Use Of Oral Pre-exposure Prophylaxis Research Articles

HIV pre-exposure prophylaxis programmatic preferences among people who inject drugs: findings from a discrete choice experiment.

Pre-exposure prophylaxis (PrEP) holds promise for decreasing new HIV infections among people who inject drugs (PWID), yet daily oral PrEP use is low, and PrEP modality and delivery strategy preferences in this population remain understudied. From May 2022-June 2023, we conducted a discrete choice experiment (DCE) with PWID in San Diego, California. Participants viewed 18 PrEP program scenarios in sets of three and chose their preferred scenario within each set. Scenarios consisted of various combinations of five characteristics: PrEP modality (injectable, implantable, oral), frequency of use (annual, bi-monthly, daily), service location (community-based organization, clinic, telemedicine), prescription access location (on-site, street outreach, mail), and adherence supports (social support, outreach worker, phone/text reminder). Multinomial logit regression estimated probabilities of choosing PrEP program scenarios as a function of the five characteristics to estimate part-worth utility scores (PWUS; reflecting relative preferences for specific characteristic values) and relative importance scores (RIS; reflecting the relative influence of each characteristic on program choice). We also explored differences by hypothesized modifiers of preferences (i.e., sex assigned at birth, housing status, injection frequency, prior PrEP awareness). Among 262 participants, mean age was 43.1 years, and most reported male sex assigned at birth (69.5%), identified as non-Hispanic (60.3%), and were previously unaware of PrEP (75.2%). Frequency of use (RIS: 51.5) and PrEP modality (RIS: 35.3) had the greatest influence on PrEP program choice. Within these characteristics, participants had relative preferences for annual use (PWUS: 0.83) and oral PrEP (PWUS: 0.57), and relative aversions to daily use (PWUS: -0.76) and implantable PrEP (PWUS: -0.53). Generally, participants did not indicate preferences for specific service or prescription access locations, or adherence supports; however, among those with prior PrEP awareness, prescription access location and adherence supports had a slightly greater influence on PrEP program choices. Our study considered diverse PrEP scenarios and highlighted potential preferences for long-acting oral modalities. Although not currently available, renewed investment in long-acting oral PrEP formulations may facilitate PrEP care engagement among PWID. Additional delivery and implementation strategy research is needed to support PrEP uptake and persistence in this population.

Initiation and continued use of oral pre-exposure prophylaxis among pregnant and postpartum women in South Africa (PrEP-PP): a demonstration cohort study

When used effectively, oral pre-exposure prophylaxis (PrEP; tenofovir disoproxil fumarate and emtricitabine) prevents maternal HIV acquisition and reduces the risk of vertical transmission. Our study aimed to better understand PrEP initiation, continued use, and adherence in pregnant and postpartum women. The PrEP in Pregnancy and Postpartum (PrEP-PP) study is a demonstration cohort study that enrolled pregnant women aged 16 years and older without HIV attending their first antenatal care visit in Cape Town, South Africa, between Aug 29, 2019, and Oct 10, 2021. Eligible, consenting women were followed up quarterly up to 12 months postpartum with regular HIV testing and offer of PrEP with ongoing adherence counselling. The primary outcome was distribution of women across the PrEP cascade (ie, initiation and continuation up to 12 months postpartum) with crude and adjusted hazard ratios (HRs). We also report on HIV incidence by pregnancy and postpartum status. Overall, 1195 pregnant women were recruited and followed up (median age 26 years, IQR 23-31; median gestational age 21 weeks, IQR 15-31); 1009 (84·4%) started PrEP at enrolment. Among women who initiated PrEP at enrolment, 668 (67·5%) of 990 continued PrEP at the 1-month follow-up, 485 (49·9%) of 972 continued at 3 months, 392 (39·4%) of 994 at 6 months, and 275 (27·4%) of 1005 at 12 months. Of 186 women who did not accept PrEP at enrolment, 70 (37·6%) of 186 subsequently initiated PrEP. Overall, 200 (18·6%) of 1076 women continued PrEP at 12 months postpartum. Of 186 women who did not initiate PrEP at baseline, 70 (37·6%) subsequently initiated PrEP during the study. Factors associated with PrEP discontinuation up to 12 months postpartum included being married or cohabiting (adjusted HR 1·32, 95% CI 1·16-1·50), condomless sex since last visit (1·43, 1·23-1·65), reporting intimate partner violence (2·03, 1·59-2·59), or depression in the past 12 months (1·53, 1·14-2·05). Overall, 16 women seroconverted over 1673·8 woman-years (HIV incidence rate 0·96 per 100 woman-years, 95% CI 0·49-1·42); 14 discontinued PrEP use and two never initiated PrEP. HIV incidence was 0·28 per 100 woman-years during pregnancy (95% CI 0·22-0·33), and the incidence rate ratio was 1·77 per 100 woman-years (0·53-5·90) 0-6 months postpartum and 2·19 per 100 woman-years (0·61-7·83) 6-12 months postpartum compared with pregnant women. There is an urgent need for the integration of PrEP into antenatal and postnatal care and interventions that address barriers to continued use, including targeted counselling during pregnancy and postpartum to reduce PrEP discontinuation. National Institute of Mental Health and Fogarty International, US National Institutes of Health. For the French translation of the abstract see Supplementary Materials section.

