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.

The burden and natural history of cardiac pathology at TB diagnosis in a high-HIV prevalence district in Zambia: protocol for the TB-Heart study.

BACKGROUND: Tuberculosis (TB) continues to be a major cause of death across sub-Saharan Africa (SSA). In parallel, non-communicable disease and especially cardiovascular disease (CVD) burden has increased substantially in the region. Cardiac manifestations of TB are well-recognised but the extent to which they co-exist with pulmonary TB (PTB) has not been systematically evaluated. The aim of this study is to improve understanding of the burden of cardiac pathology in PTB in those living with and without HIV in a high-burden setting. METHODS: This is a cross-sectional and natural history study to evaluate the burden and natural history of cardiac pathology in participants with PTB in Lusaka, Zambia, a high burden setting for TB and HIV. Participants with PTB, with and without HIV will be consecutively recruited alongside age- and sex-matched TB-uninfected comparators on a 2:1 basis. Participants will undergo baseline assessments to collect clinical, socio-demographic, functional, laboratory and TB disease impact data followed by point-of-care and standard echocardiography. Participants with PTB will undergo further repeat clinical and functional examination at two- and six months follow-up. Those with cardiac pathology at baseline will undergo repeat echocardiography at six months. DISCUSSION: The outcomes of the study are to a) determine the burden of cardiac pathology at TB diagnosis, b) describe its association with patient-defining risk factors and biochemical markers of cardiac injury and stretch and c) describe the natural history of cardiac pathology during the course of TB treatment.

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.

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.

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.

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.

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.

Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia.

BACKGROUND: HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users' ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. METHODS: Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. RESULTS: Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2-96.7) and 99.7% specific (95%CI: 99.3-99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70-91.3; specificity 99.7%, 95%CI: 99.4-99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7-96.1%; specificity 100% (95%CI: 99.8-100%) had considerably lower sensitivity. CONCLUSIONS: Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context.

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.

Insaka: mobile phone support groups for adolescent pregnant women living with HIV.

BACKGROUND: Mobile phone-based interventions have been demonstrated in different settings to overcome barriers to accessing critical psychosocial support. In this study, we aimed to assess the acceptability and feasibility of a phone-based, peer-to-peer support group intervention for adolescent pregnant women aged 15-24 years living with HIV in Zambia. METHODS: Sixty-one consenting participants were recruited from Antenatal Clinics of two large urban communities in Lusaka. They were invited to participate in the mobile phone-based intervention that allowed them to anonymously communicate in a small group led by a facilitator for 4 months. A mixed methods approach was used to assess acceptability and feasibility, including a focus group discussion, pre- and post-intervention interview and analysis of the content of the text message data generated. RESULTS: Participants reported finding the platform "not hard to use" and enjoyed the anonymity of the groups. Seventy-one percent of participants (n = 43) participated in the groups, meaning they sent text messages to their groups. Approximately 12,000 text messages were sent by participants (an average of 169 messages/user and 6 mentors in 6 groups. Topics discussed were related to social support and relationships, stigma, HIV knowledge and medication adherence. CONCLUSION: The study showed that the intervention was acceptable and feasible, and highlighted the potential of the model for overcoming existing barriers to provision of psychosocial support to this population.