Pre-exposure Prophylaxis Persistence Research Articles

Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial

BackgroundHIV incidence among pregnant and postpartum women remains high in South Africa. Pre-exposure prophylaxis (PrEP) use remains suboptimal in this population, particularly during the postpartum period when women’s engagement with routine clinic visits outside PrEP decreases. Key barriers to sustained PrEP use include the need for ongoing contact with the health facility and suboptimal counseling around effective PrEP use.MethodsStepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP), is a two-stepped unblinded, individually randomized controlled trial (RCT) that aims to optimize peripartum and postpartum PrEP use by providing a stepped package of evidence-based interventions. We will enroll 650 pregnant women (> 25 weeks pregnant) who access PrEP at a busy antenatal clinic in Cape Town at the time of recruitment and follow them for 15 months. We will enroll and individually randomize pregnant women > 16 years who are not living with HIV who are either on PrEP or interested in starting PrEP during pregnancy. In step 1, we will evaluate the impact of enhanced adherence counselling and biofeedback (using urine tenofovir tests for biofeedback) and rapid PrEP collection (to reduce time required) on PrEP use in early peripartum compared to standard of care (SOC) (n = 325 per arm). The primary outcome is PrEP persistence per urine tenofovir levels and dried blood spots of tenofovir diphosphate (TFV-DP) after 6-months. The second step will enroll and individually randomize participants from Step 1 who discontinue taking PrEP or have poor persistence in Step 1 but want to continue PrEP. Step 2 will test the impact of enhanced counseling and biofeedback plus rapid PrEP collection compared to community PrEP delivery with HIV self-testing on PrEP use (n = up to 325 postpartum women). The primary outcome is PrEP continuation and persistence 6-months following second randomization (~ 9-months postpartum). Finally, we will estimate the cost effectiveness of SCOPE-PP vs. SOC per primary outcomes and disability-adjusted life-years (DALYs) averted in both Step 1 and 2 using micro-costing with trial- and model-based economic evaluation.DiscussionThis study will provide novel insights into optimal strategies for delivering PrEP to peripartum and postpartum women in this high-incidence setting.Trial registrationNCT05322629: Date of registration: April 12, 2022.

Gaps in HIV Preexposure Prophylaxis Continuum of Care Following State Partner Services for Massachusetts Primary and Secondary Syphilis Cases, 2017 to 2018.

Human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) reduces HIV acquisition. We used a PrEP continuum of care to measure impact of field epidemiologist-facilitated referrals for PrEP-naive infectious syphilis cases across multiple clinical and pharmacy sites of care. Retrospective analysis of 2017 to 2018 primary and secondary syphilis cases, medical charts, and pharmacy data to identify PrEP education, referral offer, referral acceptance, first visit, prescription pickup (PrEP initiation) and 2 to 3 months (PrEP persistence). The HIV seroconversion was determined using database match at syphilis diagnosis date and at 12 months. χ 2 or Fisher's exact tests were used to compare demographic characteristics associated with steps with lower progression rates. Of 1077 syphilis cases, partner services engaged 662 of 787 (84%) HIV-negative cases; 490 were PrEP-naive, 266 received education, 166 were offered referral, 67 accepted referral, 30 attended an initial appointment, and 22 were prescribed PrEP. Of 16 with pharmacy data, 14 obtained medication, and 8 persisted on PrEP at 2 to 3 months. Continuum progression was lowest from (1) PrEP-naïve to receiving PrEP education, (2) offered referral to referral acceptance, and (3) referral acceptance to initial PrEP appointment. Men with male partners were more likely to receive PrEP education or accept a referral. Higher social vulnerability was associated with increased PrEP referral acceptance. Few individuals accepted PrEP referrals and persisted on PrEP. Field and clinic data capture were inconsistent, possibly underestimating referral volume and impact of field engagement. Efforts aimed at increasing referral acceptance and clinic attendance may improve PrEP uptake especially among women and heterosexual men with syphilis.

