Pre-exposure Prophylaxis Use Research Articles

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.

A mathematical model for the study of HIV/AIDS transmission with PrEP coverage increase and parameter estimation using MCMC with a Bayesian approach

In this article, we present a mathematical model for the study of HIV/AIDS considering the implementation of Pre-Exposure Prophylaxis (PrEP). As a novel element in the construction of the model, we consider the diagnosis of cases for attempting to enter the PrEP program, which allows us to study different forms of PrEP. The diagnosis of new infections helps to reduce transmission in the population because these patients are incorporated into the therapy and can achieve an undetectable viral load in blood which prevents them from infecting others. The model contains a compartment of infected persons with undetectable viral load in blood that is reached by adherence to treatment which is separated from those simply infected with the virus as they do not transmit it. Considering the structure of the model, we propose a method to study the effect of increased PrEP use and HIV incidence in a population. In the case of incidence, we took into account the stochasticity of the behavior. Besides, we find the basic reproduction number and present results that allow us to obtain the impact of the parameters associated with transmission, treatment and diagnosis on the basic reproduction number. We perform computational simulations, using demographic and HIV/AIDS data from Brazil, and utilize the Markov Chain Monte Carlo (MCMC) method with a Bayesian approach to estimate model parameters. We study two coverage increases at 25% and 35% that were selected according to the size of the Brazilian population and the daily use of PrEP. We compare the increases in coverage focused on HIV incidence, which is the number of new HIV cases infected and the number of HIV cases avoided, we conclude that by increasing PrEP coverage the incidence of HIV is reduced and the number of cases avoided increases.

Intention to use HIV pre-exposure prophylaxis (PrEP) in health sciences students

Abstract Introduction HIV is a public health issue, and as such, there are currently programs for the use of pre-exposure prophylaxis for HIV (PrEP) in various public institutions, with family physicians being one of the pillars to provide information and raise awareness among individuals at risk for HIV who wish to use these strategies. Objectives To determine the factors associated with the intention to use PrEP among university students in the healthcare field in the Veracruz-Boca del Río region. Methods A cross-sectional, prospective, and analytical study was conducted from August 2023 to March 2024, including students from healthcare-related majors at universities in the Veracruz region. An instrument was used to assess the level of knowledge about PrEP (Cronbach’s alpha of 0.8), with scores ranging from 0 to 10. Students were invited to participate in this research at different faculties of health sciences. Results 508 subjects participated, with 299 (58.9%) females and 386 (76.0%) heterosexual; 65.9% had never heard the term ‘PrEP,’ and 12% learned it from social media. The intention to use PrEP was positive in 81.5% of subjects in case of becoming a high-risk person for acquiring HIV. The level of knowledge about PrEP showed a score of 2.2 (SD ± 2.6), with 3.7% having high knowledge, 10.2% having a passing grade, and 55.9% scoring above the median (1.4) of the group’s scores. No association was identified between gender identity, sexual orientation, academic characteristics, and sources of information with the intention to use PrEP (p > 0.05). Knowledge level above the median of 6 points showed an odds ratio of 2.95 (95% CI 1.03-8.3) for the intention to use PrEP (p < 0.05). Conclusions The level of knowledge increases the probability of the intention to use PrEP in young people, making it essential for the primary care physician to carry out this training and awareness activity within their daily interactions with young patients. Key messages • It is essential to generate education programs on Prep for the population, as this will favor informed decision making on the use of these medicines in case they are required. • It is necessary to provide people with general information about Prep, since despite the existence of active programs for its distribution, most people have never heard anything about this drug scheme.

Decision Support Tool to Improve Decision-Making for HIV Pre-Exposure Prophylaxis (PrEP): Development Process and Alpha Testing.

