results At baseline, 756 of the 1023 eligible participants (73.90%) reported primarily using GSN apps to seek sexual partners, and GSN apps’ users are more likely to have high-risk behaviors such as multiple sex partners and condomless anal intercourse than other nonusers (all P<.05). During follow-up, GSN apps’ users had a significantly low level of pill-counting adherence than nonusers (adjusted odds ratio [aOR] 0.8, 95% CI 0.6-1.0, P=.038). In the event-driven group, GSN apps’ users had marginally lower levels of self-reported adherence (aOR 0.7, 95% CI 0.4-1.0, P=.060) and lower PrEP coverage of sexual practices (aOR 0.6, 95% CI 0.4-1.0, P=.038). Additionally, GSN apps’ users seemed more likely to switch from event-driven to daily regimen (aOR 1.8, 95% CI 0.9-3.3, P=.084). Conclusions GSN apps’ users are highly prevalent among MSM, despite their higher sexual risk and lower adherence levels, suggesting that eHealth needs to be introduced to the GSN platform to promote PrEP adherence. Trial Registration Chinese Clinical Trial Registry ChiCTR-IIN-17013762; https://tinyurl.com/yy2mhrv4. International Registered Report Identifier (IRRID) RR2-10.1186/s12879-019-4355-y
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Grammatico, Megan A., Koeun Choi, Anthony Moll, and Sheela Shenoi. "989. Pre-exposure Prophylaxis (PrEP) Short-Term Retention Among Heavy Alcohol Users in Rural South Africa." Open Forum Infectious Diseases 7, Supplement_1 (2020): S523. http://dx.doi.org/10.1093/ofid/ofaa439.1175.

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Abstract Background Despite widespread access to HIV testing and antiretroviral therapy (ART), men, and especially young men, remain difficult to engage in HIV services. Alcohol use disorder (AUD) further complicates engagement. Congregate alcohol venues, known as shebeens, are an ideal place to engage with young men for HIV testing, treatment, and prevention services, including pre-exposure prophylaxis (PrEP). Here we report on one-month retention in care in eligible patrons recruited from shebeens into a community-based model of PrEP delivery. Methods An all-male field team offered HIV testing at mobile clinics outside shebeens in rural Msinga sub-district of Kwazulu-Natal (KZN) province. Eligible participants were offered enrollment into a community-based model of PrEP delivery. PrEP initiators completed the AUDIT scale, with hazardous alcohol use defined as score > 6 for women and > 8 for men, and had dried blood spot (DBS) analysis for phosphatidylethanol (PEth). Loss to follow up was defined as not attending the 1 month follow up appointment, non-response to 3 separate phone calls on three separate days, and unsuccessful tracing at least once at participant’s home address. Results Between February and May 2020, 16 eligible shebeen patrons initiated PrEP, a median of 14.5 days (IQR 12.5 – 19) after initial screening. Among initiators, 93.8% were male, median age was 29.5 years (IQR 22.25 - 37), 31.2% were employed, 56.3% had running water, and 68.8% were hazardous alcohol users. One-month follow-up visits were completed with 68.8% (11/16) participants. Of those retained in care, 90.9% reported at least one sexual partner in the last month, and 54.5% reported more than one sexual partner. All sexually active participants reported inconsistent condom use. In the prior 7 days, 63.7 % of participants reported taking “all of my medication” and 36.4% reported taking “most of my medication,” verified by pill count. Hazardous alcohol use and PEth results did not predict one-month retention in this small sample Conclusion Young men engaging in risky behavior were interested and willing to engage in PrEP through a community-based PrEP model. The majority were retained in care, and all reported good adherence to PrEP, suggesting the value of differentiated service delivery to engage men in HIV prevention. Disclosures All Authors: No reported disclosures
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Rael, Christine Tagliaferri, Cody Lentz, Alex Carballo-Diéguez, et al. "Understanding the Acceptability of Subdermal Implants as a Possible New HIV Prevention Method: Multi-Stage Mixed Methods Study." Journal of Medical Internet Research 22, no. 7 (2020): e16904. http://dx.doi.org/10.2196/16904.

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Background A long-acting implant for HIV pre-exposure prophylaxis (PrEP) is in development in the Sustained Long-Action Prevention Against HIV (SLAP-HIV) trial. This could provide an alternative to oral PrEP. Objective Our mixed methods study aimed to understand (1) users’ experiences with a similar subdermal implant for contraception and (2) factors influencing the likelihood that gay and bisexual men (GBM) would use a proposed PrEP implant. Methods Work was completed in 4 stages. In stage 1, we conducted a scientific literature review on existing subdermal implants, focusing on users’ experiences with implant devices. In stage 2, we reviewed videos on YouTube, focusing on the experiences of current or former contraceptive implant users (as these implants are similar to those in development in SLAP-HIV). In stage 3, individuals who indicated use of a subdermal implant for contraception in the last 5 years were recruited via a web-based questionnaire. Eligible participants (n=12 individuals who liked implants a lot and n=12 individuals who disliked implants a lot) completed in-depth phone interviews (IDIs) about their experiences. In stage 4, results from IDIs were used to develop a web-based survey for HIV-negative GBM to rate their likelihood of using a PrEP implant on a scale (1=very unlikely and 5=very likely) based on likely device characteristics and implant concerns identified in the IDIs. Results In the scientific literature review (stage 1), concerns about contraceptive implants that could apply to the PrEP implants in development included potential side effects (eg, headache), anticipated high cost of the device, misconceptions about PrEP implants (eg, specific contraindications), and difficulty accessing PrEP implants. In the stage 2 YouTube review, individuals who had used contraceptive implants reported mild side effects related to their device. In stage 3, implant users reported that devices were comfortable, unintrusive, and presented only minor discomfort (eg, bruising) before or after insertion and removal. They mainly reported removing or disliking the device due to contraceptive-related side effects (eg, prolonged menstruation). Participants in the stage 4 quantitative survey (N=304) were mainly gay (204/238, 85.7%), white (125/238, 52.5%), cisgender men (231/238, 97.1%), and 42.0% (73/174) of them were on oral PrEP. Not having to take a daily pill increased the likelihood of using PrEP implants (mean 4.13). Requiring >1 device to achieve 1 year of protection (mean range 1.79-2.94) mildly discouraged PrEP implant use. Participants did not mind moderate bruising, a small scar, tenderness, or bleeding after insertion or removal, and an implant with a size slightly larger than a matchstick (mean ratings 3.18-3.69). Conclusions PrEP implants are promising among GBM. Implant features and insertion or removal-related concerns do not seem to discourage potential users. To ensure acceptability, PrEP implants should require the fewest possible implants for the greatest protection duration.
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Stekler, Joanne D., James M. Scanlan, Jane M. Simoni, et al. "Predictors of Art and PrEP Adherence and Medication-Taking Practices and Preferences to Inform Development of a Wrist-Worn Adherence System." AIDS Education and Prevention 30, no. 5 (2018): 357–68. http://dx.doi.org/10.1521/aeap.2018.30.5.357.

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We examined adherence, medication-taking practices, and preferences to inform development of a wrist-worn adherence system. Two convenience samples of persons taking antiretroviral therapy and HIV pre-exposure prophylaxis completed a survey. Additional online questions asked about willingness to use a wrist-worn device and reminder and feedback preferences. Among 225 participants, 13% reported adherence < 90% this was associated with younger age and clinic sample. Compared to pill bottle–using participants, mediset users less commonly reported adherence < 90% (aOR = 0.16, p = .02), and blister pack users (aOR = 6.3, p = .02) and pill roll users (aOR = 3.3, p = .04) more commonly reported adherence < 90%. Sixty-two percent of the online participants reporting adherence (< 100%) had some interest in receiving adherence reminders, including 42% with interest in receiving reminders by smartwatch notifications. Although confounders are likely, formative work identified potential users and interest in using a wrist-worn adherence system. Future work will determine its acceptability and efficacy.
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Zissette, Seth, Elizabeth E. Tolley, Andres Martinez, et al. "Adaptation and validation of simple tools to screen and monitor for oral PrEP adherence." PLOS ONE 16, no. 5 (2021): e0251823. http://dx.doi.org/10.1371/journal.pone.0251823.

