Pre-exposure Prophylaxis Formulations Research Articles

Awareness and Willingness to Use HIV Pre-exposure Prophylaxis Among Men Who Have Sex With Men in Rwanda: A Cross-Sectional Descriptive Survey.

Awareness and Willingness to Use HIV Pre-exposure Prophylaxis Among Men Who Have Sex With Men in Rwanda: A Cross-Sectional Descriptive Survey.

Incentives conditioned on tenofovir levels to support PrEP adherence among young South African women: a randomized trial.

IntroductionHIV incidence remains high among African adolescent girls and young women (AGYW), who would benefit from pre‐exposure prophylaxis (PrEP). Strategies to increase PrEP adherence and persistence need to be evaluated in African AGY, including incentives conditional on high adherence.MethodsThe 3Ps for Prevention Study was a 12‐month prospective cohort of 200 women ages 16 to 25 initiating PrEP in South Africa from 2017 to 2018. Participants received retrospective feedback about drug levels at Months 1, 2 and 3; half was randomized to receive a 200 Rand shopping voucher ($13 US) at Months 2, 3 and 4, conditioned on high intracellular tenofovir diphosphate (TFV‐DP) levels in dried blood spots (≥500 fmol/punch at Month 1, ≥700 fmol/punch at Months 2 and 3). The primary analysis was intention‐to‐treat, comparing the proportion with high PrEP adherence (≥700 fmol/punch) at Month 3 by randomized group, based on 100% efficacy among men who have sex with men.ResultsMedian age of the 200 women was 19 years (interquartile range [IQR] 17, 21); 86% had a primary sexual partner. At Month 3, the mean TFV‐DP level was 822 fmol/punch (SD 522) in the incentive group and 689 fmol/punch (SD 546) in the control group (p = 0.11). Forty‐five (56%) of 85 women in the incentive group and 35 (41%) of 85 women in the control group had TFV‐DP levels ≥700 fmol/punch (RR 1.35; 95% CI 0.98, 1.86; p = 0.067), which declined to 8% and 5% in the incentive and control groups at Month 12 (no significant difference by arm). 44% refilled PrEP without gaps, 14% had a gap of ≥3 weeks in coverage subsequently restarted PrEP and 54% accepted at the final dispensing visit at Month 9. No new HIV infections were observed after PrEP initiation.ConclusionsAmong South African AGYW initiating PrEP, drug levels indicated high PrEP adherence in almost half of women at Month 3, with a non‐statistically significant higher proportion with high adherence among those in the incentive group. Over half persisted with the 12‐month PrEP programme although high adherence declined after Month 3. Strategies to support PrEP adherence and persistence and longer‐acting PrEP formulations are needed.

Awareness of and interest in oral pre-exposure prophylaxis (PrEP) for HIV prevention and interest in hypothetical forms of PrEP among people who inject drugs in rural West Virginia

ABSTRACT Injection drug use-associated HIV outbreaks have occurred in rural communities throughout the United States, which often have limited HIV prevention services for people who inject drugs (PWID). Pre-exposure prophylaxis (PrEP) is one tool that may help fill gaps in HIV prevention programing in rural settings. Oral PrEP has been approved for use, and new PrEP formulations are under development. Research is needed to better understand interest in oral and possible forthcoming PrEP formulations among PWID. We used survey data from 407 PWID in rural West Virginia. We asked if participants had heard of, taken, and were interested in taking PrEP, and about interest in several hypothetical forms of PrEP (arm injections, abdomen injections, implants, intravenous infusions). We estimated the prevalence of interest in each formulation and assessed correlates using Chi-squared tests. A minority had heard of oral PrEP (32.6%), and few had used it (3.7%). Many were interested in using oral PrEP (58.3%). Half were interested in arm injections (55.7%). Common correlates of interest across PrEP formulations were sexual minority status, comfort talking to a doctor about sex, sex work, and sharing injection equipment. Oral and injectable PrEP have the potential to fill HIV prevention gaps for rural PWID.

