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AbstractIntroductionWith recent approvals of long‐acting (LA) HIV pre‐exposure prophylaxis (PrEP) in the form of injectable cabotegravir and the dapivirine ring, programmes need to consider how to optimize the delivery of PrEP methods, including by leveraging lessons from the past decade of oral PrEP delivery.DiscussionFramed around differentiated service delivery building blocks, the major considerations for the delivery of LA PrEP are how to reach the populations who would most benefit from PrEP, where to locate PrEP services, how to reduce the user burden of accessing and continuing with PrEP, and how to integrate PrEP with other services. Demand creation for LA PrEP and education about new LA PrEP options should be co‐developed with communities and be positively framed. Client‐facing clinical decision support tools provide information about HIV prevention and PrEP options in non‐technical ways and can support their informed decision‐making about PrEP. Training for providers is needed to increase their ability to ask about sexual and drug use behaviours in a non‐judgmental and comfortable manner as part of risk assessment, discuss harm reduction strategies and counsel about available PrEP options that fit clients' circumstances and needs. PrEP adherence support should include supportive counselling and be tailored to address an individual's particular barriers and needs. Reminders through text messaging or calls can foster PrEP persistence, given the narrow the window around dosing for injectable cabotegravir. Strategies are needed to expand PrEP delivery options, including telePrEP, pharmacy‐based PrEP, key population‐led services and mobile venues. Integrated delivery models are needed which include sexually transmitted infection testing and treatment, contraception for cis‐women not desiring to become pregnant, PrEP for pregnant women in high HIV prevalence settings, and gender‐affirming hormones and support for transgender persons.ConclusionsThe outcome of expanding PrEP options through LA PrEP formulations is to increase PrEP coverage, adherence, persistence and effectiveness by offering a choice of PrEP that meets the needs of persons who would benefit from PrEP. The lessons learned from the delivery of oral PrEP about demand creation, informed client decision‐making, provider training, adherence support and service delivery model are relevant to the delivery of LA PrEP and integration with other services.

To explore the barriers and facilitators of linkage to and retention in care amongst persons who tested positive for HIV, qualitative research was conducted in a home-based HIV counselling and testing (HBCT) project with interventions to facilitate linkages to HIV care in rural KwaZulu-Natal, South Africa. The intervention tested 1,272 adults for HIV in Vulindlela of whom 32% were HIV-positive, received point-of-care (POC) CD4 testing and referral to local HIV clinics. Those testing positive also received follow-up visits from a counsellor to evaluate linkages to care. The study employed a qualitative methodology collecting data through in-depth semi-structured interviews. Respondents included 25 HIV-positive persons who had tested as part of HBCT project, 4 intervention research counsellors who delivered the HBCT intervention and 9 government clinic staff who received referrals for care. The results show that HBCT helped to facilitate linkage to care through providing education and support to help overcome fears of stigma and discrimination. The results show the perceived value of receiving a POC CD4 result during post-test counselling, both for those newly diagnosed and those previously diagnosed as HIV positive. The results also demonstrate that in-depth counselling creates an 'educated consumer' facilitating engagement with clinical services. The study provides qualitative insights into the acceptability of confidential HBCT with same day POC CD4 testing and ART counselling as factors that influenced HIV-positive persons' decisions to link to care. This model warrants further evaluation in non-research settings to determine impact and cost-effectiveness relative to other HIV testing and referral strategies.

IntroductionAdolescents and young adults aged <25 are a key population in the HIV epidemic, with very high HIV incidence rates in many geographic settings and a large number who have limited access to prevention services. Thus, any biomedical HIV prevention approach should prepare licensure and implementation strategies for young populations. Oral pre‐exposure prophylaxis (PrEP) is the first antiretroviral‐based prevention intervention with proven efficacy across many settings and populations, and regulatory and policy approvals at global and national levels are occurring rapidly. We discuss available data from studies in the United States and South Africa on the use of oral PrEP for HIV prevention in adolescent minors, along with some of the implementation challenges.DiscussionOngoing studies in the United States and South Africa among youth under the age of 18 should provide the safety data needed by the end of 2016 to contribute to licensure of Truvada as daily PrEP in adolescents. The challenges of completing these studies as well as foreseeable broader challenges highlighted by this work are presented. Adherence to daily PrEP is a greater challenge for younger populations, and poor adherence was associated with decreased efficacy in all PrEP trials. Individual‐level barriers include limited familiarity with antiretroviral‐based prevention, stigma, product storage, and social support. Structural challenges include healthcare financing for PrEP, clinician acceptability and comfort with PrEP delivery, and the limited youth‐friendly health services available. These challenges are discussed in the context of the work done to date in the United States and South Africa, but will likely be magnified in the setting of limited resources in many other countries that are heavily impacted by HIV.ConclusionsAdolescent populations are particularly vulnerable to HIV, and oral PrEP in these populations is likely to have an impact on population‐level HIV incidence. The challenges of disseminating an HIV biomedical prevention tool requiring daily usage in adolescents are formidable, but addressing these issues and starting dialogues will lay the groundwork for the many other HIV prevention tools now being developed and tested.

