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Pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy. Few studies have explored adolescents and young people’s perspectives toward PrEP. We conducted 24 group discussions and 60 in-depth interviews with males and females aged 13–24 years in Uganda, Zimbabwe, and South Africa between September 2018 and February 2019. We used the framework approach to generate themes and key concepts for analysis following the social ecological model. Young people expressed a willingness to use PrEP and identified potential barriers and facilitators of PrEP uptake. Barriers included factors at individual (fear of HIV, fear of side effects, and PrEP characteristics), interpersonal (parental influence, absence of a sexual partner), community (peer influence, social stigma), institutional (long waiting times at clinics, attitudes of health workers), and structural (cost of PrEP and mode of administration, accessibility concerns) levels. Facilitators included factors at individual (high HIV risk perception and preventing HIV/desire to remain HIV negative), interpersonal (peer influence, social support and care for PrEP uptake), community (adequate PrEP information and sensitization, evidence of PrEP efficacy and safety), institutional (convenient and responsive services, provision of appropriate and sufficiently resourced services), and structural (access and availability of PrEP, cost of PrEP) levels. The findings indicated that PrEP is an acceptable HIV prevention method. PrEP uptake is linked to personal and environmental factors that need to be considered for successful PrEP roll-out. Multi-level interventions needed to promote PrEP uptake should consider the social and structural drivers and focus on ways that can inspire PrEP uptake and limit the barriers. Electronic supplementary material The online version of this article (10.1007/s10508-020-01880-y) contains supplementary material, which is available to authorized users.

Diversion of antiretroviral therapy (ART) for recreational use is concerning for countries with high HIV prevalence. This paper presents reports of recreational use of ART among adolescents from two HIV prevention studies in South Africa: (1) a cross-sectional survey of N = 200 adolescents and (2) a qualitative study of pre-exposure prophylaxis with N = 57 adolescents and N = 25 clinicians. Among adolescents, 3% used and 14% knew someone who used non-prescribed ART for recreational purposes. Administration included smoking (71%), snorting (15%), injecting (15%), ingesting (15%), and inserting (3%). Participants predicted increased crime as recreational use of ART increased. Future studies should investigate prevalence, composition, and diversion of ART from HIV prevention and treatment.

Self-reported HIV risk perception and behaviors are used in a variety of settings for diverse purposes, such as HIV prevention program planning and screening. Careful consideration of how youth in high HIV prevalence areas interpret these kinds of questions warrants attention. The Cognitive Interviewing Project (CIP) conducted cognitive interviews on common risk survey items with 30 cis-female and 20 MSM youth (18 to 24), who had recent sex with a male partner, in Cape Town and Vulindlela, South Africa. Results identified a number of potential issues including (1) confusing text; (2) mismatches of terms with local usage; (3) confusion with items requiring self-tailoring; (4) presentation concerns limiting selection of full range of answers; and (5) challenges reporting on information dependent on partner (eg., HIV risk, HIV status of partner). Self-report Items used to identify those at elevated risk for HIV should be evaluated with local populations to optimize shared understanding.

Background South African adolescent girls and young women (AGYW) report significant mental distress and sexual and reproductive health concerns. Mental health problems and trauma symptoms are consistently associated with sexual and reproductive health behavior. Despite their intersection, few interventions address them simultaneously or engage female caregivers (FC) as collaborators. This study presents findings from a pilot test of an empirically supported culturally adapted family-based HIV-prevention program, Informed Motivated Aware and Responsible Adolescents and Adults- South Africa (IMARA-SA), on AGYW anxiety, depression, and trauma. Methods Sixty 15–19-year-old AGYW (mean age = 17.1 years) and their FC from outside Cape Town were randomized to IMARA-SA or a health promotion control program. AGYW reported their anxiety using the GAD-7, depression using the PHQ-9, and trauma using the PC-PTSD-5 at baseline and follow-up (6–10 months post). Both interventions were delivered by Xhosa-speaking Black South African women in groups over 2 days for approximately 10 h. We examined intervention effects using zero-inflated negative binomial regression for anxiety, multinomial logistic regression for depression, and logistic regression for trauma. Results At baseline, groups did not differ in demographic characteristics but AGYW randomized to IMARA-SA had higher depression scores than controls (p = 0.04) and a greater proportion screened positive for PTSD (p = .07). Controlling for baseline mental health scores, AGYW who received IMARA-SA compared to controls had significantly fewer anxiety symptoms at follow-up (adjusted incidence rate ratio for count model = 0.54, 95% CI = 0.29–0.99, p = 0.05), were less likely to report at least one depressive symptom relative to no symptoms (relative risk ratio = 0.22, 95% CI = 0.05, 0.95, p = 0.04), and were less likely to report symptoms of PTSD relative to no symptoms, but this difference was not statistically significant. Conclusions Mental health is implicated in risky sexual behavior, and reducing emotional distress can mitigate exposure to poor sexual and reproductive health outcomes. This pilot study yielded promising findings for the mental health impact of IMARA-SA, justifying replication in a larger randomized trial. Trial registration ClinicalTrials.gov Number NCT04758390, accepted 17/02/2021.

While pre-exposure prophylaxis (PrEP) is a key HIV prevention tool for adolescents and young adults (AYAs), its initiation and sustained use is shaped by AYAs’ unique social contexts, including family. We explored the role of families in AYAs’ PrEP use through qualitative in-depth interview (IDI) data from iPrevent, an end-user study designed to identify factors that could optimize PrEP adherence among South African youth (18–24 years old). These data were collected using a semi structured guide and were analysed using an inductive approach. Several themes describing family influence on AYAs’ PrEP use emerged including family support; family attitude towards PrEP; and the family’s ability to obviate PrEP disclosure challenges. In addition, dimensions of family closeness, categorized as ‘close’, ‘in-between’ and ‘loose-knit,’ appeared important in contextualizing family influence on AYAs’ PrEP use. We found that family remains a proximal and fundamental social system in which AYA are socialized and greater family engagement could aid PrEP implementation in this priority population.