African, Caribbean, and Black (Black) communities in Canada are disproportionately affected by the HIV epidemic. Pre-exposure prophylaxis (PrEP) is a highly effective option for the prevention of HIV. However, the use of PrEP for HIV prevention among eligible Black clients in Canada remains far below the thresholds necessary to achieve the goal of zero new HIV infections. In a recent study in Toronto, PrEP-eligible Black clients were found to have decisional conflict and unmet decisional needs, which affected the quality of their decision-making process regarding the initiation and adherence to PrEP. There is evidence that decision support tools (DSTs) can improve the quality of a decision, the quality of the decision-making process, the implementation or continuation of the chosen option, and the appropriate use of health services. Despite these benefits, there is currently no DST for PrEP-eligible Black clients being asked to consider PrEP for HIV prevention. Our study aimed to develop a DST to improve PrEP decision-making for Black clients and to evaluate the tool's acceptability and usability. We developed and evaluated the PrEP DST for Black patients using the 7-step process outlined in the Ottawa Decision Support Group Guideline for the development and evaluation of DST. To facilitate the implementation of the Ottawa Decision Support Group guideline, we assembled a multidisciplinary team of primary health care providers, researchers, community members with lived experiences, and digital content designers to serve as the steering committee. First, we assessed patients' and primary health care providers' views on decisional support needs, after which we determined the content, design, and distribution plan for the DST. Subsequently, we conducted evidence synthesis, reviews, and appraisal before developing the PrEP DST prototype. The final tool was reviewed by steering committee members for completeness before acceptability and usability testing with potential Black clients and PrEP providers. The web-based DST yielded 27 pages divided into 6 distinct sections. The six sections include (1) an introduction of the DST, (2) clarify your decision, (3) knowledge, (4) a value clarification exercise, (5) support system, and (6) next steps. Both Black clients and PrEP providers reported ease of task performance, general satisfaction, and usefulness of the tool to support decision-making for Black clients. Feedback on usability centered on the need to add a user guide to increase usability. All feedback was incorporated into the final tool. A PrEP DST for Black clients developed using a systematic process and a multidisciplinary steering committee was acceptable and usable by both Black clients and PrEP providers. Further study (eg, randomized controlled trials) may be needed to evaluate the efficacy of the PrEP DST.

Addressing barriers to implementing and scaling PrEP in carceral settings: Applying insights from implementation science.

Within the United States, individuals experiencing incarceration are at higher risk for HIV acquisition compared to the general population, yet may face additional difficulty engaging in HIV prevention clinical services. HIV pre-exposure prophylaxis (PrEP) is an effective approach to preventing HIV transmission, and the Centers for Disease Control (CDC) recommends that PrEP be offered in carceral settings, particularly during the vulnerable community re-entry period. However, there have been few efforts to scale PrEP in this setting. Based on our experience implementing PrEP in Rhode Island's state carceral system, we have identified potential approaches to overcoming barriers to PrEP use in this unique practice environment by utilizing the implementation research logic model (IRLM). We then evaluated specific implementation determinants and barriers as well as strategies used to overcome those barriers to effectively scale PrEP in this setting. We developed a "toolkit," or 14-step guide, for others in the field to use for implementing PrEP in carceral settings including the development and use of clinical protocols as well as community linkage strategies. Our experiences with barriers in the carceral setting, identifying and leveraging implementation strategies, allowed us to develop a "toolkit" to guide other PrEP implementation projects in carceral settings. We encourage others to scale-out our work to other carceral settings to better reach and engage a group of individuals both at elevated risk for HIV and currently underserved by HIV prevention strategies, including PrEP.

Bone density changes in young women in Uganda using tenofovir-based HIV pre-exposure prophylaxis and depot medroxyprogesterone acetate contraception

Background: Injectable depot medroxyprogesterone acetate (DMPA) is the most common contraceptive choice among young women in Uganda, where HIV burden is high and HIV pre-exposure prophylaxis (PrEP) may be offered. For young women who choose to use both agents concurrently, it is unknown whether they will experience declines in BMD beyond those elicited by either product singly. Methods: From 2018–2022, we conducted a 2-year prospective study with women ages 16–25 years in Kampala, Uganda desiring pregnancy and HIV prevention. Women were provided condoms, injectable DMPA, and/or FTC/TDF, according to their choices and underwent annual dual x-ray absorptiometry (DXA) scans. We used tenofovir-diphosphate (TFV-DP) quantification in dried blood spots and DMPA injection dates to classify exposure. Linear regression models estimated the difference in % BMD change from baseline to month 12 for women using FTC/TDF and DMPA versus women using neither product. Results: Of 499 enrolled women, discontinuation and re-starting of contraception and PrEP was common. Women consistently using neither product (n = 39) experienced BMD increases. Women with consistent use of both products during 1 year (n = 22) experienced an average BMD loss of 1.04% at lumbar spine and hip and 1.77% at femoral neck. These losses were different relative to women who used neither agent: lumbar spine -3.35% (95% CI −5.13%, −1.56%, p = 0.001), total hip −2.24% (95% CI −3.87%, −0.60%, p = 0.009), and femoral neck −1.71% (95% CI −3.73%, 0.31%, p = 0.102). Conclusion: We observed a trend for women with concurrent DMPA and FTC/TDF PrEP use to have 1–3% lower BMD than unexposed women after 12 months.