IntroductionYoung key populations, defined in this article as men who have sex with men, transgender persons, people who sell sex and people who inject drugs, are at particularly high risk for HIV. Due to the often marginalized and sometimes criminalized status of young people who identify as members of key populations, there is a need for HIV prevention packages that account for the unique and challenging circumstances they face. Pre‐exposure prophylaxis (PrEP) is likely to become an important element of combination prevention for many young key populations.ObjectiveIn this paper, we discuss important challenges to HIV prevention among young key populations, identify key components of a tailored combination prevention package for this population and examine the role of PrEP in these prevention packages.MethodsWe conducted a comprehensive review of the evidence to date on prevention strategies, challenges to prevention and combination prevention packages for young key populations. We focused specifically on the role of PrEP in these prevention packages and on young people under the age of 24, and 18 in particular.Results and discussionCombination prevention packages that include effective, acceptable and scalable behavioural, structural and biologic interventions are needed for all key populations to prevent new HIV infections. Interventions in these packages should meaningfully involve beneficiaries in the design and implementation of the intervention, and take into account the context in which the intervention is being delivered to thoughtfully address issues of stigma and discrimination. These interventions will likely be most effective if implemented in conjunction with strategies to facilitate an enabling environment, including increasing access to HIV testing and health services for PrEP and other prevention strategies, decriminalizing key populations' practices, increasing access to prevention and care, reducing stigma and discrimination, and fostering community empowerment. PrEP could offer a highly effective, time‐limited primary prevention for young key populations if it is implemented in combination with other programs to increase access to health services and encourage the reliable use of PrEP while at risk of HIV exposure.ConclusionsReductions in HIV incidence will only be achieved through the implementation of combinations of interventions that include biomedical and behavioural interventions, as well as components that address social, economic and other structural factors that influence HIV prevention and transmission.

AbstractIntroductionSouth Africa faces epidemics of HIV and non‐communicable diseases (NCDs). The aim of this study was to characterize the prevalence of non‐communicable disease risk factors and depression, stratified by HIV status, in a community with a high burden of HIV.MethodsWe conducted a home‐based HIV counselling and testing study in KwaZulu‐Natal, South Africa between November 2011 and June 2012. Contiguous households were approached and all adults ≥18 years old were offered an HIV test. During follow‐up visits in January 2015, screening for HIV, depression, obesity, blood glucose, cholesterol and blood pressure were conducted using point‐of‐care tests.ResultsOf the 570 participants located and screened; 69% were female and 33% were HIV‐positive. NCD risk factor prevalence was high in this sample; 71% were overweight (body mass index (BMI) 25 to 29.9 kg/m2) or obese (BMI≥30 kg/m2), 4% had hyperglycaemia (plasma glucose >11.0 mmol/l/200 mg/dl), 33% had hypertension (HTN, >140/90 mmHg), 20% had hyperlipidaemia (low density cholesterol >5.2 mmol/l/193.6 mg/dl) and 12% had major depressive symptoms (nine item Patient Health Questionnaire ≥10). Of the 570 participants, 87% had one or more of HIV, hyperglycaemia, HTN, hyperlipidaemia and/or depression. Over half (56%) had two or more. Older age and female gender were significantly associated with the prevalence of both HIV infection and NCD risk factors. Around 80% of both HIV‐positive and negative persons had one of the measured risk factors (i.e. obesity, hyperglycaemia, hyperlipidaemia, HTN), or depression.ConclusionsIn a community‐based sample of adults in KwaZulu‐Natal, South Africa, the prevalence of both HIV infection and NCD risk factors were high. This study is among the first to quantify the substantial burden of NCD risk factors and depression in this non‐clinic based population.

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.

