Pre-exposure Prophylaxis Roll-out Research Articles

Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men

BackgroundGay, bisexual, and other men who have sex with men (GBMSM) represent a high-risk group for HIV transmission in Romania, yet they possess few resources for prevention. Despite having no formal access to pre-exposure prophylaxis (PrEP) through the health system, GBMSM in Romania demonstrate a high need for and interest in this medication. In anticipation of a national rollout of PrEP, this study tests the efficacy of a novel strategy, Prepare Romania, that combines two evidence-based PrEP promotion interventions for GBMSM living in Romania.MethodsThis study uses a randomized controlled trial design to examine whether GBMSM living in Romania receiving Prepare Romania, a culturally adapted counseling and mobile health intervention (expected n = 60), demonstrate greater PrEP adherence and persistence than those assigned to a PrEP education control arm (expected n = 60). Participants from two main cities in Romania are prescribed PrEP and followed-up at 3 and 6 months post-randomization. PrEP adherence data are obtained through weekly self-report surveys and dried blood spot testing at follow-up visits. Potential mediators (e.g., PrEP use motivation) of intervention efficacy are also assessed. Furthermore, Prepare Romania’s implementation (e.g., proportion of enrolled participants attending medical visits, intervention experience) will be examined through interviews with participants, study implementers, and healthcare officials.DiscussionThe knowledge gained from this study will be utilized for further refinement and scale-up of Prepare Romania for a future multi-city effectiveness trial. By studying the efficacy of tools to support PrEP adherence and persistence, this research has the potential to lay the groundwork for PrEP rollout in Romania and similar contexts.Trial registrationThis study was registered on ClinicalTrials.gov, identifier NCT05323123, on March 25, 2022.

Exploring factors hindering the uptake of HIV pre-exposure prophylaxis by potential users in Namibia.

Pre-exposure prophylaxis (PrEP) is recommended for people who are at substantial risk of HIV infection, in conjunction with other HIV prevention tools and strategies. Unfortunately, the uptake of PrEP among potential users in Namibia's Okongo district is low. The objective of this study was to explore and describe the factors that hinder the uptake of HIV PrEP by potential users at the Okongo District Hospital in Namibia. A qualitative exploratory, descriptive and contextual design was used. The study sought to understand the factors hindering uptake of HIV PrEP by potential users in the peri-urban setting of Okongo District Hospital, Namibia. Purposive sampling was used to select participants for this study, with qualitative data being gathered from semi-structured interviews with 20 potential PrEP users. The data were analysed using qualitative thematic analysis. Participants reported numerous factors hindering uptake, including level of understanding, non-compliance on the part of the health department, distances, and attitudes. Additionally, participants maintained that health workers do not put enough effort into educating patients in the different hospital departments about PrEP, and sometimes there is insufficient stock of the medicine, both of which hinder PrEP uptake. Despite the PrEP rollout, multiple obstacles continue to hinder PrEP uptake, especially in the outskirts of Okongo district. This study recognises that there is a need to work hand in hand with the support systems of both potential users.

Barriers and Facilitators to Long-Acting Injectable HIV Pre-Exposure Prophylaxis Implementation in Primary Care Since Its Approval in the United States.

HIV pre-exposure prophylaxis (PrEP) is a highly effective method to mitigate the HIV epidemic, but uptake of PrEP has been slow and is associated with racial and gender disparities. Oral PrEP requires high levels of adherence to be effective, which may disadvantage certain high-risk groups. The first injectable HIV PrEP, a drug given every 2 months rather than as a daily pill, was approved by the US Food & Drug Administration in December 2021. A Family Medicine practice in a single health organization in the United States (November 2022 to February 2023). We conducted interviews with patients and key stakeholders to characterize factors affecting long-acting injectable (LAI) PrEP implementation. Data collection and analysis were guided by the Consolidated Framework for Implementation Research. Interviews were transcribed and analyzed using guided content analysis. Twenty-five patients (n = 13) and practice stakeholders (n = 12) were interviewed. Overall, stakeholders described a very low uptake of LAI PrEP. Barriers to LAI PrEP included a lack of awareness, insurance and access issues, a lack of streamlined workflow, and a trust in pills over injectables. Facilitators to LAI PrEP implementation included the absence of a pill burden, a culture of shared decision making, and pharmacy support. Although uptake has been slow, we have identified several promising strategies for improving rollout and implementation of LAI PrEP. Approaches that can bolster rollout of LAI PrEP include having an interdisciplinary care team that is supported by PrEP navigators and pharmacists and are informed by a patient-centered model of care to increase patient engagement and trust.

