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AbstractIntroductionQuestions remain whether HIV pre‐exposure prophylaxis (PrEP) can be translated into a successful public health intervention, leading to a decrease in population‐level HIV incidence. We use examples from HIV treatment and contraceptives to discuss expectations for PrEP uptake, adherence, and persistence and their combined impact on the epidemic.DiscussionTargets for PrEP uptake must be based on the local HIV epidemic and will depend on appropriate estimates of the key populations at risk for HIV. However, there is evidence that targets, once established, can successfully be met and that uptake may increase with awareness. Messaging around adherence should include that daily adherence is the goal (except for those MSM for whom event‐driven dosing is a good fit), but perfect adherence should not be a barrier. Ideally, clients persist on PrEP for as long as they are at risk for HIV. While PrEP will be most effective when coverage is focused on high‐risk populations, normalizing rather than stigmatizing PrEP will be highly beneficial.ConclusionsWhile many challenges to PrEP implementation exist, we focused on the three key steps of uptake, adherence and persistence as measurable processes that can lead to improved coverage and decreased HIV incidence.

AbstractIntroduction: For HIV serodiscordant couples in resource‐limited settings, pregnancy is common despite the risk of sexual and/or perinatal HIV transmission. Some safer conception strategies to reduce HIV transmission during pregnancy attempts are available but often not used for reasons including knowledge, accessibility, preference and others. We sought to understand Kenyan health providers' and HIV serodiscordant couples' perspectives and experiences with safer conception.Methods: Between August 2015 and March 2016, we conducted key informant interviews (KIIs) with health providers from public and private HIV care and fertility clinics and in‐depth interviews (IDIs) and focus group discussions (FGDs) with HIV serodiscordant couples participating in an open‐label study of integrated pre‐exposure prophylaxis (PrEP) and antiretroviral therapy (ART) for HIV prevention (the Partners Demonstration Project). An inductive analytic approach identified a number of themes related to experiences with and perceptions of safer conception strategies.Results: We conducted 20 KIIs with health providers, and 21 IDIs and 4 FGDs with HIV serodiscordant couples. HIV clinic providers frequently discussed timed condomless sex and antiretroviral medications while providers at private fertility care centres were more comfortable recommending medically assisted reproduction. Couples experienced with ART and PrEP reported that they were comfortable using these strategies to reduce HIV risk when attempting pregnancy. Timed condomless sex in conjunction with ART and PrEP was a preferred strategy, often owing to them being available for free in public and research clinics, as well as most widely known; however, couples often held inaccurate knowledge of how to identify days with peak fertility in the upcoming menstrual cycle.Conclusions: Antiretroviral‐based HIV prevention is acceptable and accessible to meet the growing demand for safer conception services in Kenya, since medically assisted interventions are currently cost prohibitive. Cross‐disciplinary training for health providers would expand confidence in all prevention options and foster the tailoring of counselling to couples' preferences.

AbstractIntroduction: HIV testing is key to the delivery of pre‐exposure prophylaxis (PrEP): testing HIV‐uninfected at‐risk persons is the first step for PrEP initiation and ongoing HIV testing is an essential part of PrEP delivery. Thus, novel and cost‐effective HIV‐testing approaches to streamline delivery of PrEP are urgently needed. Within a demonstration project of PrEP for HIV prevention among high‐risk HIV serodiscordant couples in Kenya (the Partners Demonstration Project), we conducted a pilot evaluation of HIV self‐testing.Methods: Clinic visits were scheduled quarterly and included in‐clinic HIV testing using fingerstick rapid HIV tests and refills of PrEP prescriptions. HIV oral fluid self‐test kits were provided for participants to use in the two‐month interval between scheduled quarterly clinic visits. Acceptability of HIV self‐testing was assessed using both quantitative and qualitative methods.Results: We found that 222 of 226 (98%) HIV‐uninfected persons who were offered accepted self‐testing. Nearly all (96.8%) reported that using the self‐testing kit was easy. More than half (54.5%) reportedly did not share the HIV results from self‐testing with anyone and almost all (98.7%) the participants did not share the HIV self‐testing kits with anyone. Many participants reported that HIV self‐testing was empowering and reduced anxiety associated with waiting between clinic HIV tests.Conclusions: HIV self‐testing was highly acceptable and may therefore be a feasible strategy to efficiently permit routine HIV testing between PrEP refills.

