Search

Product adherence is critical to obtaining objective estimates of efficacy of pre-exposure prophylactic interventions against HIV-1 infection. With imperfect adherence, intention-to-treat analyses assess the collective effects of complete, sub-optimal and non-adherence, providing a biased and attenuated estimate of the average causal effect of an intervention. Using data from the MTN-020/ASPIRE phase III trial evaluating HIV-1 efficacy of the dapivirine vaginal ring, we conducted per-protocol, and adherence-adjusted causal inference analyses using principal stratification and marginal structural models. We constructed two adherence cut offs of ≥ 0.9 mg (low cutoff) and > 4.0 mg (high cutoff) that represent drug released from the ring over a 28-day period. The HIV-1 efficacy estimate (95% CI) was 30.8% (3.6%, 50.3%) (P = 0.03) from the per-protocol analysis, and 53.6% (16.5%, 74.3%) (P = 0.01) among the highest predicted adherers from principal stratification analyses using the low cutoff. Marginal structural models produced efficacy estimates (95% CIs) ranging from 48.8 (21.8, 66.4) (P = 0.0019) to 56.5% (32.8%, 71.9%) (P = 0.0002). Application of adherence-adjusted causal inference methods are useful in interpreting HIV-1 efficacy in secondary analyses of PrEP clinical trials. [ABSTRACT FROM AUTHOR]

Purpose of Review: This review summarizes differentiated service delivery (DSD) models for HIV treatment and prevention that have been adapted for maintaining continuity of services during the COVID-19 pandemic and proposes strategies for sustaining their benefits now and during future disruptions. Recent Findings: The COVID-19 pandemic resulted in an overburdened and disrupted health system, forcing countries to adopt and/or scale up DSD models for HIV services. While initially implemented as emergency measures, these models evolved and were refined over time to fit recipient needs ensuring continued HIV treatment and prevention services with minimal health system impact. Successful models employed task shifting, community-based delivery models, multimonth scripting and dispensing, and telehealth for remote consultation. Summary: DSD models enabled HIV services globally to be maintained during the COVID-19 pandemic. Though these models and adaptations were critical in addressing health gaps and disruptions caused by the pandemic, they were beneficial in improving efficiency and access to client-centered services and should be sustained. [ABSTRACT FROM AUTHOR]

We evaluated hair tenofovir (TFV) concentrations as an adherence metric for HIV preexposure prophylaxis during pregnancy and postpartum and compared hair levels with TFV-diphosphate levels in dried blood spots (DBSs). Overall 152 hair samples from 102 women and 36 hair-DBS paired samples from 29 women were collected from a subset of women in a cluster-randomized trial. Having a partner with HIV was associated with higher hair TFV levels (P <.001). Hair TFV concentrations were strongly correlated with DBS TFV-diphosphate levels (r = 0.76, P <.001), indicating hair as a promising cumulative adherence metric for perinatal preexposure prophylaxis assessment. [ABSTRACT FROM AUTHOR]

Introduction: Pharmacy‐delivered HIV prevention services might create more options for pregnant women to use HIV prevention tools earlier and more consistently during pregnancy. We quantified preferences for attributes of potential HIV prevention services among women of childbearing age in Western Kenya. Methods: From June to November 2023, we administered a face‐to‐face discrete choice experiment survey to women aged 15–44 in Kenya's Homa Bay, Kisumu and Siaya counties. The survey evaluated preferences for HIV prevention services, described by seven attributes: service location, travel time, type of HIV test, sexually transmitted infection (STI) testing, partner HIV testing, pre‐exposure prophylaxis (PrEP) and service fee. Participants answered a series of 12‐choice questions. Each question asked them to select one of two service options or no services—an opt‐out option. We used hierarchical Bayesian modelling levels to estimate each attribute level's coefficient and understand how attributes influenced service choice. Results: Overall, 599 participants completed the survey, among whom the median age was 23 years (IQR: 18–27); 33% were married, 20% had a job and worked regularly, and 52% had been pregnant before. Participants, on average, strongly preferred having any HIV prevention service option over none (opt‐out preference weight: −5.84 [95% CI: −5.97, −5.72]). The most important attributes were the availability of PrEP (relative importance 27.04% [95% CI: 25.98%, 28.11%]), followed by STI testing (relative importance 20.26% [95% CI: 19.52%, 21.01%]) and partner HIV testing (relative importance: 16.35% [95% CI: 15.79%, 16.90%]). While, on average, participants preferred obtaining services at the clinic more than pharmacies, women prioritized the availability of PrEP, STI testing and partner HIV testing more than the location or cost. Conclusions: These findings suggest the importance of providing comprehensive HIV prevention services and ensuring PrEP, STI testing and partner HIV testing are available. If pharmacies can offer these services, women are likely to access those services at pharmacies even if they prefer clinics. [ABSTRACT FROM AUTHOR]

Background: Contraceptive use has complex effects on sexual behaviour and mood, including those related to reduced concerns about unintended pregnancy, direct hormonal effects and effects on endogenous sex hormones. We set out to obtain robust evidence on the relative effects of three contraceptive methods on sex behaviours, which is important for guiding contraceptive choice and future contraceptive developments. Methods: This is a secondary analysis of data from the Evidence for Contraceptive Options and HIV Outcomes (ECHO) randomized trial in which 7,829 HIV-uninfected women from 12 sites in Eswatini, Kenya, South Africa and Zambia seeking contraception were randomly assigned to intramuscular depot-medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (Cu-IUD) or the levonorgestrel (LNG) implant. Data collected for 12 to 18 months using 3-monthly behavioural questionnaires that relied on recall from the preceding 3 months, were used to estimate relative risk of post-baseline sex behaviours, as well as sexual desire and menstrual bleeding between randomized groups using modified Poisson regression. Results: We observed small but generally consistent effects wherein DMPA-IM users reported lower prevalence of specified high risk sexual behaviours than implant users than Cu-IUD users (the '>' and '<' symbols indicate statistically significant differences): multiple sex partners 3.6% < 4.8% < 6.2% respectively; new sex partner 3.0% < 4.0% <5.3%; coital acts 16.45, 16.65, 17.12 (DMPA-IM < Cu-IUD); unprotected sex 65% < 68%, 70%; unprotected sex past 7 days 33% <36%, 37%; sex during vaginal bleeding 7.1%, 7.1% < 8.9%; no sex acts 4.1%, 3.8%, 3.4% (DMPA-IM > Cu-IUD); partner has sex with others 10% < 11%, 11%. The one exception was having any sex partner 96.5%, 96.9% < 97.4% (DMPA-IM < Cu-IUD). Decrease in sexual desire was reported by 1.6% > 1.1% >0.5%; amenorrhoea by 49% > 41% >12% and regular menstrual pattern by 26% <35% < 87% respectively. Conclusions: These findings suggest that women assigned to DMPA-IM may have a modest decrease in libido and sexual activity relative to the implant, and the implant relative to the Cu-IUD. We found more menstrual disturbance with DMPA-IM than with the implant (and as expected, both more than the Cu-IUD). These findings are important for informing the contraceptive choices of women and policymakers and highlight the need for robust comparison of the effects of other contraceptive methods as well. [ABSTRACT FROM AUTHOR]