PrEParing for long-acting injectable PrEP in the South: perspectives from healthcare providers in Georgia

ABSTRACT New modalities of Pre-exposure Prophylaxis (PrEP) such as long-acting injectable PrEP (LAI-PrEP) promise increased prevention of HIV transmission; however, similar biomedical interventions have not been met with universal adoption by healthcare providers or populations most affected by HIV. This qualitative study explores healthcare provider considerations for the rollout of LAI-PrEP. Eleven key-informant in-depth interviews were conducted with clinicians who prescribe daily oral PrEP. Participants reviewed a currently proposed LAI regimen and were asked to reflect on its implications for their clinical practice. Interviews were transcribed verbatim and thematically coded, with results organized using the Consolidated Framework for Implementation Research (CFIR). All participants expressed interest in prescribing LAI-PrEP and anticipated that at least some patients would be interested. Participants identified characteristics of the intervention, inner intervention setting, and outer intervention setting that will be influential in bringing LAI-PrEP to scale. Clinicians in the South have unique insights into the challenges of and opportunities for successful rollout of future PrEP regimens. Bringing these insights into a CFIR framework highlights the nuances surrounding LAI-PrEP, including structural concerns such as cost barriers and access to in-person healthcare services. It is critical to address these challenges to ensure successful implementation of new PrEP formulations.

PrEP for HIV Prevention: Evidence, Global Scale-up, and Emerging Options

Antiretroviral pre-exposure prophylaxis (PrEP) for the prevention of HIV infection was demonstrated to be efficacious and safe earlier this decade from pivotal studies using oral emtricitabine-tenofovir disoproxil fumarate. Regulatory approval and normative guidance, now for almost 70 countries worldwide, has followed. Demonstration projects have shown high uptake and population-level HIV reductions, highlighting the need for simplifying delivery and reducing current barriers to access and persistence. A portfolio of additional, next-generation PrEP formulations, currently under testing, if effective, will offer users choice and likely increase coverage and impact.

Modeling HIV Pre-Exposure Prophylaxis.

Pre-exposure prophylaxis (PrEP) has emerged as a promising strategy for preventing the transmission of HIV. Although only one formulation is currently approved for PrEP, research into both new compounds and new delivery systems for PrEP regimens offer intriguing challenges from the perspective of pharmacokinetic and pharmacodynamic modeling. This review aims to provide an overview the current modeling landscape for HIV PrEP, focused on PK/PD and QSP models relating to antiretroviral agents. Both current PrEP treatments and new compounds that show promise as PrEP agents are highlighted, as well as models of uncommon administration routes, predictions based on models of mechanism of action and viral dynamics, and issues related to adherence to therapy. The spread of human immunodeficiency virus (HIV) remains one of the foremost global health concerns. In the absence of a vaccine, other prophylactic strategies have been developed to prevent HIV transmission. One approach, known as pre-exposure prophylaxis (PrEP), allows HIV-negative individuals who are at high risk of exposure to the virus, be it through an HIV-positive sexual partner or through the shared use of drug injection equipment, to substantially reduce the risk of developing an HIV infection. PrEP is a relatively recent approach to combating the HIV epidemic, with the only currently approved treatment being Truvada, a daily oral antiretroviral (ARV) therapy initially indicated in the treatment of active HIV-1 infections, but approved for HIV PrEP in 2012. Although PrEP therapy has consistently demonstrated high efficacy in preventing HIV infection, this efficacy is dependent on patient adherence to the prescribed treatment regimen. This can present a significant problem in low- and middle-income countries, which may lack the infrastructure to provide sufficient access to PrEP medication to maintain daily dosing regimens. Furthermore, while the conventional approach has generally been to advocate for continuous administration akin to regimens used for viral suppression in infected patients, there has been some discussion of whether a better treatment paradigm might be to push for PrEP therapy primarily during those known periods of heightened exposure risk, while relying on post-exposure prophylaxis regimens to prevent infection after unanticipated exposures during low-risk periods. These considerations have led to a push for the development of long-duration and on-demand PrEP formulations, including subdermal and subcutaneous implants, slow-release intramuscular depot injections, vaginal and rectal antimicrobial gels, and intravaginal rings and dissolving films. PrEP therapy is a quickly evolving field, with a variety of antiretroviral compounds and formulations under investigation. This review aims to report on notable drugs and formulations from a pharmacokinetic/pharmacodynamic (PK/PD) modeling perspective. Given the nature of PrEP as a preventive therapy designed for long-term use, clinical trials for PrEP therapies can last for months or even years, particularly in the case of long-duration formulations. Furthermore, in contrast to antiretroviral trials in infected patients, pharmacodynamic endpoints in PrEP therapies are difficult to quantify, as the primary endpoint for efficacy is generally the rate of seroconversion. Computational modeling approaches offer flexible and powerful tools to provide insight into drug behavior in clinical settings, and can ultimately reduce the time, expense, and patient burden incurred in the development of PrEP therapies.