Interest in Oral Pre-exposure Prophylaxis Among Men Who Have Sex with Men and Transfeminine Persons in HPTN 075, a Multi-center HIV Prevention Study in Sub-Saharan Africa (2015-2017).

Use of oral pre-exposure prophylaxis (O-PrEP) for HIV prevention has not been fully utilized in sub-Saharan Africa, especially among key populations with high HIV incidence and prevalence, including men who have sex with men (MSM) and transgender women (TGW). We examined correlates of interest in O-PrEP among participants in the HIV Prevention Trials Network (HPTN) Study 075, a prospective cohort study, conducted between 2015 and 2017, across 4 sites in Kenya, Malawi, and South Africa. The study included persons assigned male sex at birth, between 18 and 44 years of age, who reported anal intercourse with a man in the past 3 months. Interest in O-PrEP and potential correlates were assessed among 297 participants who were HIV negative. 52% of the participants reported being aware of PrEP and 73% indicated interest in PrEP once informed about it. PrEP interest was not significantly associated with any of the surveyed demographic or psychosocial variables except study site. Our findings suggest a broad and general interest in O-PrEP among MSM and TGW in sub-Saharan Africa, despite relatively low awareness. While the situation around PrEP will have changed in the included countries, major questions about successful implementation still need to be addressed.

Effective preexposure prophylaxis in young women and girls, a key population for HIV prevention.

Although there is substantial momentum to scale up preexposure prophylaxis (PrEP) for HIV prevention in adolescent girls and young women (AGYW) at risk of HIV acquisition, this key population has demonstrated difficulty in sustained PrEP use. Despite being a user-controlled and discreet prevention option, effective oral PrEP use requires a series of complex daily decisions in the life of the PrEP user. In this review, we describe how the number of decisions AGYW have to execute for effective and continued PrEP use may potentially be reduced by providing simplified, integrated, differentiated sexual and reproductive health services that include PrEP, and introducing a choice of PrEP products, including less frequently dosed, longer acting and/or multipurpose prevention technology (MPT) products. PrEP uptake and effective use are enhanced when AGYW experience PrEP service delivery channels as convenient, integrated with their other sexual and reproductive health needs and matching their experiences (including limited autonomy) and lifestyle. Longer acting or less frequently dosed PrEP products or MPTs may reduce the cognitive burden associated with prevention decision-making and is, therefore, likely more suitable for the majority of AGYW who struggle with daily pill adherence. In the scaling up of HIV prevention for AGYW, implementers are encouraged to consider both PrEP products and PrEP delivery outlet preferences. Understanding and responding to AGYW's different needs will allow for preferred PrEP delivery outlets and choice in PrEP products, leading to a greater likelihood of effective PrEP use in this key population.

Barriers and facilitators to uptake and use of oral pre-exposure prophylaxis in pregnant and postpartum women: a qualitative meta-synthesis

BackgroundAcute HIV infection during pregnancy and in the postpartum period increases the risk of vertical transmission. The World Health Organization (WHO) has recommended preexposure prophylaxis for pregnant and postpartum women at risk of acquiring HIV. However, there are significant gaps between the actual practice and the ideal goal of preexposure prophylaxis implementation among pregnant and postpartum women. Therefore, it is important to determine what influences women’s implementation of preexposure prophylaxis during pregnancy and in the postpartum period. This review aims to aggregate barriers and facilitators to preexposure prophylaxis implementation among pregnant and postpartum women.MethodsA range of electronic databases, including PubMed, CINAHL Plus with Full Text, Embase, and Web of Science, were searched for potentially relevant qualitative studies. The search period extended from the establishment of the databases to March 16, 2023. This review used the ENTREQ (Enhancing transparency in reporting of qualitative research synthesis) statement to guide the design and reporting of qualitative synthesis. The methodological quality of the included studies was assessed using the Joanna Briggs Institute Critical Appraisal Checklist. The JBI meta-aggregation method was applied for guiding the data extraction, and the JBI ConQual method was applied for guiding the evaluation of the level of evidence for the synthesis.ResultsOf retrieved 2042 studies, 12 met the inclusion criteria. The total population sample included 447 participants, including 231 pregnant and postpartum women, 21 male partners, 75 healthcare providers (HCPs)/healthcare workers (HCWs), 18 policymakers, 37 mothers, and 65 women of childbearing age. A total of 149 findings with credibility ratings of “unequivocal” or “equivocal” were included in this meta-synthesis. Barriers and facilitators to preexposure prophylaxis implementation were coded into seven categories, including three facilitator categories: perceived benefits, maintaining relationships with partners, and external support, and four barriers: medication-related barriers, stigma, barriers at the level of providers and facilities, and biases in risk perception.ConclusionThis systematic review and meta-synthesis aggregated the barriers and facilitators of preexposure prophylaxis implementation among pregnant and postpartum women. We aggregated several barriers to maternal preexposure prophylaxis implementation, including medication-related factors, stigma, barriers at the level of providers and facilities, and risk perception biases. Therefore, intervention measures for improving preexposure prophylaxis services can be developed based on these points.PROSPERO NumberCRD42023412631.