AbstractUnderstanding the levels of power that adolescent girls and young women exercise in their sexual and reproductive lives is imperative to inform interventions to help them meet their goals. We implemented an adapted version of the Sexual and Reproductive Health Empowerment (SRE) Scale for Adolescents and Young Adults among 500 adolescent girls and young women aged 15–20 in Kisumu, Kenya. We used confirmatory factor analysis (CFA) to assess factor structure, and logistic regression to examine construct validity through the relationship between empowerment scores and ability to mitigate risk of undesired pregnancy through consistent contraceptive use. Participants had a mean age of 17.5, and most were students (61 percent), were currently partnered (94 percent), and reported having sex in the past 3 months (70 percent). The final, 26‐item CFA model had acceptable fit. All subscales had Cronbach's alpha scores >0.7, and all items had rotated factor loadings >0.5, indicating good internal consistency and robust factor‐variable associations. The total SRE‐Kenya (SRE‐K) score was associated with increased odds of the consistent method used in the past three months (adjusted odds ratio: 1.98, 95 percent CI: 1.29–3.10). The SRE‐K scale is a newly adapted and valid measure of sexual and reproductive empowerment specific to adolescent girls and young women in an East African setting.

AbstractIntroductionIn settings with high HIV prevalence, cervical cancer incidence rates are up to six‐fold higher than the global average of 13.1 cases per 100,000 women‐years. To inform strategies for global cervical cancer elimination, we used a dynamic transmission model to evaluate scalable screening and treatment strategies, accounting for HIV‐associated cancer risks and weighing prevention gains against overtreatment.MethodsWe developed a dynamic model of HIV‐HPV co‐infection and disease progression, which we calibrated to KwaZulu‐Natal, South Africa. Our baseline scenario reflects the current practice of HPV vaccination with a multi‐visit screening and treatment strategy involving cytology and colposcopy triage. We evaluated 13 comparator scenarios with increased vaccination coverage and one‐time, two‐time or repeat HIV‐targeted cervical cancer screening with the following single‐visit strategies: HPV DNA testing, HPV genotyping, automated visual evaluation (AVE) and HPV DNA with AVE triage. In all scenarios, HIV antiretroviral therapy, condom use and voluntary male medical circumcision continue at baseline levels. We simulated cancer incidence under each scenario from 2020 to 2120 using the 25 best‐fitting parameter sets. We present the median and range of model output from these simulations to account for parameter uncertainty.ResultsWe estimate that cervical cancer incidence will decrease by 87% with the continuation of current cervical cancer and HIV prevention strategies, from an age‐standardized rate per 100,000 women of 80.4 (range 58.2, 112.1) in 2020 to 10.7 (4.2, 29.9) in 2120. Scenarios scaling up vaccination and single‐visit strategies resulted in near‐ and long‐term gains. With repeat HIV‐targeted screening, incidence rates were projected to be 29–34% lower in 2030 relative to the baseline scenario, and elimination (incidence <4/100,000) was achieved with HPV DNA testing in 2095 and with AVE in 2114. A strategy of HPV DNA with AVE triage optimized the tradeoff between cancer cases averted and overtreatment.ConclusionsSingle‐visit screening strategies could avert a substantial burden of cervical cancer and accelerate progress towards elimination in settings with a high burden of HIV. Increasing the screening frequency among women with HIV and reducing loss‐to‐follow‐up for treatment will be key components of a successful elimination strategy.