Introduction: Adolescent girls and young women (AGYW), a priority population for HIV prevention in Africa, show high interest but difficulty in sustained effective use of pre‐exposure prophylaxis (PrEP). With ongoing PrEP scale‐up focused on increasing access, it is important to understand what influences AGYW's choice of PrEP delivery platforms. Methods: The POWER implementation study in Cape Town provided PrEP between 2017 and 2020 to AGYW (16−25 years) from four differentiated delivery platforms: mobile clinic, government facility, courier delivery or community‐based youth club. Healthcare providers at government and mobile clinics provided PrEP (initiation and refills) as part of comprehensive, integrated sexual and reproductive health services. Courier and youth club platforms provided light‐touch PrEP refill services incorporating rapid HIV self‐testing. We conducted in‐depth interviews with a purposive sample of AGYW who had ≥3 months of PrEP‐use and accessed ≥2 PrEP delivery platforms. The thematic analysis explored AGYW's preferences, decision‐making and habits related to PrEP access to inform market segmentation. Results: We interviewed 26 AGYW (median age 20) PrEP‐users between November 2020 and March 2021. AGYW PrEP‐users reported accessing different services with, 24 accessing mobile clinics, 17 courier delivery, 9 government health facilities and 6 youth clubs for their PrEP refills. Qualitative findings highlighted four potential behavioural profiles. The "Social PrEP‐user" preferred PrEP delivery in peer spaces, such as youth clubs or adolescent‐friendly mobile clinics, seeking affirmation and social support for continued PrEP use. The "Convenient PrEP‐user" favoured PrEP delivery at easily accessible locations, providing quick (courier) or integrated contraception‐PrEP refill visits (mobile and government clinic). The "Independent PrEP‐user" preferred PrEP delivery that offered control over delivery times that fit into their schedule, such as the courier service. The "Discreet PrEP‐user" highly valued privacy regarding their PrEP use (courier delivery) and avoided delivery options where unintentional disclosure was evident (youth club). Comfort with HIV self‐testing had minimal influence on PrEP delivery choice. Conclusions: Market segmentation of AGYW characterizes different types of PrEP‐users and has the potential to enhance tailored messaging and campaigns to reach specific segments, with the aim of improving sustained PrEP use and HIV prevention benefits. [ABSTRACT FROM AUTHOR]

Background Confounding introduced by individuals' sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use. Methods We conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18–45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use. Results Women in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8–3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9–4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction. Conclusions These results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use. Clinical Trials Registration NCT01617096. [ABSTRACT FROM AUTHOR]

Key Points: Question: What is the HIV incidence among cisgender women with different adherence trajectories to preexposure prophylaxis (PrEP) with emtricitabine and tenofovir disoproxil fumarate? Findings: In this pooled analysis of 6296 participants from 11 postapproval studies of PrEP in cisgender women, the overall HIV incidence was 0.72 per 100 person-years. The HIV incidence rates per 100 person-years for different PrEP adherence trajectories were 0 for consistently daily (7 doses/week), 0.13 for consistently high (4-6 doses/week), 0.49 for high but declining (from a mean of 4-6 doses/week and then declining), and 1.27 for consistently low (less than 2 doses/week) adherence. Meaning: In a pooled analysis of postapproval studies, cisgender women with daily or consistently high adherence to emtricitabine and tenofovir disoproxil fumarate for PrEP experienced very low HIV incidence. Importance: Emtricitabine and tenofovir disoproxil fumarate (F/TDF) for HIV preexposure prophylaxis (PrEP) is highly effective in cisgender men who have sex with men (MSM) when adherence is high (>4 doses/week). Real-world effectiveness and adherence with F/TDF for PrEP in cisgender women is less well characterized. Objective: To characterize the effectiveness of F/TDF for PrEP and its relationship with adherence in cisgender women. Design, Setting, and Participants: Data were pooled from 11 F/TDF PrEP postapproval studies conducted in 6 countries that included 6296 cisgender women aged 15 to 69 years conducted from 2012 to 2020. HIV incidence was evaluated according to adherence level measured objectively (tenofovir diphosphate concentration in dried blood spots or tenofovir concentration in plasma; n = 288) and subjectively (electronic pill cap monitoring, pill counts, self-report, and study-reported adherence scale; n = 2954) using group-based trajectory modeling. Exposures: F/TDF prescribed orally once a day. HIV incidence was analyzed in subgroups based on adherence trajectory. Main Outcomes and Measures: HIV incidence. Results: Of the 6296 participants, 46% were from Kenya, 28% were from South Africa, 21% were from India, 2.9% were from Uganda, 1.6% were from Botswana, and 0.8% were from the US. The mean (SD) age at PrEP initiation across all studies was 25 (7) years, with 61% of participants being younger than 25 years. The overall HIV incidence was 0.72 per 100 person-years (95% CI, 0.51-1.01; 32 incident HIV diagnoses among 6296 participants). Four distinct groups of adherence trajectories were identified: consistently daily (7 doses/week), consistently high (4-6 doses/week), high but declining (from a mean of 4-6 doses/week and then declining), and consistently low (less than 2 doses/week). None of the 498 women with consistently daily adherence acquired HIV. Only 1 of the 658 women with consistently high adherence acquired HIV (incidence rate, 0.13/100 person-years [95% CI, 0.02-0.92]). The incidence rate was 0.49 per 100 person-years (95% CI, 0.22-1.08) in the high but declining adherence group (n = 1166) and 1.27 per 100 person-years (95% CI, 0.53-3.04) in the consistently low adherence group (n = 632). Conclusions and Relevance: In a pooled analysis of 11 postapproval studies of F/TDF for PrEP among cisgender women, overall HIV incidence was 0.72 per 100 person-years; individuals with consistently daily or consistently high adherence (4-6 doses/week) to PrEP experienced very low HIV incidence. This pooled analysis of postapproval studies examines the association between baseline demographics and other characteristics and PrEP adherence trajectories with HIV incidence in women. [ABSTRACT FROM AUTHOR]

Real-time electronic adherence monitoring involves "smart" pill boxes that record and monitor openings as a proxy for pill taking and may be useful in understanding and supporting PrEP use; however, acceptability and/or feasibility for PrEP users is uncertain. We sought to understand the experiences of using a real-time electronic adherence monitor for PrEP delivery among young women in Kisumu and Thika, Kenya. We used the Wisepill device to monitor PrEP use among 18-24-year-old women for two years. Half of the participants were randomized to also receive SMS adherence reminders (daily or as needed for missed doses). We assessed acceptability quantitatively and qualitatively according to the four constructs of Unified Theory of Acceptance and Use of Technology (UTAUT): performance expectancy, effort expectancy, social influence, and facilitating conditions. We assessed feasibility by monitor functionality during periods of PrEP use. We analyzed quantitative data descriptively and compared by site and over time; qualitative data were analyzed inductively and deductively. The median age was 21 years (IQR 19–22), median education was 12 years (IQR 10–13), 182 (53%) had disclosed PrEP use, and 55 (16%) reported recent intimate partner violence. Most participants reported high levels of usefulness and high interest in using the monitor with few problems or worries reported throughout follow-up. Feasibility was high overall with some differences by site (96% functional monitor days in Kisumu vs 88% in Thika). Few monitors were reported lost (N = 29; 8%) or dysfunctional (N = 11; 3%). In qualitative interviews, electronic monitoring was perceived as useful because it supported privacy, confidentiality, easy storage, and PrEP adherence. Effort was generally considered low. Participants expressed some concern for stigma from monitor and/or PrEP use. Facilitating conditions involved the monitor size, color, and battery life. Overall, real-time electronic adherence monitoring was a highly acceptable and feasible approach to understand PrEP adherence among young women in a sub-Saharan African setting. [ABSTRACT FROM AUTHOR]

