HIV Pre-exposure Prophylaxis (PrEP) Care in Belgium: A mixed-methods Study on PrEP Users' Experiences and Service Delivery Preferences.

In Belgium, HIV pre-exposure prophylaxis (PrEP) services are mainly provided through specialised HIV clinics. To optimise PrEP uptake and retention in care, we require insights into users' perspectives on PrEP care. We aimed to elicit experiences with, and preferences for, PrEP service delivery among PrEP users in Belgium, including willingness to involve their family physician (FP) in PrEP care. We adopted a sequential mixed-methods design. We used a web-based longitudinal study among 326 PrEP users that consisted of two questionnaires at six-month intervals, and complemented this with 21 semi-structured interviews (September 2020-January 2022). We conducted descriptive analyses and logistic regression to examine factors associated with willingness to involve their FP in PrEP care. Interviews were analysed using thematic analysis. Survey respondents reported high satisfaction with care received in HIV clinics [median score 9 (IQR 8-10), 10='very satisfied']. Interviews revealed the importance of regular HIV/STI screening, and the expertise and stigma-free environment of HIV clinics. Yet, they also contextualised service delivery barriers reported in the questionnaire, including the burden of cost and challenges integrating PrEP visits into their private and professional lives. Although 63.8% (n = 208/326) of baseline respondents preferred attending an HIV clinic for PrEP follow-up, 51.9% (n = 108/208) of participants in the follow-up questionnaire reported to be willing to have their FP involved in PrEP care. Participants reporting trust in FPs' PrEP and sexual health expertise, or who didn't feel judged by their FP, were more likely to be willing to involve them in PrEP care. Therefore, we recommend a differentiated PrEP service delivery approach, including involving FPs, to make PrEP care more client-centred.

Lessons learned from implementation of four HIV self-testing (HIVST) distribution models in Zambia: applying the Consolidated Framework for Implementation Research to understand impact of contextual factors on implementation.

BACKGROUND: Although Zambia has integrated HIV-self-testing (HIVST) into its Human Immunodeficiency Virus (HIV) regulatory frameworks, few best practices to optimize the use of HIV self-testing to increase testing coverage have been documented. We conducted a prospective case study to understand contextual factors guiding implementation of four HIVST distribution models to inform scale-up in Zambia. METHODS: We used the qualitative case study method to explore user and provider experiences with four HIVST distribution models (two secondary distribution models in Antenatal Care (ANC) and Antiretroviral Therapy (ART) clinics, community-led, and workplace) to understand factors influencing HIVST distribution. Participants were purposefully selected based on their participation in HIVST and on their ability to provide rich contextual experience of the distribution models. Data were collected using observations (n = 31), group discussions (n = 10), and in-depth interviews (n = 77). Data were analyzed using the thematic approach and aligned to the four Consolidated Framework for Implementation Research (CFIR) domains. RESULTS: Implementation of the four distribution models was influenced by an interplay of outer and inner setting factors. Inadequate compensation and incentives for distributors may have contributed to distributor attrition in the community-led and workplace HIVST models. Stockouts, experienced at the start of implementation in the secondary-distribution and community-led distribution models often disrupted distribution. The existence of policy and practices aided integration of HIVST in the workplace. External factors complimented internal factors for successful implementation. For instance, despite distributor attrition leading to excessive workload, distributors often multi-tasked to keep up with demand for kits, even though distribution points were geographically widespread in the workplace, and to a less extent in the community-led models. Use of existing communication platforms such as lunchtime and safety meetings to promote and distribute kits, peers to support distributors, reduction in trips by distributors to replenish stocks, increase in monetary incentives and reorganisation of stakeholder roles proved to be good adaptations. CONCLUSION: HIVST distribution was influenced by a combination of contextual factors in variable ways. Understanding how the factors interacted in real world settings informed adaptations to implementation devised to minimize disruptions to distribution.

The impact of an innovative community-based peer-led intervention on uptake and coverage of sexual and reproductive health services among adolescents and young people 15-24 years old: results from the Yathu Yathu cluster randomised trial.

BACKGROUND: The Yathu Yathu ("For Us, By Us") cluster-randomized trial (CRT) evaluated a peer-led community-based sexual and reproductive health(SRH) intervention implemented to address persistent barriers to SRH service use among adolescents and young people (AYP). We report the impact of the intervention on coverage of key SRH services among AYP. METHODS: The trial was conducted from Jul 2019-Oct 2021 in two urban communities in Lusaka, Zambia, divided into 20 zones (~ 2350 AYP/zone). Zones were randomly allocated to intervention (N = 10) or control (N = 10) arm. In all zones, a census was conducted and all AYP aged 15-24-years offered participation. The intervention consisted of peer-led community-based hubs providing SRH services; a prevention points card (PPC) system to incentivize and track SRH service use and community engagement. This paper reports on the outcome of coverage (accessing at least one key SRH service), comparing intervention and control arms using PPC data and standard methods of analysis for CRTs. RESULTS: Among enumerated AYP, 93.6% (14,872/15,894) consented to participate from intervention zones and 95.1% (14,500/15,255) from control zones. Among those who accepted a PPC, 63.8% (9,493/14,872) accessed at least one key SRH service during the study period in the intervention arm, compared to 5.4% (776/14,500) in the control arm (adjPR 12.3 95%CI 9.3-16.2, p < 0.001). CONCLUSIONS: The Yathu Yathu intervention increased coverage of key SRH services among AYP and reached two-thirds of AYP. These findings demonstrate the potential of providing peer-led community-based SRH services. TRIAL REGISTRATION: ISRCTN75609016 (11/10/2021), clinicaltrials.gov number NCT04060420 (19/08/2019); retrospectively registered.