Exploring Attitudes Toward Pre-Exposure Prophylaxis for HIV Prevention Prior to Implementation Among Female Sex Workers in Malaysia: Results from a Qualitative Study.

Pre-exposure prophylaxis (PrEP) is an effective method for prevention of HIV transmission. Female sex workers (FSW) in Malaysia are at substantially increased risk of acquiring HIV compared to the general female population, yet little is known about this population's current HIV prevention practices or acceptance of PrEP. This study aims to inform the culturally relevant implementation of PrEP through the qualitative exploration of (1) the potential need for PrEP in this population and (2) the factors that determine FSW willingness to use oral PrEP. In-depth, semi-structured interviews (n = 30) were conducted with FSW in English, Malay, or Tamil. Transcribed and translated interviews were analyzed using a grounded theory approach. FSW express positive interest in PrEP but prefer it as a supplement to condoms, not a replacement. Perceived challenges to PrEP use include cost, adherence, and side effects. The findings suggest that in combination with condom use, PrEP may be an acceptable method of HIV prevention. Effective PrEP rollout may also include condom promotion using a peer-driven model, cost subsidies, and sex work harm reduction and empowerment components.

Implementing Differentiated and Integrated HIV Prevention Services for Adolescent Girls and Young Women: Experiences From Oral PrEP Rollout in Primary Care Services in South Africa

PurposeIn South Africa, adolescent girls and young women (AGYW, aged 15–24 years) are disproportionately affected by human immunodeficiency viruses (HIV). Oral pre-exposure prophylaxis (PrEP) has been available in South Africa since 2016; however, there is limited evidence on oral PrEP implementation and integration in real-world settings, particularly among AGYW. Project PrEP is an implementation science project that sought to inform the introduction and integration of oral PrEP as part of combination HIV prevention and sexual and reproductive health services (SRH) in South Africa. The project focused on AGYW, as a priority population in need of HIV prevention. This paper presents strategies Project PrEP employed to increase oral PrEP and SRH service access and utilization. MethodsWe present strategies employed to increase oral PrEP and SRH services uptake. Using routine monitoring data, facility assessments, stakeholder engagement, training and progress reports, and observations, we share implementation lessons learned and describe how strategies can be adapted by HIV prevention programs in different contexts. ResultsApproximately 22, 000 people initiated on oral PrEP (December 2018–December 2021) across eight facilities and four mobile clinics. Two-thirds (67%) of initiated clients were AGYW. DiscussionLessons are to be learned from the introduction of oral PrEP as implementers prepare for the introduction of new PrEP methods. Stakeholders must be continuously engaged to ensure buy-in, and social mobilization and demand creation should be contextual, focused, and innovative. Continuous staff training is needed to reinforce knowledge, and AGYW service delivery models must be local context relevant.

Developing evidence-informed indicators to monitor HIV pre-exposure prophylaxis programmes across EU/EEA countries: a multi-stakeholder consensus.

Several countries in the European Union (EU) and European Economic Area (EEA) established and/or scaled up HIV pre-exposure prophylaxis (PrEP) programmes between 2016 and 2023. Data on PrEP programmes' performance and effectiveness in reaching those most in need will be needed to assess regional progress in the roll-out of PrEP. However, there is a lack of commonly defined indicators for routine monitoring to allow for minimum comparability. We propose a harmonised PrEP monitoring approach for the EU/EEA, based on a systematic and evidence-informed consensus-building process involving a broad and multidisciplinary expert panel. We present a set of indicators, structured along relevant steps of an adapted PrEP care continuum, and offer a prioritisation based on the degree of consensus among the expert panel. We distinguish between 'core' indicators deemed essential for any PrEP programme in the EU/EEA, vs 'supplementary' and 'optional' indicators that provide meaningful data, yet where experts evaluated their feasibility for data collection and reporting as very context-dependent. By combining a standardised approach with strategic opportunities for adaptation and complementary research, this monitoring framework will contribute to assess the impact of PrEP on the HIV epidemic in Europe.

