Representativeness of participants in a randomized controlled trial on modalities of monitoring oral HIV pre-exposure prophylaxis use.

SummaryBackgroundIn 2016, the UN General Assembly set a global target of 3 million oral pre-exposure prophylaxis (PrEP) users by 2020. With this target at an end, we aimed to assess global trends in the adoption of WHO PrEP recommendations into national guidelines and numbers of PrEP users, defined as people who received oral PrEP at least once in a given year, and to estimate future trajectories of PrEP use.MethodsIn this global summary and forecasting study, data on adoption of WHO PrEP recommendations and numbers of PrEP users were obtained through the Global AIDS Monitoring system and WHO regional offices. Trends in these indicators for 2016–19 by region and for 2019 by country were described, including by gender and priority populations where data were available. PrEP user numbers were forecasted until 2023 by selecting countries with at least 3 years of PrEP user data as example countries in each region to represent possible future PrEP user trajectories. PrEP user growth rates observed in example countries were applied to countries in corresponding regions under different scenarios, including a COVID-19 disruption scenario with static global PrEP use in 2020.FindingsBy the end of 2019, 120 (67%) of 180 countries with data had adopted the WHO PrEP recommendations into national guidelines (23 in 2019 and 30 in 2018). In 2019, there were about 626 000 PrEP users across 77 countries, including 260 000 (41·6%) in the region of the Americas and 213 000 (34·0%) in the African region; this is a 69% increase from about 370 000 PrEP users across 66 countries in 2018. Without COVID-19 disruptions, 0·9–1·1 million global PrEP users were projected by the end of 2020 and 2·4–5·3 million are projected by the end of 2023. If COVID-19 disruptions resulted in no PrEP user growth in 2020, the projected number of PrEP users in 2023 is 2·1–3·0 million.InterpretationWidespread adoption of WHO PrEP recommendations coincided with a global increase in PrEP use. Although the 2020 global PrEP target will be missed, strong future growth in PrEP use is possible. New PrEP products could expand the PrEP user base, and, with greater expansion of oral PrEP, further adoption of WHO PrEP recommendations, and simplified delivery, PrEP could contribute to ending AIDS by 2030.FundingUnitaid, Bill & Melinda Gates Foundation, and WHO.

A second decade of PrEP.

Toward Greater Pre-exposure Prophylaxis Equity: Increasing Provision and Uptake for Black and Hispanic/Latino Individuals in the U.S.

In South Africa, an estimated 62% of female sex workers (FSW) are living with HIV. Oral HIV pre-exposure prophylaxis (PrEP) is effective, but FSWs' PrEP use typically declines rapidly post-initiation in service settings. We examined a pilot individualized case management (ICM) intervention aiming to increase PrEP adherence and persistence among cisgender FSW initiating PrEP in eThekwini, South Africa. To assess pathways of intervention influence and potential effectiveness, we characterize the support participants received from the case manager (CM) and the ways in which it influenced their PrEP adherence and persistence. FSW initiating PrEP through a non-governmental key populations program (n = 29) participated in the pilot ICM sessions for 12 weeks, as well as semi-structured, in-depth interviews (IDIs) at baseline, month 1, and month 3. We triangulated the IDIs with CM observation notes and PrEP program refill data through month 4. We coded textual data thematically, and produced narrative summaries and time-ordered matrices to summarize themes, assess changes over time, and compare participants who continued versus discontinued PrEP by month 4. We employed the "capability, opportunity, and motivation - behavior (COM-B)" system in interpreting the pathways through which the CM's support influenced participants' PrEP adherence and persistence and considering potential intervention enhancements. The CM provided emotional, instrumental, and informational support that positively influenced participants' PrEP use capability, opportunity, and motivation. She bolstered participants' PrEP use capability by providing reminder tools and information to manage side effects and dispel misunderstanding; opportunity by helping strategize covert PrEP use in the face of stigma, and directly resolving pill access problems stemming from mobility and housing insecurity; and motivation by providing care and accompaniment. Experiences of care, accompaniment, and other emotional support from the CM were deeply felt in context of sex work stigma, and more prominent in the narratives of participants continuing PrEP at month 4 (20/29; 69%) versus those who discontinued. Still, 31% (9/29) of participants discontinued PrEP, and key influential forms of CM support required her ongoing presence. Findings suggest both pathways of potential ICM effectiveness and impact and sustainability shortfalls, calling for larger-scale evaluation and complementary structural approaches, such as those bolstering FSW social cohesion and tackling socio-economic barriers.

