Pre-exposure Prophylaxis Adherence Research Articles

Trust in the provider and accurate self-reported PrEP adherence among adolescent girls and young women in South Africa and Zimbabwe: HPTN 082 study

BackgroundTrust is an important cornerstone of patient-provider communication. Accurate reporting of pre-exposure prophylaxis (PrEP) adherence is vital for providers to determine who needs adherence support, especially adolescent girls and young women (AGYW) disproportionately affected by newly diagnosed HIV.MethodsThis is a secondary analysis of the HPTN 082 open-label PrEP demonstration trial. From 2016–2018, 451 AGYW aged 16–25 years were enrolled in South Africa (Cape Town and Johannesburg) and Zimbabwe (Harare). PrEP was initiated by 427, and 354 (83%) had month three patient-reported adherence responses and intracellular tenofovir diphosphate (TFV-DP) measurements. The patient-reported adherence response to ‘In the past month, how often did you take the tablet?’ was dichotomized as ‘high’ if the response was every day or most days, and ‘low’ if some days or not many days or never. The biomarker marker evidence of adherence in dried blood spots was defined as ‘high’ if TFV-DP ≥ 700, and ‘low’ if < 350 fmol/punch. We used multinomial logistic regression to examine if trust in the PrEP provider was associated with concordance between patient-reported adherence and intracellular tenofovir-diphosphate (TFV-DP).ResultsAGYW who reported trust in their providers were almost four-fold (aOR 3.72, 95% CI 1.20–11.51) more likely to have concordant adherence (high self-reported adherence and high TFV-DP concentrations) compared to discordant non-adherence (high self-reported adherence and low TFV-DP concentrations).ConclusionEducation and training of providers to build trusting relationships with AGYW may lead to more accurate reporting of PrEP adherence. With accurate reporting, adequate support can be provided to bolster adherence.Trial registrationClinicalTrials.gov Identifier: NCT02732730.

The Use of Daily and On-Demand Oral Pre-Exposure Prophylaxis Dosing Strategies Among Young Adult Gay, Bisexual and Other Men who have Sex with Men Enrolled in an mHealth Adherence Intervention.

Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention option for gay, bisexual and other men who have sex with men (GBMSM). However, with newer PrEP options, a greater understanding of whether and why GBMSM switch dosing strategies is needed to inform clinical practice and research. We assessed the dosing strategies (daily or on-demand) of GBMSM enrolled in an mHealth PrEP adherence pilot intervention at four timepoints over approximately 10 months. Among GBMSM with complete data (n = 66), a consistent daily dosing strategy was used by most (73%) participants across all time points, while on-demand PrEP was used at least once during the study period by 27% of participants. A higher percentage of on-demand PrEP users self-reported as Asian/Pacific Islander and had less positive attitudes toward PrEP, adjusting for key sociodemographic variables and intervention arm. Daily PrEP users reported high numbers of sexual partners, and the primary reason that they would switch to on-demand PrEP is reduced sexual activity. At the final assessment, 75% of participants were taking daily PrEP, of whom 27% reported that they would like to switch to another option, including on-demand and long-acting injectable PrEP. While findings were largely descriptive, they showed that switches in PrEP dosing strategies are relatively common and PrEP strategy choice may vary across racial and ethnic groups.

Pre‐exposure prophylaxis adherence and discontinuation at an urban pre‐exposure prophylaxis program in Atlanta, Georgia

AbstractOral pre‐exposure prophylaxis (PrEP) effectiveness is directly correlated with medication adherence. Grady Health System (GHS) developed a PrEP program to optimize PrEP uptake in Atlanta, Georgia. The purpose of this study is to determine PrEP medication adherence and its associated factors during the first 18 months of the program's implementation. A single‐center, retrospective chart review was conducted on patients enrolled in a PrEP program in Atlanta, Georgia, between June 1, 2018 and February 29, 2020, who received more than one PrEP prescription. The primary outcome was mean adherence to PrEP, using the medication possession ratio (MPR). This study included 154 primarily young patients (mean 34 years of age), Black (70.8%), uninsured (59.1%), and cisgender men (62.3%). Mean PrEP adherence was 89.2%; 77.3% of patients had an MPR ≥ 80% (high adherence). Of all patients, 71 (46%) met PrEP discontinuation criteria. This PrEP program demonstrated high levels of PrEP adherence with discontinuation rates similar to other PrEP programs nationwide, despite a higher index of social vulnerability in the area. Future areas of research include identifying the specific program‐related factors that may optimize PrEP adherence in areas with high indices of social vulnerability.