Concepciones de usuarios sobre nuevas vías de administración de profilaxis pre-exposición para el VIH

Abstract This article aims to discuss the expectations of Homosexual Men, Bisexual Men and a Transgender Woman, who use or want to use an oral pre-exposure prophylaxis (PrEP) for the human immunodeficiency virus (HIV) about PrEP modalities. Sixteen PrEP users, who are followed up in the BCN Checkpoint, were interviewed,. The interviews were audio-recorded, subjected to thematic categorical analysis within the theoretical framework from the praxiographic perspective. They are all adapted to the use of daily oral and event-based PrEP. In relation to the new PrEP modalities (monthly pill; intramuscular injection every two months; subcutaneous injection every six months), they are all very receptive to these possibilities, but they lack information on the specificities of each and specific assessment of their needs. Comments about the use of oral PrEP are positive, and expectations regarding the new PrEP modalities are visibly high. However, the most important thing for the interviewees is the guarantee that they will have follow-up appointments to continue taking care of their affective-sexual health, which is not dependent on the type of PrEP modalities.

Users' expectations of the new pre-exposure prophylaxis for the HIV modalities.

This article aims to discuss the expectations of Homosexual Men, Bisexual Men and a Transgender Woman, who use or want to use an oral pre-exposure prophylaxis (PrEP) for the human immunodeficiency virus (HIV) about PrEP modalities. Sixteen PrEP users, who are followed up in the BCN Checkpoint, were interviewed,. The interviews were audio-recorded, subjected to thematic categorical analysis within the theoretical framework from the praxiographic perspective. They are all adapted to the use of daily oral and event-based PrEP. In relation to the new PrEP modalities (monthly pill; intramuscular injection every two months; subcutaneous injection every six months), they are all very receptive to these possibilities, but they lack information on the specificities of each and specific assessment of their needs. Comments about the use of oral PrEP are positive, and expectations regarding the new PrEP modalities are visibly high. However, the most important thing for the interviewees is the guarantee that they will have follow-up appointments to continue taking care of their affective-sexual health, which is not dependent on the type of PrEP modalities.

Preference for novel biomedical HIV pre-exposure prophylaxis methods among adolescent girls and young women in Kampala, Uganda: a mixed methods study

BackgroundNovel HIV pre-exposure prophylaxis (PrEP) methods including a potential future HIV vaccine, will increase prevention options for adolescent girls and young women (AGYW) at high risk of HIV infection in Eastern and Southern Africa, yet data on AGYW’s preferences for various PrEP methods is limited. We investigated preferences for five biomedical PrEP methods (oral, injectable, vaginal ring, implant, HIV vaccine) among 14–24-years-old AGYW in Kampala, Uganda.MethodsFrom January to December 2019, we conducted a mixed methods study including 265 high-risk AGYW. After receiving two education sessions on the five PrEP methods, participants were asked about their “most preferred PrEP method.” Multinomial logistic regression (oral PrEP as reference category) was used to determine participant characteristics associated with method preference. Results are presented as adjusted relative risk ratios (aRRR) with 95% confidence intervals (CI). In-depth interviews were conducted with 20 selected participants to examine reasons influencing PrEP preferences and suggestions for method improvements. Transcripts were analyzed thematically.ResultsParticipants preferred methods were: HIV vaccine (34.7%), oral PrEP (25.7%), injectable PrEP (24.9%), PrEP implant (13.6%), and vaginal ring (1.1%). Preference for injectable PrEP increased with every year of age (aRRR 1.22; 95% CI 1.04–1.44) and among participants with chlamydia or gonorrhoea (aRRR 2.53; 95% CI 1.08–5.90), while it was lower among participants having sexual partner(s) living with HIV or of unknown HIV status (aRRR 0.30; 95% CI 0.10–0.91). Preference for PrEP implants also increased with age (aRRR 1.42; 95% CI 1.14–1.77) and was strong among participants having ≥10 sexual partners in the past 3 months (aRRR 3.14; 95% CI 1.16–8.55), while it was lower among those with sexual partner(s) living with HIV or of unknown HIV status (aRRR 0.25; 95% CI 0.07–0.92). PrEP method preference was influenced by product attributes and prior experiences with similar product forms commonly used in health care.ConclusionAGYW have varied preferences for biomedical PrEP method and those with higher sexual behavioral risk prefer long-acting methods. As we anticipate more available PrEP options, oral PrEP use should be supported among AGYW, especially for those with sexual partners living with HIV or of unknown HIV status.