HIV Pre-Exposure Prophylaxis (PrEP) Users' Experiences of PrEP Access, Sexual Behaviour, and Well-Being During the COVID-19 Pandemic: A Welsh Qualitative Study.

HIV Pre-Exposure Prophylaxis (PrEP) has been available in Wales since 2017. The coronavirus disease (COVID-19) pandemic impacted UK sexual health services, leading to a reduction in service provision. There is a lack of research on the experiences of PrEP users during this time. We aimed to explore the experiences of PrEP users in Wales following the introduction of COVID-19 pandemic measures. We conducted a secondary data analysis of two prior interview studies (DO-PrEP and UPrEP). Data collection was undertaken between May 2020 and February 2021 using remote interviewing. Semi-structured interviews were conducted. Participants were ≥18 years of age, residents of Wales, current or previous PrEP users, and men who have sex with men (MSM). Reflexive thematic analysis was conducted. A total of 32 interviews were included in the analysis. Themes include the following: (1) PrEP use during COVID-19, (2) sexual behaviour and relationship changes following COVID-19 restrictions, (3) NHS service provision during the COVID-19 pandemic, and (4) wider contextual effects of the pandemic. Participants reported a change in PrEP use (pausing or switching to event-based PrEP). Participants reported reduced access to clinics and appointments. Support for changing to event-based PrEP was varied. Social isolation resulted in varied responses to lockdown rules, especially in later lockdowns. This study provides patient perspectives on the challenges the COVID-19 pandemic posed to PrEP use and access. It offers insights into the broader support needs around PrEP use when an individual's circumstances change. Flexible models of PrEP provision, which can be adapted to the patient's needs, will be essential as PrEP delivery extends into the wider community. Both the DO-PrEP and UPrEP studies received input from various stakeholders in the design of the topic guides for the study; these included public lay members, PrEP users, PrEP providers, and individuals involved with HIV advocacy and policy.

Syphilis testing, incidence, and reinfection among gay and bisexual men in Australia over a decade spanning HIV PrEP implementation: an analysis of surveillance data from 2012 to 2022