Motivators for oral PrEP uptake and adherence in the eThekwini municipality, KwaZulu-Natal

ABSTRACT Pre-exposure prophylaxis (PrEP) is a single daily pill that prevents a seropositive HIV status. Since 2016, South Africa has staggered PrEP roll-out, with uptake levels not reaching optimal goals. The aim of this study was to determine motivation behind PrEP initiation and adherence among South African users. A phenomenological qualitative study (n = 15) was used. Participants were purposively recruited from two primary healthcare clinics in eThekwini, KwaZulu-Natal. Thematic analysis was used to analyse the data. Three themes were identified: motivation for PrEP uptake, PrEP adherence and PrEP awareness. Initiation was influenced by healthcare professionals. Responsibility for one’s well-being, serodiscordant relationships and sexual partner’s behavioural patterns contributed toward initiation. Most were fully compliant, using reminders to negate medication forgetfulness. The internet and healthcare professionals served as information sources, however, few were aware of PrEP prior to this. Innovative ways are required to increase awareness levels and increase uptake.

Preferences and acceptability for long-acting PrEP agents among pregnant and postpartum women with experience using daily oral PrEP in South Africa and Kenya.

Long-acting pre-exposure prophylaxis (PrEP) options could overcome barriers to oral PrEP persistence during pregnancy and postpartum. We evaluated long-acting PrEP preferences among oral PrEP-experienced pregnant and postpartum women in South Africa and Kenya, countries with high PrEP coverage with pending regulatory approvals for long-acting injectable cabotegravir and the dapivirine vaginal ring (approved in South Africa, under review in Kenya). From September 2021 to February 2022, we surveyed pregnant and postpartum women enrolled in oral PrEP studies in South Africa and Kenya. We evaluated oral PrEP attitudes and preferences for long-acting PrEP methods in multivariable logistic regression models adjusting for maternal age and country. We surveyed 190 women in South Africa (67% postpartum; median age 27 years [IQR = 22-32]) and 204 women in Kenya (79% postpartum; median age 29 years [IQR = 25-33]). Seventy-five percent of participants reported oral PrEP use within the last 30 days. Overall, forty-nine percent of participants reported negative oral PrEP attributes, including side effects (21% South Africa, 30% Kenya) and pill burden (20% South Africa, 25% Kenya). Preferred PrEP attributes included long-acting method, effectiveness, safety while pregnant and breastfeeding, and free medication. Most participants (75%, South Africa and Kenya) preferred a potential long-acting injectable over oral PrEP, most frequently for a longer duration of effectiveness in South Africa (87% South Africa, 42% Kenya) versus discretion in Kenya (5% South Africa, 49% Kenya). Eighty-seven percent of participants preferred oral PrEP over a potential long-acting vaginal ring, mostly due to concern about possible discomfort with vaginal insertion (82% South Africa, 48% Kenya). Significant predictors of long-acting PrEP preference included past use of injectable contraceptive (aOR = 2.48, 95% CI: 1.34, 4.57), disliking at least one oral PrEP attribute (aOR = 1.72, 95% CI: 1.05, 2.80) and preferring infrequent PrEP use (aOR = 1.58, 95% CI: 0.94, 2.65). Oral PrEP-experienced pregnant and postpartum women expressed a theoretical preference for long-acting injectable PrEP over other modalities, demonstrating potential acceptability among a key population who must be at the forefront of injectable PrEP rollout. Reasons for PrEP preferences differed by country, emphasizing the importance of increasing context-specific options and choice of PrEP modalities for pregnant and postpartum women.

Strategies to improve PrEP uptake among West African men who have sex with men: a multi-country qualitative study.

