Understanding the language barriers to translating informed consent documents for maternal health trials in Zambia: a qualitative study.

OBJECTIVE: Providing comprehensible information is essential to the process of valid informed consent. Recruitment materials designed by sponsoring institutions in English-speaking, high-income countries are commonly translated for use in global health studies in other countries; however, key concepts are often missed, misunderstood or 'lost in translation'. The aim of this study was to explore the language barriers to informed consent, focusing on the challenges of translating recruitment materials for maternal health studies into Zambian languages. DESIGN: We used a qualitative approach, which incorporated a multistakeholder workshop (11 participants), in-depth interviews with researchers and translators (8 participants) and two community-based focus groups with volunteers from community advisory boards (20 participants). Content analysis was used to identify terms commonly occurring in recruitment materials prior to the workshop. The framework analysis approach was used to analyse interview data, and a simple inductive thematic analysis approach was used to analyse focus group data. SETTING: The study was based in Lusaka, Zambia. RESULTS: The workshop highlighted difficulties in translating research terms and pregnancy-specific terms, as well as widespread concern that current templates are too long, use overly formal language and are designed with little input from local teams. Framework analysis of in-depth interviews identified barriers to participant understanding relating to design and development of recruitment materials, language, local context and communication styles. Focus group participants confirmed these findings and suggested potential solutions to ensure the language and content of recruitment materials can be better understood. CONCLUSION: Our findings demonstrate that the way in which recruitment materials are currently designed, translated and disseminated may not enable potential trial participants to fully understand the information provided. Instead of using overly complex institutional templates, recruitment materials should be created through an iterative and interactive process that provides truly comprehensible information in a format appropriate for its intended participants.

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.

Evaluation of COVID-19 antigen rapid diagnostic tests for self-testing in Lesotho and Zambia.

INTRODUCTION: The use of antigen rapid tests (Ag-RDTs) for self-testing is an important element of the COVID-19 control strategy and has been widely supported. However, scale-up of self-testing for COVID-19 in sub-Saharan Africa is still insufficient and there is limited evidence on the acceptability of self-testing and agreement between Ag-RDT self-testing and Ag-RDT testing by professional users. A joint collaboration (Botnar Research Centre for Child Health-European & Developing countries Clinical Trials Partnership)was established between Lesotho and Zambia to address these gaps in relation to Ag-RDT self-testing and contribute to increasing its use in the region. METHODS: A cross-sectional study was conducted with qualitative and quantitative data analysis. Firstly, 14 in-depth cognitive interviews (5 in Zambia and 9 in Lesotho) were performed to assess the participants' understanding of the instructions for use (IFU) for self-testing. In a second step, evaluation of test agreement between Ag-RDT self-testing and Ag-RDT testing by professional user using SD Biosensor STANDARD Q COVID-19 Ag-RDT was performed. In Zambia, usability and acceptability of self-testing were also assessed. RESULTS: Cognitive interviews in Lesotho and Zambia showed overall good understanding of IFU. In Zambia, acceptability of self-testing was high, though some participants had difficulties in conducting certain steps in the IFU correctly. Agreement between Ag-RDT self-test and Ag-RDT by professional users in Lesotho (428 participants) and Zambia (1136 participants) was high, 97.3% (403/414, 95% CI: 95.3-98.7) and 99.8% (1116/1118, 95% CI: 99.4-100) respectively. CONCLUSION: Findings from this study support the use of Ag-RDT self-testing within COVID-19 control strategies in sub-Saharan Africa, contributing to increase the testing capacity and access in hard-to reach settings.

Demographics of sources of HIV-1 transmission in Zambia: a molecular epidemiology analysis in the HPTN 071 PopART study.

