Reduce HIV Incidence Research Articles

Finding and treating early-stage HIV infections: A cost-effectiveness analysis of the Sabes study in Lima, Peru

Sabes, a treatment-as-prevention intervention among men who have sex with men and transgender women in Lima, Peru, was developed to identify HIV during early primary infection (<3 months from acquisition) through monthly serologic assays and HIV RNA tests. Newly diagnosed individuals were rapidly linked to care and offered to initiate ART. In this study we sought to study the cost-effectiveness of Sabes compared to the standard of care (SOC) for HIV testing and initiation of treatment. We adapted a compartmental model of HIV transmission to evaluate the cost-effectiveness of the Sabes approach compared to the SOC using a government health care perspective, 20-year time horizon, and 3% annual discounting. We estimated the proportion of cases of HIV detected during early primary infection, reduction in HIV incidence and prevalence, incremental cost-effectiveness ratio (ICER), and net monetary benefit. We analyzed costs using data from the Sabes study, the Peruvian Ministry of Health, published literature, and expert consultation. The Sabes intervention is projected to identify 9294 early primary HIV infections in Lima, Peru over 20 years. The intervention costs $6,896 per early primary infection diagnosed and by 2038 is expected to decrease the fraction of early infections among prevalent infections by 62%. Sabes is expected to improve health, resulting in greater total discounted QALYs per person than the SOC (16·7 vs 16·4, respectively). Sabes had an ICER of $1431 (22% per capita GDP in Peru) per QALY compared to SOC. Our analysis suggests that in Lima, Peru the Sabes intervention could be a cost-effective approach to reduce the burden of HIV even under stringent cost-effectiveness criteria. This finding suggests that programs that use frequent HIV testing, rapid linkage to care and initiation of ART should be considered as part of a comprehensive HIV prevention strategy. National Institutes of Health.

Cost-effectiveness and impact of pre-exposure prophylaxis to prevent HIV among men who have sex with men in Asia: A modelling study.

IntroductionMore than 70% of new HIV infections in Asia occurred in eight countries in 2020: Cambodia, China, India, Indonesia, Myanmar, Nepal, Thailand, and Vietnam—with a rising incidence among men who have sex with men (MSM). The World Health Organization (WHO) recommends pre-exposure prophylaxis (PrEP) for those at risk of acquiring HIV, yet wide-scale implementation of PrEP, on a daily or event-driven basis, has been limited in Asia.MethodsThe Optima HIV model was applied to examine the impact of scaling-up PrEP over five-years to cover an additional 15% of MSM compared with baseline coverage, a target deemed feasible by regional experts. Based on behavioral survey data, we assume that covering 15% of higher-risk MSM will cover 30% of all sexual acts in this group. Scenarios to compare the impact of generic-brand daily dosing of PrEP with generic event-driven dosing (15 days a month) were modelled from the start of 2022 to the end of 2026. Cost-effectiveness of generic versus branded PrEP was also assessed for China, the only country with an active patent for branded, higher cost PrEP. The impact on new HIV infections among the entire population and cost per HIV-related disability-adjusted life year (DALY) averted were estimated from the beginning of 2022 to the end of 2031 and from 2022 to 2051.ResultsIf PrEP were scaled-up to cover an additional 15% of MSM engaging in higher-risk behavior from the beginning of 2022 to the end of 2026 in the eight Asian countries considered, an additional 100,000 (66,000–130,000) HIV infections (17%) and 300,000 (198,000–390,000) HIV-related DALYs (3%) could be averted over the 2022 to 2031 period. The estimated cost per HIV-related DALY averted from 2022 to 2031 ranged from US$600 for event-driven generic PrEP in Indonesia to US$34,400 for daily branded PrEP in Thailand. Over a longer timeframe from 2022 to 2051, the cost per HIV-related DALY averted could be reduced to US$100–US$12,700.ConclusionPrEP is a critical tool to further reduce HIV incidence in highly concentrated epidemics. Implementing PrEP in Asia may be cost-effective in settings with increasing HIV prevalence among MSM and if PrEP drug costs can be reduced, PrEP could be more cost-effective over longer timeframes.

Substance use and HIV: some considerations in a global context

ABSTRACT This brief report calls attention to the relationship between substance use and HIV from a global perspective. The epidemiology of substance use disorders among persons living with HIV and AIDS (PLWHA) is discussed along with specific caveats in the assessment of these disorders. Important macro-interventions include needle and syringe exchange programs (NSEP) and medication assisted therapy (MAT). Yet, structural interventions such as social welfare, child protection and support services for survivors of violence and abuse are necessary to reduce HIV incidence and enhance engagement in care among those living with HIV. To this extent health systems strengthening is necessary, as is integrating services provided by health and social development departments.

Integrating Enhanced HIV Pre-exposure Prophylaxis Into a Sexually Transmitted Infection Clinic in Lilongwe: Protocol for a Prospective Cohort Study.