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Introduction Oral, vaginal and other pre-exposure prophylaxis (PrEP) products for HIV prevention are in various stages of development. Low adherence poses a serious challenge to successful evaluation in trials. In a previous study, we developed tools to screen for general adherence and specifically monitor intravaginal ring adherence within the context of HIV prevention clinical trials. This study aimed to further validate the screening tool and to adapt and provide initial psychometric validation for an oral pill monitoring tool. Materials and methods We administered a cross-sectional survey between June and October 2018 at a trial site located near Cape Town, South Africa, and another in Thika, Kenya, with 193 women who had experience using daily oral pills. We fit confirmatory factor analysis models on the screening tool items to assess our previously-hypothesized subscale structure. We conducted an exploratory factor analysis of oral PrEP monitoring items to determine the underlying subscale structure. We then assessed the construct validity of each tool by comparing subscales against each other within the current sample and against our original sample, from a study conducted in four sites in South Africa, including Cape Town. Results The screening tool structure showed moderate evidence of construct validity. As a whole, the tool performed in a similar way to the original sample. The monitoring tool items, which were revised to assess perceptions about and experiences using daily oral PrEP, factored into five subscales that showed moderate to good reliability. Four of the five subscales had a similar structure overall to the vaginal ring monitoring tool from which they were adapted. Conclusions Accurate measurement of HIV-prevention product adherence is of critical importance to the assessment of product efficacy and safety in clinical trials, and the support of safe and effective product use in non-trial settings. In this study, we provide further validation for these measures, demonstrating the screening tool’s utility in additional populations and adapting the monitoring tool’s utility for different HIV-prevention products.
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Schwartz, Theresa M. "40. Those sexy STDs: opportunities for prevention in an anal dysplasia practice." Sexual Health 10, no. 6 (2013): 589. http://dx.doi.org/10.1071/shv10n6ab40.

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Young gay and bisexual men are continuing to engage in practices that permit new HIV infections. Most of them are unaware that pre-exposure prophylaxis (PrEP) with one pill a day can prevent most of these. HIV providers are poised to prescribe PrEP, but most of their patients are already HIV infected. General PCPs are considerably less knowledgeable regarding PrEP, even if they know/suspect that their patients are at risk for HIV acquisition. Anal dysplasia providers who see HIV-uninfected MSM have a unique opportunity to make an impact by identifying patients who might be candidates and providing basic information and referral. Chlamydia trachomatis (CT) infection is notoriously difficult to detect by culture. CT is also a frequent cofactor in the transmission/acquisition of HIV. Gynaecologists routinely use nucleic acid amplification tests (NAATs) to diagnose CT and gonorrhoea. Although there is no FDA-approved commercially available NAAT for the diagnosis of rectal CT, individual laboratories are able to develop and validate their own assays, if they follow the protocols established by their regulatory/governing bodies. This may not be as difficult as you would expect, with good collaboration between clinical providers and laboratory administrators. Expect your diagnosis of rectal CT infections and lymphogranuloma venereum (LGV) to increase significantly once you have an NAAT available to aid in diagnosis. Timely treatment of CT infections will decrease the number of new cases and perhaps even HIV incidence.
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Corneli, Amy, Meng Wang, Kawango Agot, Khatija Ahmed, Johan Lombaard, and Lut Van Damme. "Perception of HIV Risk and Adherence to a Daily, Investigational Pill for HIV Prevention in FEM-PrEP." JAIDS Journal of Acquired Immune Deficiency Syndromes 67, no. 5 (2014): 555–63. http://dx.doi.org/10.1097/qai.0000000000000362.

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Berruti, Marco, Niccolò Riccardi, Diana Canetti, Sergio Lo Caputo, Lucia Taramasso, and Antonio Di Biagio. "Injectable Antiretroviral Drugs: Back to the Future." Viruses 13, no. 2 (2021): 228. http://dx.doi.org/10.3390/v13020228.

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Current HIV treatment regimens provide sustained virologic suppression, at least partially restore the immune system and have limited side effects; however, they do not allow viral eradication and they are burdened by daily pill intake with a life-long commitment for the people living with HIV (PHIV). Injectable agents might represent a turning point in the care of PHIV, allowing less frequent administration of antiretroviral treatment (ART), more widespread use of pre-exposure prophylaxis (PrEP) and more stable drug levels in the blood, thus increasing the odds to get closer to end the HIV pandemic. The aim of this manuscript is to give a comprehensive review of injectable antiretrovirals that have been used in the past, which are available now, will be available in the future, and their role in the treatment of HIV infection
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Daughtridge, Giffin, Elijah Kahn-Woods, Casper Enghuus, and Shane Hebel. "The Time is Now for Disruptive Innovation in Pre-Exposure Prophylaxis Adherence Monitoring." HIV/AIDS Research and Treatment – Open Journal 7, no. 1 (2020): 5–9. http://dx.doi.org/10.17140/hartoj-7-133.

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Monitoring adherence to pre-exposure prophylaxis is a critical component of reaching ending the human immunodeficiency virus infection (HIV) epidemic goals in the US. Currently, providers still depend on “self-report” pre-exposure prophylaxis (PrEP) adherence, whereby providers ask their patients about their recent pill taking habits. There appears to be growing consensus across the HIV prevention community that “self-report” is an inadequate method of identifying that is in-need of additional adherence support services. In a recent survey, 97% of providers report utilizing self-reported adherence because it is convenient, but only 10% of these providers believe it is accurate. While “self-report” is convenient, evidence and testimonials from diverse stakeholders across the HIV prevention landscape indicate that there is a desire for more accurate, effective adherence monitoring methods. In this mini-review, we will briefly synthesize the emerging evidence and propose a solution to ensure all patients receive the support needed to protect them from HIV acquisition.
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Bachwich, Dale R., James D. Lewis, Vera O. Kowal, Brian C. Jacobson, Audrey H. Calderwood, and Michael L. Kochman. "A Phase 2 Randomized Trial of DCL-101, a Novel Pill-Based Colonoscopy Prep, vs 4L Polyethylene Glycol-Electrolyte Solution." Clinical and Translational Gastroenterology 11, no. 12 (2020): e00264. http://dx.doi.org/10.14309/ctg.0000000000000264.

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MacCarthy, Sarah, Max Izenberg, Joanna L. Barreras, Ron A. Brooks, Ana Gonzalez, and Sebastian Linnemayr. "Rapid mixed-methods assessment of COVID-19 impact on Latinx sexual minority men and Latinx transgender women." PLOS ONE 15, no. 12 (2020): e0244421. http://dx.doi.org/10.1371/journal.pone.0244421.