A Pilot Study of a Patient Navigation Intervention to Improve HIV Pre-exposure Prophylaxis Persistence Among Black/African American Men Who Have Sex With Men.

Suboptimal HIV pre-exposure prophylaxis (PrEP) care outcomes among Black/African American men who have sex with men (MSM) limits its population-level effects on HIV incidence. We conducted a pilot study of a brief patient navigation intervention aimed at improving PrEP initiation and persistence among Black/African American MSM in the Southern United States. Community health center in Jackson, MS. We recruited 60 Black/African American MSM aged 18-34 years who were newly prescribed PrEP. Participants were randomized to receive the clinic's current standard of care or an intervention condition including a single patient navigation session to discuss and address perceived barriers to initiating and maintaining access to PrEP and biweekly check-ins. Participants were followed over 6 months using survey assessments, medical chart review, and pharmacy purchase records to ascertain PrEP initiation and persistence. Participants in the intervention condition were more likely to pick up their initial PrEP prescription [RR: 1.47; 95% confidence interval (CI): 1.10 to 1.97], be retained in PrEP care at 3 months (RR: 1.62; 95% CI: 1.01 to 2.59) and 6 months (RR: 1.38; 95% CI: 0.64 to 2.93), and have access to PrEP medications greater than 80% of all study days based on pharmacy fill records (RR: 3.00; 95% CI: 1.50 to 5.98). A brief patient navigation intervention demonstrated proof-of-concept in improving PrEP initiation and persistence among Black/African American MSM in the Southern United States.

PrEP use and HIV seroconversion rates in adolescent girls and young women from Kenya and South Africa: the POWER demonstration project.

IntroductionHIV incidence remains high among African adolescent girls and young women (AGYW). The primary objective of this study is to assess pre‐exposure prophylaxis (PrEP) initiation, use, persistence and HIV acquisition among African AGYW offered PrEP in order to inform PrEP scale‐up.MethodsPOWER was a prospective implementation science evaluation of PrEP delivery for sexually active HIV‐negative AGYW ages 16–25 in family planning clinics in Kisumu, Kenya and youth and primary healthcare clinics in Cape Town and Johannesburg, South Africa. Follow‐up visits occurred at month 1 and quarterly for up to 36 months. PrEP users were defined based on the month 1 refill. PrEP persistence through month 6 was assessed using Kaplan–Meier survival analysis among AGYW with a month 1 visit, defining non‐persistence as an ≥15 day gap in PrEP availability for daily dosing. PrEP execution was evaluated in a subset with PrEP supply from the prior visit sufficient for daily dosing by measuring blood tenofovir diphosphate (TFV‐DP) levels.ResultsFrom June 2017 to September 2020, 2550 AGYW were enrolled (1000 in Kisumu, 787 in Cape Town and 763 in Johannesburg). Median age was 21 years, 66% had a sexual partner of unknown HIV status, and 29% had chlamydia and 10% gonorrhoea. Overall, 2397 (94%) initiated PrEP and 749 (31%) had a refill at 1 month. Of AGYW who could reach 6 months of post‐PrEP initiation follow‐up, 128/646 (20%) persisted with PrEP for 6 months and an additional 92/646 (14%) had a gap and restarted PrEP. TFV‐DP levels indicated that 47% (91/193) took an average of ≥4 doses/week. Sixteen HIV seroconversions were observed (incidence 2.2 per 100 person‐years, 95% CI 1.2, 3.5); 13 (81%) seroconverters either did not have PrEP dispensed in the study interval prior to seroconversion or TFV‐DP levels indicated <4 doses/week in the prior 6 weeks.ConclusionsIn this study of PrEP integration with primary care and reproductive health services for African AGYW, demand for PrEP was high. Although PrEP use decreased in the first months, an important fraction used PrEP through 6 months. Strategies are needed to simplify PrEP delivery, support adherence and offer long‐acting PrEP options to improve persistence and HIV protection.