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.

HIV Pre-exposure Prophylaxis Persistence and Adherence Among Men Who Have Sex With Men in Four US Cities.

HIV pre-exposure prophylaxis (PrEP) persistence and adherence are critical to ending the HIV epidemic in the United States. In 2017 National HIV Behavioral Surveillance, HIV-negative men who have sex with men (MSM) in 4 US cities completed a survey, HIV testing, and dried blood spots at recruitment. We assessed 3 PrEP outcomes: persistence (self-reported PrEP use at any time in the past 12 months and had tenofovir, emtricitabine, or tenofovir diphosphate detected in dried blood spots), adherence at ≥4 doses/week (self-reported past-month PrEP use and tenofovir diphosphate concentration ≥700 fmol/punch), and adherence at 7 doses/week (self-reported past-month PrEP use and tenofovir diphosphate concentration ≥1250 fmol/punch). Associations with key characteristics were examined using log-linked Poisson regression models with generalized estimating equations. Among 391 MSM who took PrEP in the past year, persistence was 80% and was lower among MSM who were younger, had lower education, and had fewer sex partners. Of 302 MSM who took PrEP in the past month, adherence at ≥4 doses/week was 80% and adherence at 7 doses/week was 66%. Adherence was lower among MSM who were younger, were Black, and had fewer sex partners. Although persistence and adherence among MSM were high, 1 in 5 past-year PrEP users were not persistent and 1 in 5 past-month PrEP users were not adherent at levels that would effectively protect them from acquiring HIV (ie, ≥4 doses/week). Efforts to support PrEP persistence and adherence should include MSM who are young, are Black, and have less education.

Adherence to HIV pre-exposure prophylaxis (PrEP) among key populations (KPs): an analytical cross-sectional study in Matayos Sub County, Busia County, Kenya

Background: A large percentage of the new cases of HIV/AIDs in Kenya are attributed to Key Populations (KPs). In Kenya, KPs contribute 33% of all new infections of HIV. It is with this realization that in 2017 the government of Kenya launched The Pre-Exposure Prophylaxis (PrEP) for HIV. The study aimed at assessing the factors influencing adherence to PrEP by KPs in Matayos sub-county, Busia County, Kenya. Methods: An analytical cross-sectional study that utilized a mixed-method data collection approach (n=343) was used to assessing the factors influencing adherence to PrEP by KPs in Matayos sub-county, Busia County, Kenya. Results: The level of adherence to PrEP using the Morisky Medical Adherence Scale-4 was established to be 37% among all KPs and 36%, 37% and 52% among CSWs, MSMs and PWIDs respectively. Chi-square analysis revealed significant relationship between Level of education (p=0.05), marital status (p=0.001), KP category (p=0.034), occupation (p=0.014), stigma (p=0.00), the perceptions of side effects (p=0.011), facility accessibility (P= 0.00), side effects (p=0.001) and adherence to PrEP. Among the MSMs condom use was established to have association to PrEP adherence (p=0.00). Conclusions: The study concluded that socio-demographic, individual characteristics, and clinical factors influence adherence to pre-exposure prophylaxis among key populations. The study recommended that key populations need more information on how to use pre-exposure prophylaxis, how it works, the side effects, what to do in case they experience the side effects and why adherence to pre-exposure prophylaxis is important.