IntroductionAntiretroviral therapy (ART) prevents HIV transmission within HIV serodiscordant couples (SDCs), but slow implementation and low uptake has limited its impact on population‐level HIV incidence. Home HIV testing and counselling (HTC) campaigns could increase ART uptake among SDCs by incorporating couples' testing and ART referral. We estimated the reduction in adult HIV incidence achieved by incorporating universal ART for SDCs into home HTC campaigns in KwaZulu‐Natal (KZN), South Africa, and southwestern (SW) Uganda.MethodsWe constructed dynamic, stochastic, agent‐based network models for each region. We compared adult HIV incidence after 10 years under three scenarios: (1) "Current Practice," (2) "Home HTC" with linkage to ART for eligible persons (CD4 <350) and (3) "ART for SDCs" regardless of CD4, delivered alongside home HTC.ResultsART for SDCs reduced HIV incidence by 38% versus Home HTC: from 1.12 (95% CI: 0.98–1.26) to 0.68 (0.54–0.82) cases per 100 person‐years (py) in KZN, and from 0.56 (0.50–0.62) to 0.35 (0.30–0.39) cases per 100 py in SW Uganda. A quarter of incident HIV infections were averted over 10 years, and the proportion of virally suppressed HIV‐positive persons increased approximately 15%.ConclusionsUsing home HTC to identify SDCs and deliver universal ART could avert substantially more new HIV infections than home HTC alone, with a smaller number needed to treat to prevent new HIV infections. Scale‐up of home HTC will not diminish the effectiveness of targeting SDCs for treatment. Increasing rates of couples' testing, disclosure, and linkage to care is an efficient way to increase the impact of home HTC interventions on HIV incidence.

IntroductionDespite scale‐up of antiretroviral therapy (ART) for treating HIV‐positive persons, HIV incidence remains elevated among those at high risk such as persons in serodiscordant partnerships. Antiretrovirals taken by HIV‐negative persons as pre‐exposure prophylaxis (PrEP) has the potential to avert infections in individuals in serodiscordant partnerships. Evaluating the cost‐effectiveness of implementing time‐limited PrEP as a short‐term bridge during the first six months of ART for the HIV‐positive partner to prevent HIV transmission compared to increasing ART coverage is crucial to informing policy‐makers considering PrEP implementation.MethodsTo estimate the real world delivery costs of PrEP, we conducted micro‐costing and time and motion analyses in an open‐label prospective study of PrEP and ART delivery targeted to high‐risk serodiscordant couples in Uganda (the Partners Demonstration Project). The cost (in USD, in 2012) of PrEP and ART for serodiscordant couples was assessed, with and without research components, in the study setting. Using Ministry of Health costs, the cost of PrEP and ART provision within a government programme was estimated, as was the cost of providing PrEP in addition to ART. We parameterized an HIV transmission model to estimate the health and economic impacts of 1) PrEP and ART targeted to high‐risk serodiscordant couples in the context of current ART use and 2) increasing ART coverage to 55% of HIV‐positive persons with CD4 ≤500 cells/µL without PrEP. The incremental cost‐effectiveness ratios (ICERs) per HIV infection and disability‐adjusted life year (DALY) averted were calculated over 10 years.ResultsThe annual cost of PrEP and ART delivery for serodiscordant couples was $1058 per couple in the study setting and $453 in the government setting. The portion of the programme cost due to PrEP was $408 and $92 per couple per year in the study and government settings, respectively. Over 10 years, a programme of PrEP and ART for high‐risk serodiscordant couples was projected to avert 43% of HIV infections compared to current practice with an ICER of $1340 per infection averted. This was comparable to ART expansion alone, which would avert 37% of infections with an ICER of $1452.ConclusionsUsing Uganda's gross domestic product per capita of $1681 as a threshold, PrEP and ART for high‐risk persons have the potential for synergistic action and are cost‐effective in preventing HIV infections in high prevalence settings. The annual cost of PrEP in this programme is less than $100 per serodiscordant couple if implemented in public clinics.

IntroductionThe successes of HIV treatment scale‐up and the availability of new prevention tools have raised hopes that the epidemic can finally be controlled and ended. Reduction in HIV incidence and control of the epidemic requires high testing rates at population levels, followed by linkage to treatment or prevention. As effective linkage strategies are identified, it becomes important to understand how these strategies work. We use qualitative data from The Linkages Study, a recent community intervention trial of community‐based testing with linkage interventions in sub‐Saharan Africa, to show how lay counsellor home HIV testing and counselling (home HTC) with follow‐up support leads to linkage to clinic‐based HIV treatment and medical male circumcision services.MethodsWe conducted 99 semi‐structured individual interviews with study participants and three focus groups with 16 lay counsellors in Kabwohe, Sheema District, Uganda. The participant sample included both HIV+ men and women (N=47) and HIV‐uncircumcised men (N=52). Interview and focus group audio‐recordings were translated and transcribed. Each transcript was summarized. The summaries were analyzed inductively to identify emergent themes. Thematic concepts were grouped to develop general constructs and framing propositional statements.ResultsTrial participants expressed interest in linking to clinic‐based services at testing, but faced obstacles that eroded their initial enthusiasm. Follow‐up support by lay counsellors intervened to restore interest and inspire action. Together, home HTC and follow‐up support improved morale, created a desire to reciprocate, and provided reassurance that services were trustworthy. In different ways, these functions built links to the health service system. They worked to strengthen individuals' general sense of capability, while making the idea of accessing services more manageable and familiar, thus reducing linkage barriers.ConclusionsHome HTC with follow‐up support leads to linkage by building "social bridges," interpersonal connections established and developed through repeated face‐to‐face contact between counsellors and prospective users of HIV treatment and male circumcision services. Social bridges link communities to the service system, inspiring individuals to overcome obstacles and access care.