Injection drug use, unknown HIV positive status, and self-reported current PrEP use among Black men who have sex with men attending U.S. Black pride events, 2014–2017

ObjectiveBlack gay, bisexual, and other men who have sex with men (BMSM) are at elevated risk for HIV infection in the United States. BMSM who inject drugs may be face even higher HIV risk. MethodsRandom time-location sampling was used to survey BMSM attending Black Pride events in 6 U.S. cities about HIV risk and protective behaviors, including injection drug use, prior HIV testing, and pre-exposure prophylaxis (PrEP). 3429 individuals who reported a HIV negative/unknown serostatus at enrollment were included in the analysis. HIV status was determined by in-field rapid HIV testing. Results3.6% of BMSM had injected drugs in their lifetime and 58.5% of BMSM who had injected drugs reported sharing syringes in the past six months. BMSM who had injected drugs more commonly reported current PrEP use than BMSM who had never injected (32.5% vs. 8.2%, p < 0.001). BMSM who had injected drugs were 3.6-fold (95% CI: 2.4, 5.4) more likely to report currently using PrEP than BMSM who had never injected after adjustment for sociodemographic, substance use, and sexual risk characteristics. Among BMSM who reported ever injecting drugs (n = 123), 31.7% tested HIV positive. HIV prevalence did not differ by self-reported PrEP use among BMSM who had injected drugs (p = 0.59). ConclusionsBMSM who inject drugs who reported currently using PrEP were no less likely to test positive for HIV than those who did not use PrEP. Wrap-around services to support consistent PrEP use and long-acting PrEP formulations may improve the effectiveness of PrEP among BMSM who inject drugs.

Drug Resistance During HIV Pre-Exposure Prophylaxis.

Clinical studies have demonstrated that use of tenofovir disoproxil fumarate with or without emtricitabine as antiretroviral pre-exposure prophylaxis (PrEP) can decrease the risk of human immunodeficiency virus (HIV) acquisition when medication adherence is high. However, the potential for PrEP to promote antiretroviral resistance remains an important public health consideration. We performed a search of the medical literature to identify studies that address HIV drug resistance during PrEP use. In this review, we summarize findings about emergent drug resistance during clinical trials of PrEP, case reports of seroconversions in patients adherent to PrEP, and animal studies of PrEP effectiveness against drug-resistant viral strains. We also discuss the potential utility of novel PrEP formulations for protection against drug-resistant HIV, the impact of drug resistance on HIV treatment options, and mathematical models that estimate the potential contribution of PrEP to population-level drug resistance. Evidence suggests that selection for HIV drug resistance with PrEP use is infrequent and most likely to occur when PrEP is used during undiagnosed acute HIV infection. Breakthrough infections during PrEP use with high adherence are possible, but appear to be rare. The prevalence of drug-resistant HIV strains needs to be monitored as PrEP is scaled up. However, the benefit of a decreased HIV incidence with wider PrEP use is likely to outweigh the risk of harms from possible increases in the prevalence of HIV drug resistance.

Advancing HIV Biomedical Prevention Research for At-Risk Adolescents.