Introduction: Delivery of oral pre‐exposure prophylaxis (PrEP) is being scaled up in Africa, but clinic‐level barriers including lengthy clinic visits may threaten client continuation on PrEP. Methods: Between January 2020 and January 2022, we conducted a quasi‐experimental evaluation of differentiated direct‐to‐pharmacy PrEP refill visits at four public health HIV clinics in Kenya. Two clinics implemented the intervention package, which included direct‐to‐pharmacy for PrEP refill, client HIV self‐testing (HIVST), client navigator, and pharmacist‐led rapid risk assessment and dispensing. Two other clinics with comparable size and client volume served as contemporaneous controls with the usual clinic flow. PrEP continuation was evaluated by visit attendance and pharmacy refill records, and time and motion studies were conducted to determine time spent in the clinics. Dried blood spots were collected to test for tenofovir‐diphosphate (TFV‐DP) at random visits. We used logistic regression to assess the intervention effect on PrEP continuation and the Wilcoxon rank sum test to assess the effect on clinic time. Results: Overall, 746 clients were enrolled, 366 at control clinics (76 during pre‐implementation and 290 during implementation phase), and 380 at direct‐to‐pharmacy clinics (116 during pre‐implementation and 264 during implementation phase). Prior to implementation, the intervention and control clinics were comparable on client characteristics (female: 51% vs. 47%; median age: 33 vs. 33 years) and PrEP continuation (35% vs. 37% at 1 month, and 37% vs. 39% at 3 months). The intervention reduced total time spent at the clinic by 35% (median of 51 minutes at control vs. 33 minutes at intervention clinics; p<0.001), while time spent on HIV testing (20 vs. 20 minutes; p = 0.50) and pharmacy (8 vs. 8 minutes; p = 0.8) was unchanged. PrEP continuation was higher at intervention versus the control clinics: 45% versus 33% at month 1, 34% versus 25% at month 3 and 23% versus 16% at month 6. TFV‐DP was detected in 85% (61/72) of samples, similar by the study group (83% vs. 85%). Conclusions: A client‐centred PrEP delivery approach with direct‐to‐pharmacy PrEP refill visits plus client HIVST significantly reduced clinic visit time by more than one‐third and improved PrEP continuation in public health HIV clinics in Kenya. [ABSTRACT FROM AUTHOR]

Introduction: Young women in sub‐Saharan Africa are a priority population for HIV prevention, yet challenges with adherence and persistence to HIV pre‐exposure prophylaxis (PrEP) are common. This study involved the development and pilot testing of My Way—a novel delivery system for PrEP and co‐packaged sexual health services. Methods: My Way was developed in Kisumu, Kenya through a user‐centred design process (2020). The intervention involves peer‐delivery and support for HIV testing and PrEP use, self‐collected vaginal swabs for sexually transmitted infection (STI) testing, pregnancy testing, oral contraceptive pills, self‐injectable medroxyprogesterone and/or condoms. My Way was assessed among 16‐ to 24‐year‐old sexually active women in a randomized controlled trial versus standard of care (SoC; 2021–2022). Use of PrEP and other sexual health services were tracked at 1, 3 and 6 months for feasibility. Acceptability was determined by questionnaire. The effect of the intervention on tenofovir diphosphate (TFV‐DP) levels was assessed by chi‐square test (primary outcome); other predictors were explored with regression analysis. Results: Among 150 women, the median age was 22 years and the median number of sexual partners was 2. Moderate/severe depression was common (60%). In the intervention arm, peers made 88% (198/225) of possible kit deliveries (177 with PrEP) and 49 STIs were diagnosed. In the SoC arm, 24% (55/225) of expected clinic visits occurred (53 with PrEP); no STI testing was performed. TVF‐DP was detected in 16 participants at 6 months: 16% (12/75) in the intervention arm versus 5% (4/75) in the SoC arm (p = 0.03). Persistence among those with ongoing HIV prevention needs (i.e. prevention‐effective persistence) was 18% (12/67) versus 7% (4/56; p = 0.08). No women acquired HIV. The intervention was significantly associated with detectable TFV‐DP (OR 3.5, 1.1‐11.4; p = 0.04); moderate/severe depression trended towards an association with TFV‐DP (OR 0.2, 0.03–1.6; p = 0.13). Conclusions: My Way is a promising delivery system for PrEP and other sexual health services among young women in Western Kenya. We found high feasibility and acceptability. PrEP use was modest, but higher with My Way compared to SoC. Long‐acting PrEP formulations may overcome important barriers to PrEP use and should be explored in combination with the My Way delivery model. [ABSTRACT FROM AUTHOR]

Copyright of AIDS & Behavior is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: Many Kenyan adolescent girls and young women (AGYW) with behaviors associated with HIV acquisition access contraception at retail pharmacies. Offering oral pre-exposure prophylaxis (PrEP) in pharmacies could help reach AGYW with PrEP services. Methods: We piloted PrEP delivery at 3 retail pharmacies in Kisumu, Kenya. AGYW purchasing contraception were offered PrEP by nurses with remote prescriber oversight. AGYW who accepted were provided with a free 1-month supply. We conducted in-depth interviews with AGYW 30 days postobtaining PrEP. Transcripts were analyzed to explore experiences of AGYW accessing PrEP at pharmacies. Results: We conducted 41 interviews. AGYW preferred pharmacies for accessing PrEP and they were willing to pay for PrEP even if available for free at clinics. Reasons for this preference included accessibility, lack of queues, and medication stockouts, privacy, anonymity, autonomy, and high-quality counseling from our study nurses. Conclusions: Pharmacies may be an important PrEP access option for this population. [ABSTRACT FROM AUTHOR]

Background: Oral HIV pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low in Africa, especially among young women who are a priority population for HIV prevention services. HIV self-testing (HIVST) has been proven to increase HIV testing in diverse populations but has been underutilized to support linkage to HIV prevention services. Most young women who initiate PrEP in Africa do so through informal peer referral. We wanted to test a model of formalized peer referral enhanced with HIVST delivery among young Kenyan women. Methods: The Peer PrEP Trial is a two-arm hybrid effectiveness-implementation cluster-randomized controlled trial being conducted in central Kenya. Eligible participants (i.e., peer providers, n = 80) are women (≥ 16–24 years) refilling or initiating PrEP at public healthcare clinics who can identify at least four peers who could benefit from PrEP and not enrolled in another HIV study. Peer providers will be 1:1 randomized to (1) formal peer PrEP referral + HIVST delivery, where they will be encouraged to refer four peers (i.e., peer clients, ≥ 16–24 years) using educational materials and HIVST kits (two per peer client), or (2) informal peer PrEP referral, where they are encouraged to refer four peer clients using informal word-of-mouth referral. In both arms, peer providers will deliver a standard PrEP referral card with information on nearby public clinics delivering PrEP services. Peer providers will complete surveys at baseline and 3 months; peer clients will complete surveys at 3 months. Our primary outcome is PrEP initiation among peer clients, as reported by peer providers at 3 months. Secondary outcomes include PrEP continuation (any refilling), HIV testing (past 3 months), sexual behaviors (past month), and PrEP adherence (past month) among peer clients, as reported by both peer providers and clients at 3 months. Implementation outcomes will include participants' perceived acceptability, appropriateness, and feasibility of the intervention as well assessments of the intervention's fidelity and cost. Discussion: Evidence from this trial will help us understand how HIVST could support health systems by facilitating linkage to PrEP services among young women who could benefit in Kenya and similar settings. Trial registration: ClinicalTrials.gov NCT04982250. Registered on July 29, 2021. [ABSTRACT FROM AUTHOR]