Willingness to use and intention to adhere to pre-exposure prophylaxis (PrEP) among men who have sex with men in Jiangsu Province, China

ABSTRACT Pre-exposure prophylaxis (PrEP) is a biomedical prevention approach that significantly reduces HIV acquisition. Our study aimed to explore factors associated with PrEP willingness and intention to adhere to PrEP among MSM through a cross-sectional survey in Nanjing, Jiangsu province, China. Location sampling (TLS) and online recruitment were used to recruit participants to gauge their PrEP willingness and intention to adhere. Of 309 HIV-negative/unknown serostatus MSM, 75.7% were willing to use PrEP and 55.3% had high intention to take PrEP daily. Willingness to use PrEP was positively associated with having a college degree or higher (AOR = 1.90, 95%CI: 1.11–3.26) and higher anticipated HIV stigma (AOR = 2.74, 95%CI: 1.13–6.61). Facilitators of intention to adhere included higher education levels (AOR = 2.12, 95%CI: 1.33–3.39) and higher anticipated HIV stigma (AOR = 3.65, 95%CI: 1.36–9.80), whereas a primary barrier was community homophobia (AOR = 0.43, 95%CI: 0.20–0.92). This study documented high willingness to use PrEP, yet lower intention to adhere to PrEP in a sample of MSM in China. Public interventions and programs to promote adherence of PrEP for MSM is urgently needed in China. Psychosocial factors should be addressed and taken into consideration for PrEP implementation and adherence programs.

HIV seroconversion among men who have sex with men who use event-driven or daily oral pre-exposure prophylaxis (CohMSM-PrEP): A multi-country demonstration study from West Africa.

Data on HIV seroconversion among men who have sex with men (MSM) using pre-exposure prophylaxis (PrEP) in West Africa are needed. This study aimed to document HIV seroconversion and associated determinants, PrEP adherence, plasma drug concentrations, and HIV drug resistance in MSM using event-driven or daily PrEP in Burkina Faso, Côte d'Ivoire, Mali, and Togo. A prospective cohort study was conducted in 2017-2021 among HIV-seronegative MSM aged 18 or over who were at high risk of HIV infection. Participants could choose between event-driven and daily PrEP, switch regimens, and discontinue or restart PrEP. The determinants of HIV incidence were investigated using a multivariate mixed-effects Poisson regression analysis. A total of 647 participants were followed for a total time of 1229.3 person-years. Of 5371 visits, event-driven PrEP was chosen in 3873 (72.1%), and daily PrEP in 1400 (26.1%). HIV incidence was 2.4 per 100 person-years (95% CI 1.5-3.6) for event-driven PrEP, and 0.6 per 100 person-years (95% CI 0.1-2.3) for daily PrEP (adjusted incidence rate ratio 4.40, 95% CI 1.00-19.36, p=0.050). Adequate adherence was lower with event-driven than daily PrEP (44.3% vs 74.9%, p<0.001). Plasma drug concentrations were undetectable in 92 (97.9%) of the 94 measures taken for 23 participants who seroconverted. Only 1 participant had resistance to PrEP drugs. HIV seroconversions mainly occurred in participants who chose event-driven PrEP. The study's data highlighted major difficulties with adherence to this regimen. Improving adherence to event-driven PrEP constitutes a major research and public health priority in this context.

A Novel Capacity-Strengthening Intervention for Frontline Harm Reduction Workers to Support Pre-exposure Prophylaxis Awareness-Building and Promotion Among People Who Use Drugs: Formative Research and Intervention Development.