BACKGROUND: In the last decade, universally available antiretroviral therapy (ART) has led to greatly improved health and survival of people living with HIV in sub-Saharan Africa, but new infections continue to appear. The design of effective prevention strategies requires the demographic characterisation of individuals acting as sources of infection, which is the aim of this study. METHODS: Between 2014 and 2018, the HPTN 071 PopART study was conducted to quantify the public health benefits of ART. Viral samples from 7124 study participants in Zambia were deep-sequenced as part of HPTN 071-02 PopART Phylogenetics, an ancillary study. We used these sequences to identify likely transmission pairs. After demographic weighting of the recipients in these pairs to match the overall HIV-positive population, we analysed the demographic characteristics of the sources to better understand transmission in the general population. FINDINGS: We identified a total of 300 likely transmission pairs. 178 (59·4%) were male to female, with 130 (95% CI 110-150; 43·3%) from males aged 25-40 years. Overall, men transmitted 2·09-fold (2·06-2·29) more infections per capita than women, a ratio peaking at 5·87 (2·78-15·8) in the 35-39 years source age group. 40 (26-57; 13·2%) transmissions linked individuals from different communities in the trial. Of 288 sources with recorded information on drug resistance mutations, 52 (38-69; 18·1%) carried viruses resistant to first-line ART. INTERPRETATION: HIV-1 transmission in the HPTN 071 study communities comes from a wide range of age and sex groups, and there is no outsized contribution to new infections from importation or drug resistance mutations. Men aged 25-39 years, underserved by current treatment and prevention services, should be prioritised for HIV testing and ART. FUNDING: National Institute of Allergy and Infectious Diseases, US President's Emergency Plan for AIDS Relief, International Initiative for Impact Evaluation, Bill & Melinda Gates Foundation, National Institute on Drug Abuse, and National Institute of Mental Health.

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.

Facilitators and barriers to COVID-19 testing in community and clinical settings: Lessons learned from Lesotho and Zambia.

The sudden emergence of the coronavirus disease 2019 (COVID-19) had a devastating impact on health systems and population health globally. To combat the spread of COVID-19, countries enacted guidelines and safety measures, including testing, contact tracing, and quarantine. It was unclear the extent to which uptake of COVID-19 testing and other health initiatives would be accepted in countries with a history of dealing with widespread communicable disease transmission such as HIV or Tuberculosis. The objective of this study was to understand and compare the facilitators and barriers to COVID-19 testing at hospital sites in two rural communities in Lesotho and community spaces (referred to as hubs) in one urban community in Zambia during active phases of COVID-19 pandemic. Individual interviews and focus group discussions (FGDs) were held during March-October 2021 to explore facilitators and barriers to COVID-19 testing. FGDs with 105 community members and health care workers, and 16 individual interviews with key informants and four mystery shoppers were conducted across the two countries. In Zambia, four mystery shopper observations, and eight hub observations were also conducted. Individual country codebooks were developed and combined; thematic analyses were then conducted using the combined codebook. Findings were compared across the two countries, and most were consistent across the two countries. Two primary themes emerged that related to both barriers and facilitators: (1) structural conditions; (2) social implications and attitudes. The structural conditions that operated as barriers in both countries included public health isolation measures and misinformation. In Lesotho, the cost of tests was an additional barrier. The only structural facilitators were in Zambia where the community hubs were found to be accessible and convenient. The social implication barriers related to fear of isolation, stigma, and mental health implications because of quarantine, perceived pain of the test, and compromised privacy. Social facilitators that led to people testing included experiencing COVID-19 firsthand and knowing people who had died because of COVID-19. Across both countries, primary barriers and facilitators to COVID-19 related to structural conditions and social implications and attitudes. Public health measures can be at odds with social and economic realities; pandemic response should balance public health control and the socio-economic needs. Data from Zambia revealed that community-based settings have the potential to increase uptake of testing services. Community-based campaigns to normalize and reduce stigma for COVID-19 testing services are needed.

Predictors of participant retention in a community-based HIV prevention cohort: perspectives from the HPTN 071 (PopART) study.

INTRODUCTION: In 2021, there were 38.4 million people living with HIV (PLHIV) globally, of which 20.6 million (54%) were living in Eastern and Southern Africa. Longitudinal studies, inclusive of community randomized trials (CRTs), provide critical evidence to guide a broad range of health care interventions including HIV prevention. In this study, we have used an individual-level cohort study design to evaluate the association between sex and other baseline characteristics and participant retention in the HPTN 071 (PopART) trial in Zambia and South Africa. METHODS: HPTN 071 (PopART) was a community randomized trial (CRT) conducted from 2013 to 2018, in 21 communities. The primary outcome was measured in a randomly selected population cohort (PC), followed up over 3 to 4 years at annual rounds. PC retention was defined as completion of an annual follow-up questionnaire. Baseline characteristics were described by study arm and Poisson regression analyses used to measure the association between baseline factors and retention. In addition, we present a description of researcher-documented reasons for study withdrawal by PC participants. RESULTS: Of the 38,474 participants enrolled during the first round of the trial (PC0), most were women (27,139, 71%) and 73% completed at least one follow-up visit. Retention was lower in men (adj RR: 0.90; 95% CI: 0.88, 0.91) and higher among older participants (adj RR: 1.23; 95% CI 1.20, 1.26) when comparing ages 35-44 to 18-24 years. Retention was higher among individuals with high socioeconomic status (SES) (adj RR 1.16; 95% CI 1.14, 1.19) and medium SES (adj RR 1.12; 95% CI 1.09, 1.14) compared to low SES. The most common reasons for study withdrawal were study refusal (23%) and relocation outside the CRT catchment area (66%). CONCLUSION: Despite challenges, satisfactory retention outcomes were achieved in PopART with limited variability across study arms. In keeping with other studies, younger age, male sex, and lower SES were associated with lower levels of retention. Relocation outside of catchment area was the most common reason for non-retention in this CRT.