Background HIV incidence among South African adolescent girls and young women (AGYW) remains high, but could be reduced by highly effective pre-exposure prophylaxis (PrEP). Unfortunately, AGYW report significant barriers to clinic-based sexual and reproductive health services. Even when AGYW access PrEP as an HIV prevention method, poor prevention-effective use was a serious barrier to achieving its optimal HIV prevention benefits. Determining the acceptability and feasibility of community-based platforms to increase AGYW’s access to PrEP, and evaluating behavioural interventions to improve prevention-effective use of PrEP are needed. Methods We propose a mixed-methods study among AGYW aged 16–25 years in Eastern Cape Province, South Africa. In the first component, a cross-sectional study will assess the acceptability and feasibility of leveraging community-based HIV counselling and testing (CBCT) platforms to refer HIV-negative, at-risk AGYW to non-clinic-based, same-day PrEP initiation services. In the second component, we will enrol 480 AGYW initiating PrEP via our CBCT platforms into a three-armed (1:1:1) randomized control trial (RCT) that will evaluate the effectiveness of adherence support interventions to improve the prevention-effective use of PrEP. Adherence will be measured over 24 months via tenofovir-diphosphate blood concentration levels. Qualitative investigations will explore participant, staff, and community experiences associated with community-based PrEP services, adherence support activities, study implementation, and community awareness. Costs and scalability of service platforms and interventions will be evaluated. Discussion This will be the first study to assess the acceptability and feasibility of leveraging CBCT platforms to identify and refer at-risk AGYW to community-based, same-day PrEP initiation services. It will also provide quantitative and qualitative results to inform adherence support activities and services that promote the prevention-effective use of PrEP among AGYW. By applying principles of implementation science, behavioural science, and health economics research, we aim to inform strategies to improve access to and prevention-effective use of PrEP by AGYW. Trial registration ClinicalTrials.govNCT03977181. Registered on 6 June 2019—retrospectively registered.

Background South Africa has the world’s largest HIV epidemic, but South African adolescent girls and young women (AGYW) acquire HIV at twice the rate of and seroconvert on average 5–7 years earlier than their male peers. Female caregivers (FC) are an untapped resource for HIV/STI prevention in South Africa and offer a novel opportunity to strengthen AGYW prevention efforts. This study will evaluate the effectiveness and cost-effectiveness of an evidence-based mother-daughter HIV/STI prevention program tested in the United States and adapted for South Africa, Informed Motivated Aware and Responsible Adolescents and Adults (IMARA), to decrease STI incident infections and increase HIV testing and counseling (HTC) and PrEP uptake in AGYW. Methods This is a 2-arm individually randomized controlled trial comparing IMARA to a family-based control program matched in time and intensity with 525 15–19-year-old Black South African AGYW and their FC-dyads in Cape Town’s informal communities. AGYW will complete baseline, 6-, and 12-month assessments. Following randomization, AGYW-FC dyads will participate in a 2-day group workshop (total 10 h) that includes joint and separate mother and daughter activities. Primary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 6 months. Secondary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 12 months, sexual behavior (e.g., condom use, number of partners), HIV incidence, and ART/PrEP adherence and intervention cost-effectiveness. AGYW who test positive for a STI will receive free treatment at the study site. HIV positive participants will be referred to ART clinics. Discussion Primary prevention remains the most viable strategy to stem new STI and HIV transmissions. HIV and STI disparities go beyond individual level factors, and prevention packages that include supportive relationships (e.g., FC) may produce greater reductions in HIV-risk, improve HTC and PrEP uptake, and increase linkage, retention, and adherence to care. Reducing new HIV and STI infections among South African AGYW is global public health priority. Trial registration ClinicalTrials.gov Number NCT04758390, accepted 02/16/2021.

BACKGROUND Long-acting injectable and implantable approaches aim to overcome some of the documented challenges with uptake and adherence to current HIV prevention methods. Youth are a key end-user population for these methods. We used qualitative methods to examine product attributes and preferences for current and future long-acting HIV prevention approaches. METHODS Ninety-five South African youth aged 18-24 years, of whom 62 were female and 33 male, completed 50 interviews and 6 focus groups. We purposively selected for previous product experience, including oral pre-exposure prophylaxis, injectable pre-exposure prophylaxis, or the vaginal ring, to ensure participants' opinions were rooted in actual experience. RESULTS Irrespective of previous method-use experience, gender, or sexual orientation, the majority expressed a preference for prevention methods formulated as injectables or implants. Several mentioned that their top priority in any product was efficacy, and for some, this overrode other concerns; for example, even if they feared pain, an implant or an injectable would be used if fully protective. Although efficacy was a top priority, there was also a clear desire across all subgroups for a product that would not interfere with sex, would stay in the system to provide protection, and that caused minimal burden, or was not apparent to others, and these characteristics were most salient for long-acting methods. CONCLUSIONS Narrative explanations for preferences converged thematically around different dimensions of "invisibility" including invisibility to oneself, one's partner and household members, and community members. End-user preferences can be used to inform product development of long-acting HIV prevention approaches formulated as injections or implants to optimize adherence and impact.

Introduction In South Africa, one in three men have reported perpetrating rape. Adolescence presents a unique developmental period for primary prevention of violence. However, few studies characterize the epidemiology of sexual violence among adolescents in South Africa. Method We evaluated rates of sexual violence behaviors using a baseline survey of N = 200 South African adolescents, age 13–15, recruited for participation in an intervention trial. The intervention focused on preventing onset of depression and sexual risk behavior among adolescents. This sample of adolescents were at elevated risk for depression and recruited using house-to-house methods in the community. Sexual perpetration behaviors were assessed using the Sexual Experiences Survey - Short Form Perpetration. Results Adolescents most frequently reported the use of coercion, incapacitation, force or threats of force to perpetrate oral sex (15%) followed by sexual touching (14%), anal sex (8%), and vaginal sex at (6%). Perpetration was more common among males compared to females with males perpetrating at a rate of 34.5% vs. 20.5% among females. Attempted perpetration was reported at alarming rates including: vaginal sex (8%), oral sex (8%), and anal sex (5%). Conclusions Primary prevention of sexual violence perpetration, including gender- and developmentally-tailored approaches, are urgently needed for adolescents.