PrEP Among Sub-Saharan African Diaspora Communities in Belgium - a Participatory Action Research Study.

In Belgium, migrants from Sub-Saharan Africa (SSA) accounted for 45% of new heterosexual HIV infections in 2021, while only 1.5% of PrEP starters were of SSA descent. We explored the acceptance of PrEP and barriers towards PrEP uptake and use among SSA migrant and diaspora communities in Belgium using a participatory action research approach. Trained community researchers (CRs), involved in all phases of the study, co-designed and moderated group discussions (GDs) while simultaneously providing information on HIV and PrEP during workshops. Extensive summaries and field notes were analysed using reflexive thematic analysis. CRs were involved in data analysis, interpretation and reporting. We conducted seven GDs with 51 participants. We identified five major themes: (1) Participants had limited PrEP knowledge, which created feelings of surprise and annoyance about not being informed. This was partly explained by (2) the taboo and stigma that surrounds sexuality and HIV, which could shape PrEP acceptance. (3) Participants shared feelings of otherness due to experiences of racism and discrimination, also in relationship to HIV prevention. (4) PrEP was considered a high-threshold prevention tool, because of its perceived side-effects and its specialized service delivery. (5) Despite nuanced opinions about PrEP, all participants agreed that PrEP promotion should be mainstreamed, so everyone can make an informed decision. In conclusion, PrEP seemed acceptable among our participants. Our qualitative study provides insights into the intersecting barriers to accessing HIV services, showing that SSA diaspora communities are 'hardly reached' rather than 'hard to reach' by PrEP promotion messages.

The impact of community-based, peer-led sexual and reproductive health services on knowledge of HIV status among adolescents and young people aged 15 to 24 in Lusaka, Zambia: The Yathu Yathu cluster-randomised trial.

BACKGROUND: The growing population of adolescents and young people (AYP) aged 15 to 24 in sub-Saharan Africa face a high burden of HIV in many settings. Unintended pregnancies among adolescent girls in the region remain high. Nonetheless, the sexual and reproductive health (SRH) service needs of AYP have remained underserved. We conducted a cluster-randomised trial (CRT) to estimate the impact of community-based, peer-led SRH service provision on knowledge of HIV status and other SRH outcomes, including met need for contraceptives. METHODS AND FINDINGS: Yathu Yathu was a cluster-randomised trial (CRT) conducted from 2019 to 2021 in 2 urban communities in Lusaka, Zambia. The communities were divided into 20 zones (approximately 2,350 AYP/zone) that were randomly allocated to the Yathu Yathu intervention or control arm. In each intervention zone, a community-based hub, staffed by peer support workers, was established to provide SRH services. In 2019, a census was conducted in all zones; all consenting AYP aged 15 to 24 were given a Yathu Yathu card, which allowed them to accrue points for accessing SRH services at the hub and health facility (intervention arm) or the health facility only (control arm). Points could be exchanged for rewards, thus acting as an incentive to use SRH services in both arms. We conducted a cross-sectional survey in 2021 to estimate the impact of Yathu Yathu on the primary outcome: knowledge of HIV status (self-reporting living with HIV or HIV testing in the last 12 months) and secondary outcomes, including use of pre-exposure prophylaxis (PrEP) in the last 12 months, current use of antiretroviral therapy (ART), and met need for contraceptive services. The sampling was stratified on sex and age group, and we analysed data at cluster-level using a two-stage process recommended for CRTs with <15 clusters/arm. A total of 1,989 AYP consented to participate in the survey (50% male); consent was similar across arms (63% consent/arm). Across zones, knowledge of HIV status ranged from 63.6% to 81.2% in intervention zones and 35.4% to 63.0% in control zones. Adjusting for age, sex, and community, knowledge of HIV status was higher in the intervention arm compared to control (73.3% versus 48.4%, respectively, adjusted prevalence ratio (PR) 1.53 95% CI 1.36, 1.72; p < 0.001). By age and sex, results were similar. There was no evidence for impact on any secondary outcomes, including current use of ART and met need for contraceptives. There were no adverse events reported in either arm. A key limitation of our trial is that approximately 35% of the AYP randomly selected for participation in the endline survey could not be reached. CONCLUSIONS: Delivering community-based, peer-led SRH services increased knowledge of HIV status among AYP, both males and females, compared with the control arm. Scaling up the highly effective Yathu Yathu strategy has the potential to make a substantial contribution to increasing access to HIV prevention and care services for young people. However, additional implementation research is needed to understand how to improve uptake of broader SRH services, beyond uptake of HIV testing. TRIAL REGISTRATION: ISRCTN75609016, clinicaltrials.gov number NCT04060420.

Facilitators and barriers to engaging with the DREAMS initiative among young women who sell sex aged 18-24 in Zimbabwe: a qualitative study.