Navigating patterns of oral PrEP use: A qualitative longitudinal study of gay, bisexual, and queer men's dynamic practices of pausing, on-demand, and stopping PrEP in Canada

The Canadian HIV pre-exposure prophylaxis (PrEP) guidelines recommend both daily and on-demand dosing for gay, bisexual, and queer men (GBQM), meeting additional risk criteria. However, limited research explored how GBQM implement pausing, on-demand, discontinuation, and resumption of PrEP, including the contextual factors affecting decision-making. Using a relationally situated implementation science framework, we examined how GBQM tailor PrEP use to changing social and sexual circumstances. We conducted 109 longitudinal interviews with current and former PrEP users from Ontario (n = 18) and British Columbia (n = 20), Canada, at three time points between 2020 and 2022. We identified three dynamic PrEP use trajectories: pausing, on-demand, and stopping. Pausing involved brief breaks followed by a return to daily use during heightened sexual activity. Others followed the 2-1-1 on-demand schedule, while some stopped PrEP with plans to resume if social and sexual circumstances change. During the COVID-19 pandemic, participants paused PrEP when sexual activities decreased, restarting daily use when sexual engagements resumed. Others paused due to relationship changes or sexual inactivity, resuming PrEP in anticipation of sex. On-demand PrEP was adopted to manage side effects or save costs. Some stopped PrEP for sustained periods due to monogamy, private insurance loss, side effects, or low perceived HIV risk. Participants expressed concerns regarding lack of information on these strategies, relying on online sources or peers for guidance. Most participants obtained enough PrEP knowledge to adapt use appropriately. Comprehensive education campaigns on adaptable PrEP use effectiveness and strategies to discontinue and resume PrEP for clinicians and GBQM should be implemented.

Experiences of oral pre-exposure prophylaxis use among heterosexual men accessing sexual and reproductive health services in South Africa: a qualitative study.

South African men face a substantial burden of HIV and are less likely to test for HIV and initiate antiretroviral therapy if tested positive and more likely to die from AIDS-related causes than women. In addition to condoms and circumcision, guidelines provide for the use of daily oral pre-exposure prophylaxis (PrEP) as an HIV prevention intervention for any men who recognize their need and request PrEP. However, heterosexual men have not been a focus of PrEP programmes, and since its introduction, there is limited literature on PrEP use among men in South Africa. This study explores the experiences, motivators and barriers to oral PrEP use among heterosexual men accessing primary healthcare services in South Africa. This study forms part of a mixed-methods implementation science study aimed at generating evidence for oral PrEP introduction and conducted in primary healthcare clinics in South Africa since 2018. Men aged ≥15 years who initiated oral PrEP and enrolled in a parent cohort study were purposefully invited to participate in an in-depth interview (IDI). Between March 2020 and May 2022, 30 men participated in IDIs exploring their motivators for PrEP use, and experiences with accessing health services. Interviews were audio recorded, transcribed and analysed thematically. The final analysis included 28 heterosexual men (18-56 years old). Motivations to initiate PrEP included fear of acquiring HIV, self-perceived vulnerability to HIV and mistrust in relationships; health systems factors which motivated PrEP use included the influence of healthcare providers, educational materials and mobile services. Perceived reduction in HIV vulnerability and changing proximity to partners were reasons for PrEP discontinuation. Side effects, daily-pill burden and stigma were noted as challenges to PrEP use. Health system barriers to PrEP use included limited PrEP availability, school and work demands, and inconsistent mobile clinic schedules. Our study reports on the experiences of heterosexual men accessing oral PrEP in real-world settings and contributes to the limited literature among this population. We highlight multiple levels which could be strengthened to improve men's PrEP use, including individual support, education among partners and communities, and addressing health system barriers to access.

Assessing Preferences for Long-Acting Injectable Pre-Exposure Prophylaxis Among Young Adult Sexual Minority Men and Transgender Women

ObjectiveOral pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission. However, oral PrEP uptake is low, particularly among sexual and gender minority youth who are vulnerable to HIV infection. Alternative methods of PrEP delivery, such as long-acting injectable (LAI) PrEP may overcome barriers and be preferred. However, attitudes and preferences of younger sexual and gender minorities towards LAI PrEP have not been well studied. The purpose of this study is to describe preferences for initiating LAI PrEP among sexual and gender minority youth. MethodsWe analyzed data collected as part of an HIV prevention randomized trial from January 2022 to February 2023, using multiple regression to identify factors associated with a preference for LAI PrEP. ResultsThe study sample (N = 265) was 50% youth of color, mean age 25 years (SD=3.4, range=18–31), and primarily identified as gay (71%) and male (91%). Forty two percent had heard of LAI PrEP and 31% preferred LAI PrEP over other prevention methods. In multiple regression analysis, LAI PrEP preference was associated with identifying as White, previous PrEP experience, and perceived LAI PrEP efficacy. ConclusionsWe conclude that gaps in awareness exist for LAI PrEP, however it may be preferred over other prevention methods especially in White youth, those with PrEP experience and higher perceptions of its efficacy. More education and outreach are needed to prevent extension of existing race and ethnicity disparities in use of oral daily PrEP to LAI PrEP.