Background: Daily, oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) reduces HIV acquisition for African women. Adherence is key to efficacy and patterns of adherence can be highly variable in real-world settings. Using group-based trajectory modeling (GBTM), we sought to identify distinct patterns of periconception PrEP adherence and evaluate potential baseline predictors of such adherence trajectories. Methods: We conducted a single-arm longitudinal study for women aged 18-35 years living in Durban, South Africa with personal or partner plans for pregnancy with a partner with HIV or of unknown serostatus. Participants were offered safer conception counseling, including daily oral PrEP; women who initiated PrEP were given a bottle with an electronic pillcap that recorded when device opens. Weekly adherence to daily PrEP was modeled using GBTM with a censored normal outcome distribution as a function of weeks since PrEP initiation. The number and functional form of the adherence trajectory groups were primarily selected based on Bayesian information criteria (BIC) and confirmed by mean estimated probabilities of group membership. A multivariable version of the selected model assessed baseline predictors of membership in adherence trajectory groups. Results: Overall mean (95% CI) adherence to PrEP was 63% (60%, 67%). We identified four groups of women with distinct patterns of adherence: (1) high (i.e., ≥6 doses per week) steady adherence throughout follow-up (22% of PrEP initiators); (2) moderate (i.e., 4-5 doses per week), but steady adherence (31%); (3) initially high, but consistently declining adherence (21%); and (4) initially moderate adherence, followed by a rapid decline and subsequent rebound (26%). In multivariable-adjusted analyses, older age was associated with membership in the high, steady adherence group as compared to the group identified with an adherence trajectory of initially high, then decline, and finally a rebound. Conclusions: GBTM is useful for exploring potential heterogeneity in longitudinal patterns of medication adherence. Although a large proportion of women in this study achieved high levels of adherence by electronic pillcap initially, far fewer women maintained these levels consistently. Knowledge of different adherence trajectories could be used to develop targeted strategies for optimizing HIV prevention during periconception. [ABSTRACT FROM AUTHOR]

Copyright of AIDS & Behavior is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: African adolescent girls and young women (AGYW) have high rates of HIV acquisition and are a priority population for HIV pre‐exposure prophylaxis (PrEP). PrEP implementation has been limited by AGYW's low perceived HIV risk and provider demands. A decision support tool (DST) with information about PrEP could improve clients' risk perception, knowledge about PrEP, informed decision‐making and motivation to use PrEP based on their risk, facilitating PrEP delivery in primary healthcare (PHC) clinics. Methods: We designed MyPrEP, a client‐facing DST about PrEP and HIV prevention, with youth‐friendly information and images. The impact of the MyPrEP tool was assessed among HIV‐negative women aged 18–25 years presenting to a PHC clinic in Johannesburg, South Africa from March 2019 to 2020. AGYW were randomized by day to the DST or a general health website as the control condition. A clinician blinded to DST versus control allocation provided standard of care counselling about PrEP, offered PrEP, administered a questionnaire and conducted sexually transmitted infection testing. The primary outcome was PrEP initiation and the secondary outcome was PrEP persistence at 1 month, determined by pharmacy dispensation records. Results: Of 386 AGYW screened, 353 were randomized (DST n = 172, control n = 181) with a median age of 21 years (interquartile range [IQR] 20, 23) and 56% (199/353) attending the clinic for HIV testing, 46% (164/353) using contraception, 15% (53/353) using condoms consistently and 37% (108/353) with a curable sexually transmitted infection. PrEP was initiated by 97% in the DST group and 94% in the control group (OR 1.79; 95% confidence interval, CI = 0.79–1.53), of whom two‐thirds planned to continue PrEP until they decided if they liked PrEP. At 1 month, PrEP persistence was 19% in the DST and 10% in the control group (OR 1.97, 95% CI 1.08–3.69). Ninety‐nine percent randomized to the DST reported satisfaction with MyPrEP. Conclusions: Among AGYW attending a South African PHC clinic, PrEP uptake was >90% with two‐fold higher PrEP persistence at 1 month in those randomized to use the MyPrEP DST. Given the need for strategies to support PrEP implementation and improve low PrEP persistence among African AGYW, a PrEP DST warrants further evaluation. [ABSTRACT FROM AUTHOR]

Introduction: Effective PrEP use is critical for impact, but data are limited on common patterns of continuation and coverage among persons using PrEP in real‐world settings. Methods: Data are from the Partners Scale‐Up Project, a programmatic stepped‐wedge cluster‐randomized trial to integrate PrEP delivery in 25 Kenyan public health facilities conducted between February 2017 and December 2021. We evaluated PrEP continuation using visit attendance and pharmacy refill records, and computed medication possession ratio to define coverage during the first year of use. Latent class mixture models were used to identify and characterize membership to different PrEP continuation patterns. Multinomial logistic regression was used to examine the association between group trajectories and demographic and behaviour characteristics. Results: Overall, 4898 persons initiated PrEP, 54% (2640) were female, mean age was 33 years (standard deviation 11) and 84% (4092) had partners living with HIV. PrEP continuation was 57%, 44%, and 34% at 1, 3, and 6 months, respectively. Four unique trajectories of PrEP coverage were identified: (1) one‐fourth (1154) exhibited consistent high coverage throughout the year with 93%, 94%, 96%, and 67% continuing PrEP at months 1, 3, 6, and 12, respectively; (2) 13% (682) showed high coverage trajectory throughout 6 months but coverage rapidly declined thereafter (94%, 93%, 63%, and 10% continued at months 1, 3, 6, and 12, respectively); (3) 18.9% (918) exhibited moderate coverage trajectory with 91% of clients refilling PrEP at month 1 but nearly all dropped‐off thereafter (37%, 5%, and 4% continued at months 3, 6, and 12, respectively); and (4) 43.8% (2144) exhibited immediate discontinuation trajectory, in which nearly all did not have any subsequent PrEP refill. Overall, being female, older age, having partners living with HIV or of unknown HIV status were statistically associated with better PrEP continuation trajectories compared to the immediate discontinuation trajectory (p <0.05 for all). Conclusions: In this analysis of a real‐world PrEP implementation programme in Kenya, we found four distinct patterns of PrEP continuation, with one‐third of users exhibiting consistent high continuation throughout 12 months and two‐fifths with immediate discontinuation patterns. These data may help guide tailored interventions to support PrEP continuation in this setting. [ABSTRACT FROM AUTHOR]