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We conducted a rapid, mixed-methods assessment to understand how COVID-19 affected Latinx sexual minority men (LSMM) and transgender women (LTGW). Using a computer-assisted telephone interviewing software, one interviewer called 52 participants (randomly sampled from a larger HIV prevention pilot study aiming to increase HIV knowledge and testing frequency; n = 36 LSMM and n = 16 LTGW) between 04/27/20-05/18/20. We quantified core domains using the Epidemic-Pandemic Impacts Inventory scale and provided important context through open-ended qualitative questions assessing: 1) COVID-19 infection history and experiences with quarantine; 2) Health and healthcare access; 3) Employment and economic impact of COVID-19. Participants reported increases in physical conflict or verbal arguments with a partner (13.5%) or other adult(s) (19.2%) due to stressors associated with the safer-at-home order. Participants also reported increased alcohol consumption (23.1%), problems with sleep (67.3%) and mental health (78.4%). Further, disruptions in access to Pre-Exposure Prophylaxis or PrEP–a daily pill to prevent HIV–occurred (33.3% of 18 participants who reported being on PrEP). Many said they received less medical attention than usual (34.6%), and LTGW reported delays in critical gender-affirming hormones/procedures. Half of the participants lost their jobs (50.0%); many undocumented participants relayed additional financial concerns because they did not qualify for financial assistance. Though no COVID-19 infections were noted, COVID-19 dramatically impacted other aspects of health and overall wellbeing of LSMM and LTGW. Public health responses should address the stressors faced by LSMM and LTGW during the COVID-19 pandemic and the impact on wellbeing.
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Agot, Kawango, Douglas Taylor, Amy L. Corneli, et al. "Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials." AIDS and Behavior 19, no. 5 (2014): 743–51. http://dx.doi.org/10.1007/s10461-014-0859-z.

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Dimitrov, D., M. C. Boily, and B. Masse. "O1-S06.02 Impact of pill sharing on drug-resistance and population-level effectiveness of a wide-scale oral PrEP intervention in resource-constrained settings." Sexually Transmitted Infections 87, Suppl 1 (2011): A35. http://dx.doi.org/10.1136/sextrans-2011-050109.32.

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Bachwich, Dale, Vera O. Kowal, Michael L. Kochman, and James D. Lewis. "Results From a Proof of Concept Study Evaluating DCL-101, a Novel Pill Colon Prep, Compared to 4L PEG-ELS in Adult Outpatients Undergoing Routine Colonoscopy." American Journal of Gastroenterology 113, Supplement (2018): S120—S121. http://dx.doi.org/10.14309/00000434-201810001-00205.

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Camp, Christina, and Parya Saberi. "Facilitators and barriers of 2-1-1 HIV pre-exposure prophylaxis." PLOS ONE 16, no. 5 (2021): e0251917. http://dx.doi.org/10.1371/journal.pone.0251917.

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An alternative strategy for men who have sex with men (MSM) experiencing challenges with daily HIV pre-exposure prophylaxis (PrEP) includes 2-1-1 dosing. Understanding 2-1-1 PrEP facilitators and barriers, especially during the SARS-CoV-2 pandemic, may guide researchers and healthcare providers in future studies and clinical preparedness. We conducted a national cross-sectional study of MSM in the US who had taken 2-1-1 PrEP to examine facilitators and barriers of this on-demand PrEP dosing option. With the shelter-in-place orders in March 2020, this study was adapted to include questions on how the SARS-CoV-2 pandemic affected participants’ PrEP use. A total of 140 individuals participated in the survey, 106 of which completed questions pertaining to the SARS-CoV-2 pandemic. The most common reasons for switching from once-daily to 2-1-1 PrEP included having sex less frequently (63.6%) and wanting to take fewer pills (46.4%). Participants reported high medication adherence based on each component of 2-1-1 PrEP dosing (>84%). The most common barriers with 2-1-1 PrEP dosing included unplanned sexual encounters resulting in missing the double-dose pre-sex (43.6%) and trouble remembering doses post-sex (29.3%). Facilitators of the 2-1-1 PrEP dosing strategy included reductions in sexual encounters (63.6%), preference to take fewer pills (46.4%), need to reduce cost (22.1%), and desire to reduce side effects (19.3%). Challenges to receiving PrEP services during the pandemic included obtaining laboratory testing (25.5%) and PrEP refills (either receipt of a refill authorization from a healthcare provider or processing of a refill from the pharmacy) (18.9%). 2-1-1 PrEP is an effective HIV prevention method; therefore, understanding facilitators and barriers of this dosing strategy can result in continuous provision of HIV prevention efforts, particularly during a pandemic.
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Felsher, Marisa, Emmanuel Koku, Stephen Lankenau, Kathleen Brady, Scarlett Bellamy, and Alexis M. Roth. "Motivations for PrEP-Related Interpersonal Communication Among Women Who Inject Drugs: A Qualitative Egocentric Network Study." Qualitative Health Research 31, no. 1 (2020): 86–99. http://dx.doi.org/10.1177/1049732320952740.

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A qualitative egocentric social network approach was taken to explore motivations for pre-exposure prophylaxis (PrEP)-related communication between women who inject drugs and network members. Eligible participants were HIV-negative, 18 years or older, and participating in a PrEP demonstration project in Philadelphia, PA, USA. The study employed content analysis of in-depth interviews to identify themes related to contextual and relational factors impacting PrEP communication within networks. Participants ( n = 20) named on average three network members, resulting in a total of 57 unique relationships. PrEP conversations occurred within 30 of the 57 relationships, and motivations were to benefit others, to benefit themselves, and due to a sense of obligation. Some conversations also occurred when a peer unexpectedly found their pills. Taking a qualitative approach to network analysis provided a nuanced understanding of how interpersonal characteristics motivated PrEP conversations. Network interventions that facilitate information diffusion and social support may increase PrEP uptake and adherence among women who inject drugs.
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Oldenburg, Catherine E., Bao Le, Hoang Thi Huyen, et al. "Antiretroviral pre-exposure prophylaxis preferences among men who have sex with men in Vietnam: results from a nationwide cross-sectional survey." Sexual Health 13, no. 5 (2016): 465. http://dx.doi.org/10.1071/sh15144.

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Background The HIV/AIDS epidemic in Vietnam is concentrated in subgroups of the population, including men who have sex with men (MSM). Pre-exposure prophylaxis (PrEP) is a viable strategy for HIV prevention, but knowledge about and preferences for PrEP delivery among Vietnamese MSM are not well understood. Methods: In 2015, an online survey was conducted with recruitment via social networking websites for MSM and peer recruitment. A description of daily oral, long-acting injectable, and rectal microbicide formulations of PrEP was provided to participants. Participants were asked about their prior awareness of and interest in PrEP, and ranked their most preferred PrEP modality. Multivariable logistic regression models were used to assess factors associated with having heard of PrEP and preference for each PrEP modality. Results: Of 548 participants who answered demographic and PrEP-related questions, 26.8% had previously heard of PrEP and most (65.7%) endorsed rectal microbicides as their most preferred PrEP delivery modality. Commonly-cited perceived barriers to uptake of PrEP included concern about side-effects, perception about being HIV positive, and family or friends finding out about their sexual behaviour. In multivariable models, older participants less often endorsed rectal microbicides (adjusted odds ratio (AOR) 0.95 per year, 95% confidence interval (CI) 0.91–0.99) and more often endorsed long-acting injectables (AOR 1.08 per year, 95% CI 1.03 to 1.14) as their preferred PrEP modality. Participants who were willing to pay more for PrEP less often endorsed rectal microbicides (AOR 0.81, 95% CI 0.72–0.92) and more often endorsed long-acting injectables (AOR 1.17, 95% CI 1.01–1.35) and daily oral pills (AOR 1.16, 95% CI 1.00–1.35) as their preferred form of PrEP. Conclusions: A variety of PrEP modalities were acceptable to MSM in Vietnam, but low knowledge of PrEP may be a barrier to implementation.
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Kimani, Makobu, Elise M. van der Elst, Oscar Chirro, et al. "“I wish to remain HIV negative”: Pre-exposure prophylaxis adherence and persistence in transgender women and men who have sex with men in coastal Kenya." PLOS ONE 16, no. 1 (2021): e0244226. http://dx.doi.org/10.1371/journal.pone.0244226.