Gay and bisexual men (GBM) remain overrepresented among syphilis diagnoses in Australia and globally. The extent to which changes in sexual networks associated with HIV pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP) may have influenced syphilis transmission among GBM at the population-level is poorly understood. We describe trends in syphilis testing and incidence among GBM in Australia over eleven years spanning widespread uptake of HIV PrEP and TasP. We analysed linked clinical data from GBM aged 16 years or older across a sentinel surveillance network in Australia from January 1, 2012, to December 31, 2022. Individuals with at least two clinic visits and with at least two syphilis tests during the observations period were included in testing and incidence analyses, respectively. Annual rates of testing and infectious syphilis incidence from 2012 to 2022 were disaggregated by HIV status and PrEP use (record of PrEP prescription; retrospectively categorised as ever or never-PrEP user). Cox regression explored associations between demographics, PrEP use and history of bacterial sexually transmissible infections (STIs) and infectious syphilis diagnosis. Among 129,278 GBM (mean age, 34.6 years [SD, 12.2]) included in testing rate analyses, 7.4% were living with HIV at entry and 31.1% were prescribed PrEP at least once during the study period. Overall syphilis testing rate was 114.0/100 person-years (py) and highest among GBM with HIV (168.4/100 py). Syphilis testing increased from 72.8/100 py to 151.8/100 py; driven largely by increases among ever-PrEP users. Among 94,710 GBM included in incidence analyses, there were 14,710 syphilis infections diagnosed over 451,560 person-years (incidence rate=3.3/100 py). Syphilis incidence was highest among GBM with HIV (6.5/100 py), followed by ever-PrEP users (3.5/100 py) and never-PrEP users (1.4/100 py). From 2012 to 2022, syphilis incidence increased among ever-PrEP users from 1.3/100 py to 5.1/100 py, and fluctuated between 5.4/100 py and 6.6/100 py among GBM with HIV. In multivariable Cox regression, previous syphilis diagnosis (adjusted hazard ratio [aHR]=1.98, 95% CI=1.83-2.14), living with HIV (aHR=1.83, 95% CI=1.12-1.25) and recent (past 12m) prescription of PrEP (aHR=1.78, 95% CI=1.61-1.97) were associated with syphilis diagnosis. Syphilis trends between GBM with HIV and GBM with evidence of PrEP use have converged over the past decade in Australia. Our findings recommend targeting emergent syphilis control strategies (e.g. doxycycline post-exposure prophylaxis) to GBM with prior syphilis diagnoses, using HIV PrEP or who are living with HIV. Australian Department of Health and Aged Care, National Health and Medical Research Council.

Preferences for pre-exposure prophylaxis delivery via online pharmacy among potential users in Kenya: a discrete choice experiment.

Oral pre-exposure prophylaxis (PrEP) is highly effective, but coverage remains low in high HIV prevalence settings. Initiating and continuing PrEP remotely via online pharmacies is a promising strategy to expand PrEP uptake, but little is known about potential users' preferences. We conducted a discrete choice experiment (DCE) to assess preferences for online pharmacy PrEP services. We partnered with MYDAWA, an online pharmacy in Nairobi, Kenya. Eligibility criteria were: ≥18 years, not known HIV positive, interested in PrEP. The DCE contained four attributes: PrEP eligibility assessment (online self-assessed, guided), HIV test type (provider administered, oral HIV self-test [HIVST], blood-based HIVST), clinical consultation (remote, in-person) and user support options (text messages, phone/video call, email). Additionally, participants indicated whether they were willing to uptake their selected service. The survey was advertised on MYDAWA's website; interested participants met staff in-person at a convenient location to complete the survey from 1 June to 20 November 2022. We used conditional logit modelling with an interaction by current PrEP use to estimate overall preferences and latent class analysis (LCA) to assess preference heterogeneity. Overall, 772 participants completed the DCE; the mean age was 25 years and 54% were female. Most participants indicated a willingness to acquire online PrEP services, with particularly high demand among PrEP-naive individuals. Overall, participants preferred remote clinical consultation, HIV self-testing, online self-assessment and phone call user support. The LCA identified three subgroups: the "prefer online PrEP with remote components" group (60.3% of the sample) whose preferences aligned with the main analysis, the "prefer online PrEP with in-person components" group (20.7%), who preferred in-person consultation, provider-administered HIV testing, and guided assessment, and the "prefer remote PrEP (18.9%)" group who preferred online PrEP services only if they were remote. Online pharmacy PrEP is highly acceptable and may expand PrEP coverage to those interested in PrEP but not accessing services. Most participants valued privacy and autonomy, preferring HIVST and remote provider interactions. However, when needing support for questions regarding PrEP, participants preferred phone/SMS contact with a provider. One-fifth of participants preferred online PrEP with in-person components, suggesting that providing multiple options can increase uptake.