Background A safe, effective vaccine is essential to eradicating human immunodeficiency virus (HIV) infection. A canarypox-protein HIV vaccine regimen (ALVAC-HIV plus AIDSVAX B/E) showed modest efficacy in reducing infection in Thailand. An analogous regimen using HIV-1 subtype C virus showed potent humoral and cellular responses in a phase 1-2a trial in South Africa. Efficacy data and additional safety data were needed for this regimen in a larger population in South Africa. Methods In this phase 2b-3 trial, we randomly assigned 5404 adults without HIV-1 infection to receive the vaccine (2704 participants) or placebo (2700 participants). The vaccine regimen consisted of injections of ALVAC-HIV at months 0 and 1, followed by four booster injections of ALVAC-HIV plus bivalent subtype C gp120-MF59 adjuvant at months 3, 6, 12, and 18. The primary efficacy outcome was the occurrence of HIV-1 infection from randomization to 24 months. Results In January 2020, prespecified criteria for nonefficacy were met at an interim analysis; further vaccinations were subsequently halted. The median age of the trial participants was 24 years; 70% of the participants were women. The incidence of adverse events was similar in the vaccine and placebo groups. During the 24-month follow-up, HIV-1 infection was diagnosed in 138 participants in the vaccine group and in 133 in the placebo group (hazard ratio, 1.02; 95% confidence interval, 0.81 to 1.30; P = 0.84). Conclusions The ALVAC-gp120 regimen did not prevent HIV-1 infection among participants in South Africa despite previous evidence of immunogenicity. (HVTN 702 ClinicalTrials.gov number, NCT02968849.).

Background The uptake and adherence of daily oral PrEP has been poor in high-risk populations in South Africa including young people. We used qualitative research methods to explore user preferences for daily and on-demand oral PrEP use among young South Africans, and to inform the identification of critical attributes and attribute-levels for quantitative analysis of user preferences, i.e. a discrete choice experiment (DCE). Methods Data were collected between September and November 2018 from eight group discussions and 20 in-depth interviews with young people 13 to 24 years in Cape Town and Johannesburg. Using a convenience sampling strategy, participants were stratified by sex and age. Interviewers used a semi-structured interview guide to discuss several attributes (dosing regimen, location, costs, side effects, and protection period) for PrEP access and use. Group discussions and in-depth interviews were audio-recorded, transcribed verbatim and translated to English. We used framework analysis to explore context-specific attributes and attribute-levels for delivering oral PrEP in South Africa. The adolescent community advisory board, expert and study team opinions were consulted for the final DCE attributes and levels. Results We enrolled 74 participants who were 51% (n = 38/74) male, had a median age of 18.5 [Interquartile range = 16–21.25] years, 91% (n = 67/74) identified as heterosexual and 49% (n = 36/74) had not completed 12th grade education. Using the qualitative data, we identified five candidate attributes including (1) dosing regimen, (2) location to get PrEP, (3) cost, (4) route of administration and (5) frequency. After discussions with experts and the study team, we revised the DCE to include the following five attributes and levels: dosing regime: daily, and on-demand PrEP; location: private pharmacy, public clinic, mobile clinic, ATM); cost: free-of-charge, R50 (~2GBP), R265 (~12GBP); side effects: nausea, headache, rash; and duration of protection: fulltime protection versus when PrEP is used). Conclusions There is limited literature on qualitative research methods describing the step-by-step process of developing a DCE for PrEP in adolescents, especially in resource-constrained countries. We provide the process followed for the DCE technique to understand user preferences for daily and on-demand oral PrEP among young people in South Africa.

Background Antiretroviral therapy (ART) is publicly available in South Africa in response to the urgent need to address HIV and AIDS. Off-label use of ARV medication alone or in combination with other substances is known as “whoonga” and “nyaope” in South Africa. Diversion of ARVs for whoonga use is not well understood, especially among adolescents. This secondary analysis explores risk and protective factors for adolescent whoonga use in a community-based HIV endemic setting. Methods Data on whoonga use were derived from a baseline survey of N = 200 adolescents recruited for participation in a randomized controlled trail to reduce adolescent HIV risk behaviors and depression. Risk and protective factors for adolescent whoonga use were explored using an ecological systems framework using one-way ANOVAs, chi-squared tests and hierarchical regression. Results Individual level factors increased the odds of whoonga use or known use such as child age OR:1.22 (95% CI, 1.03–1.43), hazardous drug use OR:1.62 (95% CI, 1.02–2.59), and hazardous alcohol OR:1.80 (95% CI, 1.05–3.09). Food insecurity appears to have a slightly protective effect on the odds of whoonga use or reports of use among people adolescents knew OR:0.649 (95% CI, 0.541–0.779). Conclusions Larger epidemiological studies should expand the surveillance of hazardous alcohol use and illicit drug use, specifically for recreational use of prescription medication. Granular data is warranted to characterize the patters of use, especially among highly vulnerable populations. Future surveillance studies that explore these multi-level relationships are warranted to further understand this phenomenon among teens in South Africa.

Background Adolescents living with HIV (ALWH) who transition from pediatric to adult care face several challenges that increase their risk of experiencing treatment interruptions and being lost to HIV care with resultant increased morbidity and mortality. To date, few studies have examined their outcomes post-healthcare transition (HCT), precluding the development and dissemination of evidence-based interventions aimed at retaining ALWH in HIV care both during and after HCT. We conducted a systematic review to synthesize the outcomes of ALWH post-HCT to provide suggestions for future directions. Methods We systematically searched several electronic databases through October 2019 using keywords for HIV, HCT and ALWH. We categorized studies by target population, country (i.e., upper-high income and low-middle income), study design (i.e., descriptive, mixed methods, quantitative), outcomes measured, and follow-up period. Results A total of 24 studies met inclusion criteria. Studies were categorized according to the following HCT outcomes: retention in HIV care post-HCT (n = 13), changes in CD4+ count and viral load post-HCT (n = 16), and mortality among ALWH post-HCT (n = 7). Most studies (n = 11) examining retention in HIV care indicated that more than 70% of ALWH were retained in care 1–2 years post-HCT while the remaining studies (n = 2) reported retention rates less than 55%. While studies indicated that CD4+ counts and viral loads tended to worsen during the first few years post-HCT, these differences were often not statistically significant. Among all ALWH who transitioned to adult care, a small proportion died within their first seven years post-HCT. Among qualitative studies, common themes included transition readiness (n = 6), provider-patient relationship in the adult clinic setting (n = 6), and concern about the adult clinic setting (n = 4). Conclusions Transition outcomes were poorest for ALWH with unsuppressed viremia pre-HCT, suggesting that this subgroup of ALWH may need greater support from their treatment teams and caregivers during and post-HCT to improve clinical outcomes.