HIV prevalence among people who use drugs (PWUD) in Baltimore, Maryland, is higher than among the general population. Pre-exposure prophylaxis (PrEP) is a widely available medication that prevents HIV transmission, yet its usefulness is low among PWUD in Baltimore City and the United States. Community-level interventions to promote PrEP uptake and adherence among PWUD are limited. We describe the development of a capacity-strengthening intervention designed for frontline harm reduction workers (FHRWs) to support PrEP awareness-building and promotion among PWUD. Our study was implemented in 2 phases in Baltimore City, Maryland. The formative phase focused on a qualitative exploration of the PrEP implementation environment, as well as facilitators and barriers to PrEP willingness and uptake, among cisgender women who use drugs. This work, as well as the existing literature, theory, and feedback from our community partners, informed the intervention development phase, which used an academic-community partnership model. The intervention involved a 1-time, 2-hour training with FHRWs aimed at increasing general PrEP knowledge and developing self-efficacy promoting PrEP in practice (eg, facilitating PrEP dialogues with clients, supporting client advancement along a model of PrEP readiness, and referring clients to PrEP services). In a separate paper, we describe the conduct and results of a mixed methods evaluation to assess changes in PrEP-related knowledge, attitudes, self-efficacy, and promotion practices among FHRWs participating in the training. The pilot was developed from October to December 2021 and implemented from December 2021 through April 2022. We leveraged existing relationships with community-based harm reduction organizations to recruit FHRWs into the intervention. A total of 39 FHRWs from 4 community-based organizations participated in the training across 4 sessions (1 in-person, 2 online synchronous, and 1 online asynchronous). FHRW training attendees represented a diverse range of work cadres, including peer workers, case managers, and organizational administrators. This intervention could prevent the HIV burden among PWUD by leveraging the relationships that FHRWs have with PWUD and by supporting advancement along the PrEP continuum. Given suboptimal PrEP uptake among PWUD and the limited number of interventions designed to address this gap, our intervention offers an innovative approach to a burgeoning public health problem. If effective, our intervention has the potential to be further developed and scaled up to increase PrEP awareness and uptake among PWUD worldwide.

Acceptability and Feasibility of a Mobile Phone Application to Support HIV Pre-exposure Prophylaxis Among Women with Opioid Use Disorder.

Despite evidence supporting HIV pre-exposure prophylaxis (PrEP) effectiveness, very few women with opioid use disorder (OUD) take PrEP. Interventions that improve medication assisted treatment (MAT) uptake and adherence may also be beneficial for PrEP. The reSET-O mobile phone app is a component of the evidence-based Therapeutic Education System, which improves retention and abstinence for people with OUD. To better understand use of this mobile health tool as a support for PrEP among women with OUD, pre-implementation contextual inquiry is needed. Therefore, we set out to assess target user characteristics, implementation barriers, feasibility, and acceptability of reSET-O. We recruited women with OUD receiving care from a community-based organization in Philadelphia to complete semi-structured interviews. All participants were prescribed reSET-O. We interviewed 20 participants (average age 37 years; 70% white, 15% Hispanic, 5% Black) from 5/2021 to 2/2022. We used an integrated analysis approach combining modified grounded theory and implementation science constructs. Half reported recent injection drug use, and 6 were taking buprenorphine. Mental health symptoms were common, and half described engaging in transactional sex. The majority expressed strong interest in PrEP. Participants reported the app would be highly acceptable for PrEP and MAT adherence support, but only two redeemed the prescription. The most common barriers included phone and internet access. Our findings highlight potential implementation challenges for the use of such an app to support PrEP use in this population. Poor uptake of the app at follow-up indicates that initial prescription redemption is a major barrier to reSET-O implementation.

Lessons Learned From the Implementation of a Pilot Study on Self-collected Specimen Return by Sexual Minority Men (Project Caboodle!): Qualitative Exploration.