Pre-exposure prophylaxis (PrEP) reduces HIV acquisition risk by >90% and is a critical lever to reduce HIV incidence. Identifying individuals most likely to benefit from PrEP and retaining them on PrEP throughout HIV risk is critical to realize PrEP's prevention potential. Individuals with sexually transmitted infections (STIs) are an obvious priority PrEP population, but there are no data from sub-Saharan Africa (SSA) confirming the effectiveness of integrating PrEP into STI clinics. Assisted partner notification may further enhance STI clinic-based PrEP programming by recruiting PrEP users from the pool of named sexual partners of individuals presenting with an incident STI. However, the acceptability, feasibility, and effectiveness of these integrated and enhanced strategies are unknown. This study aims to describe the implementation outcomes of acceptability, feasibility, and effectiveness (regarding PrEP uptake and persistence) of integrating an enhanced PrEP implementation strategy into an STI clinic in Malawi. The enhanced PrEP STI study is a prospective cohort study enrolling patients who are eligible for PrEP (aged ≥15 years) who are seeking STI services at a Lilongwe-based STI clinic. Data collection relies on a combination of in-depth interviews, patient and clinic staff surveys, and clinic record review. All enrolled PrEP users will be screened for acute HIV infection and receive quarterly testing for Neisseria gonorrhea, Chlamydia trachomatis, and syphilis. Participants will be asked to name recent sexual partners for assisted notification; returning partners will be screened for PrEP eligibility and, if interested, enrolled into the cohort of PrEP initiators. We will also enroll patients who are eligible for PrEP but choose not to initiate it, from the STI clinic. Patient participants will be followed for 6 months; we will assess self-reported PrEP use, PrEP refills, sexual behaviors, perceived HIV risk, and incident STIs. Clinic staff participants will be interviewed at baseline and at approximately 6 months and will complete surveys examining the perceived acceptability and feasibility of the integrated and enhanced PrEP strategy. Enrollment began in March 2022 and is projected to continue until February 2023, with patient participant follow-up through August 2023. The results of this study are expected to be reported in 2024. This study will generate important evidence regarding the potential integration of PrEP services into STI clinics in SSA and preliminary data regarding the effectiveness of an enhanced intervention that includes assisted partner notification as a strategy to identify potential PrEP users. Furthermore, this trial will provide some of the first insights into STI incidence among PrEP users recruited from an STI clinic in SSA-critical data to inform the use of etiologic STI testing where syndromic management is the current standard. These findings will help to design future PrEP implementation strategies in SSA. ClinicalTrials.gov NCT05307991; https://clinicaltrials.gov/ct2/show/NCT05307991. DERR1-10.2196/37395.

Individual, Interpersonal, and Structural Factors That Influence Intentions to Use Pre-exposure Prophylaxis Among Sexual Minority Men in Miami.

Pre-exposure prophylaxis for HIV or "PrEP" holds great promise for reducing HIV incidence. However, in certain geographic settings, like Miami, a US HIV epicenter, uptake of PrEP has been paradoxically very low compared to other areas of the country. The goal of the current study was to examine factors associated with low uptake of PrEP in young sexual minority men in Miami. Qualitative data were extracted from conversations during voluntary HIV/STI counseling and testing sessions with 24 young sexual minority men, most of whom identified as racial/ethnic minorities. These sessions were completed as part of a baseline visit for a combined mental and sexual health intervention trial. Thematic analysis of transcripts revealed barriers and facilitators associated with PrEP uptake at multiple levels (individual, interpersonal, and economic and healthcare systems barriers). Individual-level themes included concerns about the safety of PrEP, risk compensation, and taking daily oral medication; and potential benefits of PrEP as a backup plan to condom use to reassure and reduce worry about HIV. Interpersonal-level themes included lack of knowledgeable and affirming medical providers, changing norms within the community around "safe sex," and PrEP use in serodiscordant partnerships. Economic and healthcare systems barriers included challenges to accessing PrEP because of a lack of insurance and high out-of-pocket cost. These data can be used to inform the development of interventions aligned withEnding the HIV Epidemicpriorities to increase PrEP use among young sexual minority men living in an HIV epicenter.

Demonstration and Acceptability of a Safer Conception Intervention for Men With HIV in South Africa: Pilot Cohort Study.