BACKGROUND: Adolescent girls and young women (AGYW) are at high risk of contracting HIV and exchanging sex for financial or material support heightens their risk. In Zimbabwe, the DREAMS initiative integrated education and employment opportunities within HIV health promotion and clinical services for vulnerable young women, including those who sell sex. While most participants accessed health services, fewer than 10% participated in any social programmes. METHODS: We conducted semi-structured qualitative interviews with 43 young women aged 18-24 to understand their experiences of engaging with the DREAMS programme. We purposively sampled participants for diversity in level of education, type and location of selling sex. We analysed the data by applying the Theoretical Domains Framework to explore facilitators and barriers to engaging with DREAMS. RESULTS: Eligible women were motivated by hopes of escaping poverty, and their longer-term engagement was sustained through exposure to new social networks, including friendships with less vulnerable peers. Barriers included opportunity costs and expenses such as transport or equipment required for job placements. Participants also described pervasive stigma and discrimination related to their involvement in selling sex. Interviews highlighted the young women's struggles in a context of entrenched social and material deprivation and structural discrimination that hindered their ability to take up most of the social services offered. CONCLUSIONS: This study demonstrates that while poverty was a key driver of participation in an integrated package of support, it also constrained the ability of highly vulnerable young women to benefit fully from the DREAMS initiative. Multi-layered HIV prevention approaches such as DREAMS that seek to alter complex and longstanding social and economic deprivation address many of the challenges faced by YWSS but will only succeed if the underlying drivers of HIV risk among YWSS are also addressed.

Patterns of PrEP and condom use among PrEP users in Belgium: a web-based longitudinal study.

BACKGROUND: Tailoring pre-exposure prophylaxis (PrEP) service delivery is key to scaling-up PrEP uptake. Optimal implementation of tailored services requires, among other things, insights into patterns of PrEP use, sexual behaviours and condom use over time. METHODS: Between September 2020 and January 2022, we conducted a web-based, longitudinal study among PrEP users in Belgium. In three questionnaire rounds every six-months, we assessed PrEP and condom use, and sex with steady, casual and anonymous partners in the preceding three months. Based on the patterns of PrEP use in the preceding three months, we identified distinct PrEP use categories. We investigated differences in baseline socio-demographics and sexual behaviours by PrEP use category using Fisher's exact and one-way ANOVA tests. Patterns in PrEP and condom use over time were examined using descriptive analyses and visualised in alluvial diagrams. RESULTS: In total, 326 participants completed the baseline questionnaire, and 173 completed all three questionnaires. We identified five distinct PrEP use categories: daily (≥ 90 pills), almost daily (75-89 pills), long period (> 7 consecutive days and < 75 pills) with or without additional short period use, short period (1-7 consecutive days and < 75 pills) and no PrEP use (0 pills). During the study, percentages of individuals in each PrEP use category varied, but did not change significantly over time. At baseline, daily and almost daily users were more likely to report five or more casual sex partners, ten or more anonymous sex partners and anal sex on a weekly basis with casual or anonymous partners compared to those using PrEP for long or short periods. Up to 12.6% (n = 16/127) of participants reporting anal sex with casual or anonymous partners, indicated always using condoms and PrEP with these partners. One in three (n = 23/69) participants who reported anal sex with steady partners had condomless anal sex and did not use PrEP with these partners; with casual or anonymous partners less than 3% reported this. CONCLUSIONS: Our findings show that there is little variation in PrEP use over time and that PrEP use was associated with sexual behaviours, which could be taken into account when designing tailored PrEP care.

Does distribution of menstrual products through community-based, peer-led sexual and reproductive health services increase use of appropriate menstrual products? Findings from the Yathu Yathu trial.

BACKGROUND: Globally, millions of adolescent girls and young women (AGYW) who menstruate have limited access to appropriate and comfortable products to manage their menstruation. Yathu Yathu was a cluster randomised trial (CRT) that estimated the impact of community-based, peer-led sexual and reproductive health (SRH) services on knowledge of HIV status among adolescents and young people aged 15-24 (AYP). Among the services offered through Yathu Yathu were free disposable pads and menstrual cups. This study aimed to investigate whether the availability of free menstrual products through Yathu Yathu increased AGYW's use of an appropriate menstrual product at their last menstruation and explored the characteristics of AGYW who accessed menstrual products through Yathu Yathu. METHODS: Yathu Yathu was conducted between 2019 and 2021 in 20 zones across two urban communities of Lusaka, Zambia. Zones were randomly allocated to the intervention or standard-of-care arm. In intervention zones, a community-based hub, staffed by peers, was established to provide SRH services. In 2019, a census was conducted in all zones; all consenting AYP aged 15-24 were given a Yathu Yathu Prevention Points Card, which allowed AYP to accrue points for accessing services at the hub and health facility (intervention arm), or the health facility only (control arm). Points could be exchanged for rewards, thus acting as an incentive in both arms. We conducted a cross-sectional survey in 2021 to estimate the impact of Yathu Yathu on the primary outcome (knowledge of HIV status) and secondary outcomes. Sampling was stratified by sex and age group; we analysed data from AGYW only to estimate the impact of Yathu Yathu on use of an appropriate menstrual product (disposable or reusable pad, cup, tampon) at last menstruation. We analysed data at zone-level using a two-stage process recommended for CRTs with < 15 clusters/arm. RESULTS: Among 985 AGYW participating in the survey who had experienced menarche, the most commonly used products were disposable pads (88.8%; n = 875/985). At their last menstruation, 93.3% (n = 459/492) of AGYW in the intervention arm used an appropriate menstrual product compared to 85.7% (n = 420/490) in the control arm (adjPR = 1.09 95%CI 1.02, 1.17; p = 0.02). There was no evidence for interaction by age (p = 0.20), but use of appropriate products was higher among adolescents in the intervention arm relative to control (95.5% vs 84.5%, adjPR = 1.14 95%CI 1.04, 1.25; p = 0.006) with no evidence for a difference among young women (91.1% vs 87.0%, adjPR = 1.06 95%CI 0.96, 1.16, p = 0.22). CONCLUSIONS: Delivering community-based peer-led SRH services increased the use of appropriate menstrual products among adolescent girls aged 15-19 at the start of the Yathu Yathu study. With less economic independence, the free provision of appropriate menstrual products is critical for adolescent girls to access materials that allow them to effectively manage their menstruation.