Two phase 3 clinical trials showed that use of a monthly vaginal ring containing 25 mg dapivirine was well tolerated and reduced HIV-1 incidence in women by approximately 30% compared with placebo. We aimed to evaluate use and safety of the dapivirine vaginal ring (DVR) in open-label settings with high background rates of HIV-1 infection, an important step for future implementation.We did a phase 3B open-label extension trial of the DVR (MTN-025/HIV Open-label Prevention Extension [HOPE]). Women who were HIV-1-negative and had participated in the MTN-020/ASPIRE phase 3 trial were offered 12 months of access to the DVR at 14 clinical research centres in Malawi, South Africa, Uganda, and Zimbabwe. At each visit (monthly for 3 months, then once every 3 months), women chose whether or not to accept the offer of the ring. Used, returned rings were tested for residual amounts of dapivirine as a surrogate marker for adherence. HIV-1 serological testing was done at each visit. Dapivirine amounts in returned rings and HIV-1 incidence were compared with data from the ASPIRE trial, and safety was assessed. This study is registered with ClinicalTrials.gov, NCT02858037.Between July 16, 2016, and Oct 10, 2018, of 1756 women assessed for eligibility, 1456 were enrolled and participated in the study. Median age was 31 years (IQR 27-37). At baseline, 1342 (92·2%) women chose to take the DVR; ring acceptance was more than 79% at each visit up until 12 months and 936 (73·2%) of 1279 chose to take the ring at all visits. 12 530 (89·3%) of 14 034 returned rings had residual dapivirine amounts consistent with some use during the previous month (0·9 mg released) and the mean dapivirine amount released was greater than in the ASPIRE trial (by 0·21 mg; p0·0001). HIV-1 incidence was 2·7 per 100 person-years (95% CI 1·9-3·8, 35 infections), compared with an expected incidence of 4·4 per 100 person-years (3·2-5·8) among a population matched on age, site, and presence of a sexually transmitted infection from the placebo group of ASPIRE. No serious adverse events or grade 3 or higher adverse events observed were assessed as related to the DVR.High uptake and persistent use in this open-label extension study support the DVR as an HIV-1 prevention option for women. With an increasing number of HIV-1 prophylaxis choices on the horizon, these results suggest that the DVR will be an acceptable and practical option for women in Africa.The Microbicide Trials Network and the National Institute of Allergy and Infectious Diseases, The Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health, all components of the US National Institutes of Health.

INTRODUCTION: We tested the acceptability, feasibility, and preliminary efficacy of Our Family Our Future, a resilience-oriented intervention engaging families in prevention of adolescent HIV and depression. METHODS: South African adolescents, 13–15 years of age, with mild depressive symptoms, were randomized to intervention or wait-list using parallel assignment in a single-blind trial. HIV risk behavior and depression were evaluated at baseline, 1-, and 3-months. We examined intervention satisfaction, fidelity, trial retention, and preliminary efficacy. RESULTS: 196 adolescent-parent dyads completed eligibility screening and baseline, and N=73 dyads were randomized. All families ranked intervention quality as ‘good’ or ‘excellent’. Over 90% were satisfied with content. Facilitators were adherent to intervention protocol. All families were retained in post-intervention assessments. Intervention recipients reported diminished depressive symptoms, inconsistent condom use, and sexual activity, as well as increased HIV testing. CONCLUSIONS: Our Family Our Future is highly acceptable and feasible and should be tested in a future efficacy trial.

Gender roles and imbalances in sexual power contribute to the heightened HIV-1 risk faced by women in Sub-Saharan Africa. This has led prevention research to focus on the development of female controlled methods. Despite the design of products such as vaginal rings to be used autonomously by women, male partners and women's perceptions of relationships influence HIV prevention choices. To understand the influences that male partners and dyadic dynamics had on the use of the Dapivirine Vaginal Ring in the ASPIRE trial, this analysis of qualitative data explored the types of intimate partner relationships that women engaged in. This paper describes how partners facilitated or challenged women's ring use and how women dealt with these challenges within six different types of relationships characterized by power dynamics and commitment levels. We offer insights into how future use of female-initiated HIV prevention products can be promoted through recognition of different relationship types.

Introduction Stigma and disclosure concerns have been key barriers to oral pre‐exposure prophylaxis (PrEP) adherence for African adolescent girls and young women (AGYW) in efficacy trials. We aimed to understand the impact of these factors among African AGYW in an open‐label PrEP study. Methods HPTN 082 was an open‐label PrEP study among AGYW (ages 16 to 24) in Harare, Zimbabwe, and Cape Town and Johannesburg, South Africa from 2016 to 2018. Women starting PrEP were randomized to standard adherence support (counselling, two‐way SMS, monthly adherence clubs) or standard support plus drug‐level feedback. Serial in‐depth interviews were conducted among 67 AGYW after 13‐week and 26‐week study visits to explore experiences of stigma, disclosure and PrEP adherence. We analysed data by coding transcripts and memo‐writing and diagramming to summarize themes. Results AGYW described stigma related to sexual activity (e.g. “people say I'm a prostitute”) and being perceived to be living with HIV because of taking antiretrovirals (e.g. “my husband's friends say I'm HIV infected”). Participants who anticipated stigma were reluctant to disclose PrEP use and reported adherence challenges. Disclosure also resulted in stigmatizing experiences. Across all sites, negative descriptions of stigma and disclosure challenges were more common in the first interview. In the second interview, participants often described disclosure as an “empowering” way to combat community‐level PrEP stigma; many said that they proactively discussed PrEP in their communities (e.g. became a “community PrEP ambassador”), which improved their ability to take PrEP and encourage others to use PrEP. These empowering disclosure experiences were facilitated by ongoing HPTN 082 study activities (e.g. counselling sessions, adherence clubs) in which they could discuss PrEP‐related stigma, disclosure and PrEP adherence issues. Conclusions Stigma and disclosure challenges were initial concerns for African AGYW newly initiating PrEP but many were empowered to disclose PrEP use over their first six months of PrEP use, which helped them cope with stigma and feel more able to take PrEP regularly. PrEP programmes can foster disclosure through community and clinic‐based discussion, adherence clubs and activities normalizing sexual behaviour and PrEP use, which can reduce stigma and improve PrEP adherence and thus effectiveness.