BackgroundMany men with HIV (MWH) want to have children. HIV viral suppression minimizes sexual HIV transmission risks while allowing for conception and optimization of the health of men, their partners, and their infants.ObjectiveThis study developed and evaluated the feasibility and acceptability of an intervention to promote serostatus disclosure, antiretroviral therapy (ART) uptake and adherence, and viral suppression among MWH who want to have children in South Africa.MethodsWe developed a safer conception intervention (Sinikithemba Kwabesilisa or We give hope to men) to promote viral suppression via ART uptake and adherence, HIV serostatus disclosure, and other safer conception strategies for MWH in South Africa. Through 3 counseling and 2 booster sessions over 12 weeks, we offered education on safer conception strategies and aided participants in developing a safer conception plan. We recruited MWH (HIV diagnosis known for >1 month), not yet accessing ART or accessing ART for <3 months, in a stable partnership with an HIV-negative or unknown-serostatus woman, and wanting to have a child in the following year. We conducted an open pilot study to evaluate acceptability based on patient participation and exit interviews and feasibility based on recruitment and retention. In-depth exit interviews were conducted with men to explore intervention acceptability. Questionnaires collected at baseline and exit assessed disclosure outcomes; CD4 and HIV-RNA data were used to evaluate preliminary impacts on clinical outcomes of interest.ResultsAmong 31 eligible men, 16 (52%) enrolled in the study with a median age of 29 (range 27-44) years and a median time-since-diagnosis of 7 months (range 1 month to 9 years). All identified as Black South African, with 56% (9/16) reporting secondary school completion and 44% (7/16) reporting full-time employment. Approximately 44% (7/16) of participants reported an HIV-negative (vs unknown-serostatus) partner. Approximately 88% (14/16) of men completed the 3 primary counseling sessions. In 11 exit interviews, men reported personal satisfaction with session content and structure while also suggesting that they would refer their peers to the program. They also described the perceived effectiveness of the intervention and self-efficacy to benefit. Although significance testing was not conducted, 81% (13/16) of men were taking ART at the exit, and 100% (13/13) of those on ART were virally suppressed at 12 weeks. Of the 16 men, 12 (75%) reported disclosure to pregnancy partners.ConclusionsThese preliminary data suggest that safer conception care is acceptable to men and has the potential to reduce HIV incidence among women and their children while supporting men’s health. Approximately half of the men who met the screening eligibility criteria were enrolled. Accordingly, refinement to optimize uptake is needed. Providing safer conception care and peer support at the community level may help reach men.Trial RegistrationClinicalTrials.gov NCT03818984; https://clinicaltrials.gov/ct2/show/NCT03818984International Registered Report Identifier (IRRID)RR2-https://doi.org/10.1007/s10461-017-1719-4

Cost-effectiveness of easy-access, risk-informed oral pre-exposure prophylaxis in HIV epidemics in sub-Saharan Africa: a modelling study

SummaryBackgroundApproaches that allow easy access to pre-exposure prophylaxis (PrEP), such as over-the-counter provision at pharmacies, could facilitate risk-informed PrEP use and lead to lower HIV incidence, but their cost-effectiveness is unknown. We aimed to evaluate conditions under which risk-informed PrEP use is cost-effective.MethodsWe applied a mathematical model of HIV transmission to simulate 3000 setting-scenarios reflecting a range of epidemiological characteristics of communities in sub-Saharan Africa. The prevalence of HIV viral load greater than 1000 copies per mL among all adults (HIV positive and negative) varied from 1·1% to 7·4% (90% range). We hypothesised that if PrEP was made easily available without restriction and with education regarding its use, women and men would use PrEP, with sufficient daily adherence, during so-called seasons of risk (ie, periods in which individuals are at risk of acquiring infection). We refer to this as risk-informed PrEP. For each setting-scenario, we considered the situation in mid-2021 and performed a pairwise comparison of the outcomes of two policies: immediate PrEP scale-up and then continuation for 50 years, and no PrEP. We estimated the relationship between epidemic and programme characteristics and cost-effectiveness of PrEP availability to all during seasons of risk. For our base-case analysis, we assumed a 3-monthly PrEP cost of US$29 (drug $11, HIV test $4, and $14 for additional costs necessary to facilitate education and access), a cost-effectiveness threshold of $500 per disability-adjusted life-year (DALY) averted, an annual discount rate of 3%, and a time horizon of 50 years. In sensitivity analyses, we considered a cost-effectiveness threshold of $100 per DALY averted, a discount rate of 7% per annum, the use of PrEP outside of seasons of risk, and reduced uptake of risk-informed PrEP.FindingsIn the context of PrEP scale-up such that 66% (90% range across setting-scenarios 46–81) of HIV-negative people with at least one non-primary condomless sex partner take PrEP in any given period, resulting in 2·6% (0·9–6·0) of all HIV negative adults taking PrEP at any given time, risk-informed PrEP was predicted to reduce HIV incidence by 49% (23–78) over 50 years compared with no PrEP. PrEP was cost-effective in 71% of all setting-scenarios, and cost-effective in 76% of setting-scenarios with prevalence of HIV viral load greater than 1000 copies per mL among all adults higher than 2%. In sensitivity analyses with a $100 per DALY averted cost-effectiveness threshold, a 7% per year discount rate, or with PrEP use that was less well risk-informed than in our base case, PrEP was less likely to be cost-effective, but generally remained cost-effective if the prevalence of HIV viral load greater than 1000 copies per mL among all adults was higher than 3%. In sensitivity analyses based on additional setting-scenarios in which risk-informed PrEP was less extensively used, the HIV incidence reduction was smaller, but the cost-effectiveness of risk-informed PrEP was undiminished.InterpretationUnder the assumption that making PrEP easily accessible for all adults in sub-Saharan Africa in the context of community education leads to risk-informed use, PrEP is likely to be cost-effective in settings with prevalence of HIV viral load greater than 1000 copies per mL among all adults higher than 2%, suggesting the need for implementation of such approaches, with ongoing evaluation.FundingUS Agency for International Development, US President's Emergency Plan for AIDS Relief, and Bill & Melinda Gates Foundation.