West African men who have sex with men (MSM) remain at substantial risk of contracting HIV. Pre-exposure prophylaxis (PrEP) can be an effective game-changer in reducing the number of HIV infections in MSM communities. To optimize the roll-out of PrEP, we need to better understand how we can increase its uptake. The objective of this study was to explore the perceptions of West African MSM toward PrEP and their proposed strategies to overcome barriers to PrEP uptake within their communities. Between April 2019 and November 2021, we conducted 12 focus group discussions with 97 MSM not taking PrEP, and 64 semi-structured interviews with MSM taking PrEP, in Burkina Faso, Côte d'Ivoire, Mali, and Togo. Data collection and analysis were guided and conducted by local research teams, enabling a community-based participatory approach. A coordinating researcher collaborated with these local teams to analyze the data guided by a grounded theory approach. The results show that participants were generally positive toward PrEP and that MSM communities have become more aware of PrEP for the study. We identified three main strategies for increasing PrEP uptake. First, participants proposed to raise awareness and improve knowledge of HIV as they considered the self-perceived risk of MSM in their communities to be low. Second, because of existing misconceptions and false information, participants proposed to improve the dissemination of PrEP to allow for informed choices, e.g., via peers or PrEP users themselves. Third, as oral PrEP also entails a risk of being associated with HIV or homosexuality, strategies to avoid stigmatization (e.g., hiding pills) were deemed important. These findings indicate that the roll-out of oral PrEP and other future PrEP modalities should be accompanied by raising awareness and improving knowledge on HIV, and wide dissemination of information that focuses on the health-promoting aspect of these tools. Tailored delivery and long-acting PrEP modalities will be important to avoid potential stigmatization. Sustained efforts to prevent discrimination and stigmatization based on HIV status or sexual orientation continue to be highly important strategies to address the HIV epidemic in West Africa.

Roll-out and effectiveness of HIV pre-exposure prophylaxis in France: An overview

Oral HIV pre-exposure prophylaxis (PrEP) has been available and fully reimbursed for people at high risk of sexually acquired HIV infection in France since January 2016. To evaluate the roll-out of PrEP use in France and its real-life effectiveness. The main results of two previously published studies were presented at the second e-congress of the EPI-PHARE scientific interest group on pharmacoepidemiology and public decision support held in June 2022, and are reported in this article. Two studies were carried out using the French National Health Data System (SNDS) covering 99% of the French population. A first study aimed to evaluate the roll-out of PrEP use in France from its implementation until June 2021, globally over the entire study period, including an assessment of the impact of the coronavirus disease 2019 (COVID-19) pandemic that started in February 2020 in France. A second study using a nested case-control design was conducted in a cohort of men at high risk of HIV acquisition included between January 2016 and June 2020 to assess the effectiveness of PrEP in the real world. As of 30 June 2021, a total of 42159 people had initiated PrEP in France. Initiations increased steadily until February 2020, then slowed down sharply from the start of the COVID-19 pandemic and resumed from the first half of 2021. PrEP users were overwhelmingly men (98%), with an average age of 36 years, living in a large urban area (74%), and of whom a minority (7%) were socioeconomically disadvantaged. Throughout the study period, the level of PrEP maintenance from one semester to the next was high (80-90%). However, for 20% of PrEP initiators, no prescription renewals were recorded during the first six months, suggesting a substantial proportion of early treatment discontinuation. A minority (21%) of PrEP renewal prescriptions were made by private practitioners. Among 46706 men at high risk of HIV infection, 256 patients identified with HIV infection were matched with 1213 controls. PrEP was used by 29% of cases and 49% of controls. Overall, PrEP effectiveness reached 60% (95% confidence interval 46% to 71%), and was increased in people with high PrEP use (93% (84% to 97%)), or after excluding periods of treatment discontinuation (86% (79% to 92%)). PrEP effectiveness was significantly reduced in people under 30 years of age (26% (-21% to 54%)) and in socioeconomically disadvantaged people (-64% (-392% to 45%)), for whom low PrEP uptake rates or high PrEP discontinuation rates were frequently observed. PrEP roll-out has been strongly impacted by the COVID-19 pandemic in France. Although it has been substantial among men who have sex with men, additional measures are needed to expand access to PrEP to all other population groups that could benefit from it. Promoting adherence to PrEP (especially among young people and the socioeconomically disadvantaged) will be essential to ensure a higher level of PrEP effectiveness, which has been shown to be lower in real-life settings than in clinical trials.

Provider perspectives on service delivery modifications to maintain access to HIV pre‐exposure prophylaxis during the COVID‐19 pandemic: qualitative results from a PrEP implementation project in Kenya