Global Adoption of Guidelines on and Use of Oral Pre-Exposure Prophylaxis (PrEP): Current Situation and Future Projections

Roll-out of HIV pre-exposure prophylaxis use in France: A nationwide observational study from 2016 to 2021.

Understanding HIV Sexual Protection and Its Association With Substance Use During Sex Among MSM in an Era of Multiple Primary Prevention Products.

ObjectivesTo describe the experiences of oral HIV pre-exposure prophylaxis (PrEP) use, preferences comparing oral PrEP to future long-acting PrEP products (the dapivirine vaginal ring (PrEP ring) and injectable cabotegravir (CAB...

Clinical trial data have shown that oral pre-exposure prophylaxis (PrEP) is efficacious when taken as prescribed; however, PrEP adherence is complex and must be understood within the context of variable risk for HIV infection and use of other HIV prevention methods. Different levels of adherence may be needed in different populations to achieve HIV prevention, and the optimal methods for achieving the necessary adherence for both individual and public health benefits are unknown. Guidance for PrEP use must consider these questions to determine the success of PrEP-based HIV prevention programs. In this article, we propose a new paradigm for understanding and measuring PrEP adherence, termed prevention-effective adherence, which incorporates dynamic HIV acquisition risk behaviors and the use of HIV alternative prevention strategies. We discuss the need for daily PrEP use only during periods of risk for HIV exposure, describe key issues for measuring and understanding relevant behaviors, review lessons from another health prevention field (i.e., family planning), and provide guidance for prevention-effective PrEP use. Moreover, we challenge emerging calls for sustained, near perfect PrEP adherence regardless of risk exposure and offer a more practical and public health-focused vision for this prevention intervention.

BackgroundIn the Netherlands, HIV pre-exposure prophylaxis (PrEP) has been available since 2019. However, the extent of PrEP use prior to HIV diagnosis and development of PrEP-resistance-associated mutations (RAMs) is not known.AimWe assessed prior PrEP use and potential transmission of PrEP RAMs among men who have sex with men (MSM) and transgender persons (TGP) with a new HIV diagnosis in the Netherlands.MethodsData on prior PrEP use between 1 January 2018 and 31 December 2022 were available from the Dutch national ATHENA cohort. We assessed proportion of prior PrEP use, detected PrEP associated RAMs and assessed potential onward transmission of RAMs between 2010 and 2022 using a maximum likelihood tree.ResultsData on prior PrEP use were available for 583/1,552 (36.3%) individuals, with 16% (94/583) reporting prior PrEP use. In 489 individuals reporting no prior PrEP use, 51.5% did not use PrEP due to: low HIV-risk perception (29%), no access (19.1%), personal preference (13.1%), and being unaware of PrEP (19.1%). For PrEP users, 13/94 (13.8%) harboured a M184V/I mutation, of whom two also harboured a K65R mutation. In people with a recent HIV infection, detection of PrEP RAMs increased from 0.23% (2/862) before 2019 to 4.11% (9/219) from 2019. We found no evidence of onward transmission of PrEP RAMs.ConclusionThe prevalence of PrEP-associated RAMs has increased since PrEP became available in the Netherlands. More widespread access to PrEP and retaining people in PrEP programmes when still at substantial risk is crucial to preventing new HIV infections.

Daily and event-driven oral pre-exposure prophylaxis (PrEP) reduce the risk of HIV acquisition. PrEP use can vary over time, yet little is known about the trajectories of PrEP use irrespective of the chosen PrEP regimens among men who have sex with men (MSM). Using data from a mobile, web-based diary application collected daily from 17 August 2015 until 6 May 2018, we analysed PrEP use and sexual behaviour in two large cohorts, AMPrEP (Amsterdam, the Netherlands) and Be-PrEP-ared (Antwerp, Belgium). In both cohorts, participants could choose between daily and event-driven oral PrEP every 3 months. We used group-based trajectory modelling to identify trajectories of PrEP use over time and their determinants. In addition, we estimated the incidence rate of chlamydia, gonorrhoea and syphilis within these trajectories. We included 516 MSM (n = 322 AMPrEP; n = 194 Be-PrEP-ared), of whom 24% chose event-driven PrEP at PrEP initiation. Participants contributed 225,015 days of follow-up (median = 508 days [IQR = 429-511]). Four distinct PrEP use trajectories were identified: ≤2 tablets per week ("low frequency," 12% of the total population), 4 tablets per week ("variable," 17%), "almost daily" (31%) and "always daily" (41%). Compared to participants with "low frequency" PrEP use, participants with "variable" (odds ratio [OR] = 2.18, 95% confidence interval [CI] = 1.04-4.60) and "almost daily" PrEP use were more often AMPrEP participants (OR = 2.64, 95% CI = 1.27-5.49). "Almost daily" PrEP users were more often employed (OR = 6.76, 95% CI = 2.10-21.75) and were younger compared to participants with "low frequency" PrEP use. In addition, the number of days on which anal sex occurred was lower among participants with "low frequency" PrEP use compared to the other groups (all p<0.001). Compared to "low frequency" PrEP users, the incidence rates of chlamydia and gonorrhoea were higher for participants with "almost daily" and "always daily" PrEP use. We uncovered four distinct PrEP use trajectories, pointing to different patterns of PrEP use in practice beyond the two-regimen dichotomy. These trajectories were related to sexual behaviour and rates of sexually transmitted infection. Tailoring PrEP care according to different PrEP use patterns could be an important strategy to improve efficient PrEP delivery.