Optimising HIV pre-exposure prophylaxis and testing strategies in men who have sex with men in Australia, Thailand, and China: a modelling study and cost-effectiveness analysis

Men who have sex with men (MSM) in the Asia-Pacific region have a disproportionately high burden of HIV infection compared with the general population. Although pre-exposure prophylaxis (PrEP) for HIV is highly effective at preventing new HIV infections, the cost-effectiveness of PrEP for MSM in different countries in the Asia-Pacific region with varying PrEP coverage and HIV testing frequencies remains unstudied. We aimed to analyse the economic and health benefits of long-acting injectable cabotegravir (CAB-LA) compared with oral PrEP in high-income countries and low-income and middle-income countries within the Asia-Pacific region. We developed a decision-analytic Markov model to evaluate the population impact and cost-effectiveness of PrEP scale-up among MSM in Australia, Thailand, and China. We assumed a static cohort of 100 000 MSM aged 18 years or older who were at risk of HIV infection, with a monthly cycle length over a 40-year time period. We evaluated hypothetical scenarios with universal PrEP coverage of 80% among 100 000 suitable MSM in each country. We modelled oral PrEP and CAB-LA for MSM with diverse HIV testing frequency strategies. We adopted the health-care system's perspective with a 3% annual discount rate. We calculated the incremental cost-effectiveness ratio (ICER), measured as additional cost per quality-adjusted life-year (QALY) gained, to compare different strategies with the status quo in each country. All costs were reported in 2021 US$. We also performed one-way, two-way, and probabilistic sensitivity analyses to assess the robustness of our findings. Compared with the status quo in each country, expanding oral PrEP to 80% of suitable MSM would avert 8·1% of new HIV infections in Australia, 14·5% in Thailand, and 26·4% in China in a 40-year period. Expanding oral PrEP use with 6-monthly HIV testing for both PrEP and non-PrEP users was cost-saving for Australia. Similarly, expanding oral PrEP use remained the most cost-effective strategy in both Thailand and China, but optimal testing frequency varied, with annual testing in Thailand (ICER $4707 per QALY gained) and 3-monthly testing in China (ICER $16 926 per QALY gained) for both PrEP and non-PrEP users. We also found that replacing oral PrEP with CAB-LA for MSM could avert more new HIV infections (12·8% in Australia, 27·6% in Thailand, and 32·8% in China), but implementing CAB-LA was not cost-effective due to its high cost. The cost of CAB-LA would need to be reduced by 50-90% and be used as a complementary strategy to oral PrEP to be cost-effective in these countries. Expanding oral PrEP use for MSM, with country-specific testing frequency, is cost-effective in Australia, Thailand, and China. Due to the high cost, CAB-LA is currently not affordable as a single-use strategy but might be offered as an additional option to oral PrEP. Ministry of Science and Technology of the People's Republic of China, the Australian National Health and Medical Research Council, National Key Research and Development Program of China, and National Natural Science Foundation of China.

The effect of daily oral PrEP use during pregnancy on bone mineral density among adolescent girls and young women in Uganda.

Oral pre-exposure prophylaxis (PrEP) is recommended during pregnancy for at-risk cisgender women. Pregnancy is known to impede bone growth and tenofovir-based PrEP may also yield detrimental changes to bone health. Thus, we evaluated the effect of PrEP use during pregnancy on bone mineral density (BMD). We used data from a cohort of women who were sexually active, HIV-negative, ages 16-25 years, initiating DMPA or choosing condoms for contraception and enrolled in the Kampala Women's Bone Study. Women were followed quarterly with rapid testing for HIV and pregnancy, PrEP dispensation, and adherence counseling. Those who became pregnant were counseled on PrEP use during pregnancy per national guidelines. BMD of the neck of the hip, total hip, and lumbar spine was measured using dual-energy x-ray absorptiometry at baseline and annually. We compared the mean percent change in BMD from baseline to month 24. Among 499 women enrolled in the study, 105 pregnancies occurred in 90 women. At enrollment, the median age was 20 years (IQR: 19-21) and 89% initiated PrEP. During pregnancy, 67% of women continued using PrEP and PrEP was dispensed in 64% of visits. BMD declined significantly in women using PrEP during pregnancy compared to women who were not pregnant nor used PrEP: relative BMD change was -2.26% (95% CI: -4.63 to 0.11, p = 0.06) in the femoral neck, -2.57% (95% CI: -4.48 to -0.66, p = 0.01) in total hip, -3.06% (95% CI: -5.49 to -0.63, p = 0.001) lumbar spine. There was no significant difference in BMD loss when comparing PrEP-exposed pregnant women to pregnant women who never used PrEP. Women who became pregnant were less likely to continue PrEP at subsequent study visits than women who did not become pregnant (adjOR: 0.25, 95% CI: 0.16-0.37, p < 0.001). Based on pill counts, there was a 62% reduction in the odds of high PrEP adherence during pregnancy (adjOR = 0.38, 95% CI: 0.27-0.58, p < 0.001). Women who used PrEP during pregnancy experienced a similar reduction in BMD as pregnant women with no PrEP exposure, indicating that BMD loss in PrEP-using pregnant women is largely driven by pregnancy and not PrEP.