IntroductionOf the two million new HIV infections in adults in 2014, 70% occurred in sub‐Saharan Africa. Several African countries have already approved guidelines for pre‐exposure prophylaxis (PrEP) for individuals at substantial risk of HIV as part of combination HIV prevention but key questions remain about how to identify and deliver PrEP to those at greatest need. Throughout the continent, individuals in sero‐discordant relationships, and members of key populations (sex workers, men who have sex with men (MSM), transgender women and injection drug users) are likely to benefit from the availability of PrEP. In addition, adolescent girls and young women (AGYW) are at substantial risk in some parts of the continent. It has been estimated that at least three million individuals in Africa are likely to be eligible for PrEP according to WHO's criteria. Tens of demonstration projects are planned or underway across the continent among a range of countries, populations and delivery settings.DiscussionIn each of the target populations, there are overarching issues related to (i) creating demand for PrEP, (ii) addressing supply‐side issues and (iii) providing appropriate and tailored adherence support. Critical for creating demand for PrEP is the normalization of HIV prevention. Community‐level interventions which engage opinion leaders as well as empowerment interventions for those at highest risk will be key. Critical to supply of PrEP is that services are accessible for all, including for stigmatized populations. Establishing accessible integrated services provides the opportunity to address other public health priorities including the unmet need for HIV testing, contraception and sexually transmitted infections treatment. National policies need to include minimum standards for training and quality assurance for PrEP implementation and to address supply chain issues. Adherence support needs to recognize that social and structural factors are likely to have an important influence. Combining interventions that build self‐efficacy, empowerment and social cohesion, with evidence‐based individualized adherence support for PrEP, are most likely to be effective.ConclusionsEfficacy of tenfovir‐based PrEP is proven but many issues related to implementation remain unclear. Here, we have summarized some of the important implementation questions that need to be assessed as PrEP is rolled out across Africa.

AbstractIntroduction: Adherence is essential for pre‐exposure prophylaxis (PrEP) to protect against HIV acquisition, but PrEP use need not be life‐long. PrEP is most efficient when its use is aligned with periods of risk – a concept termed prevention‐effective adherence. The objective of this paper is to describe prevention‐effective adherence and predictors of adherence within an open‐label delivery project of integrated PrEP and antiretroviral therapy (ART) among HIV serodiscordant couples in Kenya and Uganda (the Partners Demonstration Project).Methods: We offered PrEP to HIV‐uninfected participants until the partner living with HIV had taken ART for ≥6 months (a strategy known as "PrEP as a bridge to ART"). The level of adherence sufficient to protect against HIV was estimated in two ways: ≥4 and ≥6 doses/week (per electronic monitoring). Risk for HIV acquisition was considered high if the couple reported sex with <100% condom use before six months of ART, low if they reported sex but had 100% condom use and/or six months of ART and very low if no sex was reported. We assessed prevention‐effective adherence by cross‐tabulating PrEP use with HIV risk and used multivariable regression models to assess predictors of ≥4 and ≥6 doses/week.Results: A total of 985 HIV‐uninfected participants initiated PrEP; 67% were male, median age was twenty‐nine years, and 67% reported condomless sex in the month before enrolment. An average of ≥4 doses and ≥6 doses/week were taken in 81% and 67% of participant‐visits, respectively. Adherence sufficient to protect against HIV acquisition was achieved in 75–88% of participant‐visits with high HIV risk. The strongest predictor of achieving sufficient adherence was reporting sex with the study partner who was living with HIV; other statistically significant predictors included no concerns about daily PrEP, pregnancy or pregnancy intention, females aged >25 years, older male partners and desire for relationship success. Predictors of not achieving sufficient adherence were no longer being a couple, delayed PrEP initiation, >6 months of follow‐up, ART use >6 months by the partner living with HIV and problem alcohol use.Conclusions: Over three‐quarters of participant‐visits by HIV‐uninfected partners in serodiscordant couples achieved prevention‐effective adherence with PrEP. Greater adherence was observed during months with HIV risk and the strongest predictor of achieving sufficient adherence was sexual activity.

AbstractIntroductionEffective 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.MethodsData 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.ResultsOverall, 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).ConclusionsIn 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.

AbstractIntroductionDelivery 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.MethodsBetween 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.ResultsOverall, 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%).ConclusionsA 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.