Implementation of pharmacist‐led HIV pre‐exposure prophylaxis management to increase access to care at an academic internal medicine practice

AbstractIntroductionThe ongoing human immunodeficiency virus (HIV) epidemic continues to require attention to reduce the number of new infections. HIV pre‐exposure prophylaxis (PrEP) has emerged as a highly effective strategy. Although its overall use in the United States has increased since initial approval, it is still underutilized, especially in populations disproportionately affected by HIV. One method for overcoming barriers to PrEP uptake includes utilizing pharmacists to increase access to care.MethodsFor this initiative, a pharmacist‐led PrEP service within a primary care practice was developed utilizing a collaborative practice agreement to enable ordering medications, lab tests, and immunizations. Following the sustainable initial implementation at the first site, expansion occurred to a second location. Data on referrals, patient demographics, and PrEP persistence were collected. Challenges, lessons learned, and future opportunities were also considered.ResultsSince initiating services at both practice sites, a total of 76 patients were referred from August 2018 through March 2022. The majority of patients had their sex listed as male (96%) within the electronic health record and was white (69.7%). The mean age of patients was 33 years (range, 20‐71). Of those who engaged with pharmacist‐led PrEP management, 33.9% (20/59) were retained in care for at least 1 year. There were no occurrences of seroconversion during pharmacist management. Throughout the course of implementation, areas of improvement were identified and addressed for process improvement.ConclusionOur experience supports that pharmacist‐led PrEP management in an outpatient primary care practice is a sustainable option to address certain barriers to care. However, the ability for pharmacist‐provided services may be limited by state pharmacy practice laws and/or lack of reimbursement opportunities for clinical services. Developing innovative practice models that integrate pharmacists in a variety of settings is imperative for further reducing HIV transmission.

From policy to practice: uptake of pre-exposure prophylaxis among adolescent girls and young women in United States President's Emergency Plan for AIDS Relief-supported countries, 2017-2020.

The US President's Emergency Plan for AIDS Relief's (PEPFAR) first implemented pre-exposure prophylaxis (PrEP) for HIV prevention through the Determined, Resilient, Empowered, AIDS-Free, Mentored and Safe (DREAMS) partnership in 2016. PrEP is a critical intervention to achieve the main objective of DREAMS, reducing new HIV infections among 15-14 year old adolescent girls and young women (AGYW) in 15 high HIV burdened countries. We describe uptake of PrEP among AGYW in PEPFAR. Most PrEP programs screened persons who tested HIV-negative for eligibility and offered PrEP as part of combination prevention with follow-up, including repeat HIV testing and counseling, at 3-month intervals. Platforms providing comprehensive services for AGYW were also leveraged. We examined two PEPFAR monitoring indicators, using the FY20Q4 Monitoring, Evaluation, Reporting (MER) indicator dataset to assess progress in PrEP uptake, and descriptive narratives to understand successes and challenges from fiscal year 2017 to 2020. To assess coverage, we calculated the PrEP to Need ratio (PnR) using a published methodology. From FY2017 to FY2020, 576570 total clients initiated PrEP and the number of PEPFAR countries offering PrEP doubled from 12 to 24. Of 360073 (62% of total) initiations among women, 52% were among AGYW with steady increases from year to year. Among all AGYW, 20-24-year-old women represented a significantly higher proportion of PrEP initiators than adolescents (15-19years) (64 versus 36%, P < 0.05). Of all 186985 PrEP initiations among AGYW, 99% were in DREAMS countries. Barriers, such as low demand and adherence, were addressed through outreach efforts, including mobile sites, use of technology to educate and support AGYW, media campaigns, and engaging peers in program implementation. We saw a 2.5-fold increase in PrEP uptake among AGYW from 2018 to 2019; by 2020, all DREAMS countries were implementing PrEP. However, PrEP coverage among AGYW in DREAMS countries remains low (PnR range: 0-4.1); only two have a PnR greater than 1 where there were more PrEP users than new HIV diagnoses. PrEP uptake among AGYW has grown since 2016; however, challenges remain. Tools to improve adherence are needed to improve PrEP persistence among AGYW. National policies to facilitate greater PrEP uptake among adolescents would be beneficial. A greater need for PrEP in DREAMS countries is evident and if realized, will contribute to epidemic control.