AbstractIntroductionCommunity‐based delivery of HIV pre‐exposure prophylaxis (PrEP) to South African adolescent girls and young women's (AGYW) could increase access but needs evaluation. We integrated PrEP services via home‐based services and pop‐up tents into existing community‐based HIV testing services (CB‐HTS) in Eastern Cape Province, South Africa.MethodsAfter accessing CB‐HTS via a "pop‐up" tent or home‐based services, HIV‐negative AGYW aged 16–25 years were invited to complete a baseline questionnaire and referred for PrEP services at a community‐based PrEP site co‐located with pop‐up HTS tents. A 30‐day supply of PrEP was dispensed. PrEP uptake, time‐to‐initiation, cohort characteristics and first medication refill within 90 days were measured using descriptive statistics.ResultsOf the 1164 AGYW who tested for HIV, 825 (74.3%) completed a questionnaire and 806 (97.7%) were referred for community‐based PrEP. Of those, 624 (77.4%) presented for PrEP (482/483 [99.8%] from pop‐up HTS and 142/323 [44.0%] from home‐based HTS), of which 603 (96.6%) initiated PrEP. Of those initiating PrEP following home‐based HTS, 59.1% initiated within 0–3 days, 25.6% within 4–14 days and 15.3% took ≥15 days to initiate; 100% of AGYW who used pop‐up HTS initiated PrEP the same day. Among AGWY initiating PrEP, 37.5% had a detectable sexually transmitted infection (STI). Although AGYW reported a low self‐perception of HIV risk, post‐hoc application of HIV risk assessment measures to available data classified most study participants as high risk for HIV acquisition. Cumulatively, 329 (54.6%) AGYW presented for a first medication refill within 90 days of accepting their first bottle of PrEP.ConclusionsLeveraging CB‐HTS platforms to provide same‐day PrEP initiation and refill services was acceptable to AGYW. A higher proportion of AGYW initiated PrEP when co‐located with CB‐HTS sites compared to those referred following home‐based HTS, suggesting that proximity of CB‐HTS and PrEP services facilitates PrEP uptake among AGYW. The high prevalence of STIs among those initiating PrEP necessitates the integration of STI and HIV prevention programs for AGYW. Eligibility for PrEP initiation should not be required among AHYW in high HIV burden communities. Community‐based service delivery will be crucial to maintaining access to PrEP services during the COVID‐19 pandemic and future health and humanitarian emergencies.

AbstractIntroductionHIV testing is a required part of delivery of pre‐exposure prophylaxis (PrEP) for HIV prevention. However, repeat testing can be challenging in busy, under‐staffed clinical settings, which could negatively impact PrEP uptake and continuation. We prospectively evaluated optional facility‐based HIV self‐testing (HIVST) among young women using PrEP in an implementation programme.MethodsBetween February and November 2019, we collected data from young women receiving PrEP at two family planning facilities in Kisumu, Kenya. At each PrEP follow‐up visit, women were given the option to choose between provider‐initiated testing and HIVST. We assessed factors associated with HIVST uptake and compared satisfaction with HIV testing and clinic experience between acceptors and decliners of HIVST.ResultsA total of 172 women were offered HIVST at 202 PrEP follow‐up visits. The median age was 21 years, 27% had multiple partners and 15% reported previously using HIVST. HIVST was accepted at 34.7% (70/202) of visits. Age (adjusted relative risk (aRR) 1.09 per year, 95% CI (confidence interval) 1.01 to 1.18), never being married (aRR 1.81, 95% CI 1.11 to 2.95) and having more PrEP follow‐up visits (aRR 1.13 per visit, 95% CI 1.04 to 1.23) were associated with HIVST uptake. Compared to HIVST decliners, HIVST acceptors were more likely to be very happy with their overall testing experience (73% vs. 47% of visits, p = 0.003) and were more likely to say they would use HIVST in the future (96% vs. 76%, p < 0.001). Women who accepted HIVST had shorter visits than those choosing standard provider‐initiated HIV testing (median [IQR]: 33 [32, 38] vs. 54 [41.5, 81] minutes, p = 0.003).ConclusionsIn this pilot evaluation in Kenya, about one‐third of women using PrEP opted for HIVST over provider‐initiated testing, and those choosing HIVST spent less time in the clinic and were generally satisfied with their experience. HIVST in PrEP delivery is feasible and has the potential to simplify PrEP delivery and give clients testing autonomy. Additional studies are needed to explore optimal HIV retesting strategies in PrEP delivery, including the use of HIVST in PrEP at a larger scale and in different settings.

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.