Association of HIV Intervention Uptake With HIV Prevalence in Adolescent Girls and Young Women in South Africa

In South Africa, adolescent girls and young women aged 15 to 24 years are among the most high-risk groups for acquiring HIV. Progress in reducing HIV incidence in this population has been slow. To describe HIV prevalence and HIV risk behaviors among a sample of adolescent girls and young women and to model the association between exposure to multiple or layered interventions and key HIV biological and behavioral outcomes. This cross-sectional survey was conducted between March 13, 2017, and June 22, 2018, in 2 districts in Gauteng province and in 2 districts in KwaZulu-Natal province in South Africa. A stratified cluster random sampling method was used. Participants included adolescent girls and young women aged 12 to 24 years who lived in each sampled household. Overall, 10 384 participants were enrolled in Gauteng province and 7912 in KwaZulu-Natal province. One parent or caregiver was interviewed in each household. Data analysis was performed from March 12, 2021, to March 1, 2022. DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe)-like interventions. The primary outcome was HIV prevalence. HIV status was obtained from laboratory-based testing of peripheral blood samples. Secondary outcomes included HIV testing and antiretroviral therapy uptake as well as numerous HIV risk variables that the DREAMS program sought to improve, such as pregnancy, sexually transmitted infection, intimate partner violence, and age-disparate sex. The final sample included 18 296 adolescent girls and young women (median [IQR] age, 19 [15-21] years) in 10 642 households. Approximately half of participants (49.9%; n = 8414) reported engaging in sexual activity, and 48.1% (n = 3946) reported condom use at the most recent sexual encounter. KwaZulu-Natal province had a higher HIV prevalence than Gauteng province (15.1% vs 7.8%; P < .001). Approximately one-fifth of participants (17.6%; n = 3291) were not exposed to any interventions, whereas 43.7% (n = 8144) were exposed to 3 or more interventions. There was no association between exposure to DREAMS-like interventions and HIV status. Adolescent girls and young women who accessed 3 or more interventions were more likely to have undergone HIV testing (adjusted odds ratio, 2.39; 95% CI, 2.11-2.71; P < .001) and to have used condoms consistently in the previous 12 months (adjusted odds ratio, 1.68; 95% CI, 1.33-2.12; P < .001) than those who were not exposed to any interventions. Results of this study suggest that self-reported exposures to multiple or layered DREAMS-like interventions were associated with favorable behavioral outcomes. The beneficial aspects of layering HIV interventions warrant further research to support the sexual and reproductive health of adolescent girls and young women.

Individual and healthcare supply-related HIV transmission factors in HIV-positive patients enrolled in the antiretroviral treatment access program in the Centre and Littoral regions in Cameroon (ANRS-12288 EVOLCam survey).

Despite great progress in antiretroviral treatment (ART) access in recent decades, HIV incidence remains high in sub-Saharan Africa. We investigated the role of individual and healthcare supply-related factors in HIV transmission risk in HIV-positive adults enrolled in 19 HIV services in the Centre and Littoral regions of Cameroon. Factors associated with HIV transmission risk (defined as both unstable aviremia and inconsistent condom use with HIV-negative or unknown status partners) were identified using a multi-level logistic regression model. Besides socio-demographic and behavioral individual variables, the following four HIV-service profiles, identified using cluster analysis, were used in regression analyses as healthcare supply-related variables: 1) district services with large numbers of patients, almost all practicing task-shifting and not experiencing antiretroviral drugs (ARV) stock-outs (n = 4); 2) experienced and well-equipped national reference services, most practicing task-shifting and not experiencing ARV stock-outs (n = 5); 3) small district services with limited resources and activities, almost all experiencing ARV stock-outs (n = 6); 4) small district services with a wide range of activities and half not experiencing ARV stock-outs (n = 4). Of the 1372 patients (women 67%, median age [Interquartile]: 39 [33-44] years) reporting sexual activity in the previous 12 months, 39% [min-max across HIV services: 25%-63%] were at risk of transmitting HIV. The final model showed that being a woman (adjusted Odd Ratio [95% Confidence Interval], p-value: 2.13 [1.60-2.82], p<0.001), not having an economic activity (1.34 [1.05-1.72], p = 0.019), having at least two sexual partners (2.45 [1.83-3.29], p<0.001), reporting disease symptoms at HIV diagnosis (1.38 [1.08-1.75], p = 0.011), delayed ART initiation (1.32 [1.02-1.71], p = 0.034) and not being ART treated (2.28 [1.48-3.49], p<0.001) were all associated with HIV transmission risk. Conversely, longer time since HIV diagnosis was associated with a lower risk of transmitting HIV (0.96 [0.92-0.99] per one-year increase, p = 0.024). Patients followed in the third profile had a higher risk of transmitting HIV (1.71 [1.05-2.79], p = 0.031) than those in the first profile. Healthcare supply constraints, including limited resources and ARV supply chain deficiency may impact HIV transmission risk. To reduce HIV incidence, HIV services need adequate resources to relieve healthcare supply-related barriers and provide suitable support activities throughout the continuum of care.