Adapting community-based sexual and reproductive health services for adolescents and young people aged 15-24 years in response to COVID-19 in Lusaka, Zambia: the implications on the uptake of HIV testing services.

BACKGROUND: Across Sub-Saharan Africa, adolescents and young people (AYP) aged 15-24 have limited access to sexual and reproductive health (SRH) services, including HIV testing services (HTS). In response, the Yathu Yathu study was implemented in two high-density communities in Lusaka, Zambia. Yathu Yathu provides comprehensive, community-based, peer-led SRH services, including differentiated HTS (finger-prick and HIV self-testing) and comprehensive sexuality education (CSE). We describe adaptations to the Yathu Yathu intervention in response to the COVID-19 epidemic, and implications on uptake of HTS among AYP. METHODS: Yathu Yathu provides SRH services through community-based peer-led spaces. AYP in study communities were offered prevention points cards (PPC), which incentivizes and tracks service use. Social media (WhatsApp©/Facebook©) is used to engage and inform AYP about SRH. Due to COVID-19, hubs closed from April-June 2020. We describe adaptations in response to COVID-19 and, using routinely collected PPC data, describe uptake of HTS before (September 2019-March 2020) and after (July-December 2020) adaptations in response to COVID-19. We describe reach of the Yathu Yathu Facebook page and use qualitative data to describe AYP experiences of SRH service access. RESULTS: During hub closures, CSE was delivered via video on social media, resulting in an increase in Facebook page followers from 539(April) to 891(June). WhatsApp groups evolved as a platform to deliver CSE and COVID-19 information, with higher participation among young people aged 20-24. Key service delivery adaptations included: reducing the number of participants in hubs, mandatory handwashing before entry, use of personal protective equipment by staff and provision of facemasks to AYP. HTS were provided as normal. Adaptations led to fewer AYP attending hubs. Uptake of HTS among AYP visiting hubs for the first time after COVID-19-related closures was higher (73.2%) compared to uptake before adaptations (65.9%; adjOR=1.24 95%CI 0.99, 1.56, p=0.06). Despite disappointments with some aspects of service delivery, AYP expressed happiness that hubs had reopened. CONCLUSIONS: Social media can be a useful additional platform to reach AYP with HIV prevention information during COVID-19. With proper infection control in place, HTS can safely be provided to, accessed and accepted by AYP in community-based settings during COVID-19. TRIAL REGISTRATION: National Clinical Trials NCT04060420,19th August 2019. Current Controlled Trials ISRCTN75609016 , 14th September 2021, retrospectively registered.

Engaging young people in the design of a sexual reproductive health intervention: Lessons learnt from the Yathu Yathu ("For us, by us") formative study in Zambia.

BACKGROUND: Meeting the sexual and reproductive health (SRH) needs of adolescents and young people (AYP) requires their meaningful engagement in intervention design. We describe an iterative process of engaging AYP to finalise the design of a community-based, peer-led and incentivised SRH intervention for AYP aged 15-24 in Lusaka and the lessons learnt. METHODS: Between November 2018 and March 2019, 18 focus group discussions, eight in-depth interviews and six observations were conducted to assess AYP's knowledge of HIV/SRH services, factors influencing AYP's sexual behaviour and elicit views on core elements of a proposed intervention, including: community-based spaces (hubs) for service delivery, type of service providers and incentivising service use through prevention points cards (PPC; "loyalty" cards to gain points for accessing services and redeem these for rewards). A total of 230 AYP (15 participated twice in different research activities) and 21 adults (only participated in the community mapping discussions) participated in the research. Participants were purposively selected based on age, sex, where they lived and their roles in the study communities. Data were analysed thematically. RESULTS: Alcohol and drug abuse, peer pressure, poverty, unemployment and limited recreation facilities influenced AYP's sexual behaviours. Adolescent boys and young men lacked knowledge of contraceptive services and all AYP of pre and post exposure prophylaxis for HIV prevention. AYP stated a preference for accessing services at "hubs" located in the community rather than the health facility. AYP considered the age, sex and training of the providers when choosing whom they were comfortable accessing services from. PPCs were acceptable among AYP despite the loyalty card concept being new to them. AYP suggested financial and school support, electronic devices, clothing and food supplies as rewards. CONCLUSIONS: Engaging AYP in the design of an SRH intervention was feasible, informative and considered responsive to their needs. Although AYP's suggestions were diverse, the iterative process of AYP engagement facilitated the design of an intervention that is informed by AYP and implementable. TRIAL REGISTRATION: This formative study informed the design of this trial: ClinicalTrials.gov, NCT04060420. Registered 19 August, 2019.