BackgroundTailoring pre-exposure prophylaxis (PrEP) service delivery is key to scaling-up PrEP uptake. Optimal implementation of tailored services requires, among other things, insights into patterns of PrEP use, sexual behaviours and condom use over time.MethodsBetween September 2020 and January 2022, we conducted a web-based, longitudinal study among PrEP users in Belgium. In three questionnaire rounds every six-months, we assessed PrEP and condom use, and sex with steady, casual and anonymous partners in the preceding three months. Based on the patterns of PrEP use in the preceding three months, we identified distinct PrEP use categories. We investigated differences in baseline socio-demographics and sexual behaviours by PrEP use category using Fisher’s exact and one-way ANOVA tests. Patterns in PrEP and condom use over time were examined using descriptive analyses and visualised in alluvial diagrams.ResultsIn total, 326 participants completed the baseline questionnaire, and 173 completed all three questionnaires. We identified five distinct PrEP use categories: daily (≥ 90 pills), almost daily (75–89 pills), long period (> 7 consecutive days and < 75 pills) with or without additional short period use, short period (1–7 consecutive days and < 75 pills) and no PrEP use (0 pills). During the study, percentages of individuals in each PrEP use category varied, but did not change significantly over time. At baseline, daily and almost daily users were more likely to report five or more casual sex partners, ten or more anonymous sex partners and anal sex on a weekly basis with casual or anonymous partners compared to those using PrEP for long or short periods. Up to 12.6% (n = 16/127) of participants reporting anal sex with casual or anonymous partners, indicated always using condoms and PrEP with these partners. One in three (n = 23/69) participants who reported anal sex with steady partners had condomless anal sex and did not use PrEP with these partners; with casual or anonymous partners less than 3% reported this.ConclusionsOur findings show that there is little variation in PrEP use over time and that PrEP use was associated with sexual behaviours, which could be taken into account when designing tailored PrEP care.

BackgroundThe national policy on oral pre-exposure prophylaxis (PrEP) for female sex workers (FSWs) was instituted in South Africa in 2016. FSWs were targeted for PrEP due to a Human immunodeficiency virus (HIV) prevalence of 57.7%, which is higher than the prevalence of 19.07% among the general population. Research from demonstration studies has shown that uptake of PrEP has been slower than anticipated, and the purpose of this study was to explore barriers to the uptake of PrEP among FSWs.MethodsAn in-depth qualitative study was conducted with 39 participants, 30 individual participants, and nine focus group participants. Eleven participants consisted of peer educators and two health workers from a sex work and PrEP distribution organization, the rest of the participants (1) were FSWs.ResultsThe majority of participants mentioned that little distinction was made between PrEP and antiretrovirals (ARVs) taken by FSWs living with HIV. PrEP was not distributed through public health care facilities, and health workers unknowingly labeled PrEP as ARVs. Consequently, health workers seen as experts created suspicion and contributed to the mistrust of PrEP among FSWs due to mixed messages, and equating PrEP to ARVs reduced uptake. Furthermore, failure to make a clear distinction between oral PrEP and ARVs resulted in accusations of lying, denialism, and deception leveled at users of PrEP by FSWs using ARVs, and sometimes by clients and intimate partners. FSWs using PrEP reported feeling stigmatized and thrust into interpersonal conflict with their peers after choosing PrEP, leading to broken relationships, and some resorting to taking PrEP privately or discontinuing PrEP altogether.ConclusionPre-exposure prophylaxis as an ARV targeted for the prevention of HIV among high-risk groups was found to be stigmatizing. The distinctive use of PrEP and ARVs should be correctly explained to users to minimize confusion, enable differentiation and reduce interpersonal conflict. Cohesion among sex work organizations and public health care facilities is needed to disseminate the correct knowledge on PrEP. A non-stigmatizing approach to the distribution of PrEP may serve to increase uptake and adherence.