New biomedical prevention technologies (NPTs) for HIV, including oral Pre-Exposure Prophylaxis, and vaginal and rectal microbicides and HIV vaccines in development, may contribute substantially to controlling the HIV epidemic. However, their effectiveness is contingent on product acceptability and adherence. We explored perceptions and understanding of partially effective NPTs with key populations in South African townships. From October 2013 to February 2014, we conducted six focus groups and 18 individual interviews with Xhosaspeaking adolescents (n = 14), adult men who have sex with men (MSM) (n = 15), and adult heterosexual men (n = 9) and women (n = 10), and eight key informant (KI) interviews with healthcare workers. Interviews/focus groups were transcribed and reviewed using a thematic approach and framework analysis. Overall, participants and KIs indicated scepticism about NPTs that were not 100% efficacious. Some participants equated not being 100% effective with not being completely safe, and thus not appropriate for dissemination. KIs expressedconcerns that promoting partially effective NPTs would encourage substitution of a more effective with a less effective method or encourage risk compensation. Educational and social marketing interventions that address the benefits and appropriate use of partially effective NPTs, including education and support tailored for frontline service providers, are needed to prepare for successful NPT implementation in South Africa.Keywords: Biomedical HIV prevention; translational research; qualitative methods

Vaginally-inserted HIV prevention methods have been reported to impact the sexual experience for women and their partners, and hence impacts acceptability of and adherence to the method. We analyzed in-depth interviews and focus group discussions about participants’ sexual experiences while wearing the ring, collected during the MTN-020/ASPIRE phase 3 safety and effectiveness trial of a dapivirine vaginal ring for HIV prevention in Malawi, South Africa, Uganda, and Zimbabwe. Most women reported that partners did not feel the ring during sex, however, women felt they had to manage their partners’ interaction with or reaction to the ring. In maintaining positive relationships, women were concerned about partners’ discovering ring use and about ensuring that partners had a good sexual experience with them. Finally women were concerned about how they themselves experienced sex with the ring. Some found that the ring made the vaginal environment more desirable for their partners and themselves.

We assessed the interference between vaginal ring use and menses among women who participated in the qualitative component of the MTN-020/ASPIRE vaginal ring trial in Malawi, South Africa, Uganda and Zimbabwe (N = 214). A common reason for imperfect ring adherence and premature removal of the vaginal ring cited by participants related to vaginal bleeding or menses. Whereas self-reporting via survey questions suggested that the majority (60%) of women did not mind wearing the ring while menstruating, and did not remove it (91%) during menses, in the qualitative interviews women frequently described removing the ring during menses. Their reasons included hygiene, beliefs that the ring blocked the flow of menstrual blood, fears that the ring would come out with blood or during tampon removal, and concerns around an ‘overburdened’ vagina. Examining women’s narratives and subjective experiences related to menstruation helps build a better understanding of factors affecting ring use and adherence.

Introduction Implants are a new dosage form in development for HIV pre‐exposure prophylaxis (PrEP) with potential for high adherence given that they are provider‐administered and are intended for long‐acting protection. Integrating end‐user preference into early stage product development may further overcome challenges with future product uptake and adherence. Hence, we sought to optimize the design of a PrEP implant in early‐stage development by gathering opinions about implant attributes from potential end‐users in South Africa. Methods We conducted 14 focus group discussions (FGDs) with young women and men aged 18 to 24 in Cape Town and Soshanguve, South Africa, inviting participants into discussion as co‐designers. FGDs were homogenous by gender and previous implant experience. During FGDs, we showed prototype devices and followed a semi‐structured guide with questions on history of contraceptive implant use, preferences for physical characteristics of an implant, implant biodegradability, insertion process, participant‐driven ideas for implant design, and social adoption considerations. FGDs were facilitated in English, isiXhosa, Tswana, isiZulu, or Tsonga, audio‐recorded, transcribed into English, and qualitatively coded and analysed. Results In this qualitative sample of 105 youth (68 women and 37 men), 58 participants were from Soshanguve and 47 from Cape Town, and 23% had previously used contraceptive implants. Participants expressed preferences for several implant design features; specifically, longer duration (≥6 months) was more important to most participants than the size or number of devices implanted. A majority preferred a flexible versus stiff implant to minimize palpability, thereby increasing discreetness and comfort. Nearly all participants favoured a biodegradable implant to avoid removal and thus reduce clinic visits. Concerns about the implant centred on its possible side effects and the “plastic” look of the prototype displayed for demonstration. Conclusions This study offers preliminary insights into an implant for HIV prevention that provides long‐lasting protection may be well received among young South Africans. Additionally, flexibility, discreetness, and biodegradability may increase acceptability of the implant. Such end–user feedback is being incorporated into current implant designs in the hope of creating an effective long‐acting PrEP product that is likely to achieve high uptake and adherence in target populations.

The MTN-020/ASPIRE trial evaluated the safety and effectiveness of the dapivirine vaginal ring for prevention of HIV-1 infection among African women. A nested qualitative component was conducted at six of 15 study sites in Uganda, Malawi, Zimbabwe and South Africa to evaluate acceptability of and adherence to the ring.Qualitative study participants (n = 214) were interviewed with one of three modalities: single in-depth interview, up to three serial interviews or an exit Focus Group Discussion. Using semistructured guides administered in local languages, 280 interviews were audio-recorded, transcribed, translated, coded and analyzed.We identified three key findings: first, despite initial fears about the ring's appearance and potential side effects, participants grew to like it and developed a sense of ownership of the ring once they had used it. Second, uptake and sustained adherence challenges were generally overcome with staff and peer support. Participants developed gradual familiarity with ring use through trial progression, and most reported that it was easy to use and integrate into their lives. Using the ring in ASPIRE was akin to joining a team and contributing to a broader, communal good. Third, the actual or perceived dynamics of participants' male partner relationship(s) were the most consistently described influence (which ranged from positive to negative) on participants' acceptability and use of the ring.It is critical that demonstration projects address challenges during the early adoption stages of ring diffusion to help achieve its potential public health impact as an effective, long-acting, female-initiated HIV prevention option addressing women's disproportionate HIV burden.