Self-collection of specimens at home and their return by mail might help reduce some of the barriers to HIV and bacterial sexually transmitted infection (STI) screening encountered by gay, bisexual, and other men who have sex with men (GBMSM). To evaluate the benefits and challenges of bringing this approach to scale, researchers are increasingly requesting GBMSM to return self-collected specimens as part of web-based sexual health studies. Testing self-collected hair samples for preexposure prophylaxis drug levels may also be a viable option to identify GBMSM who face adherence difficulties and offer them support. Project Caboodle! sought to evaluate the acceptability and feasibility of self-collecting at home and returning by mail 5 specimens (a finger-stick blood sample, a pharyngeal swab, a rectal swab, a urine specimen, and a hair sample) among 100 sexually active GBMSM in the United States aged between 18 and 34 years. In this manuscript, we aimed to describe the key lessons learned from our study's implementation and to present recommendations offered by participants to maximize the rates of self-collected specimen return. Following the specimen self-collection phase, a subset of 25 participants (11 who returned all 5 specimens, 4 who returned between 1 and 4 specimens, and 10 who did not return any specimens) was selected for in-depth interviews conducted via a videoconferencing platform. During the session, a semistructured interview guide was used to discuss the factors influencing decisions regarding returning self-collected specimens for laboratory processing. The transcripts were analyzed using template analysis. University branding of web-based and physical materials instilled a sense of trust in participants and increased their confidence in the test results. Shipping the specimen self-collection box in plain unmarked packaging promoted discretion during transit and on its receipt. Using different colored bags with matching color-coded instructions to self-collect each type of specimen minimized the potential for confusion. Participants recommended including prerecorded instructional videos to supplement the written instructions, providing information on the importance of triple-site bacterial STI testing, and adding a reminder of the types of testing that would and would not be conducted on hair samples. Participants also suggested tailoring the specimen self-collection box to include only the tests that they might be interested in completing at that time, adding real-time videoconferencing to the beginning of the study to introduce the research team, and sending personalized reminders following the delivery of the specimen self-collection box. Our results offer valuable insights into aspects that facilitated participant engagement in self-collected specimen return, as well as areas for potential improvement to maximize return rates. Our findings can help guide the design of future large-scale studies and public health programs for home-based HIV, bacterial STI, and preexposure prophylaxis adherence testing. RR2-10.2196/13647.

198 Meta-analysis of Transgender Exclusion from PrEP Clinical Trials

OBJECTIVES/GOALS: To evaluate access to Pre-Exposure Prophylaxis (PrEP) medications for transgender individuals examining how systemic and sociocultural obstacles play a role. Additionally, analyzing the impact of trans-exclusion in clinical trials investigating PrEP efficacy on the trans-HIV care model. METHODS/STUDY POPULATION: By examining the clinicaltrials.gov database, inclusion and exclusion criteria will be collected for Phase III trials of FTC/TAF (Descovy) and FTC/TDF (Truvada) as PrEP for Human Immunodeficiency Virus (HIV). Secondly, trends of physicians’ prescription of PrEP will be analyzed to track post-approval usage and deduce the acceptance and adherence of PrEP by transgender patients. Thirdly, post-approval marketing strategies of PrEP medications will be documented to see key demographics that biopharmaceutical companies are targeting. Finally, relevant literature about trans healthcare will be analyzed to identify key short fallings to support conclusions and justify recommendations for greater transgender clinical trial enrollment and reformations to current standard practices. RESULTS/ANTICIPATED RESULTS: After a preliminary literature review of published Phase III trials for Descovy and Truvada , there is a marked lack of transgender patient enrollment. Contemporary literature argues that this lag in enrollment has downstream effects on trust and acceptance of PrEP as safe and effective by cohorts in the transgender community. The examination of prescribing information for Descovy and Truvada for PrEP reveals a minimal effort to advise doctors of the increased risk for infection in the transgender demographic. Through continued research, I expect to elaborate on the cross-discipline impacts of trans-exclusion, including increased rates of HIV infection, sociocultural and financial barriers to PrEP, and stigmatizing doctor interactions with transgender patients. DISCUSSION/SIGNIFICANCE: The current trans-HIV treatment paradigm lags behind in its sensitivity and nuance, preventing the most equitable distribution of care. Only with more inclusion of transgender individuals in clinical trials can we hope to promote greater awareness and trust for PrEP as effective for HIV.

An Assessment of HIV Risk, Perceptions of Risk, and Potential Adherence to Preexposure Prophylaxis Among HIV-Negative People With Injection Drug Use Who Access Mobile Outreach Services.