AbstractIntroductionIn Africa, oral pre‐exposure prophylaxis (PrEP) is largely provided via over‐burdened public HIV care clinics. Successfully incorporating PrEP services into these clinics may require adaptations to practices outlined in national implementation guidelines and modifications to routine existing service delivery. We aimed to describe adaptations made by public HIV clinics in Kenya to integrate PrEP delivery into existing services.MethodsThe Partners Scale‐Up Project aimed to catalyse integration of PrEP in 25 public HIV care clinics. Between May and December 2018, we conducted qualitative interviews with health providers and documented clinic observations in technical assistance (TA) reports to understand the process of PrEP service integration. We analysed 36 health provider interview transcripts and 25 TA reports to identify clinic‐level adaptations to activities outlined in Kenyan Ministry of Health PrEP guidelines and modifications made to existing service delivery practices to successfully incorporate PrEP services. Identified adaptations were reported using the expanded framework for reporting adaptations and modifications (FRAME).ResultsAll clinics (n = 25) performed HIV testing, HIV risk assessment, PrEP education and adherence counselling as stipulated in the guidelines. Most clinics initiated clients on PrEP without creatinine testing if otherwise healthy. While monthly refill appointments are recommended, a majority of clinics issued PrEP users two to three months of pills at a time. Clinics also implemented practices that had not been specified in the guidelines including incorporating PrEP‐related topics into routine health talks, calling clients with missed PrEP appointments, discussing PrEP service delivery in regular staff meetings, 'fast‐tracking' PrEP clients and dispensing PrEP in clinic rooms rather than at clinic‐based pharmacies. PrEP initiation numbers were highest among clinics that did not require creatinine testing, conducted peer on‐the‐job PrEP training and those that discussed PrEP delivery in their routine meetings. Above‐average continuation was observed among clinics that discussed PrEP in their routine meetings, dispensed PrEP in clinic rooms and offered PrEP at nonregular hours.ConclusionsHealth providers in public HIV care clinics instituted practices and made innovative adaptations to PrEP delivery to reduce barriers for clients and staff. Encouraging clinic level adaptations to national implementation guidelines will facilitate scale‐up of PrEP delivery.

AbstractIntroductionPost‐abortion clinics located in regions with high HIV burden may ideal locations to integrate counselling and delivery of HIV pre‐exposure prophylaxis (PrEP), aligning with normative goals for integrated delivery of HIV and reproductive health care. The objective of this study was to gauge the degree to which Kenyan women seeking care for a pregnancy loss, including induced abortion, are at risk for HIV and whether women would welcome an introduction to PrEP prior to discharge from post‐abortion care.MethodsWe conducted a mixed‐methods study from August 2019 to February 2020 with women ages 15 to 30 recruited sequentially as they were accessing post‐abortion care at public and private facilities in Thika and Kisumu, Kenya. Data collection was through a cross‐sectional survey and laboratory testing for common sexually transmitted infections (N = 200), and in‐depth interviews (N = 30). Descriptive statistics summarize PrEP knowledge and referrals and a multivariable log‐link binomial model estimated correlates of receiving a referral for PrEP. Qualitative data were analysed using inductive and deductive approaches.ResultsAmong 200 HIV‐negative women (median age 21.0, interquartile range 19.0 to 22.0), the prevalence of Chlamydia trachomatis was 18.2% and Neisseria gonorrhoeae was 2.0%. Half of the women scored ≥5 on a validated tool that would correspond to an expected HIV incidence of 9.5% per year. Approximately half (55.8%) of women were familiar with PrEP prior to the study and 33.3% received a referral from study staff to a clinic offering PrEP. In qualitative interviews, women expressed interest in accessing PrEP from the gynaecology ward that provided post‐abortion care but they preferred alternative locations for PrEP refills.ConclusionsKenyan women accessing post‐abortion care have substantial HIV risk and were favourable about the idea of receiving support to initiate PrEP as part of care offered during post‐abortion care. These settings can be integrated into national PrEP programmes as locations providing PrEP referrals and initiation.

AbstractIntroductionPartner notification services (PNS) increase theHIVstatus knowledge and linkage to care and treatment. However, it is unclear ifPNScan facilitate linkage ofHIV‐negative partners to prevention services such as pre‐exposure prophylaxis (PrEP). Using qualitative methods, we explored provider perspective regarding the interaction of PrEPavailability,PNSand antiretroviral treatment (ART) outcomes within a project integrating PrEPservices intoHIVcare clinics in eight counties in western and central Kenya.MethodsFrom May 2017 to August 2018, data on integrated PrEPservice delivery including its interaction withPNSwere collected through 71 key informant in‐depth interviews with healthcare providers and 24 standardized technical assistance reports summarizing implementation at the participating clinics. Thus, the perspective was from that of providers; analyses focused on emergent themes relatingPNSto PrEPandARTservices.ResultsProviders found that PrEPintegration provided an additional concrete prevention option forHIV‐negative partners and created a motivation to offerPNSto persons living withHIV. PrEPavailability also seemed to operate as an incentive for those living withHIVto participate inPNS, which in turn enhanced identification of potential PrEPclients and created an environment for discussingHIVtransmission risk. Providers commented that initiatingHIV‐negative partners on PrEPenhanced mutual monitoring of health outcomes, including improved adherence toARTby partners living withHIV. Clinics noted prioritizing people living withHIVwith detectable viral loads forPNSin order to identifyHIV‐negative partners who would benefit most from PrEP. Providers felt motivated by the apparent synergistic interaction ofPNS, PrEPandART.ConclusionsProviders felt that the integration of PrEPintoHIVcare clinics stimulated the provision ofPNS, andPNSwas used to improve the identification of potential PrEPclients. The integrated combination ofPNS, PrEPandARTis synergistic and should be promoted inHIVclinics.