Awareness of, willingness to use, and experiences with Pre-exposure prophylaxis among youth in Nigeria

BackgroundYouth (ages 14–24) in Nigeria have disproportionately high rates of new HIV infection. Pre-exposure prophylaxis could substantially reduce new infections among youth but has not been scaled up. This cross-sectional study aimed to assess Pre-exposure prophylaxis awareness, willingness to use, and prior use of Pre-exposure prophylaxis among youth in Nigeria.MethodsThis is a secondary analysis of cross-sectional data from a quasi-experimental pilot study (clinical trial NCT04070287). The analysis focused on Pre-exposure prophylaxis awareness, willingness to use, and prior use among 324 youth recruited between September 2019 to March 2020. Descriptive statistics were calculated as frequencies and percentages for categorical variables and means and standard deviations for continuous variables.ResultsOf the 324 participants, the mean age and standard deviation were 21.17 (± 2.20) years. The majority were 20–24 years old (75.9%) and male (57.7%). Only 30.7% used condoms consistently over three months. Regarding Pre-exposure prophylaxis awareness and willingness, 62.6% had never heard of Pre-exposure prophylaxis, and 158 (50.1%) reported willingness to use Pre-exposure prophylaxis. Only 10 (3.2%) reported having used Pre-exposure prophylaxis.ConclusionNigerian youth have low awareness of and prior use of Pre-exposure prophylaxis. Given the gap between prior use and willingness to use Pre-exposure prophylaxis, our findings suggest missed opportunities to prevent new HIV infections among youth in Nigeria. Efforts to increase awareness and uptake of Pre-exposure prophylaxis among this population should consider youth-led Pre-exposure prophylaxis outreach efforts and effectively communicate the benefits of Pre-exposure prophylaxis to this population.Trial RegistrationNCT04070287, the Date of registration of the trial is 20-07-2019.

Evaluating the impact of HIV pre-exposure prophylaxis on pregnancy, infant, and maternal health outcomes in Malawi: PrIMO study protocol

BackgroundIncident HIV during the perinatal period significantly impedes elimination of Mother-to-Child HIV Transmission (eMTCT) efforts. Pre-Exposure Prophylaxis (PrEP) effectively reduces HIV acquisition, and new agents like injectable Cabotegravir (CAB-LA) offer potential advantages for pregnant and breastfeeding women. The Pregnancy, Infant, and Maternal health Outcomes (PrIMO) study will compare rates of composite adverse pregnancy outcomes, and infant adverse events, growth and neurodevelopment between mother-infant dyads receiving CAB-LA and those receiving oral PrEP in Malawi.MethodsPrIMO is an observational cohort study involving: (1) the development of a PrEP Pregnancy Registry for longitudinal surveillance of pregnant women on PrEP in Malawi; and (2) the enrolment of a prospective safety cohort of 621 pregnant women initiating oral PrEP or CAB-LA and their subsequent infants. The registry will include all women continuing or initiating PrEP during pregnancy across targeted sites in Lilongwe and Blantyre districts. The safety cohort will enrol a subset of those women and their infants from Bwaila District Hospital in Lilongwe, Malawi. We hypothesize that CAB-LA’s safety will be comparable to daily oral PrEP regarding adverse pregnancy outcomes, maternal/infant adverse events, and infant development. Participants in the cohort will choose either oral PrEP or CAB-LA and will be followed until 52 weeks post-delivery. Safety data will be collected from all mother-infant pairs and qualitative interviews will be conducted with a subset of purposively selected women (n = 50) to assess the acceptability of each PrEP modality.DiscussionThe PrIMO study will provide critical data on the safety of CAB-LA in pregnant and breastfeeding women and their infants. Results will guide clinical recommendations as the Malawi Ministry of Health prepares for the rollout of CAB-LA to this population. Evaluation of Registry implementation will inform its expansion to a nationwide safety monitoring system for PrEP use during pregnancy, with implications for similar systems in the region.Trial Registration numberNCT06158126. The study was prospectively registered (5 December 2023) in ClinicalTrials.gov.

Trajectories of Adherence to Oral Pre-exposure Prophylaxis and Risks of HIV and Sexually Transmitted Infections.