BackgroundSince June 2017, oral pre-exposure prophylaxis (PrEP) has been reimbursed in Belgium for people at substantial risk of HIV. To inform the national PrEP programme, we described sociodemographic characteristics of PrEP users, PrEP dispensing practices, testing for HIV and sexually transmitted infections (STIs; gonorrhoea, chlamydia and syphilis), and incidence of HIV and STIs.MethodsAnalysis of routinely collected social health insurance claims data from all individuals who were dispensed at least one PrEP prescription between June 2017 and December 2019. Using logistic regression adjusted for age, we examined associations between sociodemographic characteristics and having been dispensed PrEP only once in the first six months of PrEP use.ResultsOverall, 4559 individuals were dispensed PrEP. Almost all PrEP users were male (99.2%, 4522/4559), with a median age of 37 years (IQR 30–45). A minority were entitled to an increased healthcare allowance (11.4%, 514/4559). 18% (657/3636) were dispensed PrEP only once in the first six months of PrEP use. PrEP users younger than 25 years, unemployed, entitled to an increased healthcare allowance, and who initiated PrEP between January 2019 and June 2019 were more likely to have had no PrEP dispensing after initiation compared to their counterparts. The testing rates for bacterial STIs and HIV were 4.2 tests per person-year (95% CI 4.1–4.2) and 3.6 tests per person-year (95% CI 3.5–3.6), respectively. Twelve individuals were identified to have seroconverted during the study period, resulting in an HIV incidence rate of 0.21/100 person-years (95% CI 0.12–0.36). The incidence of bacterial STIs was 81.2/100 person-years (95% CI 78.7–83.8).ConclusionsThe study highlights challenges in PrEP persistence and a high incidence of bacterial STIs among individuals receiving PrEP. Tailored prevention support is crucial for individuals with ongoing HIV risk to optimise PrEP effectiveness. Integrated STI testing and prevention interventions within PrEP care are necessary to mitigate STI acquisition and transmission among PrEP users.

IntroductionUntil September 2019, pre‐exposure prophylaxis (PrEP) with tenofovir disoproxil/emtricitabine for HIV prevention was not covered by health insurance plans in Germany, and was only available through private prescriptions with self‐pay or through informal non‐prescription sources. The objective of this study was to investigate the proportion of informal PrEP use among PrEP users and to identify factors of public health relevance that might be associated with informal PrEP use.MethodsWe conducted a cross‐sectional study recruiting PrEP users independent of their PrEP source. Clients from anonymous community testing checkpoints, users of three dating apps for men who have sex with men residing in Germany and users of a PrEP community website, were recruited to complete a short anonymous online survey. Participants were recruited between 24 July and 3 September 2018. The results were analysed using univariable and multivariable logistic regressions.ResultsWe recruited 2005 participants currently using PrEP. The median age was 38 years, and 80.3% of the participants identified themselves as male (missing: 19.1%). Overall, 71.6% obtained PrEP through medical services with a private prescription or a clinical trial, and 17.4% obtained PrEP through informal sources (missing: 11.0%). The most common informal sources were ordering online from another country (8.8%), travel abroad (3.6%), and friends (2.5%). Factors associated with informal PrEP use were on demand/intermittent dosing (adjusted OR: 3.5, 95% CI 2.5 to 5.0) and not receiving medical tests during PrEP use (adjusted OR: 3.2, 95% CI 2.0 to 5.2). In addition, informal PrEP users who did not take PrEP daily had a strongly increased risk of starting PrEP without prior medical tests (adjusted stratum‐specific OR = 31.7, 95% CI 4.6 to 219.5).ConclusionsInformal PrEP use was associated with a higher risk of not getting tested before and during PrEP use, which could lead to HIV infections resistant to tenofovir and emtricitabine if people with undiagnosed HIV use PrEP. Health insurance plans that cover PrEP and the accompanying routine tests could ensure adequate medical supervision of PrEP users and reduce barriers to PrEP use. Our findings strongly support the implementation of PrEP programmes in countries with similar patterns of informal PrEP use.