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Background Transgender women (TGW) and men who have sex with men (MSM) in sub-Saharan Africa have high HIV acquisition risks and can benefit from daily pre-exposure prophylaxis (PrEP). We assessed PrEP adherence by measuring tenofovir-diphosphate (TFV-DP) levels and explore motives for PrEP persistence in TGW and MSM. Methods Participants were enrolled in a one-year PrEP programme and made quarterly visits irrespective of whether they were still using PrEP. At their month 6 visit, participants provided a dried blood spot to test for TFV-DP levels; protective levels were defined as those compatible with ≥4 pills per week (700–1249 fmol/punch). Before TFV-DP levels were available, a sub-set of these participants were invited for an in-depth interview (IDI). Semi-structured IDI topic guides were used to explore motives to uptake, adhere to, and discontinue PrEP. IDI data were analyzed thematically. Results Fifty-three participants (42 MSM and 11 TGW) were enrolled. At month 6, 11 (20.7%) participants (8 MSM and 3 TGW) were lost to follow up or stopped taking PrEP. Any TFV-DP was detected in 62.5% (5/8) of TGW vs. 14.7% of MSM (5/34, p = 0.01). Protective levels were detected in 37.5% of TGW (3/8), but not in any MSM. Nineteen IDI were conducted with 7 TGW and 9 MSM on PrEP, and 1 TGW and 2 MSM off PrEP. Unplanned or frequent risky sexual risk behaviour were the main motives for PrEP uptake. Among participants on PrEP, TGW had a more complete understanding of the benefits of PrEP. Inconsistent PrEP use was attributed to situational factors. Motives to discontinue PrEP included negative reactions from partners and stigmatizing healthcare services. Conclusion While MSM evinced greater adherence challenges in this PrEP programme, almost 40% of TGW were protected by PrEP. Given high HIV incidences in TGW these findings hold promise for TGW PrEP programming in the region.
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Hornak, J. Patrik. "1318. Are We PrEPared? Awareness and Prescribing Patterns of HIV Pre-Exposure Prophylaxis (PrEP) by Internal Medicine Resident Physicians at an Academic Medical Center." Open Forum Infectious Diseases 5, suppl_1 (2018): S403. http://dx.doi.org/10.1093/ofid/ofy210.1151.

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Abstract Background HIV PrEP uptake remains low by primary care physicians, amongst whom increased awareness has been positively associated with its adoption. Prior studies have also revealed deficits in knowledge and comfort providing PrEP amongst internal medicine (IM) trainees. This is among the first reports of assessing PrEP uptake by IM residents; this appears to be the first examining pre- and post-instruction assessment of prescribing attitudes following a single lecture on the topic. Methods An anonymous, online survey was distributed to all IM residents at our institution to measure baseline PrEP awareness and prescribing patterns. A comprehensive PrEP lecture was formulated with assistance from infectious diseases (ID) faculty; focus was paid to addressing concerns about cost, safety, risk behavior compensation, and drug resistance. The lecture was made available electronically to those unable to attend the live session. PrEP knowledge and prescribing attitudes were measured and compared pre- and post-lecture. Fisher’s exact test was used for descriptive statistics. Results Of 97 initial surveys distributed, 41 were completed. A majority of respondents were aware of PrEP (68%). A modest number had either prescribed PrEP or referred a prospective patient to an ID specialist in the prior year (15%). The majority preferred to learn about PrEP with a dedicated didactic session (76%). Compared with baseline data, following the lecture, residents were better able to identify both the number of daily pills required (100% vs. 49%, P = 0.007) and the proper medication regimen (100% vs. 49%, P = 0.007); there was no significant difference in self-reported comfort with providing PrEP (89 vs. 65%, P = 0.25). In the post-lecture survey, nearly half reported a preference to refer a PrEP candidate to an ID specialist or PrEP clinic (43%). Conclusion These findings suggest value in providing PrEP education to IM trainees, but indicate that a single lecture may not be effective for ultimately improving its adoption by this important group of physicians. Determining the optimal method for incorporating PrEP into residency curricula deserves further study. Despite efforts to expand PrEP into the realm of primary care, many of these physicians may continue to defer management of these patients to ID/HIV clinicians. Disclosures All authors: No reported disclosures.
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Phanuphak, Nittaya, Thanthip Sungsing, Jureeporn Jantarapakde, et al. "Princess PrEP program: the first key population-led model to deliver pre-exposure prophylaxis to key populations by key populations in Thailand." Sexual Health 15, no. 6 (2018): 542. http://dx.doi.org/10.1071/sh18065.

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Background No data are available on the feasibility of pre-exposure prophylaxis (PrEP) delivered by trained key population (KP) community health workers. Herein we report data from the KP-led Princess PrEP program serving men who have sex with men (MSM) and transgender women (TGW) in Thailand. Methods: From January 2016 to December 2017, trained MSM and TGW community health workers delivered same-day PrEP service in community health centres, allowing clients to receive one PrEP bottle to start on the day of HIV-negative testing. Visits were scheduled at Months 1 and 3, and every 3 months thereafter. Uptake, retention and adherence to PrEP services and changes in risk behaviours over time are reported. Results: Of 1467 MSM and 230 TGW who started PrEP, 44.1% had had condomless sex in the past 3 months. At Months 1, 3, 6, 9 and 12, retention was 74.2%, 64.0%, 56.2%, 46.7% and 43.9% respectively (lower in TGW than MSM at all visits; P<0.001), with adherence to at least four PrEP pills per week self-reported by 97.4%, 96.8%, 96.5%, 97.5% and 99.5% of respondents respectively (no difference between MSM and TGW). Logistic regression analysis identified age >25 years, being MSM and having at least a Bachelors degree significantly increased retention. Condomless sex did not change over the 12-month period (from 47.2% to 45.2%; P=0.20). New syphilis was diagnosed in 4.9% and 3.0% of PrEP clients at Months 6 and 12 (cf. 7.0% at baseline; P=0.007). Among PrEP adherers and non-adherers, there were one and six HIV cases of seroconversion respectively, which resulted in corresponding HIV incidence rates (95% confidence interval) of 0.27 (0.04–1.90) and 1.36 (0.61–3.02) per 100 person-years. Conclusion: Our KP-led PrEP program successfully delivered PrEP to MSM and TGW. Innovative retention supports are needed, especially for TGW and those who are young or with lower education levels. To scale-up and sustain KP-led PrEP programs, strong endorsement from international and national guidelines is necessary.
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Kaewpoowat, Quanhathai, Pongpun Saokhieo, Radchanok Songsupa, Taweewat Supindham, and Suwat Chariyalertsak. "1285. PrEP Acceptability, Uptake, and Adherence Among Young Men Who Have Sex with Men and Transgender Women in PrEP Demonstration Project, Chiang Mai, Thailand." Open Forum Infectious Diseases 6, Supplement_2 (2019): S462—S463. http://dx.doi.org/10.1093/ofid/ofz360.1148.