Pre-exposure prophylaxis (PrEP) effectiveness is highly dependent on medication adherence, which is associated with differential HIV risks and possibly sexually transmitted infection (STI). This retrospective cohort study of PrEP users (01/01/2012-12/31/2021) used the MarketScan database of commercially insured enrollees to examine PrEP adherence trajectory groups' associations with HIV and STI acquisition risks. Distinct PrEP adherence trajectories were identified by group-based trajectory modeling among individuals who used oral PrEP. The primary outcome was HIV acquisition incidence, and secondary was STI rate, compared among trajectory groups. Inverse probability treatment weighting time-varying Cox proportional hazards models assessed HIV acquisition, and Poisson regression models assessed STI. Among 23 258 oral PrEP users, 4 distinct PrEP adherence patterns were identified: minimal use (10.5% of the cohort), rapidly declining (25.4%), gradually declining (24.3%), and consistently high (39.8%). Compared with the minimal use group, the gradually declining (adjusted hazard ratio [AHR], 0.53; 95% CI, 0.31-0.90) and consistently high (AHR, 0.50; 95% CI, 0.30-0.84) PrEP adherence groups showed decreased HIV incidence risks. Compared with the minimal use group, the rapidly declining (adjusted incidence rate ratio [AIRR], 1.35; 95% CI, 1.07-1.72), gradually declining (AIRR, 1.73; 95% CI, 1.38-2.18), and consistently high (AIRR, 2.06; 95% CI, 1.64-2.58) groups were associated with increased STI risk. These findings underscore the benefits of continuing and remaining adherent to PrEP and may also inform public health strategies, clinical guidelines, and interventions aimed at maximizing the effectiveness of PrEP in reducing new HIV infections while developing targeted strategies to prevent STIs with PrEP use.

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.

Applying CFIR to assess multi-level barriers to PrEP delivery in rural South Africa: Processes, gaps and opportunities for service delivery of current and future PrEP modalities

Despite established efficacy for oral pre-exposure prophylaxis (PrEP) in reducing HIV incidence, multi-level barriers within the health system, clinics, and the processes that shape practice have hindered service delivery and subsequent population-level effects. We applied the Consolidated Framework for Implementation Research (CFIR) to assess the context of PrEP delivery for adolescent girls and young women (AGYW) in rural South Africa and identify the factors supporting and impeding PrEP implementation to develop strategies to improve PrEP delivery. Between 2021 and 2022, we conducted in-depth interviews with five young women with PrEP use experience and 11 healthcare providers as well as four key informant stakeholder interviews. Tailored interviews organized around the CFIR domains provided multiple perspectives on the inter-connected processes, gaps, and opportunities between health systems, clinics, communities, and PrEP services. Shifts in PrEP policies, funding pressures, and inconsistent communications from the National Department of Health spurred fragmented planning, engagement, execution, and monitoring of PrEP delivery processes within clinics already struggling to address multiple population health needs. Resulting challenges included: conflicting priorities within clinics and across NGO partners, unclear goals and targets, staffing and space constraints, and insufficient community engagement. Individual clinics’ implementation climate and readiness to deliver PrEP varied in terms of operational plans and delivery models. Interviewees reported complexity of initiation procedures and support for PrEP maintenance, with opportunities to improve systems communications and processes to facilitate integrated services and more user-friendly experiences. Applying CFIR identified opportunities to strengthen PrEP delivery across levels within this complex service delivery setting.

Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: Protocol for a Randomized Controlled Trial.

HIV prevention is a public health priority. Despite progress in recent years, pre-exposure prophylaxis (PrEP) use remains suboptimal especially among groups disproportionately impacted by new HIV diagnoses such as gender and sexual minorities of color. Multiple barriers including a lack of PrEP providers and challenges with attending quarterly monitoring visits contribute to low PrEP uptake and retention. Home-based PrEP (HB-PrEP) services could reduce stigma, increase convenience, expand health system capacity for PrEP care, and improve PrEP retention. Home Option Testing for PrEP (HOT4PrEP) is a hybrid randomized controlled trial (RCT) that aims to examine whether HB-PrEP care is acceptable to PrEP users, feasible to implement in a sexual health clinic setting, and impacts PrEP retention. The RCT will recruit 458 persons currently taking or soon to initiate PrEP at a sexual health clinic in Seattle, Washington, and randomize them to continue the standard of care or have the option to use HB-PrEP for 2 of 3 triannual PrEP follow-up visits. Participants in the intervention arm will be sent home kits containing gonorrhea and chlamydia swabs and Tasso devices for blood self-collection. The primary outcome is PrEP retention between groups at 20 months; secondary outcomes include user satisfaction and acceptability, feasibility, self-reported PrEP adherence, and sexually transmitted infection (STI) incidence. Interviews with PrEP users and clinic staff will elucidate barriers and facilitators of implementation. The HOT4PrEP RCT began enrolling in March 2022, was on hold during the height of the US mpox epidemic, then resumed enrollment in December 2022. Of the first 100 enrollees, the median age is 34 years, and most are cisgender gay men (89/100, 89%) with at least some college education (91/100, 91%). Among the 49 participants randomized to the HB-PrEP option, 33 (67%) chose to self-collect samples at home at least once, of whom 27 (82%) successfully returned test kits for HIV and STI testing. Primary PrEP retention and qualitative analyses are ongoing. Implementation of HB-PrEP into a high-volume sexual health clinic seems to be feasible and acceptable to early RCT enrollees. This strategy has the potential to address individual and systemic barriers associated with initiating and persisting on PrEP, such as increasing sexual health agency and expanding clinical capacity to serve greater numbers of PrEP users. ClinicalTrials.gov NCT05856942; https://clinicaltrials.gov/study/NCT05856942. DERR1-10.2196/56587.