Effects of a multimedia campaign on HIV self-testing and PrEP outcomes among young people in South Africa: a mixed-methods impact evaluation of ‘MTV Shuga Down South’

IntroductionInnovative HIV technologies can help to reduce HIV incidence, yet uptake of such tools is relatively low among young people. To create awareness and demand among adolescents and young adults,...

The case for prevention – Primary HIV prevention in the era of universal test and treat: A mathematical modeling study

SummaryBackgroundAs antiretroviral therapy (ART) has scaled up and HIV incidence has declined, some have questioned the continued utility of HIV prevention. This study examines the role and cost-effectiveness of HIV prevention in the context of “universal test and treat” (UTT) in three sub-Saharan countries with generalized HIV epidemics.MethodsScenarios were created in Spectrum/Goals models for Lesotho, Mozambique, and Uganda with various combinations of voluntary medical male circumcision (VMMC); pre-exposure prophylaxis; and a highly effective, durable, hypothetical vaccine layered onto three different ART scenarios. One ART scenario held coverage constant at 2008 levels to replicate prevention modeling studies that were conducted prior to UTT. One scenario assumed scale-up to the UNAIDS treatment goals of 90-90-90 by 2025 and 95-95-95 by 2030. An intermediate scenario held ART constant at 2019 coverage. HIV incidence was visualized over time, and cost per HIV infection averted was assessed over 5-, 15-, and 30-year time frames, with 3% annual discounting.FindingsEach prevention intervention reduced HIV incidence beyond what was achieved by ART scale-up alone to the 90-90-90/95-95-95 goals, with near-zero incidence achievable by combinations of interventions covering all segments of the population. Cost-effectiveness of HIV prevention may decrease as HIV incidence decreases, but one-time interventions like VMMC and a durable vaccine may remain cost-effective and even cost-saving as ART is scaled up.InterpretationPrimary HIV prevention is still needed in the era of UTT. Combination prevention is more impactful than a single, highly effective intervention. Broad population coverage of primary prevention, regardless of cost-effectiveness, will be required in generalized epidemic countries to eradicate HIV.

Impact of the DREAMS Partnership on social support and general self-efficacy among adolescent girls and young women: causal analysis of population-based cohorts in Kenya and South Africa

IntroductionThe Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS) Partnership aimed to influence psychosocial processes that promote empowerment among adolescent girls and young women (AGYW), and reduce HIV incidence. We...

Integrating and Disseminating Pre-Exposure Prophylaxis (PrEP) Screening and Dispensing for Black Men Who Have Sex With Men in Atlanta, Georgia: Protocol for Community Pharmacies.

BackgroundBlack men who have sex with men (BMSM) suffer from alarmingly high rates of HIV in the United States. Pre-exposure prophylaxis (PrEP) can reduce the risk of HIV infection by 99% among men who have sex with men, yet profound racial disparities in the uptake of PrEP persist. Low PrEP uptake in BMSM is driven by poor access to PrEP, including inconvenient locations of PrEP-prescribing physicians, distrust of physicians, and stigma, which limit communication about PrEP and its side effects. Previous work indicates that offering HIV prevention services in pharmacies located in low-income, underserved neighborhoods is feasible and can reduce stigma because pharmacies offer a host of less stigmatized health services (eg, vaccinations). We present a protocol for a pharmacy PrEP model that seeks to address challenges and barriers to pharmacy-based PrEP specifically for BMSM.ObjectiveWe aim to develop a sustainable pharmacy PrEP delivery model for BMSM that can be implemented to increase PrEP access in low-income, underserved neighborhoods.MethodsThis study design is a pilot intervention to test a pharmacy PrEP delivery model among pharmacy staff and BMSM. We will examine the PrEP delivery model’s feasibility, acceptability, and safety and gather early evidence of its impact and cost with respect to PrEP uptake. A mixed-methods approach will be performed, including three study phases: (1) a completed formative phase with qualitative interviews from key stakeholders; (2) a completed transitional pilot phase to assess customer eligibility and willingness to receive PrEP in pharmacies during COVID-19; and (3) a planned pilot intervention phase which will test the delivery model in 2 Atlanta pharmacies in low-income, underserved neighborhoods.ResultsData from the formative phase showed strong support of pharmacy-based PrEP delivery among BMSM, pharmacists, and pharmacy staff. Important factors were identified to facilitate the implementation of PrEP screening and dissemination in pharmacies. During the transitional pilot phase, we identified 81 individuals who would have been eligible for the pilot phase.ConclusionsPharmacies have proven to be a feasible source for offering PrEP for White men who have sex with men but have failed to reach the most at-risk, vulnerable population (ie, BMSM). Increasing PrEP access and uptake will reduce HIV incidence and racial inequities in HIV. Translational studies are required to build further evidence and scale pharmacy-based PrEP services specifically for populations that are disconnected from HIV prevention resources.International Registered Report Identifier (IRRID)DERR1-10.2196/35590