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Abstract Background Young men who have sex with men (YMSM) and transgender women (YTGW) are at high risk for HIV acquisition. In attempt to end the HIV epidemic, the comprehensive HIV prevention packages should be offered. However, the PrEP persistent among this population in western studies was low. The acceptability, uptake and persistent among Thai YMSM/YTGW PrEP clients were explored. Methods This is a sub-study of PrEP implementation project in Chiang Mai Thailand which was conducted during December 2015–February 2017. In the main study, PrEP@PIMAN, 105 participants who were 18 years and older, able to read and write in Thai, creatinine clearance ≥60 mL/minute, negative urine protein, and HBs-Ag-negative YMSM/YTGW were enrolled. Twelve months of PrEP along with quarterly visit and comprehensive HIV prevention package were offered. The data were collected through interview and computer-assisted self-interview. Each participant voluntary made their own decision about PrEP uptake. Results Sixty participants (57% of the main study) were youth, aged 16–24 years old. Of those, 82% were gay men and 12% were TGW (self-identified). Mean age was 21 years old and 80% were university/college students. At baseline, median partner in past 3 month was 3 (range 0–52). Approximately one-fourth of the participants reported history of sexually transmitted diseases (STDs) and 8% has positive TPHA at baseline. Majority (72%) initiated PrEP with 70% at the enrollment 2% during the study. PrEP was discontinued in 25% (10/42) due to nonserious side effects, participant preference or lost to follow-up (see Figure 1). The retention rate at 12 month were 70%. PrEP use was not consistent (see Figure 2). Only 30% reported adherence ≥60% (or equivalent to ≥4 pills/ week) throughout the study period. There was no seroconversion during 49 person-year of follow-up with 5 confirmed new STDs (incidence of 10/100 person-year). Conclusion This project demonstrated a good uptake with varying PrEP adherence rate among Thai YMSM and YTGW. The PrEP persistent was persistence could be improved. Further interventions and strategies should be explored to enhance PrEP adherence among this population. Disclosures All authors: No reported disclosures.
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Singhal, Vibha, Kathryn E. Ackerman, Amita Bose, Landy Paola Torre Flores, Hang Lee, and Madhusmita Misra. "Impact of Route of Estrogen Administration on Bone Turnover Markers in Oligoamenorrheic Athletes and Its Mediators." Journal of Clinical Endocrinology & Metabolism 104, no. 5 (2018): 1449–58. http://dx.doi.org/10.1210/jc.2018-02143.

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Abstract Objective Transdermal, but not oral, estrogen replacement improves bone mineral density (BMD) in athletes with oligoamenorrhea (OA). Our objective was to determine mechanisms that may explain the impact of route of estrogen administration on bone outcomes. Methods Seventy-three participants with OA between 14 and 25 years old received (i) a 17β-estradiol transdermal patch continuously with cyclic oral micronized progesterone (PATCH), (ii) a combined ethinyl estradiol and desogestrel pill (PILL), or (iii) no estrogen/progesterone (NONE) for 12 months. We evaluated morning fasting levels of a marker of bone formation [N-terminal propeptide of type 1 procollagen (P1NP)], a marker of bone resorption (N-telopeptide), IGF-1, insulinlike growth factor binding protein 3, total testosterone, estradiol, SHBG, sclerostin, preadipocyte factor-1 (Pref-1), brain-derived neurotrophic factor (BDNF), calcium, 25(OH) vitamin D, and PTH levels at baseline and 12 months. Results Groups did not differ for age, weight, exercise activity, or markers of bone formation at baseline. Over 12 months, P1NP decreased the most in the PILL group (P = 0.03) associated with a decrease in IGF-1 levels (r = 0.37; P = 0.003). Sclerostin, Pref-1, and BDNF decreased in the PATCH group over 12 months. PATCH had the greatest increases in estradiol (P ≤ 0.0001), and estradiol increases were associated with increases in bone density. Conclusion Transdermal 17β-estradiol given over 12 months does not cause the decrease in IGF-1 observed with oral ethinyl estradiol. It also leads to decreases in sclerostin, Pref-1, and BDNF, which may mediate the beneficial effects of estrogen.
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Delgado-Poust, Antonia L. "engaño de la piel: la transmutación alquímica del sujeto transexual en "La piel que habito"." Pasavento. Revista de Estudios Hispánicos 8, no. 1 (2020): 237–58. http://dx.doi.org/10.37536/preh.2020.8.1.699.

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El presente artículo considera el proceso creativo y transformativo por el que pasa el protagonista transexual de La piel que habito (2011) y lo equipara al proceso antiguo de la alquimia, pues ambos tienen como objetivo el perfeccionamiento, la imitación y la adulteración, o falsificación, de la naturaleza. El propósito principal del ensayo, aparte de delinear los elementos alquímicos presentes en el filme, es explorar la (con)fusión de ciertos binarios, como lo auténtico y lo artificial, lo masculino y lo femenino y el Yo y el Otro. Se plantea que, como en la alquimia, Almodóvar presenta a la figura del transexual –o del hermafrodita– como el ser perfecto, o la Piedra Filosofal, ya que encarna tanto lo femenino como lo masculino en un solo cuerpo. Además, a semejanza del oro alquímico y de las obras de arte, se propone que el protagonista, Vicente/Vera, representa una copia más perfecta de su referente original, lo cual subraya su nebulosa autenticidad existencial. Al final de este estudio, se establece un vínculo entre la transformación física y ontológica de Vicente/Vera y la mise-en-scène que este realiza para poder sobrevivir. Se concluye que el carácter transformativo e ilusorio de lo teatral concuerda con el aspecto experimental y artificioso de la alquimia.
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Ugachi, Hirokazu, Yoshiyuki Kaji, Yoshinori Matsui, et al. "ICONE15-10293 Development of in-pile SCC test technique and crack initiation behavior using pre-irradiated austenitic stainless steel at JMTR." Proceedings of the International Conference on Nuclear Engineering (ICONE) 2007.15 (2007): _ICONE1510. http://dx.doi.org/10.1299/jsmeicone.2007.15._icone1510_148.

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Tayukin, G. I., V. V. Fursov, and M. V. Balura. "SEASONAL SOIL FREEZING IMPACT ON FOUNDATIONS OF BUILDINGS (LIQUEFIED HYDROCARBON DEPOT TERMINAL)." Vestnik Tomskogo gosudarstvennogo arkhitekturno-stroitel'nogo universiteta. JOURNAL of Construction and Architecture, no. 6 (December 29, 2019): 186–98. http://dx.doi.org/10.31675/1607-1859-2019-21-6-186-198.

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The paper presents the analysis of the influence of seasonal freezing and thawing of clay soils on structural deformation. Studies are performed at the construction site of liquefied hy-drocarbon depot terminal. Additional surveys are carried out after the winter construction peri-od. In autumn and winter, loam was frozen at the base of the foundations. In spring and sum-mer, pit soils were soaked with meltand storm-water. On the pit walls erosion developed tie-in flows of meltwater at the bottom of the pit, which led to significant deviations from the de-sign position of the erected depot foundations, which were dismantled, and the concrete prepa-ration for retaining walls was destroyed almost everywhere. The study shows that the subsidence properties of loams degrade after soaking. It is there-fore unnecessary to reduce drawdown of designed and partially executed expensive measures. Initially, under the ground horizontal depots and retaining walls pile foundations are con-structed. Finally, foundations are erected in open pits with a depth of 4.0–5.8 m of monolithic reinforced concrete on a natural base. For the latter option, the project requires a large amount of excavation works at the open pit with a volume of about 10 thousand cubic meters and re-placing them by the same volume of compacted coarse-grained marble sand and gravel. It is shown that the most efficient and reliable option are pile foundations with a high grillage and also effective anti-rubble measures developed in TSUAB. In the pile variant, it is proposed to use piles 8 and 9 m long with a permissible load of 250 kN and 260 kN, respectively. The de-veloped proposals can be applied in the construction of the 2nd stage of the depot terminal.
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Franco, Robert. "“Seropedagogy”." Radical History Review 2021, no. 140 (2021): 9–20. http://dx.doi.org/10.1215/01636545-8841658.