Background: HIV endpoint-driven clinical trials increasingly provide oral pre-exposure prophylaxis (PrEP) as standard of prevention during the trial, however, among participants desiring to continue using PrEP at trial exit, little is known about post-trial PrEP access and continued use. Methods: We conducted one-time, semi-structured, face-to-face, in-depth interviews with 13 women from Durban, South Africa, from November to December 2021. We interviewed women who initiated oral PrEP as part of the HIV prevention package during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial, elected to continue using PrEP at study exit, and were given a 3-month PrEP supply and referred to facilities for PrEP refills at the final trial visit. The interview guide probed for barriers and enablers to post-trial PrEP access, and current and future PrEP use. Interviews were audio-recorded and transcribed. Thematic analysis was facilitated using NVivo. Results: Of the 13 women, six accessed oral PrEP post-trial exit, but five later discontinued. The remaining seven women did not access PrEP. Barriers to post-trial PrEP access and continued use included PrEP facilities having long queues, inconvenient operating hours, and being located far from women's homes. Some women were unable to afford transport costs to collect PrEP. Two women reported visiting their local clinics and requesting PrEP but were informed that PrEP was unavailable at the clinic. Only one woman was still using PrEP at the time of the interview. She reported that the PrEP facility was located close to her home, staff were friendly, and PrEP education and counselling were provided. Most women not on PrEP reported wanting to use it again, particularly if barriers to access could be alleviated and PrEP was easily available at facilities. Conclusions: We identified several barriers to post-trial PrEP access. Strategies to enhance PrEP access such as a reduction in waiting queues, convenient facility operating hours, and making PrEP more widely available and accessible are needed. It is also worth noting that oral PrEP access has expanded in South Africa from 2018 till now and this could improve access to PrEP for participants exiting trials who desire to continue PrEP. [ABSTRACT FROM AUTHOR]

Introduction: The global incidence of sexually transmitted infections (STIs) has been rapidly increasing over the past decade, with more than one million curable STIs being acquired daily. Young women in sub-Saharan Africa have a high prevalence and incidence of both curable STIs and HIV. The use of doxycycline as a prophylaxis to prevent STIs is promising; however, clinical trials, to date, have only been conducted among men who have sex with men (MSM) in high-income settings. We describe the characteristics of participants enrolled in the first trial to determine the efficacy of doxycycline post-exposure prophylaxis (PEP) to reduce STI incidence among women taking daily, oral HIV pre-exposure prophylaxis (PrEP). Methods: This is an open-label 1:1 randomized clinical trial on the efficacy of doxycycline PEP compared with standard of care (e.g., quarterly STI screening and treatment) to reduce incident bacterial STIs – Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum – among Kenyan women aged ≥18 and ≤30 years. All were also taking HIV pre-exposure prophylaxis (PrEP). We describe the baseline characteristics, STI prevalence, and STI risk perception of participants. Results: Between February 2020 and November 2021, 449 women were enrolled. The median age was 24 years (IQR 21–27), the majority were never married (66.1%), 370 women (82.4%) reported having a primary sex partner, and 33% had sex with new partners in the three months prior to enrolment. Two-thirds (67.5%, 268 women) did not use condoms, 36.7% reported transactional sex, and 43.2% suspected their male partners of having sex with other women. Slightly less than half (45.9%, 206 women) were recently concerned about being exposed to an STI. The prevalence of STIs was 17.9%, with C. trachomatis accounting for the majority of infections. Perceived risk of STIs was not associated with the detection of an STI. Conclusion: Young cisgender women using HIV PrEP in Kenya and enrolled in a trial of doxycycline postexposure prophylaxis had a high prevalence of curable STIs and represent a target population for an STI prevention intervention. [ABSTRACT FROM AUTHOR]

Introduction: The delivery of daily, oral HIV pre‐exposure prophylaxis (PrEP) at private pharmacies may overcome barriers to PrEP delivery at public healthcare facilities, including HIV‐associated stigma, long wait times and overcrowding. Methods: At five private, community‐based pharmacies in Kenya, a care pathway for PrEP delivery (ClinicalTrials.gov: NCT04558554) was piloted—the first of its kind in Africa. Pharmacy providers screened clients interested in PrEP for HIV risk, then used a prescribing checklist to identify clients without medical conditions that might contraindicate PrEP safety, counsel them on PrEP use and safety, conduct provider‐assisted HIV self‐testing and dispense PrEP. For complex clinical cases, a remote clinician was available for consultation. Clients who did not meet the checklist criteria were referred to public facilities for free services delivered by clinicians. Pharmacy providers dispensed a 1‐month PrEP supply at initiation and a 3‐month supply thereafter at a client fee of 300 KES (∼$3 USD) per visit. Results: From November 2020 to October 2021, pharmacy providers screened 575 clients, identified 476 who met the prescribing checklist criteria and initiated 287 (60%) on PrEP. Among pharmacy PrEP clients, the median age was 26 years (IQR 22–33) and 57% (163/287) were male. The prevalence of behaviours associated with HIV risk among clients was high; 84% (240/287) reported sexual partners with unknown HIV status and 53% (151/287) reported multiple sexual partners (past 6 months). PrEP continuation among clients was 53% (153/287) at 1 month, 36% (103/287) at 4 months and 21% (51/242) at 7 months. During the pilot observation period, 21% (61/287) of clients stopped and restarted PrEP and overall pill coverage was 40% (IQR 10%–70%). Nearly, all pharmacy PrEP clients (≥96%) agreed or strongly agreed with statements regarding the acceptability and appropriateness of pharmacy‐delivered PrEP services. Conclusions: Findings from this pilot suggest that populations at HIV risk frequently visit private pharmacies and PrEP initiation and continuation at pharmacies is similar to or exceeds that at public healthcare facilities. Private pharmacy‐based PrEP delivery, conducted entirely by private‐sector pharmacy staff, is a promising new delivery model that has the potential to expand PrEP reach in Kenya and similar settings. [ABSTRACT FROM AUTHOR]

Introduction: Multiple antiretroviral agents have demonstrated efficacy for human immunodeficiency virus (HIV) pre‐exposure prophylaxis (PrEP). As a result, clinical trials of novel agents have transitioned from placebo‐ to active‐controlled designs; however, active‐controlled trials do not provide an estimate of efficacy versus no use of PrEP. Counterfactual placebo comparisons using other data sources could be employed to provide this information. Methods: We compared the active‐controlled study (HPTN 084) of injectable cabotegravir (CAB‐LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) among women from seven countries in Africa to three external, contemporaneous randomized HIV prevention trials from which we constructed counterfactual placebo estimates. We used direct standardization via analysis weights to achieve the same distribution of person‐years between the external study and HPTN 084, across strata predictive of HIV risk (country and selected risk covariates). We estimated prevention efficacy against a counterfactual placebo to provide information on the use of CAB‐LA and FTC/TDF compared to no intervention. We compared the counterfactual placebo findings for FTC/TDF to previous placebo‐controlled trials, adjusted for observed adherence to daily pills. Results: Distribution of age and baseline prevalence of gonorrhoea and chlamydia were similar among matched counterfactual placebo and observed HPTN 084 arms after standardization. Counterfactual estimates of CAB‐LA versus placebo in all three settings showed a consistent risk reduction of 93%–94%, with lower bounds of the confidence intervals above 72%. Observed adherence (quantifiable tenofovir in plasma) in HPTN 084 was 54%–56%, and estimated efficacy of daily oral FTC/TDF against a counterfactual placebo was consistent with a predicted risk reduction of 39%–40% for this level of daily pill use. Conclusions: Counterfactual placebo rates of HIV acquisition derived from external trial data in similar locations and time can be used to support estimates of placebo‐based efficacy of a novel HIV prevention agent. External trial data must be standardized to be representative of the clinical trial cohort testing the novel HIV prevention agent, accounting for confounders. [ABSTRACT FROM AUTHOR]