HIV pre-exposure prophylaxis (PrEP) is an essential prevention strategy being scaled up for priority populations in Kenya, including for HIV serodiscordant couples. The COVID-19 pandemic posed challenges to PrEP rollout. We conducted a qualitative study of PrEP providers to understand how clinics adjusted PrEP delivery during the COVID-19 pandemic. Since 2017, the Partners Scale-Up Project has integrated PrEP into 25 HIV clinics in Central and Western Kenya. We conducted qualitative interviews with 40 purposively sampled clinic personnel. We interviewed personnel once during the first pandemic wave (May-Aug 2020) and again after some decline in COVID-19 rates (Nov-Jan 2021). We analysed data using inductive memo-writing and summarized data by themes along the PrEP delivery cascade, guided by the Framework for Reporting Adaptation and Modifications (FRAME). We interviewed 27 clinical officers, five nurses, four health records and information officers, and four counsellors from Central (n=20) and Western (n=20) Kenya. About half (n=19) were female, with a median age of 32 (IQR: 29-34) and 2.3 years of experience delivering PrEP (IQR: 2-3). All participants reported clinic changes in PrEP demand creation and service delivery during the pandemic. Modifications occurred during PrEP implementation and sustainment phases, were partly reactive to the pandemic and also facilitated by interim Ministry of Health guidance on PrEP delivery during COVID, and were made by PrEP delivery teams, clients and clinic managers. Commonly reported modifications included dispensing multiple-month PrEP refills, intensifying phone-based client engagement and collaborating with other HIV clinics to ensure that clients with prolonged stays in other regions could continue to access PrEP. Some clinics also adopted practices to streamline visits, such as within clinical-room PrEP dispensing, pre-packing PrEP and task-shifting. Most providers liked these changes and hoped they would continue after the pandemic subsides. COVID-19 served as a catalyst for PrEP delivery innovations in Kenya. HIV clinics successfully and rapidly adapted their PrEP demand creation, refill and retention strategies to promote PrEP uptake and effective use. These modified implementation strategies highlight opportunities to streamline the delivery of PrEP, as well as other HIV and chronic care services, and strengthen engagement with populations post-pandemic.

Knowledge and attitudes about HIV pre-exposure prophylaxis: Evidence from in-depth interviews and focus group discussions with policy makers, healthcare providers, and end-users in Lesotho.

Studies on knowledge and attitudes about HIV pre-exposure prophylaxis (PrEP) have mostly focused on key populations in North America and Europe. To inform Lesotho's national rollout of PrEP to the general population, this study aimed to characterize knowledge and attitudes about PrEP among policy makers, implementing partners, healthcare providers, and PrEP end-users in Lesotho. Respondents were purposively selected to participate based on personal experience in the development and implementation of Lesotho's PrEP program, or the personal use of PrEP. We conducted 106 in-depth interviews with policy makers (n = 5), implementing partners (n = 4), and end-users (current PrEP users = 55; former PrEP users = 36; and PrEP "decliners" = 6). In addition, we held 11 focus group discussions (FGDs) with a total of 105 healthcare providers. Interview and FGD transcripts were analyzed following the tenets of Grounded Theory. Respondents expressed positive attitudes toward PrEP, owing to experienced and perceived personal, familial, and societal benefits. PrEP was viewed as i) an opportunity for serodiscordant couples to remain together, ii) a means of conceiving children with minimized risk of HIV infection, iii) providing a sense of agency and control, and iv) an avenue for addressing the HIV epidemic in Lesotho. Respondents demonstrated understanding of PrEP's intended use, eligibility requirements, and modality of use. However, respondents also reported that several important misconceptions of PrEP were common among adults in Lesotho, including a belief that PrEP protects against sexually transmitted infections other than HIV, promotes promiscuity, prevents pregnancy, causes seroconversion, and provides lifelong protection from taking the pill just once. In addition to building on the perceived advantages of PrEP to shape a positive message, Lesotho's national rollout of PrEP will likely benefit from a communication strategy that specifically addresses the common misconceptions of PrEP identified in this study.

Low incidence of HIV infection and decreasing incidence of sexually transmitted infections among PrEP users in 2020 in Germany