Social response to the delivery of HIV self-testing in households: experiences from four Zambian HPTN 071 (PopART) urban communities.

BACKGROUND: Door-to-door distribution of HIV self-testing kits (HIVST) has the potential to increase uptake of HIV testing services (HTS). However, very few studies have explored the social response to and implications of door-to-door including secondary distribution of HIVST on household relations and the ability of individuals to self-test with or without supervision within households. METHODS: A CRT of HIVST distribution was nested within the HPTN 071 (PopART) trial, in four Zambian communities randomised to receive the PopART intervention. The nested HIVST trial aimed to increase knowledge of HIV status at population level. Between February 1 and April 30, 2017, 66 zones (clusters) within these four communities were randomly allocated to either the PopART standard of care door-to-door HTS (33 clusters) or PopART standard of care door-to-door HTS plus oral HIVST (33 clusters). In clusters randomised to HIVST, trained Community HIV care provider (CHiPs) visited households and offered individuals aged ≥ 16 and eligible for an offer of HTS the choice of HIV testing using HIVST or routine door-to-door HTS (finger-prick RDT). To document participants' experiences with HIVST, Interviews (n = 40), observations (n = 22) and group discussions (n = 91) with household members and CHiPs were conducted. Data were coded using Atlas.ti 7 and analysed thematically. RESULTS: The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs. Door-to-door distribution of HIVST kits was appreciated for being novel, convenient, private, empowering, autonomous and easy-to-use. Literacy and age influenced accurate usage of HIVST kits. The novelty of using oral fluids to test for HIV raised questions, some anxiety and doubts about the accuracy of HIVST. Although HIVST protected participants from experiencing clinic-based stigma, it did not address self-stigma. Within households, HIVST usually strengthened relationships but, amongst couples, there were a few reports of social harms. CONCLUSION: Door-to-door distribution of HIVST as a choice for how to HIV test is appreciated at community level and provides an important testing option in the sub-Saharan context. However, it should be accompanied by counselling to manage social harms and by supporting those testing HIV-positive to link to care.

Application of an HIV Prevention Cascade to Identify Gaps in Increasing Coverage of Voluntary Medical Male Circumcision Services in 42 Rural Zambian Communities.

Increased coverage of voluntary medical male circumcision (VMMC) is needed in countries with high HIV prevalence. We applied an HIV-prevention cascade to identify gaps in male circumcision coverage in Zambia. We used survey data collected in 2013 and 2014/15 to describe circumcision coverage at each time-point, and prevalence of variables related to demand for and supply of VMMC. We explored whether circumcision coverage in 2014/15 was associated with demand and supply among uncircumcised men in 2013. Results show that circumcision coverage was 11.5% in 2013 and 18.0% in 2014/15. Levels of having heard of circumcision and agreeing with prevention benefits was similar at both time-points (79.8% vs 83.2%, and 49.7% vs 50.7%, respectively). In 2013, 39.3% of men perceived services to be available compared to 54.7% in 2014/15. Levels of having heard of circumcision in 2013 was correlated with and higher perceived service availability associated with coverage in 2014/15. VMMC coverage was low in these study sites. Knowledge of prevention tools and of service availability are necessary to increase coverage but alone are insufficient.

Changes Over Time in HIV Prevalence and Sexual Behaviour Among Young Female Sex-Workers in 14 Sites in Zimbabwe, 2013-2016.

Young female sex-workers (FSW) aged 18-24 are at high risk of HIV due to high numbers of sexual partners, difficulty negotiating condom use, increased risk of gender-based violence, and limited access to services. Here we describe changes in sexual behaviours among young FSW across Zimbabwe between 2013 and 2016, and risk factors for prevalent HIV in 2013 and 2016. FSW ≥ 18 years were recruited using respondent-driven sampling in 14 sites across Zimbabwe in 2013 and 2016 as part of the SAPPH-IRe trial. We collected data on socio-demographics and sexual behaviour and offered HIV testing. Statistical analyses were RDS-II weighted. Characteristics of young FSW aged 18-24 were described, stratified by age. Logistic regression was used to assess difference in sexual behaviours by reported HIV status between 2013 and 2016, and to explore associations with prevalent HIV in 2013 and 2016. 656 young FSW were recruited in 2013 and 503 in 2016. Characteristics of young FSW were similar across both surveys. HIV prevalence was similar at both time points (35% vs 36%) and rose steeply with age. Compared to young FSW in 2013, reported condom-less sex with a steady partner and condom-less sex with clients was higher in 2016 among women self-reporting HIV negative status (OR = 6.41; 95%CI: 3.40-12.09; P<0.001) and (OR = 1.69; 95%CI: 1.14-2.51, P = 0.008), respectively, but not among young FSW self-reporting HIV positive status (OR = 2.35; 95%CI: 0.57-9.76; P = 0.236) and (OR = 1.87; 95%CI: 0.74-4.74; P = 0.186). After adjusting for age in 2016, young FSW who had ever been married had increased odds of testing HIV positive (OR = 1.88; 95% CI 1.04-3.39; P = 0.036) compared with those who had never married. Young FSW who completed secondary education or higher were less likely to test HIV positive (OR = 0.41; 95% CI 0.20-0.83; P = 0.012) compared with those with primary education or less. Young FSW remain at very high risk of HIV. Strategies to identify young FSW when they first start selling and refer them into services that address their economic, social and sexual vulnerabilities are critical.