Intimate partner violence (IPV) has been associated with poorer mental health outcomes and increased human immunodeficiency virus (HIV) risk behaviors. We examine the relations between IPV, mental health symptomology (defined as psychological distress and alcohol misuse), and engagement in HIV risk behaviors among a sample of South African women who participated in a randomized controlled trial of CHARISMA, an intervention to increase women's agency to use oral pre-exposure prophylaxis (PrEP) safely and consistently as well as mitigate relationship challenges. We also examined the impact of trial participation on women's mental health, as well as the impact of psychological distress on the effectiveness of the CHARISMA intervention. Mental health symptomology and IPV exposure were prevalent and associated with some HIV risk and protective behaviors. Trial participation reduced psychological distress. There was no evidence for mental health symptomology impacting the effectiveness of the CHARISMA intervention. [ABSTRACT FROM AUTHOR]

Introduction: Gendered power inequalities impact adolescent girls' and young women's (AGYW) sexual and reproductive health (SRH) outcomes. We investigated the influence of sexual relationship power on AGYW's SRH outcomes, including HIV pre-exposure prophylaxis (PrEP) persistence. Methods: The POWER study in Kisumu, Kenya, and Cape Town and Johannesburg, South Africa provided PrEP to 2,550 AGYW (aged 16-25). AGYW's perceived power in their primary sexual relationship was measured among the first 596 participants enrolled using the Sexual Relationship Power Scale's (SRPS) relationship control sub-scale. Multivariable regression was used to test for (1) key sociodemographic and relationship characteristics associated with relationship power; and (2) the association of relationship power with SRH outcomes including PrEP persistence. Results: In this cohort, the mean SRPS score was 2.56 (0.49), 542 (90.9%) initiated PrEP; 192 (35.4%) persisted with PrEP at 1 month of which 46 (24.0% of 192) persisted at 6 months. SRPS were significantly lower among AGYW who cohabited with their sex partner (-0.14, 95% CI: -0.24 to -0.04, p = 0.01), or had ≥1 sex partner (-0.10, 95% CI: -0.19 to -0.00, p = 0.05). AGYW with lower SRPS were more likely to not know their partner's HIV status (aOR 2.05, 95% CI: 1.27 to 3.33, p < 0.01), but SRPS was not associated with PrEP persistence, STI infection, condom, or hormonal contraception use. Discussion: AGYW's reasons for initiating PrEP and reasons for continuously using PrEP may be different. While low relationship power was associated with perceived HIV vulnerability, AGYW's PrEP persistence may be influenced by more than relationship power. [ABSTRACT FROM AUTHOR]

Background Nicotine replacement therapy, bupropion, and varenicline are smoking cessation medications (SCMs) shown to be similarly effective in people with and without human immunodeficiency virus (PWH and PWoH, respectively), although rates of receipt of these medications are unknown. Methods We identified patients in the Veterans Aging Cohort Study with electronic health record-documented current smoking using clinical reminder data for tobacco use (2003–2018). We measured receipt of SCMs using Veterans Affairs pharmacy data for outpatient prescriptions filled 0–365 days after current smoking documentation. We used log-linear, Poisson-modified regression models to evaluate the relative risk (RR) for receiving SCM by human immunodeficiency virus (HIV) status, the annual rate of receipt, and rate difference among PWH relative to PWoH. Results The sample included 92 632 patients (29 086 PWH), reflecting 381 637 documentations of current smoking. From 2003 to 2018, the proportion receiving SCMs increased from 15% to 34% for PWH and from 17% to 32% among PWoH. There was no statistical difference in likelihood of receiving SCM by HIV status (RR, 1.010; 95% confidence interval [CI],.994–1.026). Annual rates of receiving SCM increased for PWH by 4.3% per year (RR, 1.043; 95% CI, 1.040–1.047) and for PWoH by 3.7% per year (RR, 1.037; 95% CI, 1.036–1.038; rate difference +0.6% [RR, 1.006; 95% CI, 1.004–1.009]). Conclusions In a national sample of current smokers, receipt of SCM doubled over the 16-year period, and differences by HIV status were modest. However, fewer than 35% of current smokers receive SCM annually. Efforts to improve SCM receipt should continue for both groups given the known dangers of smoking. [ABSTRACT FROM AUTHOR]

Hydroxychloroquine (HCQ) was initially promoted as an oral therapy for early treatment of coronavirus disease 2019 (COVID‐19). Conventional meta‐analyses cannot fully address the heterogeneity of different designs and outcomes of randomized controlled trials (RCTs) assessing the efficacy of HCQ in outpatients with mild COVID‐19. We conducted a pooled analysis of individual participant data from RCTs that evaluated the effect of HCQ on hospitalization and viral load reduction in outpatients with confirmed COVID‐19. We evaluated the overall treatment group effect by log‐likelihood ratio test (−2LL) from a generalized linear mixed model to accommodate correlated longitudinal binary data. The analysis included data from 11 RCTs. The outcome of virological effect, assessed in 1560 participants (N = 795 HCQ, N = 765 control), did not differ significantly between the two treatment groups (−2LL = 7.66; p = 0.18) when adjusting for cohort, duration of symptoms, and comorbidities. The decline in polymerase chain reaction positive tests from day 1 to 7 was 42.0 and 41.6 percentage points in the HCQ and control groups, respectively. Among the 2037 participants evaluable for hospitalization (N = 1058 HCQ, N = 979 control), we found no significant differences in hospitalization rate between participants receiving HCQ and controls (odds ratio 0.995; 95% confidence interval 0.614–1.610; −2LL = 0.0; p = 0.98) when adjusting for cohort, duration of symptoms, and comorbidities. This individual participant data meta‐analysis of 11 HCQ trials that evaluated severe acute respiratory syndrome‐coronavirus 2 viral clearance and COVID‐19 hospitalization did not show a clinical benefit of HCQ. Our meta‐analysis provides evidence to support the interruption in the use of HCQ in mild COVID‐19 outpatients to reduce progression to severe disease. [ABSTRACT FROM AUTHOR]

MTN-025/HOPE was an open-label trial of the dapivirine vaginal ring conducted in four African countries between 2016 and 2018. Women were first offered one ring monthly (at baseline, months 1 and 2), thereafter, transitioned to a more applicable real-world dispensation schedule, − 3 rings quarterly (at months 3, 6 and 9). Logistic regression analysis was used to assess correlates of ring acceptance at baseline and through follow-up. A total of 1456 women (median age 31 years) enrolled, 1342 (92.2%) accepted the ring at baseline and 1163 (79.9%) accepted the ring(s) at all visits. Changing ring dispensation from a monthly to a quarterly schedule had no negative effect on acceptance. Having a primary partner and him knowing about the ring being offered in HOPE, use of long-acting contraception (implants, injections, IUDs) or sterilization were associated with ring acceptance, along with prior strong intention to use the ring in the future. Efforts should consider these factors when rolling out the ring for HIV prevention. [ABSTRACT FROM AUTHOR]