Demographic and behavioral characteristics of urban and non-urban PrEP-using MSM in the South

ABSTRACT Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention intervention; however, most studies of PrEP adherence and persistence among men who have sex with men (MSM) have been conducted with MSM who live in urban areas. The experiences of PrEP-using MSM in non-urban areas might differ due to increased barriers to culturally competent care. We examined similarities and differences among urban and non-urban PrEP-using MSM in the southern United States, the region with the highest number of annual HIV diagnoses. We surveyed a total of 78 (n = 25 non-urban, n = 53 urban) PrEP-using MSM. Self-reported adherence was high across all participants. No differences were observed with respect to PrEP persistence, source of PrEP, or reasons for PrEP initiation. Fewer non-urban than urban men reported STI testing in the past 12 months. Overall, we observed few differences comparing urban and non-urban PrEP-using MSM. Additional studies are needed to describe differences in PrEP initiation comparing urban and non-urban MSM.

Barriers and Facilitators to HIV Pre-Exposure Prophylaxis Uptake, Adherence, and Persistence Among Transgender Populations in the United States: A Systematic Review.

HIV pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV; however, PrEP use among transgender individuals remains low. We conducted a systematic review to identify barriers and facilitators to PrEP uptake, adherence, and persistence among transgender individuals in the United States. We conducted a literature search in PubMed and CINAHL databases in March 2021 and followed PRISMA guidelines. Studies were eligible if they were published in a peer-reviewed journal and reported interest, uptake, adherence, and/or persistence of PrEP use among transgender individuals. Articles that did not disaggregate results for transgender participants were excluded. Data from included articles were coded using content analysis and narratively synthesized using a framework matrix. We screened 254 unique articles published after US Food and Drug Administration approval of PrEP, and 33 articles were included in the review. Five themes were identified in the literature, including (1) PrEP concentrations were lower among individuals taking feminizing hormones, but the difference did not appear clinically significant; (2) concerns regarding interactions between gender-affirming hormone therapy and PrEP remain a large barrier; (3) PrEP initiation may facilitate increased self-advocacy and self-acceptance; (4) lack of trust in medical institutions impacts PrEP uptake; and (5) social networks have a significant influence on PrEP knowledge, interest, and adherence. Additional research is needed involving transgender men and nonbinary persons, and efforts to improve PrEP persistence among the transgender community are needed. Training health care providers to provide inclusive and affirming care is perhaps one of the strongest areas for intervention to increase PrEP uptake and persistence.

The Potential of Telecommunication Technology to Address Racial/Ethnic Disparities in HIV PrEP Awareness, Uptake, Adherence, and Persistence in Care: A Review.

Pre-exposure prophylaxis (PrEP) is highly effective in preventing new HIV infection, but uptake remains challenging among Black and Hispanic/Latino persons. The purpose of this review was to understand how studies have used electronic telecommunication technology to increase awareness, uptake, adherence, and persistence in PrEP care among Black and Hispanic/Latino persons and how it can reduce social and structural barriers that contribute to disparities in HIV infection. Of the 1114 articles identified, 10 studies were eligible. Forty percent (40%) of studies focused on Black or Hispanic/Latino persons and 80% addressed social and structural barriers related to PrEP use such as navigation or access to PrEP. Mobile health designs were more commonly used (50%) compared to telehealth (30%) and e-health (20%) designs. There is a need to increase the development of telecommunications interventions that address the needs of Black and Hispanic/Latino persons often challenged with uptake and adherent use of PrEP.

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.

Cost-Effectiveness of Interventions to Improve HIV Pre-exposure Prophylaxis Initiation, Adherence, and Persistence Among Men Who Have Sex With Men.