Long-term HIV Pre-exposure Prophylaxis Trajectories Among Racial & Ethnic Minority Patients: Short, Declining, & Sustained Adherence.

HIV pre-exposure prophylaxis (PrEP) requires continued use at an effective dosage to reduce HIV incidence. Data suggest early PrEP drop-off among many populations. We sought to describe PrEP use over the first year among racial and ethnic minority patients in the US. Racial and ethnic minority patients initiating PrEP at a federally qualified health center in Chicago, IL. Using electronic health records, we determined the adherence (≥6 weekly doses) trajectories over the first year of PrEP use and compared baseline and time-varying patient characteristics. From 2159 patients, we identified 3 PrEP use trajectories. Sustained use was the most common (40%) trajectory, followed by short use (30%) and declining use (29%). In adjusted models, younger age, Black race, as well as gender, sexual orientation, insurance status at baseline, and neighborhood were associated with trajectory assignment; within some trajectories, insurance status during follow-up was associated with odds of monthly adherence (≥6 weekly doses). Among racial and ethnic minorities, a plurality achieved sustained PrEP persistence. Access to clinics, insurance, and intersectional stigmas may be modifiable barriers to effective PrEP persistence; in addition, focus on younger users and beyond gay, cismale populations are needed.

Pre-Exposure Prophylaxis for HIV Infection as a Public Health Tool.

The efficacy of pre-exposure prophylaxis, PrEP, with antiviral agents for prevention of HIV infection has been demonstrated in multiple randomized controlled trials and demonstration projects. These trials have studied prevention at the individual level. The effectiveness of PrEP as a public health intervention to reduce HIV incidence at community and population levels is being actively evaluated but is less well described. In reviewing the available data on PrEP as a public health intervention, three significant examples have demonstrated success, and all have been among communities of gay, bisexual and other men who have sex with men (MSM).

Pre-exposure prophylaxis as an opportunity for engagement in HIV prevention among South African adolescents

ABSTRACT Pre-exposure prophylaxis (PrEP) offers a potential biomedical strategy to reduce HIV incidence among adolescent populations disproportionately affected by HIV. There is limited evidence on the social and clinical implications, including engagement in HIV prevention efforts, of PrEP for South African adolescents, who face high HIV risk. We conducted a mixed-methods study in Western Cape, South Africa from 2015 to 2016. Adolescents (N = 35) aged 16–17 and clinical service providers working with adolescents (N = 25) were recruited from community and clinic settings. Adolescents and service providers completed a survey about their overall perceptions of PrEP and completed interviews guided by semi-structured protocols. We performed descriptive analysis of quantitative data using SPSS and thematic analysis of qualitative data using NVivo. The majority of adolescents endorsed future PrEP use for themselves and partners, and all clinical service providers endorsed future PrEP use for sexually active adolescents. Both adolescents and service providers identified PrEP as an opportunity to engage youth as active participants in HIV prevention. Service providers also viewed PrEP as a potential mechanism for shifting life trajectories. Findings from this study enhance our understanding of the considerations needed to engage adolescents and clinical service providers in the roll-out of oral PrEP in South Africa.

Enhancing domestic violence advocates' ability to discuss HIV pre-exposure prophylaxis (PrEP): Feasibility and acceptability of an educational intervention.