Despite significant additions to the HIV prevention toolbox, infection rates across the United States continue to rise among vulnerable adolescents and young adults. Access to these interventions by youth at risk for HIV is limited by the lack of data about their safety and use, compounding the myriad contextual barriers to effectively preventing HIV in this group. The NIH-funded Adolescent Trials Network implemented an innovative approach to the inclusion of adolescents at risk for HIV infection who consented for their own participation in the first adolescent study of HIV pre-exposure prophylaxis (PrEP). This model of mature minor consent was supported by state-based adolescent treatment statutes that extend an adolescent's ability to consent to participation in research with a sufficient prospect of clinical benefit from the intervention to justify the potential risks, and a balance of benefits and risks that is at least as favorable as available evidence-based alternatives. Important data on the safety and patterns of PrEP use by at-risk adolescents prompted the FDA to revise the label. The expanded indication of PrEP for HIV prevention in adolescents is hoped to inform clinical guidelines and provides a powerful tool to reduce new infections in the United States among vulnerable at-risk adolescents. Lessons learned from this years-long iterative endeavor have implications for improving access to the rapidly evolving landscape of HIV prevention modalities, including recently implemented studies of long-acting PrEP formulations designed to reduce the burden of daily adherence required by oral PrEP, a major clinical pitfall for adolescent clinicians and their patients.

Sex Tourism and Pre-Exposure Prophylaxis Modality Preferences Among Men Who Have Sex With Men

Sex tourism among men who have sex with men (MSM) has been associated with increased risk for human immunodeficiency virus (HIV) due to sexually scripted environments characterized by multiple sexual partners, increased availability of alcohol and drugs, and limited availability of HIV-prevention services. The current study examined the knowledge of and likelihood of using different modalities of pre-exposure prophylaxis (PrEP), an important biomedical HIV-prevention strategy, among MSM in Paris who have engaged in sex tourism. A sample of 580 MSM from a highly popular geosocial-networking smartphone application in Paris, France, participated in the survey. Of the 580 MSM, 444 participants reported an HIV-negative status and represent the analytic sample for this study. Approximately 27% reported engaging in sexual tourism. MSM who engaged in sex tourism were more likely to aware of on-demand PrEP and more likely to express interest in using on-demand PrEP (adjusted risk ratio [aRR] = 1.26; 95% confidence interval [CI] = 1.03–1.53, aRR = 1.29; 95% CI = 1.04–1.61, respectively) than MSM who never engaged in sex tourism. Moreover, participants who engaged in sex tourism were more likely to express interest in rectal microbicides or both rectal and penile microbicides (aRR = 1.34; 95% CI = 1.13–1.59, aRR = 1.26; 95% CI = 1.03–1.55, respectively) than participants who had not engaged in sex tourism. With the high likelihood of interest in using alternative forms of PrEP in MSM who engage in sex tourism, this study suggests potential benefits for these alternative forms of PrEP for this specific population and underscores the importance of their continued development.

Favoring “Peace of Mind”: A Qualitative Study of African Women's HIV Prevention Product Formulation Preferences from the MTN-020/ASPIRE Trial

Abstract Several formulations of HIV pre-exposure prophylaxis (PrEP) have shown varying levels of effectiveness in women. Little information is known about preference across formulations, especially among product experienced women. Seventy-one women (48% married; median age 26; range 18–45) who were participating in a vaginal ring trial for HIV prevention in Malawi, South Africa, Uganda, and Zimbabwe underwent an in-depth interview at their last study visit, during which they were presented with pictures and descriptions of nine possible product formulations (male and female condoms, oral tablets, injectables, implants, and a vaginal gel, ring, insert, and film). Each formulation was discussed, highlighting salient attribute(s) and contextual factors that may have informed stated preferences. Participants expressed most interest for long-acting PrEP formulations (rings, 94%; implants, 39%; injections, 34%), which were generally favored over short-acting ones. Participants appreciated the continuous protec...