IntroductionObjectives of this study, as part of a nation-wide HIV pre-exposure prophylaxis (PrEP) evaluation project, were to determine the incidence of infections with HIV, chlamydia, gonorrhea, syphilis, hepatitis A/B/C in persons using PrEP, and to describe the health care funded PrEP use in Germany. Additionally, factors associated with chlamydia/gonorrhea and syphilis infections were assessed.MethodsAnonymous data of PrEP users were collected at 47 HIV-specialty centers from 09/2019–12/2020. Incidence rates were calculated per 100 person years (py). Using longitudinal mixed models, we analyzed risk factors associated with sexually transmitted infections (STIs).Results4620 PrEP users were included: 99.2% male, median age 38 years (IQR 32–45), 98.6% men who have sex with men (MSM). The median duration of PrEP exposure was 451 days (IQR 357–488), totaling 5132 py. Four HIV infections were diagnosed, incidence rate 0,078/100py (95% CI 0.029–0.208). For two, suboptimal adherence was reported and in the third case, suboptimal adherence and resistance to emtricitabine were observed. One infection was likely acquired before PrEP start. Incidence rates were 21.6/100py for chlamydia, 23.7/100py for gonorrhea, 10.1/100py for syphilis and 55.4/100py for any STI and decreased significantly during the observation period. 65.5% of syphilis, 55.6% of chlamydia and 50.1% of gonorrhea cases were detected by screening of asymptomatic individuals. In a multivariable analysis among MSM younger age, PrEP start before health insurance coverage and daily PrEP were associated with greater risk for chlamydia/gonorrhea. Symptom triggered testing and a history of STI were associated with a higher risk for chlamydia/gonorrhea and syphilis. A significantly lower risk for chlamydia/gonorrhea and syphilis was found for observations during the COVID-19 pandemic period.ConclusionsWe found that HIV-PrEP is almost exclusively used by MSM in Germany. A very low incidence of HIV infection and decreasing incidence rates of STIs were found in this cohort of PrEP users. The results were influenced by the SARS-CoV-2 pandemic. Rollout of PrEP covered by health insurance should be continued to prevent HIV infections. Increased PrEP availability to people at risk of HIV infection through the elimination of barriers requires further attention. Investigation and monitoring with a longer follow-up would be of value.

"PrEP should be available all the time and everywhere": A qualitative assessment of family planning and PrEP integration in Lesotho.

BackgroundLesotho has a high HIV burden, with women disproportionately affected. Increased access points for HIV prevention services, including oral pre-exposure prophylaxis (PrEP), should be considered. Using family planning (FP) settings for PrEP services may contribute to greater uptake of HIV prevention methods.MethodologyThis formative qualitative assessment was conducted in Maseru District, Lesotho and included in-depth interviews with 15 key informants, 10 FP providers in public facilities and community sites, and 15 FP and PrEP clients from facility and community sites. Interviews were audio recorded and in lieu of producing transcripts, teams completed semi-structured data extraction tables after each interview. Findings were compiled and synthesized by participant group into matrices and themes identified through deductive and inductive analysis.ResultsPolicy makers were generally supportive of integration but felt hampered by lack of integration policies and separation of HIV and FP departments at Ministry of Health. Funders stressed the need for coordination among partners to avoid duplication of efforts. Partners felt clients would be interested in PrEP/FP integration and that PrEP demand creation and education were crucial needs. Most providers supported integration, stressing the potential benefit to clients. Barriers discussed included heavy workloads, staff shortages, training needs, separate registers for FP and PrEP, and commodity stock-outs. Providers discussed strengthening integrated services through training, increasing staffing, having job aids and guidelines, merging the FP and PrEP registers, and marketing services together to create demand for both. Clients were overwhelmingly willing to have longer visits to receive comprehensive services and were supportive of receiving PrEP services from FP providers. Clients not using PrEP expressed willingness and interest to use. Clients' suggestions for successful integration included consulting with youth, conducting community outreaches, and improving provider availability.ConclusionsExisting FP platforms are established and well-utilized; thus providing opportunities for integrating PrEP. This assessment found support across all groups of respondents for providing PrEP within FP settings and identified a number of facilitators and barriers to integration. As PrEP rollout is relatively nascent in many countries, deepening the evidence base early will enable the utilization of findings to build stronger integrated programs with wider coverage.

Engaging HIV-prevention ambassadors to promote oral PrEP among adolescent girls and young women: results of a Zimbabwe field test

The HIV Prevention Ambassador Training Package for Adolescent Girls and Young Women was created in collaboration with adolescent girls and young women (AGYW) to improve skills, knowledge, and attitudes about oral pre-exposure prophylaxis (PrEP) among peer “ambassadors”. It was field tested with 17 ambassadors in Mazowe District, Zimbabwe and changes in ambassadors’ knowledge and attitudes about oral PrEP, as well as changes in oral PrEP uptake among AGYW in the district, were assessed. The training package improved oral PrEP knowledge among trained ambassadors and built AGYW’s skills to advocate for oral PrEP awareness and rollout. Use of the training package correlated with a 59% increase in oral PrEP uptake among AGYW in Mazowe District in the seven months following the training. The ambassador training package could help support oral PrEP introduction and scale up in countries with high HIV incidence by engaging AGYW in oral PrEP rollout in their communities.