The purpose of this study was to assess HIV risk, perceptions of risk, and potential adherence to preexposure prophylaxis (PrEP) for the prevention of HIV infection among people who inject drugs (PWID), who self-report HIV negative status and access mobile outreach intravenous drug use (IVDU) services. Participants (N = 93) were non-Hispanic White (59.1%) and Hispanic (36.6%), between the ages of 18 and 63 years, primarily male (58.1%), who reported a length of IVDU between 1 and >20 years and accessed mobile outreach IVDU services in a metropolitan area of the Southwestern United States; all self-reported HIV-negative status. Self-report questionnaires completed via iPad included HIV risk behavior, perceived risk of HIV, and beliefs about medicines. PWID perceived themselves at a low risk for HIV with minimal concerns about contracting HIV. High levels of comorbidities (schizophrenia, anxiety, depression, hepatitis, diabetes, and hypertension), substance use, and limited HIV protective behavior and social support existed; women reported significantly more risk behaviors and comorbidities. Positive attitudes toward and interest in use of medication for HIV prevention were present, however, with concurrent concerns regarding long-term medication use and the potential to forget medications. PrEP adherence for PWID presents challenges for clinicians. Addressing perceptions of PrEP, perceived and actual risk for contracting HIV, potential barriers to PrEP adherence, social support, and treatment of comorbidities in primary care and IVDU outreach services potentially enhances PrEP maintenance among PWID, notably women.

Addressing the Need for a Preexposure Prophylaxis Monitoring and Evaluation Implementation Guide: Experience From Zambia.

The HIV care continuum comprises well-defined steps and indicators. In contrast, indicators along the preexposure prophylaxis (PrEP) cascade are still in the early stages of implementation. Monitoring and evaluation (M&E) of PrEP services is critical to optimizing PrEP uptake and adherence during periods of HIV risk. We provide an overview of global indicators for PrEP, describe the development process and outcomes of Zambia's 2022 National Pre-Exposure Prophylaxis (PrEP) Program Monitoring & Evaluation Implementation Guide, and discuss the guide's implications for other countries in sub-Saharan Africa. During the scale-up of PrEP, the Zambia Ministry of Health (MOH) and the National HIV/AIDS/STI/TB Council recognized the need for a national unified monitoring system to guide the effective implementation of PrEP services. Stakeholders from the MOH, civil society, professional organizations, funding agencies, and implementing partners developed the National Pre-Exposure Prophylaxis (PrEP) Program Monitoring & Evaluation Implementation Guide. This guide is aligned with the existing global indicators from the World Health Organization and the U.S. President's Emergency Plan for AIDS Relief and adapted to the country's needs, context, and health information systems. Zambia's experience in developing the guide has highlighted the importance of strengthening client-level monitoring systems for HIV prevention, ensuring flexibility of the PrEP monitoring system to accommodate PrEP delivery modalities and differentiated service delivery models, and training health workers to enhance PrEP services and deliver care PrEP services along the continuum to prevent HIV acquisition effectively. Using a collaborative and consensus-based approach, Zambia developed its first national PrEP M&E implementation guide to provide standardized guidelines for optimizing the delivery, monitoring, and evaluation of PrEP service delivery. Zambia's experience can inform other countries in sub-Saharan Africa as they develop national M&E implementation approaches for PrEP.

Understanding Retention in the HIV Pre-Exposure Prophylaxis Cascade Among Cisgender Women.