To help achieve Ending the HIV Epidemic (EHE) goals of reducing new HIV incidence, pre-exposure prophylaxis (PrEP) use and engagement must increase despite multidimensional barriers to scale-up and limitations in funding. We investigated the cost-effectiveness of interventions spanning the PrEP continuum of care. Men who have sex with men in Atlanta, GA, a focal jurisdiction for the EHE plan. Using a network-based HIV transmission model, we simulated lifetime costs, quality-adjusted life years (QALYs), and infections averted for 8 intervention strategies using a health sector perspective. Strategies included a status quo (no interventions), 3 distinct interventions (targeting PrEP initiation, adherence, or persistence), and all possible intervention combinations. Cost-effectiveness was evaluated incrementally using a $100,000/QALY gained threshold. We performed sensitivity analyses on PrEP costs, intervention costs, and intervention coverage. Strategies averted 0.2%-4.2% new infections and gained 0.0045%-0.24% QALYs compared with the status quo. Initiation strategies achieved 20%-23% PrEP coverage (up from 15% with no interventions) and moderate clinical benefits at a high cost, while adherence strategies were relatively low cost and low benefit. Under our assumptions, the adherence and initiation combination strategy was cost-effective ($86,927/QALY gained). Sensitivity analyses showed no strategies were cost-effective when intervention costs increased by 60% and the strategy combining all 3 interventions was cost-effective when PrEP costs decreased to $1000/month. PrEP initiation interventions achieved moderate public health gains and could be cost-effective. However, substantial financial resources would be needed to improve the PrEP care continuum toward meeting EHE goals.

Alignment of PrEP use and sexual behavior over four months among men who have sex with men in the southern United States.

Unlike antiretrovirals for HIV treatment, pre-exposure prophylaxis (PrEP) does not require continual adherence to be fully effective; rather, PrEP adherence is important only in the context of episodes of sexual risk. Therefore, studies of PrEP adherence and persistence must incorporate contemporaneous measurement of sexual behavior. Short, frequent surveys of PrEP use and sexual behavior allow for the measurement of the alignment between PrEP use and sexual behavior. We assessed the feasibility of using biweekly PrEP use and sexual behavior questionnaires to measure adherence and persistence on PrEP over a period of four months. We also measured the alignment of PrEP use and condomless anal sex. PrEP-using MSM in the southern US were recruited using online advertisements. Participants completed a baseline survey followed by brief surveys every two weeks for 16 weeks to report their PrEP use and sexual behavior over the preceding two-week period. Study retention was high: 91% of participants completed the baseline and final survey and, overall, 86% of study surveys were completed. Self-reported PrEP adherence and persistence were high, but instances of PrEP non-adherence were observed to frequently overlap with episodes of condomless anal sex. The most prominent reasons cited for missing PrEP doses were being too busy, not having PrEP on hand, and not being sexually active. Completing short, biweekly surveys of PrEP use and sexual behavior is feasible and acceptable to MSM in the southern US. Future studies should investigate incorporating biomarker measurements to validate self-reported adherence.

Mapping Interests in Event-Driven and Long-Acting Pre-exposure Prophylaxis Formulations onto the HIV Risk Environment of Street-Based Female Sex Workers: A Latent Class Analysis.

Despite growing availability, HIV pre-exposure prophylaxis (PrEP) uptake and adherence remains suboptimal among female sex workers (FSW) in the United States. Using cross-sectional data from a survey of 236 street-based cisgender FSW in Baltimore, Maryland, we examined interest in event-driven and long-acting PrEP formulations. Latent class analysis identified discrete patterns of interest in five novel PrEP agents. Multinomial latent class regression then examined factors associated with probabilistic class membership. A three-class solution emerged as the best-fit latent class model: Injectable Acceptors (~ 24% of sample), Universal Acceptors (~ 18%), and Non-Acceptors (~ 58%). Compared to Non-Acceptors, Universal Acceptors had significantly (p < 0.05) higher odds of reporting condomless vaginal sex with clients, client condom coercion, and client-perpetrated physical violence. Relative to Non-Acceptors, Injectable Acceptors were distinguished by significantly higher rates of condomless vaginal sex with clients and injection drug use. Expanding PrEP options for FSW could help overcome barriers to PrEP initiation and persistence.