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Abstract Since the beginnings of the HIV/AIDS pandemic, pedagogy has been a crucial survival strategy, especially when government agencies failed to prevent mass deaths. However, contemporary sex education on HIV/AIDS—if taught to undergraduates before they arrive on campus—often does not account for the disproportionate effects of the pandemic on racial minorities and global South countries. In this teaching essay, the author describes how his course on the history of HIV/AIDS takes a global approach to highlight that the AIDS crisis is not over. Starting with histories of HIV/AIDS in the United States, Haiti, China, and elsewhere that sought to find a scapegoat for the pandemic, the course then turns to the global power of the pharmaceutical industry. It examines the marketing and lobbying strategies of companies such as Gilead, which use the stigma of HIV/AIDS to transform impoverished global South countries into new markets for research and capital extraction. Finally, it also highlights how the AIDS crisis remains an ongoing struggle against racial disparities in health care that prevent access to life-saving treatments and preventative drugs such as Truvada and Descovy for pre-exposure prophylaxis (PrEP). Using a range of materials from podcasts to pills, the author introduces students to the globalizing forces that take the bodies of the poor, women, and Black, Latinx, trans, and global South citizens as expendable in the fight against HIV/AIDS.
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Felzien, Gregory S., Sean J. McIntosh, Ekaterina S. Taneva, et al. "784. Do Patients and Healthcare Professionals See Eye-to-Eye on the Usefulness of Strategies for Promoting HIV Care?" Open Forum Infectious Diseases 6, Supplement_2 (2019): S347—S348. http://dx.doi.org/10.1093/ofid/ofz360.852.

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Abstract Background Many studies have identified barriers to achieving goals for HIV care, thereby informing various intervention strategies. However, whether a given strategy can effectively overcome key barriers may depend on the extent to which patients and healthcare professionals (HCPs) agree that it is useful. To address this gap, we conducted a survey study to compare patients’ and HCPs’ perceptions of strategies for promoting HIV prevention, medication adherence, and care retention. Methods The survey was administered to patients and their HCPs as part of collaborative educational programs held in 12 community clinics in urban and suburban areas across 6 southeastern states. Participants included each clinic’s staff and their patients living with or at risk for HIV infection. The surveys listed 12 strategies for overcoming barriers to HIV prevention, adherence, and retention. Patients and HCPs rated the extent to which each strategy would be helpful for achieving desired goals (scale: 1 = very unhelpful to 5 = very helpful). We conducted χ 2 or Fisher’s exact tests to assess between-group differences in the frequency of pooled ratings of 4 (helpful) and 5 (very helpful). Results Surveys were completed by 224 patients (69% with HIV diagnosis, mean age 47 years, 42% women, 75% African American) and 39 HCPs (42% health educators/counselors, 31% nurse practitioners, 24% social workers, 3% physicians). Among other findings (Figures 1–3), similar percentages of patients and HCPs, respectively, gave ratings of 4 or 5 for taking pills (PrEP) that prevent HIV (83%, 80%); using a smartphone app with medication reminders (78%, 74%); and making it easier to get clinic appointments (90%, 85%). More discordant perceptions, all reflecting lower percentages of 4 or 5 ratings among patients than HCPs, were evident for talking with a counselor (82%, 90%); getting support from friends and family (82%, 92%); and improving relationships with clinic staff (85%, 100%). Conclusion These findings may inform interventions that are perceived by both patients and HCPs to be helpful for promoting HIV prevention, medication adherence, and retention. Effective interventions must address any discordance between patients and HCPs in the usefulness of selected strategies. Disclosures All authors: No reported disclosures.
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Bjertrup, Pia Juul, Nqobile Mmema, Velibanti Dlamini, et al. "PrEP reminds me that I am the one to take responsibility of my life: a qualitative study exploring experiences of and attitudes towards pre-exposure prophylaxis use by women in Eswatini." BMC Public Health 21, no. 1 (2021). http://dx.doi.org/10.1186/s12889-021-10766-0.

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Abstract Background Pre-exposure-prophylaxis (PrEP) has been heralded for its potential to put women in control of preventing HIV infection, but uptake and continuation rates have been disappointing in high-incidence settings in sub-Saharan Africa. We explored structural and social factors that influenced PrEP use among young women and pregnant or breastfeeding women in rural Eswatini. Methods We conducted two in-depth interviews with ten women on PrEP, and one-time in-depth interviews with fourteen women who declined or discontinued PrEP. Interviews covered decision-making processes around PrEP initiation and experiences with pill-taking. In-depth interviews were conducted with nine health workers, covering experiences in delivering PrEP services, and two focus group discussions were held with men to elicit their perceptions of PrEP. Interviews and discussions were audio-recorded, translated, transcribed and analysed thematically, using an inductive approach. Results PrEP initiation and use were experienced by many women as empowering them to take control of their health and well-being, and stay HIV free, facilitating them to realise their aspirations relating to motherhood and educational attainment. However, the social norms that defined relationship dynamics with partners or family members either undermined or promoted this empowerment potential. In particular, young women were rarely supported by family members to take PrEP unless it was perceived to be for protecting an unborn child. Stigmatisation of pill-taking through its associations with HIV and the burden of daily pill-taking also contributed to PrEP discontinuation. Conclusions Unlike many prevention tools, PrEP enabled women to achieve a sense of control over their lives. Nevertheless, women’s agency to continue and adhere to PrEP was influenced by social and structural factors including gender norms, family expectations of young women, relationship dynamics and stigma related to HIV. Future interventions should address these barriers to promote PrEP use among sexually-active women.
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Goldwirt, Lauriane, Rebecca Bauer, Geoffroy Liegeon, et al. "Estimated pill intake with on-demand PrEP with oral TDF/FTC using TFV-DP concentration in dried blood spots in the ANRS IPERGAY trial." Journal of Antimicrobial Chemotherapy, July 19, 2021. http://dx.doi.org/10.1093/jac/dkab253.

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Abstract Background Tenofovir diphosphate (TFV-DP) concentration in dried blood spots (DBSs) is a reliable pharmacokinetics biomarker of adherence to tenofovir disoproxil fumarate (TDF). We aimed to use DBSs to estimate pill intake among participants using on-demand pre-exposure prophylaxis (PrEP) and to identify predictive factors associated with higher TFV-DP concentrations. Methods DBSs were collected at the last study visit of the open-label phase of the ANRS IPERGAY study, assessing on-demand oral TDF/emtricitabine for PrEP among MSM and transgender female participants. We quantified TFV-DP in DBSs centrally. We assessed correlation between pill count and TFV-DP concentration by Spearman correlation and explored associations between participant demographics, sexual behaviour and PrEP use during sexual intercourse (SI) with TFV-DP concentrations by univariate and multivariate logistic regression models. Results The median age of the 245 participants included in this study was 40 years, with a median body weight of 73 kg. Median (IQR) TFV-DP concentration reached 517 (128–868) fmol/punch, corresponding to an estimated intake of 8–12 tablets per month (2–3 doses per week). Only 39% of participants had a TFV-DP concentration above 700 fmol/punch. TFV-DP concentrations were moderately correlated with pill count (r: 0.59; P < 0.001). In multivariate analysis, only systematic use of PrEP during SI and more frequent episodes of SI in the past 4 weeks were significantly associated with higher TFV-DP levels [OR (95% CI): 11.30 (3.62–35.33) and 1.46 (1.19–1.79), respectively; P < 0.001]. Conclusions Among participants using on-demand PrEP, estimated pill intake reached 8–12 tablets per month and was correlated with frequency and systematic use of PrEP for SI.
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Begg, Lorna, Rebecca Brodsky, Barbara Friedland, Sanyukta Mathur, Jim Sailer, and George Creasy. "Estimating the market size for a dual prevention pill: adding contraception to pre-exposure prophylaxis (PrEP) to increase uptake." BMJ Sexual & Reproductive Health, July 31, 2020, bmjsrh—2020–200662. http://dx.doi.org/10.1136/bmjsrh-2020-200662.