Background:Survivors of intimate partner violence are at elevated risk for HIV acquisition, yet there is limited research on the best strategies to optimize biomedical HIV prevention, such as pre-exposure prophylaxis among this population. Domestic violence agencies are critical collaborating partners and function as potential entry points into HIV prevention services for survivors; however, limited knowledge regarding HIV prevention has been an important barrier to advocate-led discussions. This study aimed to develop, implement, and evaluate an HIV prevention intervention for domestic violence advocates.Setting:A nonrandomized, group-based intervention with pre-intervention, immediate post-intervention, and 3-month post-intervention periods were conducted with multiple domestic violence agencies in Mississippi.Methods:Overall, 25 domestic violence advocates participated in the two-session intervention. Surveys were administered to assess pre-exposure prophylaxis knowledge, self-efficacy, subjective norms, and willingness to provide HIV prevention services to intimate partner violence survivors. Generalized estimating equations were conducted to assess change in behavioral outcomes over time.Results:Compared to pre-intervention, there were significant increases at immediate and 3-month post-intervention in advocates’ intervention acceptability, pre-exposure prophylaxis knowledge, and self-efficacy to provide HIV prevention information, discuss pre-exposure prophylaxis eligibility criteria, assist pre-exposure prophylaxis-engaged clients, and initiate pre-exposure prophylaxis counseling.Conclusion:This group-based intervention enhanced domestic violence advocates’ acceptability, pre-exposure prophylaxis knowledge, and self-efficacy to offer HIV care information, discuss pre-exposure prophylaxis eligibility, assist pre-exposure prophylaxis-engaged survivors, and initiate pre-exposure prophylaxis counseling with intimate partner violence survivors. Efforts should focus on training domestic violence advocates in HIV prevention care for survivors and also include these agencies in collaborative strategies to reduce HIV incidence.

Characterizing and mapping the spatial variability of HIV risk among adolescent girls and young women: A cross-county analysis of population-based surveys in Eswatini, Haiti, and Mozambique.

BackgroundTo stem the HIV epidemic among adolescent girls and young women (AGYW), prevention programs must target services towards those most at risk for HIV. This paper investigates approaches to estimate HIV risk and map the spatial heterogeneity of at-risk populations in three countries: Eswatini, Haiti and Mozambique.MethodsWe analyzed HIV biomarker and risk factor data from recent population-based household surveys. We characterized risk using three approaches: complementary log-log regression, latent class analysis (LCA), and presence of at least one risk factor. We calculated the proportion and 95 percent confidence intervals of HIV-negative AGYW at risk across the three methods and employed Chi-square tests to investigate associations between risk classification and HIV status. Using geolocated survey data at enumeration clusters and high-resolution satellite imagery, we applied algorithms to predict the number and proportion of at-risk AGYW at hyperlocal levels.ResultsThe any-risk approach yielded the highest proportion of at-risk and HIV-negative AGYW across five-year age bands: 26%-49% in Eswatini, 52%-67% in Haiti, and 32%-84% in Mozambique. Using LCA, between 8%-16% of AGYW in Eswatini, 37%-62% in Haiti, and 56%-80% in Mozambique belonged to a high vulnerability profile. In Haiti and Mozambique, the regression-based profile yielded the lowest estimate of at-risk AGYW. In general, AGYW characterized as “at risk” across the three methods had significantly higher odds of HIV infection. Hyperlocal maps indicated high levels of spatial heterogeneity in HIV risk prevalence and population density of at-risk AGYW within countries.ConclusionCharacterizing risk among AGYW can help HIV prevention programs better understand the differential effect of multiple risk factors, facilitate early identification of high-risk AGYW, and design tailored interventions. Hyperlocal mapping of these at-risk populations can help program planners target prevention interventions to geographic areas with populations at greatest risk for HIV to achieve maximal impact on HIV incidence reduction.

848. Approaches to Optimize Recruitment of Historically Underrepresented Black and Hispanic/LatinX MSM, Transgender, and Gender Non-binary Individuals into the Lenacapavir for PrEP (PURPOSE 2) Trial