HIV remains a significant public health concern in the United States, with 34,800 new cases diagnosed in 2019; of those, 18% were among women. Oral pre-exposure prophylaxis (PrEP) with daily tenofovir disoproxil fumarate/emtricitabine is effective and safe, reducing HIV transmission by up to 92% in women. Though studies demonstrate low rates of PrEP adherence among cisgender women prescribed oral PrEP, little is known about the factors that shape PrEP continuation among them. This study focuses on understanding the experiences of cisgender women who have initiated PrEP to gain insight into the factors that shape PrEP continuation. We conducted semi-structured interviews with (N = 20) women who had been prescribed oral PrEP. Interviews were guided by the social-ecological framework to identify multilevel factors affecting PrEP continuation; we specifically examined the experience of engagement and retention in the PrEP cascade. We recruited women who had been prescribed oral PrEP by a government-sponsored sexual health center or a hospital-based family planning clinic in Washington, DC. Factors facilitating PrEP continuation included a positive emotional experience associated with PrEP use, high perceived risk of HIV acquisition, and high-quality communication with health care providers. The most common reason for PrEP discontinuation was low perceived HIV risk (n = 11). Other factors influencing discontinuation were side effects, a negative emotional experience while using PrEP, and negative interactions with the health care system. This study underscores the importance of specific multi-level factors, including the provision of high-quality communication designed to resonate with women and shared decision making between women and their health care providers.

Perspectives of Young Men Who Have Sex with Men on PrEP Adherence and Peer Navigation: A Qualitative Study.

HIV incidence is disproportionately high among young cisgender men who have sex with men (YMSM), but YMSM are less likely than adults to use HIV pre-exposure prophylaxis (PrEP). Among YMSM living with HIV, peer navigation programs have been effective in linkage to care and increasing medication adherence; such programs may aid HIV-uninfected YMSM in overcoming barriers to engagement in PrEP care. We conducted 32 semi-structured qualitative interviews at a community health center in Massachusetts, USA, specializing in sexual and gender minority health with four sub-groups of YMSM who: (1) had never discussed PrEP with a medical provider, (2) had discussed PrEP with a medical provider but declined a prescription, (3) were prescribed PrEP and have sub-optimal adherence (taking fewer than 4 pills per week), and (4) were prescribed PrEP and were optimally adherent. Domains addressed in the interviews included knowledge of PrEP and HIV prevention, barriers and facilitators to PrEP adherence, and attitudes toward peer navigation for PrEP. Interviews were transcribed and coded using thematic analysis methodology. Multiple themes emerged from the interviews, including finding that perceived costs, anticipated stigma, sexual activity, and relationship status influence PrEP uptake and adherence; establishing pill-taking routines is an important adherence facilitator; and peer navigators could offer benefits for PrEP adherence.

Study protocol for an efficacy trial of the “PrEP for Health” intervention to increase HIV PrEP use among people who inject drugs

BackgroundHIV incidence has recently increased among people who inject drugs (PWID) across the United States, with outbreaks occurring in states with long-standing syringe service programs (SSPs) including Massachusetts (MA). Antiretroviral pre-exposure prophylaxis (PrEP) is an evidence-based HIV prevention strategy recommended for PWID, but uptake in this marginalized population is extraordinarily low.MethodsWe describe the design and procedures for a National Institute on Drug Abuse (NIDA)-funded (R01) randomized controlled trial (RCT) testing the efficacy of “PrEP for Health,” a multicomponent behavioral intervention to increase PrEP uptake, adherence, and persistence among HIV-negative PWID attending SSPs in two areas of the U.S. Northeast that are heavily affected by injection-related HIV transmission. Participants are equally randomized to receive the “PrEP for Health” intervention (involving individually tailored HIV and PrEP education, motivational interviewing, problem-solving skills and planning, and ongoing navigation support) or an enhanced standard of care (eSOC) control condition involving a brief educational video on the utility of PrEP for HIV prevention. Co-primary outcomes are PrEP uptake (using medical/pharmacy records) and adherence (using tenofovir quantification in hair samples); a secondary outcome is PrEP persistence (using medical/pharmacy records) over 12 months. Major assessments occur at baseline, 1-, 3-, 6-, and 12-month follow-up visits. Planned analyses will examine intervention efficacy, specific hypothesized conceptual mediators of the intervention effect (e.g., self-perceived HIV risk; PrEP knowledge, interest in use, motivation, and behavioral skills) and epidemiologically linked moderators (e.g., age; gender; condomless vaginal or anal sex).DiscussionFindings from our extensive preliminary research with the study population revealed that a multicomponent, theory-based intervention targeting PrEP knowledge, motivation, self-efficacy, behavioral skills, and structural barriers to PrEP access is urgently needed for PWID who are at risk of HIV acquisition. We also learned that SSPs represent a highly acceptable service setting for delivering such interventions. In this study, we are evaluating the efficacy of the “PrEP for Health” intervention. If efficacious, findings from our implementation evaluation could help guide its dissemination to diverse SSPs and possibly other community-based settings accessed by this population.Trial registrationClinicalTrials.gov number NCT04430257, registered June 12, 2020.