“Sex without fear”: exploring the psychosocial impact of oral HIV pre-exposure prophylaxis on gay men in England

Gay, bisexual, and other men who have sex with men (GBMSM) experience a high prevalence of psychosocial health problems, such as harmful substance use and depression, as well as being disproportionately affected by HIV. HIV Pre-Exposure Prophylaxis (PrEP) may provide psychosocial benefits beyond its intended purpose of reducing HIV infection. We explore the psychosocial impact of oral PrEP use on gay men in England using qualitative data from the PROUD study. From February 2014 to January 2016, semi-structured in-depth interviews were conducted with 40 gay men and one trans woman. Participants were purposively recruited based on trial arm allocation, adherence, and sexual risk behaviours. By removing HIV risk from sex, PrEP improves users’ wellbeing by reducing HIV-related anxiety and internalised stigma and increasing HIV prevention self-efficacy, sexual pleasure, and intimacy. In turn, these psychological changes may influence behaviour in the form of greater sexual freedom, reduced harmful drug use, and more protective sexual health behaviours. However, PrEP may create internal conflict for some gay men, due to its disruption of social norms around condom use and its perceived influence on their sexual behaviour leading to reduced condom self-efficacy. These findings provide a baseline of PrEP’s psychosocial impact amongst some of the first PrEP users in England and supports calls to consider the psychosocial impact of PrEP in prescribing guidelines.

Family influences on oral PrEP use among adolescent girls and young women in Kenya and South Africa.

Effective use of oral HIV pre-exposure prophylaxis (PrEP) has been lower among African adolescent girls and young women (AGYW) than among older women, young men who have sex with men, and serodiscordant heterosexual couples in the region. Efforts to build PrEP support have centered around peers and male partners, but the family may also play an important role. This qualitative study aimed to describe family influence on PrEP use among AGYW in in three African cities. POWER (Prevention Options for Women Evaluation Research) was a PrEP demonstration project among 2550 AGYW (16-25 years old) in Johannesburg and Cape Town, South Africa and Kisumu, Kenya conducted from 2017 to 2020. In-depth interviews and focus group discussions were conducted with 136 AGYW participants to explore their PrEP views and experiences, including awareness and interest in PrEP; barriers and facilitators to uptake and use; the influence of family, peers, intimate partners, and community; and the key types of support for their PrEP use. Transcripts were coded and analysed thematically. The decision to initiate PrEP was associated with fear and anxiety linked to anticipated stigma from family members, and with family's lived HIV experience. Family disclosure, especially to mothers, was important to participants, as most lived with their families and considered it essential for them to obtain their mother's approval to use PrEP. Most family members, particularly mothers, provided instrumental, emotional, informational and appraisal support to participants using PrEP, including reminders, encouragement, and problem-solving. Participants reported that family members with insufficient information about PrEP safety and efficacy and who voiced concerns were a substantial barrier to their use. However, they often became supportive after receiving more PrEP information. Families, particularly mothers, can play an important role in supporting PrEP use. PrEP programmes should leverage family support to help with PrEP persistence by providing basic information to families about PrEP safety and efficacy. AGYW using PrEP should be encouraged to selectively disclose PrEP use to build support and counseled on how to disclose and address family concerns.