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IntroductionUptake of oral pre-exposure prophylaxis (PrEP) remains low. The objective of this analysis was to estimate the potential market size in priority sub-Saharan African countries for a 28-day dual prevention pill (DPP) regimen containing the active pharmaceutical ingredients in oral PrEP and oral contraceptive pills (OCPs) for the prevention of HIV and unintended pregnancy.MethodsWe selected 15 countries in sub-Saharan Africa for analysis. Population estimates were based on United Nations Population Division data from 2017. Low, medium and high rates (range 0.25% to 25%) of estimated conversion from current contraceptive method to the DPP were applied by country based on HIV prevalence (≥10% vs <10%), current contraceptive method (OCP, condom or unmet need for contraception) and age group (15–24 or 25–49 years).ResultsIn these 15 countries, between 250 000 and 1.25 million women could switch from their current contraceptive method to the DPP. Given that current PrEP use in the 15 countries combined is estimated to be 113 250 (women and men), the most conservative market size estimate would more than double the number of women currently using PrEP.ConclusionsBy leveraging the existing market for OCPs and assuming modest conversion from condom users and women with an unmet need for contraception, the DPP could lead to a 2- to 10-fold increase in PrEP usage in these 15 sub-Saharan African countries, expanding the broader public health benefit of this proven HIV prevention strategy.
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Okeke, Nwora Lance, Tony McLaurin, Ruth Gilliam-Phillips, et al. "Awareness and acceptability of HIV pre-exposure prophylaxis (PrEP) among students at two historically Black universities (HBCU): a cross-sectional survey." BMC Public Health 21, no. 1 (2021). http://dx.doi.org/10.1186/s12889-021-10996-2.

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Abstract Background Despite young African American adults (ages 18–24) being among the highest risk groups for HIV infection, little is known about their awareness of HIV pre-exposure prophylaxis (PrEP) – a once daily pill shown to be > 90% effective in preventing HIV. To explore awareness and acceptability of PrEP among college students in this demographic, we conducted a survey of attendees at two large historically Black universities (HBCU) in North Carolina. Methods We administered a 14-item questionnaire to students at two HBCUs in North Carolina between February and April 2018. Questions were formatted in a yes/no or multiple choice format. Questionnaire items specifically addressed PrEP awareness and acceptability. Surveys were administered to students at a campus health fair and while transiting the campus student union via iPad. Response to all questions was optional. We fit a logistic regression model to determine association of key demographic determinants with PrEP acceptability and awareness. Statistical analyses were conducted using SAS 9.4 (SAS, Cary, NC). Results Overall, 210 students participated in the survey, of which 60 completed all survey items as presented. The survey cohort was 75% female, 89% heterosexual and 39% freshmen. The mean age of respondents was 19.8 years (SD: 1.8). Fifty-two percent of survey respondents reported that they were aware of PrEP prior to the time of survey administration. Only 3% of respondents reported that they were on PrEP. The most common sources of information on PrEP were campus health services (24%) and non-social media advertising (15%). Of respondents who were aware of PrEP, 61% reported that they had heard about in the 6 months prior to survey administration, while only 19% say they were aware of it for more than a year. Regarding acceptability of PrEP, 58% of respondents reported that they would take a once a day pill for HIV if they were at risk. Our logistic regression analysis found no statistically significant associations between key demographic factors and PrEP awareness. However, persons who perceived themselves to be at risk for HIV acquisition were more likely to find once daily oral PrEP (relative risk 2.66 (95% CI 1.31–5.42)) as an acceptable prevention strategy than the rest of the survey cohort. Conclusions African American HBCU students are becoming aware of PrEP, and generally perceive the intervention as acceptable and worth consideration.
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Pasipanodya, Elizabeth C., Jamila Stockman, Thupten Phuntsog, et al. "“PrEP”ing for a PrEP demonstration project: understanding PrEP knowledge and attitudes among cisgender women." BMC Women's Health 21, no. 1 (2021). http://dx.doi.org/10.1186/s12905-021-01348-8.

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Abstract Background Prior to implementing a pre-exposure prophylaxis (PrEP) demonstration study, we sought to explore cisgender women’s experiences with HIV prevention, PrEP knowledge and attitudes, and anticipated barriers and facilitators for PrEP uptake and adherence in Southern California. Methods Three focus groups were held with cisgender women of mixed HIV serostatus in San Diego and Los Angeles between November 2015 and January 2016. Women were recruited through local testing sites, community-based organizations, and social media. Focus groups were audio-recorded and transcripts were analyzed using thematic analysis. Results Twenty-two women participated in focus groups, with median age 44 (IQR 30–53) and 6 identifying as non-Hispanic Black, 7 non-Hispanic White, 8 Latina and 1 mixed race. Despite limited prior PrEP knowledge and no PrEP experience, participants expressed interest in taking PrEP. Anticipated benefits were freedom from worry about HIV and control over sexual health; however, these were tempered by concerns including the possibility of increased HIV risk behaviors and potential side effects. Cisgender women reported potential barriers to PrEP uptake and adherence barriers, like competing priorities and poor PrEP access. Conversely, PrEP facilitators included utilizing practical tools such as phone apps and pill boxes as well as receiving encouragement from loved ones and support from other cisgender women on PrEP, women living with HIV and their medical providers. Conclusions Although PrEP awareness was low, participants recognized the importance of PrEP and ways to facilitate adherence. Exploring perspectives of cisgender women is integral to developing effective interventions to support PrEP uptake and adherence for women at elevated risk for HIV.
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Nguyen, Long Hoang, Huong Lan Thi Nguyen, Bach Xuan Tran, et al. "A qualitative assessment in acceptability and barriers to use pre-exposure prophylaxis (PrEP) among men who have sex with men: implications for service delivery in Vietnam." BMC Infectious Diseases 21, no. 1 (2021). http://dx.doi.org/10.1186/s12879-021-06178-5.

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Abstract Background HIV Pre-exposure prophylaxis (PrEP) is being considered for implementation among MSM nationwide in Vietnam. However, there may be concerns about potential obstacles for PrEP adherence among Vietnamese MSM. This study aims to assess the acceptability to use PrEP, potential barriers and facilitators, and the preferences for PrEP service accessibility and delivery among Vietnamese MSM. Methods Four focus group discussions (FGDs) were conducted with 30 HIV-negative MSM in January 2018 in Hanoi, Vietnam. FGDs explored MSM’s awareness regarding PrEP, perceived benefits and barriers of PrEP use, and willingness to use PrEP. FGDs were audio-recorded and transcribed verbatim. Content analysis was used. Results The mean age of participants was 23.9 years old. Most participants realized the advantages of PrEP given its efficacy in HIV risk reduction and expressed high motivation and interest to use PrEP in the future. PrEP was considered as a supplement alongside condoms. Common concerns about PrEP included side-effects, forgetting to take the pill daily, stigmatization due to using PrEP, negative attitudes toward PrEP from other MSM and accessibility of PrEP. Participants would prefer an injectable PrEP regime if available as it was seen as easier to adhere to. Concerns were also raised that PrEP usage could be interpreted as an indication of engaging in sexual risk behavior for HIV, potentially causing suspicion in love relationships or by family and friends. Participants preferred to receive PrEP in civil business organizations and MSM-friendly clinics, and recommended that pharmacy stores would not be suitable for PrEP implementation due to lack of trust and fear of fake drugs. Conclusion This study indicated a high level of willingness to use PrEP among MSM in Vietnam in combination with condom. Strategies to raise awareness of PrEP, reduce stigma towards PrEP, and improve the accessibility among MSM in Vietnam is needed. Existing MSM-friendly clinics were recommended to implement PrEP programs in Vietnam.
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Friedland, Barbara A., Sanyukta Mathur, and Lisa B. Haddad. "The Promise of the Dual Prevention Pill: A Framework for Development and Introduction." Frontiers in Reproductive Health 3 (June 23, 2021). http://dx.doi.org/10.3389/frph.2021.682689.