Assessing the Impact of HIV Preexposure Prophylaxis Scale-Up on Gonorrhea Incidence Among Gay and Bisexual Men in Sydney: A Mathematical Modeling Study.

The rollout of preexposure prophylaxis (PrEP) for HIV prevention among gay and bisexual men (GBM) is associated with increases in condomless anal intercourse, potentially increasing the incidence of other sexually transmissible infections (STIs). We developed an individual-based mathematical model to simulate the transmission of Neisseria gonorrhoeae among GBM in Sydney, accounting for changes in sexual practices, STI testing, and PrEP use. We calibrated and validated the model using reported incidence rates for HIV-positive and HIV-negative GBM from 2010 to 2019. Scenarios were run with varying PrEP uptake, PrEP-related STI testing, and PrEP-related sexual behavior and testing intervals up to 2030 to assess the impact of PrEP use on gonorrhea incidence. Preexposure prophylaxis uptake and associated 3-monthly STI testing from 2015 onward resulted in a predicted increase from 20 to 37 N. gonorrhoeae infections per 100 person-years among HIV-negative GBM by the end of 2020. This is lower than the counterfactual predictions of 45 per 100 person-years if PrEP were not scaled up and 48 per 100 person-years with nonadherence to 3-monthly STI testing. Increasing the time between STI tests for PrEP users by 1 month from 2018 results in the incidence rate among HIV-negative GBM increasing by 8% by 2030. If PrEP coverage doubles from 24% to 53%, incidence among HIV-negative GBM declines by ~25% by 2030. Behavior change due to widespread PrEP use may lead to significant increases in gonorrhea incidence in GBM, but the recommended quarterly STI testing recommended for PrEP users should reduce incidence by 18% by 2030.

The Public Debates Regarding the Use of the Contraceptive Pill and PrEP: What can the Arguments Used Tell Us About Attitudes Surrounding Sexual and Reproductive Rights in Norway?

The introduction of pre-exposure prophylaxis (PrEP) in 2012 in the US ushered in new technology for preventing HIV in people who are seen as at risk of contracting HIV. However, the rollout of PrEP has been filled with various debates and controversies ranging from concerns about effectiveness, adherence levels, cost-effectiveness, and moral responsibility for HIV prevention. In this context, some commentators have noted the uncanny similarities between this debate on PrEP and the debates that surrounded the launch of the oral contraceptive pill (the Pill) some 50 years ago. In this article, we provide the first to our knowledge analysis that compares how debates surrounding the launch of the Pill and debates which emerged concerning the launch of PrEP. Our analytical setting is the launch of the Pill in Norway in the 1960s and the launch of PrEP in 2016. Moreover, we wanted to focus on how both pharmaceuticals were framed in news media in Norway. We argue that such an analysis can tell us something about how the pharmaceuticalization of sex and sexuality often becomes dominated by discourses of morality and pivots around various issues of responsibility, in particular when it comes to female and gay sexualities.

Casting a Wide Net: HIV Drug Resistance Monitoring in Pre-Exposure Prophylaxis Seroconverters in the Global Evaluation of Microbicide Sensitivity Project.

Evidence of HIV drug resistance (HIVDR) in individuals using oral pre-exposure prophylaxis (PrEP) who acquire HIV is limited to clinical trials and case studies. More data are needed to understand the risk of HIVDR with oral PrEP during PrEP rollout. Mechanisms to collect these data vary, and are dependent on cost, scale of PrEP distribution, and in-country infrastructure for the identification, collection, and testing of samples from PrEP seroconverters. The Global Evaluation of Microbicide Sensitivity (GEMS) project, in collaboration with country stakeholders, initiated HIVDR monitoring among new HIV seroconverters with prior PrEP use in Eswatini, Kenya, South Africa, and Zimbabwe. Standalone protocols were developed to assess HIVDR among a national sample of PrEP users. In addition, HIVDR testing was incorporated into existing demonstration projects for key populations. Countries are supportive of conducting a time-limited evaluation of HIVDR during the early stages of PrEP rollout. As PrEP rollout expands, the need for long-term HIVDR monitoring with PrEP will need to be balanced with maintaining national HIV drug resistance surveillance for pretreatment and acquired drug resistance. Laboratory capacity is a common obstacle to setting up a monitoring system. Establishing HIV resistance monitoring within PrEP programs is feasible. Approaches to drug resistance monitoring may evolve as the PrEP programs mature and expand. The methods and implementation support offered by GEMS assisted countries in developing methods to monitor for drug resistance that best fit their PrEP program needs and resources.