Eita! Reaching Communities and Young People to Drive Demand for Oral Pre-Exposure Prophylaxis in South Africa

PurposeThis paper describes a holistic but flexible demand creation strategy for pre-exposure prophylaxis (PrEP) in national public health-care settings in low-income to middle-income countries. MethodsWe describe the development and implementation of a model to drive demand for oral PrEP uptake and use as part of comprehensive sexual and reproductive health services in South Africa: The Eita! model. The project adapted two existing response hierarchy models (marketing models used to describe the stages individuals move through from being unaware to using a product), to formulate the Eita! model. Using the RE-AIM framework, we report on the reach, effectiveness, adoption, implementation, and maintenance of the Eita! model. ResultsMore than 34 million connections were made from December 2018 to 2021 through a variety of channels: social media and websites, at events and mobile clinic outreach, and radio and community dialogs. There were 42,447 adolescent girls and young women reached in-person during this time, 16,823 adolescent girls and young women presented for sexual and reproductive health services, and of those 14,637 (87%) initiated on PrEP. The model was implemented in eight health-care facilities and four mobile clinics in three provinces in South Africa. A total of 26 trainings were delivered to project staff implementing the strategy. Various demand creation resources, such as materials and online platforms, have since been adopted by the National Department of Health as national tools. DiscussionThe Eita! model was successfully implemented to support the uptake of HIV prevention services and rollout of biomedical prevention products, and can be adapted by other low-income to middle-income countries.

Evaluating the use of oral pre-exposure prophylaxis among pregnant and postpartum adolescent girls and young women in Cape Town, South Africa.

Adolescent girls and young women (AGYW) in South Africa are at a higher risk of acquiring HIV. Despite the increasing availability of daily oral pre-exposure prophylaxis (PrEP) for HIV prevention, knowledge on PrEP use during pregnancy and postpartum periods at antenatal care (ANC) facilities remains inadequate. Data from HIV-uninfected pregnant women in Cape Town, South Africa, were used in this study. These women aged 16-24 years were enrolled in the PrEP in pregnancy and postpartum (PrEP-PP) cohort study during their first ANC visit. Using the PrEP cascade framework, the outcomes of the study were PrEP initiation (prescribed tenofovir disoproxil fumarate and emtricitabine at baseline), continuation (returned for prescription), and persistence [quantifiable tenofovir diphosphate (TFV-DP) in dried blood samples]. The two primary exposures of this study were risk perception for HIV and baseline HIV risk score (0-5), which comprised condomless sex, more than one sexual partner, partner living with HIV or with unknown serostatus, laboratory-confirmed sexually transmitted infections (STIs), and hazardous alcohol use before pregnancy (Alcohol Use Disorders Identification Test for Consumption score ≥ 3). Logistic regression was used to examine the association between HIV risk and PrEP, adjusting for a priori confounders. A total of 486 pregnant women were included in the study, of which 16% were "adolescents" (aged 16-18 years) and 84% were "young women" (aged 19-24 years). The adolescents initiated ANC later than the young women [median = 28 weeks (20-34) vs. 23 weeks (16-34), p = 0.04]. Approximately 41% of the AGYW were diagnosed with sexually transmitted infection at baseline. Overall, 83% of the AGYW initiated PrEP use during their first ANC. The percentage of PrEP continuation was 63% at 1 month, 54% at 3 months, and 39% at 6 months. Approximately 27% consistently continued PrEP use through 6 months, while 6% stopped and restarted on PrEP use at 6 months. With a higher risk score of HIV (≥2 vs. ≤1), the AGYW showed higher odds of PrEP continuation [adjusted odds ratio: 1.85 (95% CI: 1.12-3.03)] through 6 months, adjusting for potential confounders. Undergoing the postpartum period (vs. pregnant) and having lower sexual risk factors were found to be the barriers to PrEP continuation. TFV-DP concentration levels were detected among 49% of the AGYW, and 6% of these women had daily adherence to PrEP at 3 months. AGYW were found to have high oral PrEP initiation, but just over one-third of these women continued PrEP use through 6 months. Pregnant AGYW who had a higher risk of acquiring HIV (due to condomless sex, frequent sex, and STIs) were more likely to continue on PrEP use through the postpartum period. Pregnant and postpartum AGYW require counseling and other types of support, such as community delivery and peer support to improve their effective PrEP use through the postpartum period. ClinicalTrials.gov, NCT03826199.

Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa.