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.

Delays in seeking, reaching and access to quality cancer care in sub-Saharan Africa: a systematic review.

OBJECTIVES: Late presentation and delays in diagnosis and treatment consistently translate into poor outcomes in sub-Saharan Africa (SSA). The aim of this study was to collate and appraise the factors influencing diagnostic and treatment delays of adult solid tumours in SSA. DESIGN: Systematic review with assessment of bias using Risk of Bias in Non-randomised Studies of Exposures (ROBINS-E) tool. DATA SOURCES: PubMed and Embase, for publications from January 1995 to March 2021. ELIGIBILITY CRITERIA: Inclusion criteria: quantitative or mixed-method research, publications in English, on solid cancers in SSA countries. EXCLUSION CRITERIA: paediatric populations, haematologic malignancies, and assessments of public perceptions and awareness of cancer (since the focus was on patients with a cancer diagnosis and treatment pathways). DATA EXTRACTION AND SYNTHESIS: Two reviewers extracted and validated the studies. Data included year of publication; country; demographic characteristics; country-level setting; disease subsite; study design; type of delay, reasons for delay and primary outcomes. RESULTS: 57 out of 193 full-text reviews were included. 40% were from Nigeria or Ethiopia. 70% focused on breast or cervical cancer. 43 studies had a high risk of bias at preliminary stages of quality assessment. 14 studies met the criteria for full assessment and all totaled to either high or very high risk of bias across seven domains. Reasons for delays included high costs of diagnostic and treatment services; lack of coordination between primary, secondary and tertiary healthcare sectors; inadequate staffing; and continued reliance on traditional healers and complimentary medicines. CONCLUSIONS: Robust research to inform policy on the barriers to quality cancer care in SSA is absent. The focus of most research is on breast and cervical cancers. Research outputs are from few countries. It is imperative that we investigate the complex interaction of these factors to build resilient and effective cancer control programmes.

Uptake of medical male circumcision with household-based testing, and the association of traditional male circumcision and HIV infection.

OBJECTIVES: Voluntary medical male circumcision (VMMC) is an important component of combination HIV prevention. Inclusion of traditionally circumcised HIV negative men in VMMC uptake campaigns may be important if traditional male circumcision is less protective against HIV acquisition than VMMC. METHODS: We used data from the HIV Prevention Trials Network (HPTN) 071 (PopART) study. This cluster-randomized trial assessed the impact of a combination prevention package on population-level HIV incidence in 21 study communities in Zambia and South Africa. We evaluated uptake of VMMC, using a two-stage analysis approach and used discrete-time survival analysis to evaluate the association between the types of male circumcision and HIV incidence. RESULTS: A total of 10 803 HIV-negative men with self-reported circumcision status were included in this study. At baseline, 56% reported being uncircumcised, 26% traditionally circumcised and 18% were medically circumcised. During the PopART intervention, 11% of uncircumcised men reported uptake of medical male circumcision. We found no significant difference in the uptake of VMMC in communities receiving the PopART intervention package and standard of care {adj. rate ratio=1·10 [95% confidence interval (CI) 0.82, 1.50, P  = 0.48]}. The rate of HIV acquisition for medically circumcised men was 70% lower than for those who were uncircumcised adjusted hazard ratio (adjHR) = 0.30 (95% CI 0.16-0.55; P  < 0.0001). There was no difference in rate of HIV acquisition for traditionally circumcised men compared to those uncircumcised adjHR = 0.84 (95% CI 0.54, 1.31; P  = 0.45). CONCLUSIONS: Household-based delivery of HIV testing followed by referral for medical male circumcision did not result in substantial VMMC uptake. Traditional circumcision is not associated with lower risk of HIV acquisition.