Oral HIV pre-exposure prophylaxis use and resistance-associated mutations among men who have sex with men and transgender persons newly diagnosed with HIV in the Netherlands: results from the ATHENA cohort, 2018 to 2022.

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.

HIV Preexposure Prophylaxis Use Among U.S. Veterans using Veterans Health Administration Services, 2014─2022

Objectives. It is important to monitor national HIV preexposure prophylaxis (PrEP) use in the United States. However, PrEP use data in the Veterans Health Administration (VHA) system are not included in the current monitoring surveillance. To address this gap, we examined the trends in PrEP use among U.S. Veterans receiving health services in the VHA system. Methods. We analyzed 2014-2022 VHA data to identify the annual number and prevalence of persons aged ≥18 years prescribed PrEP, stratified by sex, age, race and ethnicity, and region. We also assessed trends by calculating the estimated annual percent change (EAPC) and 95% confidence intervals (CIs) using Poisson models. Results. The number of Veterans prescribed PrEP increased from 361 in 2014 to 6,050 in 2022 with an EAPC of 29.6% (95% CI, 22.6–37.1). Of 6,050 Veterans with PrEP prescriptions in 2022, 95.2% were men, 4.8% were women, 50.4% were White, 24.5% Black or African American (Black) and 14.0% Hispanic or Latino. The prevalence of Black and Hispanic or Latino individuals prescribed PrEP increased significantly from 2014-2022. Conclusion. VHA data fill a gap in monitoring PrEP use in the United States. We observed an increasing trend in the number of Veterans prescribed PrEP similar to trends among persons with commercial or public health insurance.

PrEP Stigma as a Minority Stressor among Black Sexual Minority Men: A Mixed-Methods Study.

Black sexual minority men (BSMM) remain disproportionately affected by HIV, yet Pre-exposure prophylaxis (PrEP) uptake in this population remains relatively low. Informed by minority stress theory, PrEP stigma may manifest in and exacerbate societal marginalization based on sexuality and race. We used an exploratory sequential mixed-methods approach to determine if PrEP-specific stigma was associated with reduced PrEP uptake among BSMM, and qualitatively explored how PrEP use is stigmatized among BSMM. We analyzed cross-sectional data from a pilot sample of BSMM (n = 151) collected in late 2020 in the United States, testing for associations between PrEP stigma and PrEP use using modified Poisson regression. Subsequently, we selected participants (n = 23) from this sample for qualitative interviews starting in 2022. Responses to questions related to PrEP stigma were analyzed using thematic analysis. PrEP stigma was associated less than half the PrEP use (aPR = 0.43, 95% CI = 0.24, 0.75) among BSMM after adjustment. Qualitatively, we identified three major themes in how PrEP use is stigmatized among BSMM: PrEP-specific sexual stigma, intersections between PrEP and HIV stigma, and PrEP misinformation and disinformation. Aligned with minority stress theory, each theme was based in part in stigma related to sexuality or race. We found strong relationships between PrEP stigma and PrEP use independent of several sociobehavioral factors. Each of our themes were based in part in minority stressors, and underscore the importance of culturally competent PrEP promotion efforts towards BSMM. Addressing stigma is a core component of health equity efforts towards ending the HIV epidemic.