Adolescent girls and young women (AGYW) face barriers that jeopardize their prevention-effective use of daily oral pre-exposure prophylaxis (PrEP). We sought to understand factors that influence AGYW's prolonged breaks in PrEP use, and their decisions to re-initiate or discontinue using PrEP in the context of a community-based adherence support intervention. In-depth interviews (IDIs) were conducted between December 2019 and April 2021 with purposively selected AGYW (aged 16-25) enrolled in the Community PrEP Study (CPS) in Buffalo City Metro Health District, Eastern Cape Province, South Africa. AGYW were offered monthly PrEP for 24 months at two community-based study sites. Interview guides were informed by the Information-Motivation-Behavioural Skills Model, and data were analysed using illustrative code reports and a case analysis. A total of 603 participants were enrolled and initiated on PrEP in the parent study. Fifty-three IDIs were conducted with 50 CPS participants. Findings revealed that external factors (e.g. local movement, school holidays and medication side-effects) and social conflicts (e.g. discretion and partner mistrust) directly influenced breaks in PrEP usage. A decrease in one's self-perception of HIV risk prolonged the duration of these "PrEP breaks." Once PrEP refill visits were missed, some AGYW delayed returning for refills out of fear of being scolded by study staff. The differences between those participants who eventually re-initiated PrEP and those who disengaged from PrEP use can be attributed to social support and encouragement, level of familiarity with PrEP, risk perceptions, self-initiated discussions with staff and diminishing side effects. Despite implementing a community-based PrEP delivery platform and behavioural intervention that included support for daily oral PrEP adherence and disclosure, participants struggled with consistent daily oral PrEP use. Unpredictable life events, including local movement and schooling schedules, in addition to being judged for their perceived behaviours, pose a challenge for consistent pill pick-up for AGYW and habit formation. Long-acting injectable PrEP may mitigate a number of these external barriers. Interventions that integrate long-term planning skills, how to navigate existing social judgements and how to access sources of social support may further improve habit formation for PrEP use, regardless of its formulation.

Male partners' support and influence on pregnant women's oral PrEP use and adherence in Malawi.

Daily oral pre-exposure prophylaxis (PrEP) is a safe and effective HIV prevention method for pregnant and postpartum women, but adherence barriers exist. Understanding the role of male partners in supporting PrEP use may inform strategies to support PrEP adherence among pregnant and breastfeeding women. To understand male partners' involvement in women's use of PrEP, we conducted in-depth interviews with pregnant women in Lilongwe, Malawi who had recently decided to use PrEP (n = 30) and their male partners (n = 20) in the context of a PrEP adherence trial. Women were purposively recruited to ensure variation in their partners' HIV status. Interviews were conducted in Chichewa using a semistructured guide. We followed a thematic approach to analyze the interview data. Most male partners were receptive to women using PrEP during pregnancy because it eased their fears of the woman and baby acquiring HIV. Men often played a key role in women's PrEP adherence by providing daily reminders and encouragement to adhere to their medication. The majority of women appreciated this support from the men as it lessened the burden of remembering to take their medications daily on their own and aided their adherence. However, several women who lacked male partner support spoke of wanting their partners to be more involved. Many men living with HIV found the mutual support beneficial for their antiretroviral therapy adherence, while men without HIV or with status unknown appreciated knowing that the family was protected. While most men were open to women continuing PrEP beyond the current study, some would only support it if women were still at risk for acquiring HIV. In this study, male partners were strongly motivated to support the PrEP adherence of their female partners as a way of ensuring that the pregnant women and unborn babies were protected against HIV. Promoting disclosure and tangible support that arises organically among men may be helpful, but programs to enhance this support and identify ways to support women who do not receive support from their partners or do not wish to disclose their PrEP use to partners may be needed.

High PrEP uptake, adherence, persistence and effectiveness outcomes among young Thai men and transgender women who sell sex in Bangkok and Pattaya, Thailand: findings from the open-label combination HIV prevention effectiveness (COPE) study.

Daily oral pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection, but no study has evaluated combination prevention interventions with PrEP for transgender women (TGW) and men who have sex with men (MSM) who sell sex. The Combination Prevention Effectiveness (COPE) study was a community-based, non-randomized implementation study in Bangkok and Pattaya, Thailand. Participants were HIV-negative MSM and TGW aged 18-26 years who reported exchanging sex with men in the prior 12 months and who met 2014 U.S. Public Health Service PrEP eligibility criteria. The intervention included quarterly HIV testing, semiannual testing for sexually transmitted infections, provision of condoms with lubricant, and the opportunity to initiate or end daily oral PrEP use at any time during study participation. Participants taking PrEP received monthly adherence counseling and short message service reminders. The primary outcome was HIV incidence rate ratio (IRR) on PrEP vs. not on PrEP. Secondary outcomes were PrEP initiation, PrEP use at 12 months, and PrEP adherence. From October 2017 to August 2019, 846 participants were enrolled: 531 (62.8%) immediately initiated PrEP; 104 (12.3%) subsequently initiated PrEP, and 211 (24.9%) never initiated PrEP. Among those initiating PrEP within 30 days of enrollment; 85.9% were on PrEP at the 12-months. When taking PrEP, participants reported adherent PrEP use at 94.2% of quarterly assessments. Ten HIV seroconversions occurred without PrEP use (incidence rate [IR]=3.42 per 100 person-years [PY]; 95% CI=1.64-6.30), while zero cases occurred with PrEP use (IR=0.0 per 100PY; 95% CI=0.0-0.62), with IRR=0.0 (95% CI=0.0-0.22; p<0.001). Young Thai MSM and TGW who exchange sex can have high PrEP uptake, persistence and adherence, and low HIV incidence when offered in supportive community-based settings. U.S. National Institute of Allergy and Infectious Diseases; Centers for Disease Control and Prevention.