Adolescents and young people account for 40% of all new HIV infections each year, with South Africa one of the hardest hit countries, and having the largest population of people living with HIV. Although adolescent HIV prevention has been delivered through diverse modalities in South Africa, and although family-based approaches for adolescent HIV prevention have great potential for highly affected settings such as South Africa, there is a scarcity of empirically tested family-based adolescent HIV preventive interventions in this setting. We therefore conducted focus groups and in-depth interviews with key informants including clinicians, researchers, and other individuals representing organizations providing HIV and related health services to adolescents and parents (N = 82). We explored family perspectives and interactions around topics such as communication about sex, HIV, and relationships. Participants described aspects of family interactions that presented both challenges and opportunities for family-based adolescent HIV prevention. Parent–child communication on sexual topics were taboo, with these conversations perceived by some adults as an invitation for children to engage in HIV risk behavior. Parents experienced social sanctions for discussing sex and adolescents who asked about sex were often viewed as disrespectful and needing discipline. However, participants also identified context-appropriate strategies for addressing family challenges around HIV prevention including family meetings, communal parenting, building efficacy around parent–adolescent communication around sexual topics, and the need to strengthen family bonding and positive parenting. Findings indicate the need for a family intervention and identify strategies for development of family-based interventions for adolescent HIV prevention. These findings will inform design of a family intervention to be tested in a randomized pilot trial (ClinicalTrials.gov #NCT02432352).