Persistence on oral pre-exposure prophylaxis (PrEP) among female sex workers in eThekwini, South Africa, 2016-2020.

Despite the established efficacy of PrEP to prevent HIV and the advantages of a user-controlled method, PrEP uptake and persistence by women in both trials and demonstration projects has been suboptimal. We utilized real-world data from an HIV service provider to describe persistence on oral PrEP among female sex workers (FSW) in eThekwini, South Africa. We examined time from PrEP initiation to discontinuation among all FSW initiating PrEP at TB HIV Care in eThekwini between 2016-2020. We used a discrete time-to-event data setup and stacked cumulative incidence function plots, displaying the competing risks of 1) not returning for PrEP, 2) client discontinuation, and 3) provider discontinuation. We calculated hazard ratios using complementary log-log regression and sub-hazard ratios using competing risks regression. The number of initiations increased each year from 155 (9.3%, n = 155/1659) in 2016 to 1224 (27.5%, n = 1224/4446) in 2020. Persistence 1-month after initiation was 53% (95% CI: 51%-55%). Younger women were more likely to discontinue PrEP by not returning compared with those 25 years and older. Risk of discontinuation through non-return declined for those initiating in later years. Despite the COVID-19 pandemic, a greater number of initiations and sustained persistence were observed in 2020. Low levels of PrEP persistence were observed, consistent with data among underserved women elsewhere. Encouragingly, the proportion of women persisting increased over time, even as the number of women newly initiating PrEP and staff workload increased. Further research is needed to understand which implementation strategies the program may have enacted to facilitate these improvements and what further changes may be necessary.

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 (PrEP) Initiation and Retention Among Young Kenyan Women.

The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, Safe) Initiative works to reduce HIV infection among adolescent girls and young women (AGYW) through prevention interventions including Pre-Exposure Prophylaxis (PrEP). Pamoja CBO in Kisumu, Kenya implemented DREAMS. We describe PrEP initiation and persistence in 549 AGYW who started PrEP through Pamoja and factors associated with discontinuation. Median persistence time was 308days (95% CI 245, 382) with 59% of AGYW discontinuing by the end of the study. The most common reasons for stopping PrEP were lack of perceived risk (27.9%) and relocation (18.7%). Inthe multivariable model, only age < 18 was associated with stopping PrEP. Younger age was associated with shorter time to discontinuation. Implementing PrEP through DREAMS was successful in supporting initiation of PrEP for AGYW. However, low rates of persistence at 1 year emphasizes the need for strategies to support PrEP persistence if HIV elimination is to be achieved.

855. Persistence on F/TAF versus F/TDF for HIV Pre-Exposure Prophylaxis: A Real-World Evidence Analysis in the United States