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Women of reproductive age need multipurpose prevention technology (MPT) products to address two overlapping health risks: unintended pregnancy and HIV. Currently, condoms are the only available MPT, however male condoms are not within the control of a woman, and the use of female condoms has been limited by low acceptability and cost. Oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, yet uptake and adherence among women have been low to date. Women globally need more options for HIV and pregnancy prevention. Several MPTs for simultaneous HIV and pregnancy prevention are in various stages of development and clinical testing, although most are many years away from market launch. A dual prevention pill (DPP), a daily oral pill combining oral contraceptives and PrEP, both of which are licensed, approved products in many low- and middle-income countries (LMIC), is likely to be the fastest route to getting an MPT product into the hands of women. The DPP is one option that could enhance method choice, particularly for women who are already using oral contraceptives. By leveraging the oral contraceptive market and reaching women currently using condoms or with an unmet need for contraception, the DPP has the potential to increase the uptake of PrEP. The successful rollout of the DPP will require careful consideration of user-, provider-, and product-centered factors during product development and introduction. Early attention to these interrelated factors can help ensure that the DPP has the ideal characteristics for maximum product acceptability, that effective and quality services are designed and implemented, and that users can make informed choices, demand the product, and use it effectively. The proposed framework outlines key considerations for the effective development and introduction of the DPP, which could also facilitate integration models for future MPTs.
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Kasaro, Margaret Phiri, Ntazana Sindano, Manze Chinyama, et al. "Integration of HIV Prevention With Sexual and Reproductive Health Services: Evidence for Contraceptive Options and HIV Outcomes Study Experience of Integrating Oral Pre-exposure HIV Prophylaxis in Family Planning Services in Lusaka, Zambia." Frontiers in Reproductive Health 3 (July 13, 2021). http://dx.doi.org/10.3389/frph.2021.684717.

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The WHO guideline on the integration of family planning (FP) and pre-exposure HIV prophylaxis (PrEP) to enhance the health of women and adolescent girls is reflected in the Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection, 2020. There is however a dearth of data on the integration of PrEP and FP in Zambia. We describe the integration of oral PrEP in FP services using the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study experience at Kamwala District Health Center in Lusaka, Zambia. The provision of oral PrEP at Kamwala started in October 2017, lasting for ~11 months, and utilized the model where initial processes to offer PrEP were on-site followed by off-site referral to laboratory and PrEP provider services. The characteristics of 658 women who enrolled in ECHO at Kamwala are representative of women accessing FP services in Lusaka. About 644 of the enrollees were offered oral PrEP. The proportion of women accepting PrEP was low at 1.08% and the proportion of study visits at which PrEP was requested was also low at 0.57%. Those who accepted PrEP were above 20 years old, married, with at least primary education, sexual behavior, and risk comparable to decliners. The ECHO study experience indicates that the setup and integration of oral PrEP and FP services are feasible in the setting. However, uptake of PrEP was very low. Possible contributory factors were as follows: (1) timing of introduction of PrEP midway in the study, (2) PrEP being a new intervention, (3) challenges of autonomy of young women to include a daily pill into their lives and anticipated challenges to adherence because of fear of adverse events, (4) possible underdetermined risk due to use of an unvalidated risk assessment tool and assessment by health care provider vs. self-assessment, and (5) extra layer of challenges to negotiate due to needing for off-site referrals. Following these findings, we conclude that further research through demonstration projects of integration of oral PrEP and FP may provide solutions to low uptake. This information is critical for scaling up of integration HIV prevention services and sexual and reproductive health (SRH) services.
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O'Malley, Gabrielle, Kristin M. Beima-Sofie, Stephanie D. Roche, et al. "Health Care Providers as Agents of Change: Integrating PrEP With Other Sexual and Reproductive Health Services for Adolescent Girls and Young Women." Frontiers in Reproductive Health 3 (May 28, 2021). http://dx.doi.org/10.3389/frph.2021.668672.

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Background: Successful integration of pre-exposure prophylaxis (PrEP) with existing reproductive health services will require iterative learning and adaptation. The interaction between the problem-solving required to implement new interventions and health worker motivation has been well-described in the public health literature. This study describes structural and motivational challenges faced by health care providers delivering PrEP to adolescent girls and young women (AGYW) alongside other SRH services, and the strategies used to overcome them.Methods: We conducted in-depth interviews (IDIs) and focus group discussions (FGDs) with HCWs from two demonstration projects delivering PrEP to AGYW alongside other SRH services. The Prevention Options for the Women Evaluation Research (POWER) is an open label PrEP study with a focus on learning about PrEP delivery in Kenyan and South African family planning, youth mobile services, and public clinics at six facilities. PrIYA focused on PrEP delivery to AGYW via maternal and child health (MCH) and family planning (FP) clinics in Kenya across 37 facilities. IDIs and FGDs were transcribed verbatim and analyzed using a combination of inductive and deductive methods.Results: We conducted IDIs with 36 participants and 8 FGDs with 50 participants. HCW described a dynamic process of operationalizing PrEP delivery to better respond to patient needs, including modifying patient flow, pill packaging, and counseling. HCWs believed the biggest challenge to sustained integration and scaling of PrEP for AGYW would be lack of health care worker motivation, primarily due to a misalignment of personal and professional values and expectations. HCWs frequently described concerns of PrEP provision being seen as condoning or promoting unprotected sex among young unmarried, sexually active women. Persuasive techniques used to overcome these reservations included emphasizing the social realities of HIV risk, health care worker professional identities, and vocational commitments to keeping young women healthy.Conclusion: Sustained scale-up of PrEP will require HCWs to value and prioritize its incorporation into daily practice. As with the provision of other SRH services, HCWs may have moral reservations about providing PrEP to AGYW. Strategies that strengthen alignment of HCW personal values with professional goals will be important for strengthening motivation to overcome delivery challenges.
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Chai, Peter R., Yassir Mohamed, Georgia Goodman, et al. "Development of a digital pill and respondent behavioral intervention (PrEPSteps) for HIV pre-exposure prophylaxis adherence among stimulant using men who have sex with men." Translational Behavioral Medicine, August 28, 2021. http://dx.doi.org/10.1093/tbm/ibab117.

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Abstract The efficacy of pre-exposure prophylaxis (PrEP) for HIV prevention in men who have sex with men (MSM) is contingent upon consistent adherence. Digital pill systems (DPS) provide real-time, objective measurement of ingestions and can inform behavioral adherence interventions. Qualitative feedback was solicited from MSM who use stimulants to optimize a cognitive behavioral therapy (CBT)-based intervention (LifeSteps), used in conjunction with a DPS, to promote PrEP adherence (PrEPSteps). Seven focus groups and one individual qualitative interview were conducted in Boston, MA with cisgender, HIV-negative MSM who reported stimulant use and current PrEP use or interest. Focus groups and interviews explored reactions to the DPS and PrEPSteps messaging components: contingent reinforcement (CR), corrective feedback (CF), LifeSteps, and substance use Screening, Brief Intervention, and Referral to Treatment (SBIRT). Quantitative assessments were administered. Qualitative data were analyzed using applied thematic analysis. Twenty MSM participated. Most were White (N = 12), identified as homosexual or gay (N = 15), and college-educated (N = 15). Ages ranged from 24 to 68 years (median 35.5). Participants were willing to engage with the DPS and viewed it as beneficial for promoting adherence. Confirmatory CR messages were deemed acceptable, and a neutral tone was preferred. CF messages were viewed as most helpful and as promoting individual responsibility. LifeSteps was perceived as useful for contextualizing nonadherence. However, SBIRT was a barrier to DPS use; concerns around potential substance use stigma were reported. MSM who use stimulants were accepting of the DPS and PrEPSteps intervention. CR, CF, and LifeSteps messages were viewed as helpful, with modifications pertaining to tone and content; SBIRT messages were not preferred.
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Dimitrov, Dobromir. "Impact of Pill Sharing on Drug Resistance Due to a Wide-Scale Oral Prep Intervention in Generalized Epidemics." Journal of AIDS & Clinical Research 01, S5 (2013). http://dx.doi.org/10.4172/2155-6113.s5-004.

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