Predictors of HIV-related risk perception and PrEP acceptability among young adult female family planning patients

ABSTRACTHIV pre-exposure prophylaxis (PrEP) presents new opportunities for HIV prevention. While women comprise approximately 20% of new HIV infections in the US, significant questions remain about how to most effectively facilitate PrEP uptake for this population. Family planning clinics are a dominant source of health care for young women and support an estimated 4.5 million women annually. We explore characteristics associated with HIV risk perception and PrEP acceptability among young adult women seeking reproductive health services in a high-prevalence setting. A cross-sectional, clinic-based survey was conducted with women ages 18–35 (n = 146) seeking health care at two family planning clinics in the greater Baltimore, Maryland area, from January to April 2014. An estimated 22% of women reported being worried about HIV risk, and 60% reported they would consider taking a pill daily to prevent HIV. In adjusted models, HIV-related worry was associated with having no college education, being single or dating more than one person, practicing consistent condom use during vaginal sex, and having ever traded sex. PrEP acceptability was significantly associated with being Black (71% vs. 49%, AOR 2.23, CI: 1.89–2.64) and having ever traded sex (83% vs. 58%, AOR 4.94, CI: 2.00–12.22). For women with a history of intimate partner violence (IPV), PrEP acceptability was significantly lower (57% vs. 62%, AOR .71, CI: .59–.85) relative to their non-abused counterparts. Results suggest that family planning clinics may be a natural setting for PrEP discussion and roll-out. They should be considered in the context of integrating HIV prevention with reproductive health services. Women with a trauma history may need additional support for implementing HIV prevention in the form of PrEP.

Familiarity with and Preferences for Oral and Long-Acting Injectable HIV Pre-exposure Prophylaxis (PrEP) in a National Sample of Gay and Bisexual Men in the U.S.

We sought to determine preferences for oral versus long-acting injectable (LAI) PrEP among gay and bisexual men (GBM). We surveyed a national U.S. sample of 1071 GBM about forms of PrEP. LAI PrEP was found to be acceptable among 43.2% of men when injected monthly compared with 53.6% of men when injected every 3months. When asked to choose between forms of PrEP, 46.0% preferred LAI, 14.3% oral, 21.7% whichever was most effective, 10.1% had no preference, and 7.8% would not take PrEP. There were no differences in PrEP preferences by race/ethnicity, income, region of residence, or relationship status. Those unwilling to take PrEP were significantly older than those who preferred LAI PrEP and those who would take either. Those who preferred the most effective form were younger, had less education, and reported more recent club drug use. Those who reported condomless anal sex and those who thought they were good PrEP candidates were more willing to take PrEP. Long-term health and side effects were of the greatest concern for both LAI and oral PrEP. The availability of LAI PrEP has the potential to increase uptake among GBM. The results of ongoing clinical trials of LAI PrEP will need to demonstrate similar or greater efficacy as daily Truvada for uptake to be maximized.

Potential Clinical and Economic Value of Long-Acting Preexposure Prophylaxis for South African Women at High-Risk for HIV Infection.

Background. For young South African women at risk for human immunodeficiency virus (HIV) infection, preexposure prophylaxis (PrEP) is one of the few effective prevention options available. Long-acting injectable PrEP, which is in development, may be associated with greater adherence, compared with that for existing standard oral PrEP formulations, but its likely clinical benefits and additional costs are unknown.Methods. Using a computer simulation, we compared the following 3 PrEP strategies: no PrEP, standard PrEP (effectiveness, 62%; cost per patient, $150/year), and long-acting PrEP (effectiveness, 75%; cost per patient, $220/year) in South African women at high risk for HIV infection (incidence of HIV infection, 5%/year). We examined the sensitivity of the strategies to changes in key input parameters among several outcome measures, including deaths averted and program cost over a 5-year period; lifetime HIV infection risk, survival rate, and program cost and cost-effectiveness; and budget impact.Results. Compared with no PrEP, standard PrEP and long-acting PrEP cost $580 and $870 more per woman, respectively, and averted 15 and 16 deaths per 1000 women at high risk for infection, respectively, over 5 years. Measured on a lifetime basis, both standard PrEP and long-acting PrEP were cost saving, compared with no PrEP. Compared with standard PrEP, long-acting PrEP was very cost-effective ($150/life-year saved) except under the most pessimistic assumptions. Over 5 years, long-acting PrEP cost $1.6 billion when provided to 50% of eligible women.Conclusions. Currently available standard PrEP is a cost-saving intervention whose delivery should be expanded and optimized. Long-acting PrEP will likely be a very cost-effective improvement over standard PrEP but may require novel financing mechanisms that bring short-term fiscal planning efforts into closer alignment with longer-term societal objectives.