Profile of Persons Recently Infected with HIV-1 in Belgium: New Insights to Tailor Prevention Efforts.

Despite wide availability of prevention and treatment services, including the ongoing roll-out of pre-exposure prophylaxis (PrEP), the HIV epidemic is not under control in Belgium. Hence, there is a recognized need to improve case finding and early diagnosis to curb the further spread of HIV more effectively. The objective of the present study was to improve insight into the profiles of persons recently infected with HIV-1 and on their prevention trajectory. Between May 2018 and December 2022, we selected persons diagnosed in Belgium within three months of the presumed infection date. We then analyzed information collected using a questionnaire covering topics on HIV testing, sexually transmitted infections (STIs), PrEP use, sexual behavior, partner notification and substance use. The data obtained were analyzed alongside information derived from phylogenetic cluster analysis of the viral source of infection. A total of 93 persons with a recent HIV-1 infection completed the questionnaire, the majority (74%) being MSM, 14% were heterosexual women and 12% were heterosexual men. Nearly one-third of participants engaged in sexual activity with an average of 2 to 5 casual partners around the presumed time of infection. A significant percentage reported frequent substance use during sexual activity (65%), being previously diagnosed with STI (65%) and using condoms infrequently (44%). 63% reported a testing frequency of at least one HIV test per year before being diagnosed and 46% notified their previous sex partner(s) after being diagnosed. Over 20% of respondents (including 11 MSM, 4 heterosexual men and 5 heterosexual women) reported exclusive sexual activity with their steady partner. Eight participants (9%, all MSM, 75% born outside of Belgium) reported PrEP use in the past. No significant differences in behavioral characteristics were found between persons who were part of a local transmission cluster (48%) and persons that were not part of a cluster (47%). The study results revealed that the majority of persons diagnosed early with HIV-1 infection in Belgium exhibited characteristics corresponding to a high-at-risk population and were aware of this risk, as evidenced by a high testing frequency. However, partner notification rates were low and use and awareness of PrEP limited. A notable group of persons not corresponding to the high-risk profiles was also identified. This information may help to expose missed opportunities for prevention and contribute to enhancing the implementation of future prevention measures.

Low HIV Testing and PrEP Uptake of Adolescent and Young Men who have Sex with Men in Vietnam.

Little is known about HIV testing, pre-exposure prophylaxis (PrEP) awareness and uptake among adolescent and young men who have sex with men (AYMSM) in Vietnam. We conducted an online survey among AYMSM in Vietnam to determine the prevalence of HIV testing, PrEP awareness, uptake and their correlates. From December 2022-March 2023, 120 HIV-negative AYMSM from 15 to 19 years old in Hanoi and Ho Chi Minh city, Vietnam were recruited through peer referral to complete an online survey, which included questions on demographics, sexual behaviors, HIV risk perception and knowledge, HIV and sexually transmitted infections (STI) testing, PrEP awareness and uptake. Separate multivariable models were used to determine the correlates of HIV testing, PrEP awareness and uptake. Only 58% of participants had ever been tested for HIV. The majority of participants had heard of PrEP before (82%), but only 36% had ever used PrEP. HIV knowledge (aPR (adjusted prevalence ratio) = 1.59; 95%CI:1.06-2.39), a history of STI testing (aPR = 1.32; 95%CI:1.06-1.64), having had anal sex with another man (aPR = 4.49; 95%CI:1.40-14.38) and lower HIV risk perception (aPR = 0.62; 95%CI:0.47-0.83) were associated with HIV testing. HIV knowledge (aPR = 1.38; 95%CI:1.06-1.78) and a history of STI testing (aPR = 1.16; 95%CI:1.03-1.32) were also associated with PrEP awareness. Higher HIV risk perception was negatively associated with PrEP use (aPR = 0.59; 95%CI:0.35-0.99). Our findings underscored the urgent need for further research to explore the causes of the gaps in HIV testing and PrEP use as well as to design innovative interventions tailored to the needs of AYMSM to support HIV testing and PrEP use.