Evaluating the impact of DREAMS on HIV incidence among young women who sell sex: protocol for a non-randomised study in Zimbabwe.

BACKGROUND: "Determined, Resilient, AIDS-free, Mentored and Safe" (DREAMS) is a package of biomedical, social and economic interventions offered to adolescent girls and young women aged 10-24 years with the aim of reducing HIV incidence. In four of the six DREAMS districts in Zimbabwe, DREAMS includes an offer of oral pre-exposure prophylaxis (DREAMS+PrEP), alongside interventions to support demand and adherence, to women aged 18-24 who are at highest risk of HIV infection, including young women who sell sex (YWSS). This evaluation study addresses the question: does the delivery of DREAMS+PrEP through various providers reduce HIV incidence among YWSS Zimbabwe? We describe our approach to designing a rigorous study to assess whether DREAMS+PrEP had an impact on HIV incidence. METHODS: The study design needed to account for the fact that: 1) DREAMS+PrEP was non-randomly allocated; 2) there is no sampling frame for the target population for the evaluation; 3) there are a small number of DREAMS districts (N = 6), and 4) DREAMS+PrEP is being implemented by various providers. The study will use a cohort analysis approach to compare HIV incidence among YWSS in two DREAMS+PrEP districts to HIV incidence among YWSS in non-DREAMS comparison sites. YWSS will be referred to services and recruited into the cohort through a network-based (respondent-driven) recruitment strategy, and followed-up 12- and 24-months after enrolment. Women will be asked to complete a questionnaire and offered HIV testing. Additional complications of this study include identifying comparable populations of YWSS in the DREAMS+PrEP and non-DREAMS comparison sites, and retention of YWSS over the 24-month period. The primary outcome is HIV incidence among YWSS HIV-negative at study enrolment measured by repeat, rapid HIV testing over 24-months. Inference will be based on plausibility that DREAMS+PrEP had an impact on HIV incidence. A process evaluation will be conducted to understand intervention implementation, and document any contextual factors determining the success or failure of intervention delivery. DISCUSSION: HIV prevention products of known efficacy are available. Innovative studies are needed to provide evidence of how to optimise product use through combination interventions to achieve population impact within different contexts. We describe the design of such a study.

Evaluating the impact of the DREAMS partnership to reduce HIV incidence among adolescent girls and young women in four settings: a study protocol.

BACKGROUND: HIV risk remains unacceptably high among adolescent girls and young women (AGYW) in southern and eastern Africa, reflecting structural and social inequities that drive new infections. In 2015, PEPFAR (the United States President's Emergency Plan for AIDS Relief) with private-sector partners launched the DREAMS Partnership, an ambitious package of interventions in 10 sub-Saharan African countries. DREAMS aims to reduce HIV incidence by 40% among AGYW over two years by addressing multiple causes of AGYW vulnerability. This protocol outlines an impact evaluation of DREAMS in four settings. METHODS: To achieve an impact evaluation that is credible and timely, we describe a mix of methods that build on longitudinal data available in existing surveillance sites prior to DREAMS roll-out. In three long-running surveillance sites (in rural and urban Kenya and rural South Africa), the evaluation will measure: (1) population-level changes over time in HIV incidence and socio-economic, behavioural and health outcomes among AGYW and young men (before, during, after DREAMS); and (2) causal pathways linking uptake of DREAMS interventions to 'mediators' of change such as empowerment, through to behavioural and health outcomes, using nested cohort studies with samples of ~ 1000-1500 AGYW selected randomly from the general population and followed for two years. In Zimbabwe, where DREAMS includes an offer of pre-exposure HIV prophylaxis (PrEP), cohorts of young women who sell sex will be followed for two years to measure the impact of 'DREAMS+PrEP' on HIV incidence among young women at highest risk of HIV. In all four settings, process evaluation and qualitative studies will monitor the delivery and context of DREAMS implementation. The primary evaluation outcome is HIV incidence, and secondary outcomes include indicators of sexual behavior change, and social and biological protection. DISCUSSION: DREAMS is, to date, the most ambitious effort to scale-up combinations or 'packages' of multi-sectoral interventions for HIV prevention. Evidence of its effectiveness in reducing HIV incidence among AGYW, and demonstrating which aspects of the lives of AGYW were changed, will offer valuable lessons for replication.

The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations.