Experiences of men who have sex with men when initiating, implementing and persisting with HIV pre-exposure prophylaxis.

IntroductionHIV pre‐exposure prophylaxis (PrEP) involves the use of antiretroviral medication in HIV‐negative individuals considered to be at risk of acquiring HIV. It has been shown to prevent HIV and has been available in Wales since July 2017. Measuring and understanding adherence to PrEP is complex as it relies on the simultaneous understanding of both PrEP use and sexual activity. We aimed to understand the experiences of men who have sex with men (MSM) living in Wales initiating, implementing and persisting with HIV PrEP.MethodsWe conducted semistructured interviews with MSM PrEP users in Wales who participated in a cohort study of PrEP use and sexual behaviour. Following completion of the cohort study, participants were invited to take part in a semistructured interview about their experiences of taking PrEP. We aimed to include both individuals who had persisted with and discontinued PrEP during the study. The interview topic guide was informed by the ABC taxonomy for medication adherence and the theory of planned behaviour. We analysed our data using reflexive thematic analysis.ResultsTwenty‐one participants were interviewed, five having discontinued PrEP during the cohort study. The developed themes focused on triggers for initiating PrEP, habitual behaviour, drivers for discontinuation and engagement with sexual health services. Stigma surrounding both PrEP and HIV permeated most topics, acting as a driver for initiating PrEP, an opportunity to reduce discrimination against people living with HIV, but also a concern around the perception of PrEP users.ConclusionThis is the first study to investigate PrEP‐taking experiences incorporating established medication adherence taxonomy. We highlight key experiences regarding the initiation, implementation and persistence with PrEP and describe how taking PrEP may promote positive engagement with sexual health services. These findings may be useful for informing PrEP rollout programmes and need to be explored in other key populations.Patient and Public ContributionPrEP users, in addition to PrEP providers and representatives of HIV advocacy and policy, were involved in developing the topic guide for this study.

Integration of HIVprevention and sexual and reproductive health in the era of anti-retroviral-based prevention: findings from assessments in Kenya, Malawi and Zimbabwe.

Background:Though substantial progress has helped curb the HIV epidemic, high rates of new HIV infections persist among adolescent girls and young women (AGYW) in sub-Saharan Africa, reflecting critical gaps in reaching them with integrated HIV prevention and sexual and reproductive health (SRH) services. The scale-up of oral pre-exposure prophylaxis (PrEP) and multiple novel HIV prevention products on the horizon offer countries a unique opportunity to expand innovative approaches to deliver comprehensive, integrated HIV prevention/SRH services. Methods:This article comparatively analyzes findings from rapid assessments in Kenya, Malawi and Zimbabwe across key themes to highlight cross-country trends and contextual realities around HIV prevention/SRH integration, with a focus on oral PrEP and contraception. In Kenya and Zimbabwe, assessments were completed by Ministries of Health (MOH) and the HIV Prevention Market Manager and include 20 health facility assessments, 73 key informant interviews (KIIs) and six community dialogues. In Malawi, the assessment was completed by the MOH and Georgetown University Center for Innovation in Global Health and includes 70 KIIs and a review of national policies and program implementation in Blantyre. Findings were contextualized through a review of literature and policies in each country. Results:Across countries, the policy environment is conducive to HIV prevention/SRH integration, though operationalization presents ongoing challenges, with most policies preceding and not accounting for oral PrEP rollout. National coordination mechanisms, youth-friendly health services and prevention of mother-to-child transmission programs are promising practices, while siloed and resource-constrained health systems, limited provider capacity, underfunded demand generation and structural factors exacerbate barriers to achieving integration. Conclusions:As new HIV prevention products are introduced, demand for integrated HIV prevention/SRH services is likely to grow. Investing in HIV prevention/SRH integration can help to ensure a sustainable response to the HIV epidemic, streamline service delivery and improve the health outcomes and lives of AGYW.