BackgroundBlack and Hispanic/Latinx gay and other men who have sex with men (MSM), transgender women (TGW), transgender men (TGM), and gender nonbinary individuals (GNB) have been historically underrepresented in HIV prevention trials despite being disproportionately affected by the disease. Therefore, studies of pre-exposure prophylaxis (PrEP), a highly effective intervention for reducing HIV incidence, should include these individuals, and doing so would promote generalizability of the findings.MethodsPURPOSE 2 (GS-US-528-9023) will evaluate a twice-yearly long-acting subcutaneous, first in class capsid inhibitor, lenacapavir, for PrEP in MSM, TGW, TGM, and GNB in the US, Brazil, Peru, and South Africa. The study team adopted a multifactorial approach to address historic underrepresentation. This included a literature review to assess successful evidence-based approaches for increasing enrollment of Black and Hispanic/ LatinX MSM, TG, and GNB individuals. We engaged with community and patient advocates as well as key stakeholders to solicit feedback prior to protocol development.ResultsWe established a trial-specific Global Community Advisory Group and implemented their recommendations for site selection, investigator and staff diversity, and strong linkage with community-based organizations. We recruited new community-based research sites and principal investigators (PIs) to mirror historically underrepresented populations and emphasized mentorship of junior sub-Is by seasoned PIs to support enrollment and retention. We developed required trainings for all study and site staff on good participatory practices for PrEP, anti-racism and transgender cultural humility. We established recruitment goals of 50% Black and 20% Hispanic/LatinX MSM in the US, and 20% TGW study-wide. Our strategy to ensure achievement of these overall goals involves nuanced site-specific recruitment goals considering site capacity, local demographics, and HIV incidence data. We will review metrics weekly during enrollment and make any necessary adjustments. ConclusionUsing novel approaches, we have carefully chosen with whom, where, and how we will collaborate to increase the diversity, equity, and inclusion in the PURPOSE 2 trial.Disclosures Michelle Cespedes, MD, MS, Gilead Sciences Inc. (Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support)GlaxoSmithKline (Scientific Research Study Investigator, Research Grant or Support) Jill Blumenthal, MD, Gilead Sciences (Grant/Research Support, Scientific Research Study Investigator) Karam Mounzer, MD, Epividian (Advisor or Review Panel member)Gilead Sciences Inc. (Consultant, Scientific Research Study Investigator, Research Grant or Support, Speaker’s Bureau)Janssen (Consultant, Research Grant or Support, Speaker’s Bureau)Merck (Research Grant or Support, Speaker’s Bureau)ViiV Healthcare (Consultant, Speaker’s Bureau) Moti Ramgopal, MD FACP FIDSA, Abbvie (Scientific Research Study Investigator, Speaker’s Bureau)Gilead (Consultant, Scientific Research Study Investigator, Speaker’s Bureau)Janssen (Consultant, Scientific Research Study Investigator, Research Grant or Support, Speaker’s Bureau)Merck (Consultant, Scientific Research Study Investigator)ViiV (Consultant, Scientific Research Study Investigator, Speaker’s Bureau) Ayana Elliott, DNP, APRN, FNP-C, NEA-BC, Gilead Sciences Inc. (Employee, Shareholder) A.C. Demidont, MD, Gilead Sciences Inc. (Employee, Shareholder) C. Chauncey Watson, MD, Gilead Sciences Inc. (Employee, Shareholder) Christoph C. Carter, MD, Gilead Sciences Inc. (Employee, Shareholder) Alex Kintu, MD, ScD, Gilead Sciences Inc. (Employee, Shareholder) Moupali Das, MD, Gilead Sciences Inc. (Employee, Shareholder) Jared Baeten, MD, PHD, Gilead Sciences Inc. (Employee, Shareholder) Onyema Ogbuagu, MD, Gilead Sciences Inc. (Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Other Financial or Material Support)ViiV Healthcare (Advisor or Review Panel member)

The effect of providing women sustained access to HIV self-tests on male partner testing, couples testing, and HIV incidence in Kenya: a cluster-randomised trial.

HIV self-testing can overcome barriers to HIV testing, but its potential as an HIV prevention strategy for women in sub-Saharan Africa has not been assessed. We examined whether sustained provision of self-tests to women promotes testing among sexual partners and reduces HIV incidence. We conducted a pair-matched cluster-randomised trial in 66 community clusters in Siaya County, Kenya. Clusters were communities with a high prevalence of transactional sex, including beach communities along Lake Victoria and inland communities with hotspots for transactional sex such as bars and hotels. Within clusters, we recruited HIV-negative women aged 18 years or older with two or more sexual partners within the past 4 weeks. In each of the 33 cluster pairs, we randomly assigned clusters to an intervention and comparison group. In intervention clusters, we provided participants with multiple self-tests at regular intervals and encouraged secondary distribution of self-tests to sexual partners. In comparison clusters, we provided participants referral cards for facility-based testing. Follow-up visits and HIV testing occurred at 6-month intervals for up to 24 months. The primary outcome of HIV incidence among all participants who contributed at least one HIV test was analysed using discrete-time mixed effects models. This study is registered with ClinicalTrials.gov, NCT03135067. Between June 4, 2017, and Aug 31, 2018, we enrolled 2090 participants (1033 in the 33 intervention clusters and 1057 in the 33 comparison clusters). Participants' median age was 25 years (IQR 22-31) and 1390 (66·6%) of 2086 participants reported sex work as an income source. 1840 participants completed the 18-month follow-up and 570 participants completed the 24-month follow up, which ended on March 25, 2020, with a median follow-up duration of 17·6 months. HIV incidence was not significantly different between the intervention and comparison groups (1·2 vs 1·0 per 100 person-years; hazard ratio 1·2, 95% CI 0·6-2·3, p=0·64). Social harms related to study participation occurred in three participants (two in the intervention group and one in the comparison group). Sustained provision of multiple self-tests to women at high risk of HIV infection in Kenya enabled secondary distribution of self-tests to sexual partners but did not affect HIV incidence. National Institute of Mental Health; Center for Health Incentives and Behavioral Economics; National Institute of Allergies and Infectious Diseases; University of Pennsylvania Center for AIDS Research.