BACKGROUND: Knowledge of HIV status remains below target in sub-Saharan Africa, especially among men and adolescents. HIV self-testing (HIVST) is a novel approach that enables unique distribution strategies, with potential to be highly decentralised and to provide complementary coverage to facility-based testing approaches. However, substantial gaps in evidence remain on the effectiveness and cost-effectiveness of HIVST, particularly in rural settings, and on approaches to facilitate linkage to confirmatory HIV testing, prevention, and treatment services. This protocol describes two cluster-randomized trials (CRT) included within the UNITAID/PSI HIV Self-Testing Africa (STAR) project. METHODS: Two independent CRTs were designed around existing reproductive health programmes in rural Malawi and rural/peri-urban Zambia. Common features include use of constrained randomisation to allocate health clinic catchment areas to either standard HIV testing (SOC) or SOC plus community-based distribution of OraQuick HIV Self Tests (Bethlehem, PA USA, assembled in Thailand) by trained lay distributors selected by the community. Community-based distribution agents will be trained (3-day curriculum) to provide brief demonstration of kit use and interpretation, information and encouragement to access follow up services, and management of social harm. The primary outcome of both CRTs is the proportion of the population aged 16 years and older who tested for HIV within the 12-month intervention period. Secondary outcomes in both trials include lifetime HIV testing, antiretroviral therapy (ART) initiation and ART use. Circumcision status among males will be a secondary outcome in Zambia and clinic-level demand for ART will be a secondary outcome in Malawi. Outcomes will be measured using cross-sectional household surveys, and routine data extraction from participating clinics. Costing studies will be used to evaluate the cost-effectiveness of the intervention arm. Qualitative research will be used to guide distribution and explore reasons for testing and linkage to onward care. DISCUSSION: The STAR-Malawi and STAR-Zambia trials will provide rigorous evidence of whether community-based lay HIVST distribution is an effective and cost-effective approach to increasing coverage of HIV testing and demand for follow-on HIV services in rural and peri-urban communities in sub-Saharan Africa. TRIAL REGISTRATION: Clinicaltrials.gov, Malawi: NCT02718274 , 18 March 2016; Zambia: NCT02793804 , 3 June 2016. Protocol date: 21 February 2018.

Self-reported uptake of STI testing services among adolescents and young people aged 15-24 years: Findings from the Yathu Yathu cluster randomized trial in Lusaka, Zambia.

There is little evidence regarding community-based delivery of STI testing and treatment for youth aged 15-24 (AYP) in Zambia. In a cluster-randomised trial, we evaluated whether offering syndromic STI screening through community-based, peer-led sexual and reproductive health services (Yathu Yathu) with referral to a local health facility for testing, increased self-reported testing for STIs (other than HIV) among AYP. Two communities in Lusaka were divided into 10 zones each (20 zones in total); by community, zones were randomly allocated (1:1) to Yathu Yathu or control. Monitoring data were used to describe syndromic STI screening through Yathu Yathu and an endline cross-sectional survey used to evaluate the impact of Yathu Yathu on self-reported ever and recent (last 12 months) STI testing. 10,974 AYP accessed Yathu Yathu; 66.6% (females-67.7%; males-64.7%) were screened for STIs, 6.2% reported any STI symptoms. In the endline survey, 23.3% (n = 350/1501) of AYP who ever had sex ever STI tested; 13.5% (n = 174/1498) who had sex in the last 12 months recently STI tested. By trial arm, there was no difference in self-reported ever or recent STI testing among all AYP. Among men aged 20-24, there was evidence that ever STI testing was higher in the Yathu Yathu compared to control arm (24.1% vs 16.1%; adjPR = 1.67 95%CI = 1.02, 2.74; p = 0.04). Among AYP who ever STI tested, 6.6% (n = 23) reported ever being diagnosed with an STI. Syndromic STI management through community-based, peer-led services showed no impact on self-reported STI testing among AYP. Research on community-based delivery of (near) point-of-care diagnostics is needed. Trial registration number(s): NCT04060420 https://clinicaltrials.gov/ct2/show/NCT04060420; and ISRCTN75609016; https://doi.org/10.1186/ISRCTN75609016.

Factors associated with use of community-based, peer-led sexual and reproductive health services by adolescent boys and young men aged 18-24 in Lusaka, Zambia: A case control study nested in the Yathu Yathu trial.

INTRODUCTION: Adolescents and young people (AYP) aged 15-24 years have the least access to facility-based sexual and reproductive health (SRH) services, including HIV services. The Yathu-Yathu cluster-randomized trial (CRT) in Zambia tested whether a novel peer-led community-based approach increased knowledge of HIV status amongst AYP. In this nested case-control study, we aimed to identify factors associated with non-attendance to the Yathu Yathu hubs by adolescent boys and young men (ABYM) aged 18-24-years. METHODS: Yathu Yathu was a CRT conducted in two communities in Lusaka, Zambia, with 10 intervention and 10 control zones. AYP in all zones were offered prevention points cards (PPC), which incentivized and tracked service use at the hubs and health facility. In intervention zones, services were provided to AYP through community-based spaces (hubs) led by peer support workers. In these zones, cases were defined as those not having accessed any service at a hub and controls as those that accessed at least one service. Data were collected from October 2020 to January 2021 and analysed using methods appropriate for unmatched case-control studies. RESULTS: 161 cases and 160 controls consented to participate in the study. Participants aged 20-24 years (adjOR 1.99, 95%CI 1.26-3.12, p = 0.003), who were educated up to college level (adjOR 8.47,95%CI 2.08-34.53, p = 0.001) or who reported being employed in the last 12 months (adjOR 2.15, 95%CI 1.31-3.53, p = 0.002) were more likely to not attend the hubs. ABYM who had a friend with a PPC were more likely to attend the hubs (adjOR 0.18 95%CI 0.09-0.35, p<0.001). Most cases reported having their last HIV test at the local government health facility (58%) while most controls reported HIV-testing at a Yathu Yathu hub (82%). Among the controls, 84% (134/160) rated the hub experience as excellent. Among cases, 65% (104/161) stated they didn't visit the hubs "due to employment". CONCLUSIONS: Despite Yathu Yathu services being community-based and more accessible compared to health facilities, we found age, education and employment were associated with not attending hubs. Strategies are needed to reach employed young men who may not have access to SRH/HIV services during conventional working hours and to better utilise peer networks to increase service use.