Background: For individuals who face challenges accessing clinic-based HIV preexposure prophylaxis (PrEP), differentiated service delivery models are needed to expand access and reach. During a pilot study testing a novel pharmacy-delivered oral PrEP model in Kenya, we used routine programmatic data to identify early implementation barriers and actions that providers and study staff took in response to the barriers. Methods: We trained pharmacy providers at five private pharmacies in Kisumu and Kiambu Counties to initiate and continue clients at risk of HIV acquisition on PrEP for a fee of 300 KES per visit (∼$3 USD) using a prescribing checklist with remote clinician oversight. Research assistants stationed at the pharmacies completed weekly observation reports of pharmacy-delivered PrEP services using a structured template. We analyzed reports from the first 6 month of implementation using content analysis and identified multi-level early implementation barriers and actions taken to address these. We then organized the identified barriers and actions according to the Consolidated Framework for Implementation Research (CFIR). Results: From November 2020 to May 2021, research assistants completed 74 observation reports (∼18/pharmacy). During this period, pharmacy providers screened 496 potential PrEP clients, identified 425 as eligible for pharmacydelivered PrEP services, and initiated 230 (54%) on PrEP; 125 of 197 (63%) clients eligible for PrEP continuation refilled PrEP. We identified the following early implementation barriers to pharmacy-delivered PrEP services (by CFIR domain): high costs to clients (intervention characteristics), client discomfort discussing sexual behaviors and HIV testing with providers (outer setting), provider frustrations that PrEP delivery was time-consuming and disruptive to their workflow (inner setting), and provider hesitancy to deliver PrEP due to concerns about encouraging sexual promiscuity (characteristics of individuals). To help address these, pharmacy providers implemented a self-screening option for behavioral HIV risk assessment for prospective PrEP clients, allowed flexible appointment scheduling, and conducted pharmacy PrEP trainings for newly hired staff. Conclusion: Our study provides insight into early barriers to implementing pharmacydelivered PrEP services in Kenya and potential actions to mitigate these barriers. It also demonstrates how routine programmatic data can be used to understand the early implementation process. [ABSTRACT FROM AUTHOR]

Introduction: Integrating pre‐exposure prophylaxis (PrEP) delivery for pregnant and postpartum women within maternal and child health (MCH) clinics is feasible and acceptable. It is unknown whether a risk‐guided model would facilitate appropriate PrEP use among MCH attendees better than universally offering PrEP. Methods: The PrEP Implementation for Mothers in Antenatal Care (PrIMA) study was a cluster randomized trial to assess two models for PrEP delivery among pregnant women seeking routine MCH care at 20 public clinics in Kenya between January 2018 and July 2019 (NCT03070600). In the Universal arm, all participants received PrEP counselling and self‐selected whether to initiate PrEP. In the Targeted arm, participants underwent an HIV risk assessment, including an objective risk‐scoring tool and an offer of HIV self‐tests for at‐home partner testing; those determined to be at high risk received a PrEP offer. Participants were followed through 9 months postpartum. Primary outcomes included incident HIV and appropriate PrEP use (defined as PrEP uptake among those at high risk and no PrEP uptake for those not at risk). Outcomes were compared using intention‐to‐treat analyses, adjusting for baseline HIV risk and marital status. Results: Among 4447 women enrolled, the median age was 24.0 years (interquartile range [IQR]: 20.9, 28.3), and most were married (84.8%). The median gestational age at enrolment was 24 weeks (IQR: 20, 30). Women in the Targeted arm were more likely to be at high risk for HIV acquisition at baseline (51.6% vs. 33.3%). During 4638 person‐years (p‐yr) of follow‐up, there were 16 maternal HIV infections with no difference in maternal HIV incidence between arms: 0.31/100 p‐yr (95% CI: 0.15, 0.65) Targeted and 0.38/100p‐yr (95% CI: 0.20, 0.73) Universal (adjusted relative risk [aRR]: 0.85 [CI: 0.28, 2.55]). There was no significant difference in the frequency of appropriate PrEP use between the arms (68.2% vs. 59.1% in Targeted vs. Universal, respectively) (aRR: 1.03 [CI: 0.96, 1.10]). Conclusions: Given comparable maternal HIV incidence and PrEP uptake in Universal and Targeted approaches, and the simplicity that universal PrEP offers, our findings suggest that universal PrEP counselling is optimal for integrating PrEP in MCH systems. [ABSTRACT FROM AUTHOR]

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

Effective contraceptives are a global health imperative for reproductive-aged women. However, there remains a lack of rigorous data regarding the effects of contraceptive options on vaginal bacteria and inflammation. Among 218 women enrolled into a substudy of the ECHO Trial (NCT02550067), we evaluate the effect of injectable intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel implant (LNG), and a copper intrauterine device (Cu-IUD) on the vaginal environment after one and six consecutive months of use, using 16S rRNA gene sequencing and multiplex cytokine assays. Primary endpoints include incident BV occurrence, bacterial diversity, and bacterial and cytokine concentrations. Secondary endpoints are bacterial and cytokine concentrations associated with later HIV seroconversion. Participants randomized to Cu-IUD exhibit elevated bacterial diversity, increased cytokine concentrations, and decreased relative abundance of lactobacilli after one and six months of use, relative to enrollment and other contraceptive options. Total bacterial loads of women using Cu-IUD increase 5.5 fold after six months, predominantly driven by increases in the concentrations of several inflammatory anaerobes. Furthermore, growth of L. crispatus (MV-1A-US) is inhibited by Cu2+ ions below biologically relevant concentrations, in vitro. Our work illustrates deleterious effects on the vaginal environment induced by Cu-IUD initiation, which may adversely impact sexual and reproductive health.Here, in a randomized trial, the authors comparatively evaluate the effect of a copper intrauterine device versus other contraceptive options on the vaginal environment after one and six consecutive months of use, finding to exert changes on the vaginal microbiota that may potentially lead to detrimental sex and reproductive health. [ABSTRACT FROM AUTHOR]

Introduction: Many Kenyan adolescent girls and young women (AGYW) with behaviors associated with HIV acquisition access contraception at retail pharmacies. Offering oral pre-exposure prophylaxis (PrEP) in pharmacies could help reach AGYW with PrEP services. Methods: We piloted PrEP delivery at 3 retail pharmacies in Kisumu, Kenya. AGYW purchasing contraception were offered PrEP by nurses with remote prescriber oversight. AGYW who accepted were provided with a free 1-month supply. We conducted in-depth interviews with AGYW 30 days postobtaining PrEP. Transcripts were analyzed to explore experiences of AGYW accessing PrEP at pharmacies. Results: We conducted 41 interviews. AGYW preferred pharmacies for accessing PrEP and they were willing to pay for PrEP even if available for free at clinics. Reasons for this preference included accessibility, lack of queues, and medication stockouts, privacy, anonymity, autonomy, and high-quality counseling from our study nurses. Conclusions: Pharmacies may be an important PrEP access option for this population. [ABSTRACT FROM AUTHOR]