Disseminating complex primary outcome results from a community-randomised trial to Zambian communities: lessons learned using a community dialogue approach in the HPTN 071 (PopART) trial.

The HPTN 071 (PopART) trial of universal HIV testing and treatment to reduce HIV incidence was conducted in nine communities in South Africa and 12 in Zambia. The trial's primary outcome results were complicated to explain. Dissemination of these complicated results in participating communities in Zambia was done using a community dialogue approach. The approach, which involved interactive activities and a gradual and systematic approach to discussion of results in each community, facilitated respect and inclusion of participants in the dissemination process. The use of local language, pictures, images, and familiar analogies enhanced comprehension of the findings and created a two-way communication process between researchers and participants. The dialogue approach enabled both groups to use community perspectives, lived experiences, and local socio-structural features to interpret the trial results. Further, community members reflected on what the results meant to them individually and collectively. Although this community dialogue was both productive and appreciated, making this community interpretation apparent across disciplines in key quantitative scientific outputs remained a challenge.

Assessing knowledge, acceptability and social implications of a peer-to-peer HIV self-testing kit distribution model among adolescents aged 15-24 in Zambia and Uganda-HISTAZU: a mixed-method study protocol.

INTRODUCTION: HIV self-testing (HIVST) across sub-Saharan African countries may be acceptable as it overcomes significant barriers to clinic-based HIV testing services such as privacy and confidentiality. There are a number of suggested HIVST distribution models. However, they may not be responsive to the testing service needs of adolescents and young people (AYP). We will investigate the knowledge, acceptability and social implications of a peer-to-peer distribution model of HIVST kits on uptake of HIV prevention including pre-exposure prophylaxis, condoms, and voluntary medical male circumcision and testing services and linkage to anti-retroviral therapy among AYP aged 15-24 in Zambia and Uganda. METHODS AND ANALYSIS: We will conduct an exploratory mixed methods study among AYP aged 15-24 in Uganda and Zambia. Qualitative data will be collected using audio-recorded in-depth interviews (IDIs), focus group discussions (FGDs), and participant observations. All IDIs and FGDs will be transcribed verbatim, coded and analysed through a thematic-content analysis. The quantitative data will be collected through a structured survey questionnaire derived from the preliminary findings of the qualitative work and programme evaluation quantitative data collected on uptake of services from a Zambian trial. The quantitative phase will evaluate the number of AYP reached and interested in HIVST and the implication of this on household social relations and social harms. The quantitative data will be analysed through bivariate analyses. The study will explore any social-cultural and study design barriers or facilitators to uptake of HIVST. ETHICS AND DISSEMINATION: This study is approved by the Uganda Virus Research Institute Research and Ethics committee, Uganda National Council for Science and Technology, University of Zambia Biomedical Ethics Committee, Zambia National Health Research Authority and the London School of Hygiene and Tropical Medicine. Dissemination activities will involve publications in peer-reviewed journals, presentations at conferences and stakeholder meetings in the communities.

"You have a self-testing method that preserves privacy so how come you cannot give us treatment that does too?" Exploring the reasoning among young people about linkage to prevention, care and treatment after HIV self-testing in Southern Malawi.

BACKGROUND: Young people, aged 16-24, in southern Malawi have high uptake of HIV self-testing (HIVST) but low rates of linking to services following HIVST, especially in comparison, to older generations. The study aim is to explore the barriers and facilitators to linkage for HIV prevention and care following uptake of HIV self-testing among young Malawians. METHODS: We used qualitative methods. Young people aged 16-24 who had received HIVST; community-based distribution agents (CBDAs) and health care workers from the linked facilities were purposively sampled from two villages in rural southern Malawi. RESULTS: We conducted in-depth interviews with thirteen young people (9 female) and held four focus groups with 28 healthcare workers and CBDAs. Young people strongly felt the social consequences associated with inadvertent disclosure of HIV sero-status were a significant deterrent to linkage at their stage in life. They also felt communication on testing benefits and the referral process after testing was poor. In contrast, they valued encouragement from those they trusted, other's positive treatment experiences and having a "strength of mind". CBDAs were important facilitators for young people as they are able to foster a trusting relationship and had more understanding of the factors which prevented young people from linking following HIVST than the healthcare workers. Young people noted contextual barriers to linkage, for example, being seen on the road to the healthcare centre, but also societal gendered barriers. For example, young females and younger adolescents were less likely to have the financial independence to link to services whilst young males (aged 19-24) had the finances but lacked a supportive network to encourage linkage following testing. Overall, it was felt that the primary "responsibility" for linking to formal healthcare following self-testing is shouldered by the young person and not the healthcare system. CONCLUSIONS: Young people are happy to self-test for HIV but faced barriers to link to services following a self-test. Potential interventions for improving linkage suggested by this analysis include the establishment of youth-friendly linkage services, enhanced lines of communication between young people and healthcare providers and prioritising linkage for future interventions when targeting young people following HIVST.