BackgroundPersistence to preexposure prophylaxis (PrEP) is an important determinant of its efficacy, but evidence on real-world persistence is lacking. This study assesses adherence to F/TDF and F/TAF for PrEP both in terms of discontinuation and re-initiation patterns. MethodsWe identified HIV-negative individuals in the United States who initiated F/TDF or F/TAF for PrEP between October 2019 and December 2020 from a de-identified prescription claims database; users taking generic F/TDF were excluded. Non-persistence was defined as a prescription fill gap of >30 days; discontinuation included switch from F/TDF to F/TAF or F/TAF to F/TDF. We used survival analyses to estimate persistence, Cox regressions to compare the hazard ratios (HR) of discontinuation, and logistic regression to compare the odds ratios of re-initiation after discontinuation.ResultsAmong F/TAF users (N=82,402) median age at PrEP initiation was 35 years (interquartile range [IQR] 28−47) and median PrEP persistence was 4 months (IQR 1.8-8.9), compared to 31 years (IQR 25−40) and 2 months (IQR 1.0-3.8) for F/TDF users (N=48,501). PrEP persistence at 60 and 90 days was higher among F/TAF users than F/TDF users (Figure). F/TDF users were 2.5 times more likely to discontinue than F/TAF users, with more marked differences in older users than that in younger users (p for interaction between discontinuation and age group < 0.01, Table). We also observed a higher rate of discontinuation of F/TDF versus F/TAF if PrEP was prescribed by internal medicine or infectious disease physicians than by family medicine physicians (data not shown). After discontinuation, F/TAF users were 1.7 times more likely than F/TDF users to re-initiate PrEP; the association was not different by age.Persistence rates of F/TAF and F/TDF for PrEP by time of PrEP initiation Hazard ratios (HR) and corresponding 95% confidence intervals (CI) of non-persistence and odds ratios (OR) of re-initiation after discontinuation for users of F/TAF and F/TDF for PrEP in the US, Oct 2019 – Dec 2020 ConclusionIn this real-world analysis, the F/TAF for PrEP regimen was associated with higher persistence and re-initiation than F/TDF for PrEP. These findings underscore the dynamic nature of PrEP utilization in the real-world and the importance of interventions aimed at improving PrEP persistence and re-initiation in people who would benefit from PrEP. Disclosures Li Tao, MD, PhD, Gilead Sciences Inc (Employee, Shareholder) Valentina Shvachko, MS, Gilead Sciences Inc (Employee, Shareholder) Moupali Das, MD, Gilead Sciences Inc. (Employee, Shareholder) Christoph C. Carter, MD, Gilead Sciences Inc. (Employee, Shareholder) Jared Baeten, MD, PHD, Gilead Sciences Inc. (Employee, Shareholder) David Magnuson, PharmD, Gilead Sciences Inc (Employee, Shareholder)

Adaptation of a Theory-Based Social Networking and Gamified App-Based Intervention to Improve Pre-Exposure Prophylaxis Adherence Among Young Men Who Have Sex With Men in Bangkok, Thailand: Qualitative Study.

BackgroundHIV disproportionately affects young Thai men who have sex with men (YMSM). Recent studies report a high incidence and prevalence of HIV among Thai YMSM. The Thai national guidelines have recommended pre-exposure prophylaxis (PrEP) since 2014 for key populations; free PrEP has been piloted since 2019. Smartphone-based mobile health (mHealth) interventions provide an optimal platform for innovative PrEP adherence interventions for Thai YMSM.ObjectiveThis study aims to adapt the P3 (Prepared, Protected, emPowered) app, developed with YMSM and transwomen in the United States to improve PrEP adherence and persistence for YMSM in Thailand. The app aims to provide daily adherence support and addresses gaps in staff available for large-scale PrEP rollout needed to see population-level effects of HIV prevention.MethodsWe conducted focus group discussions (FGDs) with YMSM and key informant interviews (KIIs) with PrEP care providers in Bangkok, Thailand, to investigate PrEP adherence facilitators and barriers, preferences for functions and features in mHealth apps among YMSM, and how to best adapt the P3 app to the Thai context. We conducted four FGDs with 4-8 participants per group and 15 KIIs.ResultsFor FGDs, 23 YMSM participated with a mean age of 20 years (range 18-21), 96% (22/23) enrolled in full-time education, and all owned smartphones. The mean age of KII participants was 40 (range 26-60) years; most were state health service providers, with the majority being counselors (6/15, 40%) and physicians (6/15, 40%). Overall, the facilitators and barriers for PrEP adherence identified were similar to those of MSM and YMSM globally including the United States. Key themes included general recommendations for improving mHealth apps in Thailand, such as presenting reliable information in an appealing format, minimizing privacy risks, and addressing connectivity challenges. Additional themes focused on P3 Thailand adaptations and were related to cultural and stylistic preferences, engagement strategies, and recommendations for new functions. To develop the adapted app, P3 Thailand, these findings were balanced with resource limitations resulting in the prioritization of minor modifications: changes in app esthetics (color scheme, iconography, and imagery) and changes in the presentation of information in two of the app’s features. FGDs identified similar PrEP adherence facilitators and barriers to those already addressed within the app.ConclusionsThe core elements of the P3 app address major PrEP facilitators and barriers for Thai YMSM; however, changes to the app features, including stylistic presentation, were needed to appropriately customize the app to the Thai context. Given the similarities of facilitators and barriers for PrEP adherence globally, adapting existing PrEP mHealth solutions based on input from end users and key informants provides a promising approach. However, partnerships with local app designers and developers can improve the adaptation process and final product.Trial RegistrationClinicalTrials.gov NCT04413708; http://clinicaltrials.gov/ct2/show/NCT04413708