Correlates of self-reported and biomarker based adherence to daily oral HIV pre-exposure prophylaxis among a cohort of predominantly men who have sex with men in Nigeria.

HIV pre-exposure prophylaxis (PrEP) significantly reduces the risk of HIV acquisition. However, studies have demonstrated discordance between self-reported measures and biomedical benchmarks of PrEP adherence. We estimated the correlation between self-reported PrEP adherence and PrEP biomarkers and explored factors associated with adherence among men who have sex with men (MSM) in Nigeria. TRUST-PrEP, an open-label, prospective study; conducted in Abuja between April 2018 and May 2019. MSM ≥ 18 years with substantial HIV risk were enrolled. Participants reported PrEP adherence in the last month using a 4-point scale from "poor" to "perfect" and serum samples for PrEP biomarkers were collected at months 3 and 9. Serum tenofovir concentration was measured by liquid chromatography-tandem mass spectrometry and considered protective for adherence if ≥ 4.2 ng/ml. Spearman's rank correlation was used to estimate correlation between self-reported adherence and measured tenofovir levels. Generalized estimating equations with a logit link was used to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for associations between self-reported adherence and laboratory-measured adherence. A total of 219 MSM with median age 23 (interquartile range 20-27) years had at least one PrEP biomarker assay. Only 66/219 (30%) had at least one record of protective tenofovir concentration. Correlation between tenofovir and self-reported adherence at 3 and 9 months were 0.1 and 0.02 respectively. Furthermore, 17/219 (8%,) and 49/219 (22%) had serum tenofovir of 4.2-35.4 ng/mL and ≥ 35.5 ng/mL, corresponding to at least 4 and 7 days' PrEP use in a week, respectively. PrEP adherence was higher among participants introduced to PrEP in the clinics compared with communities (aOR: 8.35, 95%CI: [3.24, 21.5]) and those with same-sex practices family disclosure (aOR: 3.60 95% CI: [1.73, 7.51]). Self-reported PrEP adherence poorly correlated with biomarkers. Facilitating clinic-based PrEP introduction and disclosure of same-sex practices to family among MSM may improve PrEP adherence.

Depression and PrEP uptake, interruption, and adherence among young women in Uganda

ABSTRACT Depression is a common cause of morbidity globally and can impact adherence to medications, posing challenges to medication-based HIV prevention. The objectives of this work are to describe the frequency of depression symptoms in a cohort of 499 young women in Kampala, Uganda and to determine the association of depression symptoms with use of HIV pre-exposure prophylaxis (PrEP). Mild or greater depression, assessed by the patient health questionnaire (PHQ-9), was experienced by 34% of participants at enrollment. Participants with mild depression symptoms tended to uptake PrEP, request PrEP refills, and adhere to PrEP with similar frequency to women with no/minimal signs of depression. These findings highlight opportunities to leverage existing HIV prevention programs to identify women who may benefit from mental health services and may not otherwise be screened. Trial registration: ClinicalTrials.gov identifier: NCT03464266..

High prevalence and incidence of gonorrhoea and chlamydia in young women eligible for HIV pre-exposure prophylaxis in South Africa and Zimbabwe: results from the HPTN 082 trial

IntroductionWe investigated the prevalence, incidence and factors associated with sexually transmitted infections (STIs) among young African women seeking HIV pre-exposure prophylaxis (PrEP).MethodsHPTN 082 was a prospective, open-label PrEP study enrolling...