Table of contents A1 Introduction to the 2nd synchronicity forum of GHRI/CHVI-funded Canadian and African HIV prevention and vaccine teams O1 Voluntary medical male circumcision for prevention of heterosexual transmission of HIV in adult males in Soweto: What do indicators and incidence rate show? Hillary Mukudu, Neil Martinson, Benn Sartorius O2 Developing a peer-led community mobilization program for sex workers in Soweto: HIV risk and demographics Jenny Coetzee, Janan Dietrich, Kgaugelo Mokgatswana, Rachel Jewkes, Glenda E. Gray O3 Salient beliefs about adherence: A qualitative survey conducted as part of the demonstration study on "treatment as prevention" (TasP) and "pre-exposure prophylaxis" (PrEP) among female sex workers (FSWS) in Cotonou, Benin Marylène Dugas, Luc Béhanzin, Fernand A. Guédou, Marie-Pierre Gagnon, Michel Alary O4 Relative perception of risk as a driver of unsafe sexual practices among key populations: Cases of fisherfolk and women and their partners involved in multiple sexual partnerships in Uganda Rwamahe Rutakumwa, Martin Mbonye, Thadeus Kiwanuka, Sarah Nakamanya, Richard Muhumuza, Winfred Nalukenge, Janet Seeley O5 Exploring the acceptability of new biomedical HIV prevention technologies among MSM, adolescents and heterosexual adults in South Africa Millicent Atujuna, Melissa Wallace, Ben Brown, Linda Gail Bekker, Peter A. Newman O6 HIV-susceptible target cells in foreskins after voluntary medical male circumcision in South Africa Rushil Harryparsad, Abraham J. Olivier, Heather B. Jaspan, Douglas Wilson, Janan Dietrich, Neil Martinson, Hillary Mukudu, Nonhlanhla Mkhize, Lynn Morris, Gianguido Cianci, Minh Dinh, Thomas Hope, Jo-Ann S. Passmore, Clive M. Gray O7 HIV-1 proteins activate innate immune responses via TLR2 heterodimers Bethany M. Henrick, Xiao-Dan Yao, Kenneth L. Rosenthal, the INFANT Study Team O8 Characterization of an innate factor in human milk and mechanisms of action against HIV-1 Bethany M. Henrick, Xiao-Dan Yao, Anna G. Drannik, Alash’le Abimiku, Kenneth L. Rosenthal, the INFANT Study Team O9 Secretor status and susceptibility to HIV infections among female sex workers in Nairobi, Kenya Nadia Chanzu, Walter Mwanda, Julius Oyugi, Omu Anzala O10 Natural Killer cell recall responsiveness to Gag-HIV-1 peptides of HIV-1 exposed but uninfected subjects are associated with peripheral CXCR6+ NK cell subsets Moustapha Mbow, Sabelle Jallow, Moussa Thiam, Alberta Davis, Assane Diouf, Cheikh T. Ndour, Moussa Seydi, Tandakha N. Dieye, Souleymane Mboup, Martin Goodier, Eleanor Rilley, Assan Jaye O11 Profiles of resistance: Local innate mucosal immunity to HIV-1 in commercial sex workers Xiao-Dan Yao, RW. Omange, Bethany M. Henrick, Richard T. Lester, Joshua Kimani, T. Blake Ball, Francis A. Plummer, Kenneth L. Rosenthal O12 Early antiretroviral therapy and pre-exposure prophylaxis for HIV prevention among female sex workers in Cotonou, Benin: A demonstration project Luc Béhanzin, Fernand A. Guédou, Nassirou Geraldo, Ella Goma Mastétsé, Jerôme Charles Sossa, Marcel Djimon Zannou, Michel Alary O13 Building capacity for HIV prevention trials: Preliminary data from a Nigerian cohort of HIV exposed sero-negatives (HESN) Sophia Osawe, Evaezi Okpokoro, Felicia Okolo, Stephen Umaru, Rebecca Abimiku, Sam Audu, Pam Datong, Alash’le Abimiku O14 Equipping healthcare professionals with skills required for the conduct of clinical trials in an effort to build capacity. Lessons learned Jacquelyn Nyange, Joyce Olenja, Gaudensia Mutua, Walter Jaoko, Gloria Omosa-Manyonyi, Bashir Farah, Maureen Khaniri, Omu Anzala O15 Educational technology to support active learning for HIV researchers and planners Anne Cockcroft, Kendra Tonkin, Indu Girish, Puna Mhati, Ashley Cunningham, Neil Andersson O16 From Lake Kivu (Rwanda) and Lake Malawi (Tanzania) to the shores of Lake Victoria (Uganda): Strengthening laboratory capacity through Good Clinical Laboratory Practice training Bashir Farah, Jackton Indangasi, Walter Jaoko, Gaudensia Mutua, Maureen Khaniri, Jacquelyn Nyange, Omu Anzala O17 Rilpivirine and etravirine resistance mutations in HIV-1 subtype C infected patients on a non-nucleoside reverse transcriptase inhibitor-based combination antiretroviral therapy in Botswana Thabo Diphoko, Simani Gaseitsiwe, Victoria Maiswe, Thato Iketleng, Dorcas Maruapula, Keabetswe Bedi, Sikhulile Moyo, Rosemary Musonda, Mark Wainberg, Joseph Makhema, Vladimir Novitsky, Richard Marlink, Max Essex O18 From home-based HIV testing to initiation of treatment: The AIDS Support Organization (TASO) Experience with Home-based HIV Counselling and Testing (HBHCT) among Adolescents in Uganda, 2005-2011 Stephen Okoboi, Livingstone Ssali, Sam Kalibala, Josephine Birungi, Aggrey Egessa, Jonathan Wangisi, Lyavala Joanne Okullu, Celestin Bakanda, Francis Obare41 O19 Feasibility study on using real time medication monitoring among HIV infected and Tuberculosis patients in Kilimanjaro, Tanzania I. Marion Sumari-de Boer, Hadija H. Semvua, Jossy van den Boogaard, Krisanta W. Kiwango, Kennedy M. Ngowi, Pythia T. Nieuwkerk, Rob E. Aarnoutse, Ireen Kiwelu, Eva Muro, Gibson S. Kibiki O20 Deaths still among sero-discordant cohort in Nigeria despite Access to treatment Ruth Datiri, Grace Choji, Sophia Osawe, Evaezi Okpokoro, Felicia Okolo, Stephen Umaru, Rebecca Abimiku, Samuel Audu, Pam Datong, Alash’le Abimiku O21 Therapeutic HIV-1 vaccine trials in Denmark and Guinea-Bissau Fomsgaard A, Karlsson I, Jensen KJ, Jensen SS, Leo-Hansen C, Jespersen S, Da Silva Té D, Rodrigues CM, da Silva ZJ, Janitzek CM, Gerstoft J, Kronborg G, the WAPHIR Group O22 Willingness to participate in a HIV vaccine Trial among HIV exposed sero-negative (HESN) persons in Jos, Nigeria Evaezi Okpokoro, Sophia Osawe, Ruth Daitiri, Grace Choji, Stephen Umaru, Felicia Okolo, Pam Datong, Alash'le Abimiku O23 Clinical research volunteers’ perceptions and experiences of screening for enrolment at KAVI-Institute of Clinical Research, Kenya Nyariki Emily, Olenja Joyce, Lorway R. Robert, Anzala Anzala O24 Gut microbiome, HIV-exposure, and vaccine responses in South African infants Katie Viljoen, Jerome Wendoh, Elvis Kidzeru, Ulas Karaoz, Eoin Brodie, Gerrit Botha, Nicola Mulder, Clive Gray, William Cameron, Alain Stintzi, Heather Jaspan, for the INFANT study team O25 Analysis of HIV pol diversity in the concentrated HIV epidemic in Saskatchewan Paul N. Levett, David Alexander, Naveed Gulzar, Prabvir S. Grewal, Art F. Y. Poon, Zabrina Brumme, P. Richard Harrigan, James I. Brooks, Paul A. Sandstrom, Stryker Calvez, Stephen E. Sanche, Jamie K. Scott P1 Evaluating a HIV vaccine research community engagement programme at two HIV prevention research centres in the Western Cape Leslie Swartz, Ashraf Kagee, Anthea Lesch, Zuhayr Kafaar, Anneliese De Wet P2 Validating HIV acquisition risk score using a cohort HIV exposed sero-negative persons in a discordant relationship in Jos, Nigeria, West Africa Evaezi Okpokoro, Sophia Osawe, Ruth Daitiri, Grace Choji, Stephen Umaru, Felicia Okolo, Pam Datong, Alash'le Abimiku P3 Bridging the gap between adults and adolescents and youth adults (AYA) – Employing a youth-centred approach to investigate HIV risk among AYA in Soweto and Durban, South Africa Janan Dietrich, Tricia Smith, Laura Cotton, Stefanie Hornschuh, Martin van der Watt, Cari L. Miller, Glenda Gray, Jenni Smit, Manjeetha Jaggernath, Thumbi Ndung’u, Mark Brockman, Angela Kaida, on behalf of the AYAZAZI study teams P4 Neighbours to sex workers: A key population that has been ignored Maureen Akolo, Joshua Kimani, Prof Larry Gelmon, Michael Chitwa, Justus Osero P5 Young women’s access to structural support programmes in a district of Botswana Anne Cockcroft, Nobantu Marokoane, Leagajang Kgakole, Boikhutso Maswabi, Neo Mpofu, Umaira Ansari, Neil Andersson P6 Voices for action from peri-urban Ugandan students, teachers and parents on HIV/STI prevention: Qualitative research results Nakinobe Elizabeth, Miiro George Mukalazi, Zalwango Flavia, Nakiyingi-Miiro Jessica, Kaleebu Potiano P7 Engaging Social Media as an education tool on the fly: The use of Facebook for HIV and Ebola prevention and awareness amongst adolescents in Uganda John Ross Semwanga, Emily Nyanzi, Saidat Namuli Musoke, Elizabeth Nakinobe, George Miiro, Edward Katongole Mbidde, Tom Lutalo, Pontiano Kaleebu P8 Circulating HIV-1 subtypes among sexual minority populations in Zambia Ray Handema, Graham P. Chianzu P9 The Development of HIV Bio-bank resource management to support clinical trial and Intervention research: WAPHIR experience Moussa Thiam, Diabou Diagne-Gueye, Mame K. Ndiaye, Moustapha Mbow, Birahim P. Ndiaye, Ibrahima Traore, Mamadou C. Dia, Gilleh Thomas, Coumba Tour-Kane, Souleymane Mboup, Assan Jaye P10 Capacity building for clinical trials as a novel approach for scaling up HIV prevention research initiatives in East Africa: achievements and challenges Emily Nyanzi, Edward Katongole Mbidde, Pontiano Kaleebu, Juliet Mpendo, Joshua Kimani, Josephine Birungi, Winnie Muyindike, Andrew Kambugu P11 Community and media perspective of research; an advocacy workshop on HIV prevention research Hachizovu Sebastian, Handema Ray, Chaponda Mike, Kabuya Jean Bertin, Mulenga Modest P12 Development of a quantitative HIV-1 and HIV-2 real time PCR (qRT-PCR) viral load assay Moussa Thiam, Omar Janha, Alberta Davis, Alfred Amambua-Ngwa, Davis C. Nwakanma, Souleymane Mboup, Assan Jaye P13 Differential effects of sex in a West African Cohort of HIV-1, HIV-2 and HIV-1/2 dual infected patients: Men are worse off Sanne Jespersen, Bo Langhoff Hønge, Joakim Esbjörnsson, Candida Medina, David Da Silva TÉ, Faustino Gomes Correira, Alex Lund Laursen, Lars Østergaard, Andreas Andersen, Peter Aaby, Christian Erikstrup, Christian Wejse, for the Bissau HIV Cohort study group P14 HIV-infected adolescents in transition from pediatric to adult HIV care in Dakar, Senegal: sample characteristics and immunological and virological profiles Siry Dieye, Moussa Sarr, Haby Sy, Helene D Mbodj, Marianne Ndiaye, Amy Ndiaye, Seydi Moussa, Assan Jaye, Souleymane Mboup100 P15 Molecular characterization of vertically transmitted HIV-1 among children born to HIV-1 seropositive mothers in Northern Tanzania Balthazar M. Nyombi, Elichilia R. Shao, Innocent B. Chilumba, Sikhulile Moyo, Simani Gaseitsiwe, Rosemary Musonda P16 Breast-fed HIV-1 exposed infants play catch up. A preliminary report Pam Datong, Bucky Inyang, Sophia Osawe, Abel Izang, Chundung Cole, Felicia Okolo, Bill Cameron, Kenneth Rosenthal, Clive Gray, Heather Jaspan, Alash’le Abimiku, the INFANT study team P17 The frequency of N348I mutation in patient failing combination antiretroviral treatment In Botswana Boitumelo Seraise, Kerstin Andrea-Marobela, Sikhulile Moyo, Rosemary Musonda, Joseph Makhema, Max Essex, Simani Gaseitsiwe