\u201cPrEP\u2019s just to secure you like insurance\u201d: a qualitative study on HIV pre-exposure prophylaxis (PrEP) adherence and retention among black cisgender women in Mississippi

BackgroundPre-exposure prophylaxis (PrEP) has the potential to reduce transmission of HIV among Black cisgender women in the Southern United States (U.S.); however, national data suggests that PrEP initiation is lowest in the South and among Black women compared to other U.S. regions and white women. This study applied intersectionality and PrEP multilevel resilience frameworks to assess how socio-structural and clinical contexts shaped PrEP persistence among Black cisgender women in Mississippi.MethodsSemi-structured interviews were conducted with eight Black cisgender women in Jackson, Mississippi. This sample was purposively recruited to include PrEP-initiated Black cisgender women.ResultsSix themes identified that shaped PrEP care among Black cisgender women: (1) internal assets, (2) sole responsibility to HIV prevention, (3) added protection in HIV serodifferent relationships, (4) financial issues, (5) trust and distrust in the medical system, and (6) side effects. Black cisgender women reported that PrEP persistence increased control over their sexual health, reduced anxiety about HIV, and promoted self-care. Black cisgender women also indicated that medication assistance programs increased PrEP affordability resulting in continued persistence.ConclusionsIn addition to preventing HIV, PrEP may yield secondary positive impacts on the health and relationships of Black cisgender women. However, very few Black cisgender women in the South are using PrEP given intersectional barriers and thus necessitates adaptive strategies to support PrEP initiation and persistence. Efforts aimed at increasing the coverage of PrEP among Black cisgender women should consider implementation strategies responsive to lived realities of Black women.

Pre-exposure Prophylaxis Uptake, Adherence, and Persistence: A Narrative Review of Interventions in the U.S.

Since 2012, HIV pre-exposure prophylaxis (PrEP) has been available to prevent HIV transmission; yet, uptake, adherence, and persistence to PrEP have been suboptimal. This narrative review examines the latest interventions and programs to improve all 3 stages of PrEP adherence and reviews ongoing studies to promote effective PrEP use. From 2017 to 2020, a total of 20 studies analyzed different individual- and structural-level approaches to increase PrEP adherence, including behavior change interventions, technology-based interventions (e.g., short message service messages and mobile applications), and alternate delivery strategies (e.g., pharmacy-based PrEP, integration with other services, and home delivery). Most published interventions involved men who have sex with men, although 3 assessed women (2 transgender, 1 cisgender). Randomized, controlled data support 3 behavioral change interventions and 1 technology-based intervention. Alternate delivery strategies seem promising, although more robust study designs are generally needed. In addition, data on the alignment of ongoing HIV risk and PrEP persistence (i.e., prevention-effective adherence) were limited. The authors also identified 20 ongoing studies that are promoting PrEP adherence. Future work should be inclusive of all at-risk groups in the U.S., including African American and Latinx heterosexual populations and people who inject drugs. Proven and promising approaches may work well in combination and may also need to be adapted with the introduction of long-acting pre-exposure prophylaxis formulations. Collectively, this body of work indicates considerable progress toward understanding the role PrEP adherence will play in Ending the HIV Epidemic in the U.S. that will be bolstered by the outcomes of ongoing trials.