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.

Closing the gap: did delivery approaches complementary to home-based testing reach men with HIV testing services during and after the HPTN 071 (PopART) trial in Zambia?

INTRODUCTION: The HPTN 071 (PopART) trial demonstrated that universal HIV testing-and-treatment reduced community-level HIV incidence. Door-to-door delivery of HIV testing services (HTS) was one of the main components of the intervention. From an early stage, men were less likely to know their HIV status than women, primarily because they were not home during service delivery. To reach more men, different strategies were implemented during the trial. We present the relative contribution of these strategies to coverage of HTS and the impact of community hubs implemented after completion of the trial among men. METHODS: Between 2013 and 2017, three intervention rounds (IRs) of door-to-door HTS delivery were conducted in eight PopART communities in Zambia. Additional strategies implemented in parallel, included: community-wide "Man-up" campaigns (IR1), smaller HTS campaigns at work/social places (IR2) and revisits to households with the option of HIV self-testing (HIVST) (IR3). In 2018, community "hubs" offering HTS were implemented for 7 months in all eight communities. Population enumeration data for each round of HTS provided the denominator, allowing for calculation of the proportion of men tested as a result of each strategy during different time periods. RESULTS: By the end of the three IRs, 65-75% of men were reached with HTS, primarily through door-to-door service delivery. In IR1 and IR2, "Man-up" and work/social place campaigns accounted for ∼1 percentage point each and in IR3, revisits with the option of self-testing for ∼15 percentage points of this total coverage per IR. The yield of newly diagnosed HIV-positive men ranged from 2.2% for HIVST revisits to 9.9% in work/social places. At community hubs, the majority of visitors accepting services were men (62.8%). In total, we estimated that ∼36% (2.2% tested HIV positive) of men resident but not found at their household during IR3 of PopART accessed HTS provided at the hubs after trial completion. CONCLUSIONS: Achieving high coverage of HTS among men requires universal, home-based service delivery combined with an option of HIVST and delivery of HTS through community-based hubs. When men are reached, they are willing to test for HIV. Reaching men thus requires implementers to adapt their HTS delivery strategies to meet men's needs. CLINICAL TRIAL NUMBER: NCT01900977.

Adolescent Health Series: Engagement with young people as partners in health research: Four case studies from Sub-Saharan Africa.

OBJECTIVES: Existing health services for young people (YP)(10-24 years), which are predominantly designed for but not with young people, often do not meet YP's needs. The 2018 Global Consensus Statement on meaningful adolescent and youth engagement affirms that YP have a fundamental right to actively and meaningfully engage in all matters that affect their lives. We present four case studies from three countries in sub-Saharan Africa as practical examples of the engagement of young people as partners in health research. We critically reflect on best practices to inform and guide the increasing adoption of collaborative approaches. METHODS: We developed a narrative summary of each case study through review of study documentation and discussions with research staff and young people. A youth engagement framework was used to describe partnership activities according to the following dimensions: purpose, process, positioning, perspective, power relations, place and protection. We reflected on innovative practices used, overall level of participation achieved and strategies to address ethical, logistical and/or financial barriers. RESULTS: In all case studies, we found evidence of engagement activities that aligned with the Global Consensus Statement on Meaningful Youth Engagement. However, access to participation was often uneven and despite efforts, marginalised young people continue to have insufficient opportunities to engage. Furthermore, although young people had some opportunity to influence the research methods, many of the key design decisions had been determined prior to their involvement. In our case studies, researchers had built in insufficient opportunities to evaluate the level and impact of youth engagement. CONCLUSIONS: We therefore recommend early involvement of young people in the research process so that they can contribute to setting the research agenda, the design of planned studies and thus increase the scope of their engagement from the beginning. Youth engagement activities need to be evaluated from the perspective of all stakeholders including young people themselves with a focus on opportunities to engage, the level of engagement achieved and impact of engagement. From the beginning, researchers should provide space for learning, and involve young people in encouraging critical reflection of what does not yet work, as well as what does, to enable improvements.