Placebo-controlled trials of pre-exposure prophylaxis (PrEP) have reported challenges with study-product uptake and use, with the greatest challenges reported in studies with young women in sub-Saharan Africa. We conducted a qualitative sub-study to explore experiences with open-label PrEP among young women in Cape Town, South Africa participating in HTPN 067/Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking (ADAPT). HPTN 067/ADAPT provided open label oral FTC/TDF PrEP to young women in Cape Town, South Africa who were randomized to daily and non-daily PrEP regimens. Following completion of study participation, women were invited into a qualitative sub-study including focus groups and in-depth interviews. Interviews and groups followed a semi-structured guide, were recorded, transcribed, and translated to English from isiXhosa, and coded using framework analysis. Sixty of the 179 women enrolled in HPTN 067/ADAPT participated in either a focus group (six groups for a total of 42 participants) or an in-depth interview (n=18). This sample of mostly young, unmarried women identified facilitators of and barriers to PrEP use, as well as factors influencing study participation. Cross-cutting themes characterizing discourse suggested that women placed high value on contributing to the well-being of one's community (Ubuntu), experienced a degree of skepticism towards PrEP and the study more generally, and reported a wide range of approaches towards PrEP (ranging from active avoidance to high levels of persistence and adherence). A Mutuality Framework is proposed that identifies four dynamics (distrust, uncertainty, alignment, and mutuality) that represent distinct interactions between self, community and study and serve to contextualize women's experiences. Implications for better understanding PrEP use, and non-use, and intervention opportunities are discussed. In this sample of women, PrEP use in the context of an open-label research trial was heavily influenced by underlying beliefs about safety, reciprocity of contributions to community, and trust in transparency and integrity of the research. Greater attention to factors positioning women in the different dynamics of the proposed Mutuality Framework could direct intervention approaches in clinical trials, as well as open-label PrEP scale-up.

This study explores the effects of antiretroviral treatment (ART) programmes on health-care human resources in South Africa. The study included two parts, a questionnaire-based survey of 269 health workers published earlier and a qualitative study of 21 purposively selected health practitioners involved in ART scale up. Contrary to what has been presented in literature, our survey showed that health workers in ART programmes experienced higher levels of morale, lower stress, lower sickness absenteeism and higher levels of job satisfaction. This paper uses qualitative data to provide insights into the working environment of ART workers and examines some possible explanations for our survey findings. The key factors that contribute to the different perception of working environment by ART workers identified in this study include bringing hope to patients, delaying deaths, acquiring training and the ability to better manage and monitor the disease.

Background The loss of human resource capacity has had a severe impact on the health system in South Africa. This study investigates the causes of migration focussing on the role of salaries and benefits. Health professionals from public, private and non-governmental (NGO) health facilities located in selected peri–urban and urban areas in KwaZulu-Natal, South Africa were surveyed about their current positions and attitudes toward migration. Methods The study uses cross-sectional data collected in 2009. A total of 694 health professionals (430 in the public sector, 133 in the NGO sector and 131 in the private sector) were surveyed. An additional 11 health professionals were purposively selected for in-depth interviews. Odds ratios with 95% confidence intervals were calculated to determine whether salaries influenced HWs decisions to migrate. Results HWs decision to move was not positively associated with lower salaries. It was found, instead, that the consideration to move was determined by other factors including age, levels of stress experienced and the extent to which they were satisfied at their current place of work. Conclusions The OSD appears to have lowered the risk of HWs migrating due to low salaries. However, the results also indicate that the South African Department of Health needs to improve working conditions for HWs within the public health sector to assist in retention.