Implementation research ethics can be particularly challenging when pregnant women have been excluded from earlier clinical stages of research given greater uncertainty about safety and efficacy in pregnancy. The evaluation of human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) during pregnancy offered an opportunity to understand important ethical considerations and social influences shaping women's decisions to participate in the evaluation of PrEP and investigational drugs during pregnancy. We conducted interviews with women ( n = 51), focus groups with male partners (five focus group discussions [FGDs]), interviews with health providers ( n = 45), four FGDs with pregnant/postpartum adolescents and four FGDs with young women. Data were analyzed using thematic content analysis, including ethical aspects of the data. Our study reveals that women navigate a complex network of social influences, expectations, support, and gender roles, not only with male partners, but also with clinicians, family, and friends when making decisions about PrEP or other drugs that lack complete safety data during pregnancy.

AbstractIntroductionGlobally, schistosomes infect approximately 200 million people, with 90% of infections in sub‐Saharan Africa. Schistosomiasis is hypothesized to increase HIV‐1 acquisition risk, and multiple cross‐sectional studies reported strong associations. We evaluated this hypothesis within four large prospective cohorts.MethodsWe conducted nested case‐control analyses within three longitudinal cohorts of heterosexual HIV‐1 serodiscordant couples and one female sex worker (FSW) cohort from Kenya and Uganda. The serodiscordant couples studies were conducted between 2004 and 2012 while the FSW cohort analysis included participant follow‐up from 1993 to 2014. Cases HIV‐1 seroconverted during prospective follow‐up; three controls were selected per case. The presence of circulating anodic antigen in archived serum, collected prior to HIV‐1 seroconversion, identified participants with active schistosomiasis; immunoblots determined the schistosome species. Data from serodiscordant couples cohorts were pooled, while the FSW cohort was analysed separately to permit appropriate confounder adjustment.ResultsWe included 245 HIV‐1 seroconverters and 713 controls from the serodiscordant couples cohorts and 330 HIV‐1 seroconverters and 962 controls from the FSW cohort. The prevalence of active schistosomiasis was 20% among serodiscordant couples and 22% among FSWs. We found no association between schistosomiasis and HIV‐1 acquisition risk among males (adjusted odds ratio (aOR) = 0.99, 95% CI 0.59 to 1.67) or females (aOR = 1.21, 95% CI 0.64 to 2.30) in serodiscordant couples. Similarly, in the FSW cohort we detected no association (adjusted incidence rate ratio (aIRR) = 1.11, 95% CI 0.83 to 1.50). Exploring schistosome species‐specific effects, there was no statistically significant association between HIV‐1 acquisition risk andSchistosoma mansoni(serodiscordant couples: aOR = 0.90, 95% CI 0.56 to 1.44; FSW: aIRR = 0.83, 95% CI 0.53 to 1.20) orSchistosoma haematobium(serodiscordant couples: aOR = 1.06, 95% CI 0.46 to 2.40; FSW: aIRR = 1.64, 95% CI 0.93 to 2.87) infection.ConclusionsSchistosomiasis was not a strong risk factor for HIV‐1 acquisition in these four prospective studies.S. mansoniwas responsible for the majority of schistosomiasis in these cohorts, and our results do not support the hypothesis thatS. mansoniinfection is associated with increased HIV‐1 acquisition risk.S. haematobiuminfection was associated with a point estimate of elevated HIV‐1 risk in the FSW cohort that was not statistically significant, and there was no trend towards a positive association in the serodiscordant couples cohorts.