Defining success with HIV pre-exposure prophylaxis: a prevention-effective adherence paradigm.

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.

Injectable agents for pre-exposure prophylaxis: lessons learned from contraception to inform HIV prevention.

Long-acting injectable (LAI) forms of preexposure prophylaxis (PrEP) are in clinical trials, generating much hope for HIV prevention. But this is not the first time that an injectable form of preventive medication has emerged: the contraceptive agent depomedroxyprogesterone acetate (DMPA) has an important precedent. DMPA's long journey, its initial reception, and ongoing implementation challenges can help inform the field of HIV prevention as we plan for approval, acceptance, and scale-up of LAI-PrEP. DMPA faced a long regulatory journey in the USA, with a lag of 25 years from initial application (1967) to approval (1992). Acceptance after introduction was rapid, but challenges hampered scale-up. Specific lessons learned include that extensive acceptability work is needed in parallel to product development. Also, low continuation rates, challenges with timing of initiation, and difficulty ensuring access for the most vulnerable populations have limited DMPA's impact. A new subcutaneous formulation presents opportunities for administration outside of clinical settings and for self-administration. Those involved in LAI-PrEP development and those who plan to be involved in its future implementation must consider these lessons and possible solutions from DMPA to ensure a successful future for this new HIV prevention modality.

Rethinking HIV prevention to prepare for oral PrEP implementation for young African women.

IntroductionHIV incidence remains high among young women in sub-Saharan Africa in spite of scale-up of HIV testing, behavioural interventions, antiretroviral treatment and medical male circumcision. There is a critical need to critique past approaches and learn about the most effective implementation of evidence-based HIV prevention strategies, particularly emerging interventions such as pre-exposure prophylaxis (PrEP).DiscussionWomen in sub-Saharan Africa are at increased risk of HIV during adolescence and into their 20s, in part due to contextual factors including gender norms and relationship dynamics, and limited access to reproductive and sexual health services. We reviewed behavioural, behavioural economic and biomedical approaches to HIV prevention for young African women, with a particular focus on the barriers, opportunities and implications for implementing PrEP in this group. Behavioural interventions have had limited impact in part due to not effectively addressing the context, broader sexual norms and expectations, and structural factors that increase risk and vulnerability. Of biomedical HIV prevention strategies that have been tested, daily oral PrEP has the greatest evidence for protection, although adherence was low in two placebo-controlled trials in young African women. Given high efficacy and effectiveness in other populations, demonstration projects of open-label PrEP in young African women are needed to determine the most effective delivery models and whether women at substantial risk are motivated and able to use oral PrEP with sufficient adherence to achieve HIV prevention benefits.ConclusionsSocial marketing, adherence support and behavioural economic interventions should be evaluated as part of PrEP demonstration projects among young African women in terms of their effectiveness in increasing demand and optimizing uptake and effective use of PrEP. Lessons learned through evaluations of implementation strategies for delivering oral PrEP, a first-generation biomedical HIV prevention product, will inform development of new and less user-dependent PrEP formulations and delivery of an expanding choice of prevention options in HIV prevention programmes for young African women.

Role of oral pre-exposure prophylaxis (PrEP) in current and future HIV prevention strategies.

Treatment as prevention is expected to have a major role in reducing HIV incidence, but other prevention interventions will also be required to bring the epidemic under control, particularly among key populations. One or more forms of pre-exposure prophylaxis (PrEP) will likely play a critical role. Oral PrEP with emtricitabine-tenofovir (Truvada®) is currently available in the US and some other countries, but uptake has been slow. We review the concerns that have contributed to this slow uptake and discuss current and future research in this critical area of HIV prevention research.

The importance of choice in the rollout of ARV-based prevention to user groups in Kenya and South Africa: a qualitative study.