Temporal trends in, and risk factors for, HIV seroconversion among female sex workers accessing Zimbabwe's national sex worker programme, 2009-19: a retrospective cohort analysis of routinely collected HIV testing data.

BACKGROUND: The frequency of new HIV infections among female sex workers in sub-Saharan Africa is poorly understood. We used routinely collected data that enable unique identification of repeat HIV testers to assess temporal trends in seroconversion and identify associated risk factors for female sex workers accessing Sisters with a Voice, Zimbabwe's national sex worker programme. METHODS: We pooled HIV testing data gathered between Sept 15, 2009, and Dec 31, 2019, from 36 Sisters programme sites in Zimbabwe. We included female sex workers aged 16 years or older with an HIV-negative test and at least one subsequent programme test. We calculated HIV seroconversion rates (using the midpoint between the HIV-positive test and the last negative test as the seroconversion date) and estimated rate ratios to compare 2-year periods by using Poisson regression, with robust SEs to account for clustering by site and adjusting for age and testing frequency to assess temporal trends. We did sensitivity analyses to explore assumptions about seroconversion dates and the effects of variation in follow-up time on our conclusions. FINDINGS: Our analysis included data for 6665 female sex workers, 441 (7%) of whom seroconverted. The overall seroconversion rate was 3·8 (95% CI 3·4-4·2) per 100 person-years at risk. Seroconversion rates fell with time since first negative HIV test. After adjustment, there was evidence of a decrease in seroconversion rates from 2009 to 2019 (p=0·0053). In adjusted analyses, being younger than 25 years, and having a sexually transmitted infection diagnosis at a previous visit, were significantly associated with increased seroconversion rates. Our findings were mostly robust to sensitivity analyses, but when 1 month before an HIV-positive test was used as the seroconversion date, seroconversion rates no longer fell with time. INTERPRETATION: We identified high rates of seroconversion shortly after linkage to programme services, which emphasises the need to strengthen HIV prevention programmes from first contact with female sex workers in Zimbabwe. New infections among female sex workers remain challenging to measure, but longitudinal analysis of routine testing data can provide valuable insights into seroconversion rates and associated risk factors. FUNDING: UN Population Fund, Deutsche Gesellschaft für Internationale Zusammenarbeit, the Bill & Melinda Gates Foundation, The Global Fund to Fight AIDS, Tuberculosis and Malaria, US President's Emergency Plan for AIDS Relief, US Agency for International Development, and the Elton John AIDS Foundation.

HIV incidence among women engaging in sex work in sub-Saharan Africa: a systematic review and meta-analysis.

Introduction: HIV incidence among women in sub-Saharan Africa (SSA) has declined steadily, but it is unknown whether new infections among women who engage in sex work (WESW) have declined at a similar rate. We synthesised estimates of HIV incidence among WESW in SSA and compared these to the wider female population to understand levels and trends in incidence over time. Methods: We searched Medline, Embase, Global Health, Popline, Web of Science, and Google Scholar from January 1990 to October 2022, and grey literature for estimates of HIV incidence among WESW in SSA. We included studies reporting empirical estimates in any SSA country. We calculated incidence rate ratios (IRR) compared to age-district-year matched total female population incidence estimates. We conducted a meta-analysis of IRRs and used a continuous mixed-effects model to estimate changes in IRR over time. Results: From 32 studies between 1985 and 2020, 2,194 new HIV infections were observed in WESW over 51,000 person-years (py). Median HIV incidence was 4.3/100py (IQR 2.8-7.0/100py), declining from a median of 5.96/100py between 1985 and 1995 to a median of 3.2/100py between 2010 and 2020. Incidence among WESW was nine times higher than in matched total population women (RR 8.6, 95%CI: 5.7-12.9), and greater in Western and Central Africa (RR 22.4, 95%CI: 11.3-44.3) than in Eastern and Southern Africa (RR 5.3, 95%CI: 3.7-7.6). Annual changes in log IRRs were minimal (-0.1% 95%CI: -6.9 to +6.8%). Conclusions: Across SSA, HIV incidence among WESW remains disproportionately high compared to the total female population but showed similar rates of decline between 1990 and 2020. Improved surveillance and standardisation of approaches to obtain empirical estimates of sex worker incidence would enable a clearer understanding of whether we are on track to meet global targets for this population and better support data-driven HIV prevention programming.