Low perceived HIV risk is a barrier to effective pre-exposure prophylaxis (PrEP) use among African adolescent girls and young women (AGYW). Single-item risk perception measures are stigmatizing and alienating to AGYW and may not predict PrEP use. There is a need for a tool capturing domains of perceived HIV risk and salience that align with PrEP use among AGYW. This HIV PrEP study was conducted in Kampala, Uganda. We developed and piloted the 9-item "HIV Salience and Perception" (HPS) scale (range: 9–36); higher scores indicate beliefs of higher vulnerability to HIV. We administered the scale to Ugandan AGYW participating in an ongoing cohort study at enrollment, one, three and six months. PrEP dispensing was measured quarterly and adherence was measured daily via Wisepill (high adherence: ≥80% of expected pill bottle openings). We assessed scale performance and used generalized estimating equations to determine associations between scale score and PrEP use. Among 499 AGYW, 54.1% of our sample was ≥ 20 years (range:16–25). The median HPS score was 18 (range:8–33; α = 0.77). Higher score was associated with PrEP dispensing (aRR = 1.07 per point increase; 95% CI = 1.01–1.13; p-value = 0.02) in the overall cohort and among only those ≥ 20 years (aRR = 1.10; 95% CI = 1.03–1.19; p-value = 0.01). We did not observe an association between scale score and PrEP adherence. AGYW scoring higher on a novel HPS scale were more likely to initiate and obtain PrEP refills through 6 months. This scale may capture drivers of PrEP dispensing and could inform PrEP delivery and counseling for AGYW. [ABSTRACT FROM AUTHOR]

Few studies have focused on understanding pre-exposure prophylaxis (PrEP) non-initiation among young, high-risk women in sub-Saharan Africa. This study aimed to qualitatively explore why young women in Kenya at high-risk for HIV chose not to enroll in a PrEP adherence trial. We performed 40 semi-structured interviews with young high-risk women assessing concerns about PrEP and/or study participation. We also assessed community-level factors influencing decision-making around PrEP through 10 focus groups involving peers, young men, caregivers, and community leaders. Our qualitative data reflect the complexity of navigating barriers preventing PrEP initiation in settings where taking PrEP may be perceived as immoral behavior. Framed within the context of risk perception, the decision to start PrEP may run counter to the potential risk of losing support from one's community. Our findings suggest that approaches addressing social norms, while de-medicalizing HIV prevention services, are needed to further increase PrEP uptake among young Kenyan women. [ABSTRACT FROM AUTHOR]

Adherence to oral pre-exposure prophylaxis (PrEP) is challenging, and cellular technology offers a promising opportunity for support. However, a recent randomized controlled trial found that SMS reminders did not improve PrEP adherence. We used qualitative methods to explore the trial participants' experiences with the SMS intervention. We conducted serial in-depth interviews with 54 young Kenyan women, using inductive and deductive content analysis. Initially, SMS reminders were highly acceptable. Participants expressed enthusiasm with receiving the reminders because of the coded nature of the SMS reminders; they also helped in 'habit forming' with daily adherence. However, overtime, participants reported growing concerns about privacy, self-efficacy, and responsibility and SMS fatigue. Participants also reported other challenges, including phone loss, poor telephone network, and lack of electricity. Further research to explore if SMS reminders in alternative formats or with different frequency is needed, in addition to identification of alternate adherence support strategies. [ABSTRACT FROM AUTHOR]

Poor marital satisfaction is associated with high-risk sexual behavior and HIV transmission. We tested whether a counselor-led couple education and counseling intervention dubbed Waya (paternal aunt) would improve marital satisfaction and reduce HIV risk behavior among married couples in Kisumu County, western Kenya. In a pre–post design, we enrolled 60 heterosexual married couples at high risk for HIV to undergo five 1-h couple education and counseling sessions over 56 days. We collected self-reported data on marital satisfaction, the number of sex partners, and condom use with extramarital partners at pre- and post-intervention visits. We used Wilcoxon and McNemar tests to examine the association of our intervention with marital relationship satisfaction and reduction in HIV risk sexual behavior. The intervention was associated with marital relationship satisfaction score improvement from a median of 5 (interquartile range [IQR], 4–5) to 6 (IQR, 6–7) among men and 4 (IQR, 3–5) to 6 (IQR, 5–6) among women (p <.01). The intervention was also associated with reducing HIV risk sexual behaviors depicted by a reduction in the number of sex partners in the past one month and an increase in consistent extramarital condom use. The number of sex partners reduced from a median of 2 (IQR, 1–2) to 1 (IQR, 1–2) and consistent extramarital condom use increased from 4% at baseline to 56% among men. Our intervention was associated with improvements in marital relationship satisfaction and reductions in HIV high-risk behaviors necessary for achieving epidemic control in HIV hotspots such as fishing communities in western Kenya. [ABSTRACT FROM AUTHOR]

In the Phase IIIB MTN-025/HOPE open label extension trial, participants were offered the dapivirine vaginal ring as HIV prophylaxis, and those who accepted the ring received semi real-time individual adherence feedback, based on residual drug level (RDL) from returned rings, during Motivational Interviewing-based counseling. Counseling messages, based on the best knowledge at the time, framed RDL results in terms of ring use and HIV protection, from no use /no protection (0 RDL) to high use /high protection (3 RDL). At six HOPE sites, in-depth-Interviews (IDIs) about RDL were conducted with 64 participants who had received at least one RDL result. We found mixed interpretations of what the RDL meant and strong emotional reactions with a focus on the external validation of the level itself. Counseling was critical to help participants process their reactions to the RDL and make decisions accordingly (i.e., persistence, adherence improvement, and/or switching to another HIV prevention method). Providing drug adherence feedback was complex to implement yet proved useful as a component of a multi-pronged adherence support strategy. [ABSTRACT FROM AUTHOR]

Summary: Few studies have characterized bone mineral density (BMD) among health young African women. In our study of 496 Ugandan women age ≤25 years, we found that women had healthy BMD that were lower on average than the standard reference ranges. Reference ranges available for BMD measurements need greater precision. Purpose: Data describing bone mineral density (BMD), nutrient intake, and body composition among healthy, young women in sub-Saharan Africa are limited. Using baseline data from a cohort of young, healthy Ugandan women, we summarize bone health and associated risk factors for reduced bone mass. Methods: Using baseline data from Ugandan women ages 16–25 years who enrolled in an ongoing cohort study of bone health with concurrent use of injectable contraception and oral HIV pre-exposure prophylaxis, we describe the distribution of BMD, nutrient intake, physical activity, and body composition. The association of low BMD (1 or more standard deviations below the age, sex, and race-matched reference range from the USA) and calcium intake, vitamin D intake, physical activity, and body composition was estimated using multivariable logistic regression. Results: In 496 healthy, Ugandan women with median age of 20 years (interquartile range [IQR] 19–21) and median fat:lean mass ratio of 0.55 (IQR 0.46–0.64), median lumbar spine and total hip BMD was 0.9g/cm2 (IQR 0.9–1.0) each. For lumbar spine, Z-score distributions were lower overall than the reference population and 9.3% and 36.3% of women had Z-score >2 and >1 standard deviations below the reference range, respectively. For total hip, Z-scores were similar to the reference population and 1.0% and 12.3% of women had Z-score >2 and >1 standard deviations below the reference range, respectively. In the week prior to enrollment, 41.1% of women consumed >7 servings of calcium, 56.5% had >7 servings of vitamin D, and 98.6% reported ≥2.5 h of physical activity. Having greater body fat was associated with greater frequency of low lumbar spine BMD (p<0.01 for fat:lean mass ratio, total body fat percentage, waist circumference, and BMI). Conclusion: Young Ugandan women exhibited healthy levels of BMD that were lower than the reference range population. [ABSTRACT FROM AUTHOR]