IntroductionStakeholders continue to discuss the appropriateness of antiretroviral-based pre-exposure prophylaxis (PrEP) for HIV prevention among sub-Saharan African and other women. In particular, women need formulations they can adhere to given that effectiveness has been found to correlate with adherence. Evidence from family planning shows that contraceptive use, continuation and adherence may be increased by expanding choices. To explore the potential role of choice in women's use of HIV prevention methods, we conducted a secondary analysis of research with female sex workers (FSWs) and men and women in serodiscordant couples (SDCs) in Kenya, and adolescent and young women in South Africa. Our objective here is to present their interest in and preferences for PrEP formulations – pills, gel and injectable.MethodsIn this qualitative study, in Kenya we conducted three focus groups with FSWs, and three with SDCs. In South Africa, we conducted two focus groups with adolescent girls, and two with young women. All focus groups were audio-recorded, transcribed and translated into English as needed. We structurally and thematically coded transcripts using a codebook and QSR NVivo 9.0; generated code reports; and conducted inductive thematic analysis to identify major trends and themes.ResultsAll groups expressed strong interest in PrEP products. In Kenya, FSWs said the products might help them earn more money, because they would feel safer accepting more clients or having sex without condoms for a higher price. SDCs said the products might replace condoms and reanimate couples’ sex lives. Most sex workers and SDCs preferred an injectable because it would last longer, required little intervention and was private. In South Africa, adolescent girls believed it would be possible to obtain the products more privately than condoms. Young women were excited about PrEP but concerned about interactions with alcohol and drug use, which often precede sex. Adolescents did not prefer a particular formulation but noted benefits and limitations of each; young women's preferences also varied.ConclusionsThe circumstances and preferences of sub-Saharan African women are likely to vary within and across groups and to change over time, highlighting the importance of choice in HIV prevention methods.

Barriers and facilitators to pre-exposure prophylaxis (PrEP) eligibility screening and ongoing HIV testing among target populations in Bondo and Rarieda, Kenya: results of a consultation with community stakeholders.

BackgroundAs pre-exposure prophylaxis (PrEP) moves closer to availability in developing countries, practical considerations for implementation become important. We conducted a consultation with district-level community stakeholders experienced in HIV-prevention interventions with at-risk populations in Bondo and Rarieda, Kenya to generate locally grounded approaches to the future rollout of oral PrEP to four populations: fishermen, widows, female sex workers, and serodiscordant couples.MethodsThe 20 consultation participants represented the Ministry of Health, faith- and community-based organizations, health facilities, community groups, and nongovernmental organizations. Participants divided into breakout groups and followed a structured discussion guide asking them to identify barriers to implementing HIV-prevention interventions (including PrEP) with each population. Questions also solicited solutions for addressing these barriers, as well as other facilitators for PrEP implementation. In particular, questions focused on how to encourage people to screen for PrEP eligibility by having HIV and other blood tests and how to encourage compliance with ongoing HIV testing.ResultsThe barriers and facilitators/solutions discussants provided were frequently population-specific, but there were also broad-level similarities across populations. Service delivery barriers to HIV-prevention interventions concerned the need for staff trained to address the needs of particular populations. Service delivery facilitators to provision of ongoing HIV testing consisted of offering testing options besides facility-based testing. Stigma was the main community-level barrier for all groups, whereas barriers at the level of target populations included mobility; lifestyle and life circumstances, especially cultural norms among fishermen and widows; and fears, lack of awareness, and misinformation. Proposed facilitators and strategies for addressing community- and population-level barriers included topic-specific education within the populations and community, involvement of partners and family members, mass HIV testing, and peer educators. Barriers to PrEP uptake included non-adherence to pill taking and missing clinic visits. For drug adherence, facilitators were counselling and involving family members. Discussants suggested that client reminders, e.g., home visits, were needed to encourage clients to keep their clinic appointments.ConclusionsStrategies for encouraging eligibility screening and ongoing HIV testing will have local and population-specific aspects. Our results nonetheless apply to similar populations throughout sub-Saharan Africa and reach beyond oral PrEP to other ARV-based PrEP formulations.