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Background: During adolescence, behaviours are initiated that will have substantial impacts on the individual's short-term and long-term health and well-being. However, adolescents rarely have regular contact with health services, and available services are not always appropriate for their needs. We co-developed with adolescents a health and well-being check-up programme (Y-Check). This paper describes the methods to evaluate the feasibility, acceptability, short-term effects and cost-effectiveness of Y-Check in three African cities., Method: This is a multi-country prospective intervention study, with a mixed-method process evaluation. The intervention involves screening, on-the-spot care and referral of adolescents through health and well-being check-up visits. In each city, 2000 adolescents will be recruited in schools or community venues. Adolescents will be followed-up at 4 months. The study will assess the effects of Y-Check on knowledge and behaviours, as well as clinical outcomes and costs. Process and economic evaluations will investigate acceptability, feasibility, uptake, fidelity and cost effectiveness., Ethics and Dissemination: Approval has been received from the WHO (WHO/ERC Protocol ID Number ERC.0003778); Ghana Health Service (Protocol ID Number GHS-ERC: 027/07/22), the United Republic of Tanzania National Institute for Medical Research (Clearance No. NIMR/HQ/R.8a/Vol.IX/4199), the Medical Research Council of Zimbabwe (Approval Number MRCZ/A/2766) and the LSHTM (Approval Numbers 26 395 and 28312). Consent and disclosure are addressed in the paper. Results will be published in three country-specific peer-reviewed journal publications, and one multicountry publication; and disseminated through videos, briefs and webinars. Data will be placed into an open access repository. Data will be deidentified and anonymised., Trial Registration Number: NCT06090006., Competing Interests: Competing interests: PB and VB are WHO staff members. The opinions expressed are theirs and do not necessarily represent the policies and positions of the WHO. The other authors declared no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objectives: Hazardous drinking (HD) and substance use (SU) can lead to disinhibited behaviour and are both growing public health problems among Southern African youths. We investigated the prevalence of SU and HD and their association with risky sexual behaviour among youth in Zimbabwe., Design: Data analysis from a population-based survey conducted between October 2021 and June 2022 to ascertain the outcomes of a cluster randomised trial (CHIEDZA: Trial registration number:NCT03719521). Trial Stage: Post-results., Setting: 24 communities in three provinces in Zimbabwe., Participants: Youth aged 18-24 years living in randomly selected households., Outcome Measures: HD was defined as an Alcohol Use Disorders Identification Test score ≥8, SU was defined as ever use of ≥1 commonly used substances in the local setting., Results: Of 17 585 participants eligible for this analysis, 61% were women and the median age was 20 (IQR: 19-22) years. Overall, 4.5% and 7.0% of participants reported HD and SU, respectively. Men had a substantially higher prevalence than women of HD (8.2% vs 1.9%) and SU (15.1% vs 1.5%). Among men, after adjusting for socio-demographic factors, we found increased odds of having >1 sexual partner in those who engaged in SU (adjusted OR (aOR)=2.67, 95% CI: 2.21 to 3.22), HD (aOR=3.40, 95% CI: 2.71 to 4.26) and concurrent HD and SU (aOR=4.57,95% CI: 3.59 to 5.81) compared with those who did not engage in HD or SU. Similarly, there were increased odds of receiving/providing transactional sex among men who engaged in SU (aOR=2.51, 95% CI: 1.68 to 3.74), HD (aOR=3.60, 95% CI: 2.24 to 5.79), and concurrent HD and SU (aOR=7.74, 95% CI: 5.44 to 11.0). SU was associated with 22% increased odds of inconsistent condom use in men (aOR=1.22, 95% CI: 1.03 to 1.47). In women, the odds of having >1 sexual partner and having transactional sex were also increased among those who engaged in SU and HD., Conclusion: SU and HD are associated with sexual behaviours that increase the risk of HIV acquisition in youth. Sexual and reproductive health interventions must consider HD and SU as potential drivers of risky sexual behaviour in youths., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Sexually transmitted infections (STIs) can cause serious morbidity, including pelvic inflammatory disease, and adverse pregnancy outcomes. In low/middle-income countries, limited laboratory infrastructure has resulted in a syndrome-based approach being used for management of STIs, which has poor sensitivity and specificity, leading to considerable underdiagnosis and overtreatment. The WHO has called for development and evaluation of strategies to inform replacement of syndromic management by diagnostic testing.The aim of this project is to evaluate a strategy of point-of-care testing for six STIs in antenatal care (ANC) in Zimbabwe., Methods and Analysis: A prospective interventional study will be conducted in ANC clinics in Harare province, Zimbabwe. One thousand pregnant women will be recruited when registering for routine ANC. Alongside routine HIV and syphilis testing, participants will be offered an integrated screening package including testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and hepatitis B. All individuals with STIs will receive treatment, partner notification services, risk reduction counselling and referral if needed according to national guidelines. Gonorrhoea samples will be cultured and tested for antimicrobial resistance as per WHO enhanced gonococcal antimicrobial surveillance programme guidelines.The primary outcome measure is the composite prevalence of CT, NG, TV, syphilis and hepatitis B. A mixed-methods process evaluation and economic evaluation will be conducted to understand the acceptability, feasibility and cost-effectiveness of integrated STI testing, compared with standard of care (syndromic management)., Ethics and Dissemination: The study protocol was approved by the Medical Research Council of Zimbabwe, the Biomedical Research and Training Institute Institutional Review Board, and the London School of Hygiene & Tropical Medicine Research Ethics Committee. Results will be submitted to open-access peer-reviewed journals, presented at academic meetings and shared with participating communities and with national and international policymaking bodies., Trial Registration Number: NCT05541081., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To estimate the prevalence of common mental health disorders (CMDs) and emotional and behavioural disorders among young people and to explore the correlates of CMDs risk., Setting: Five urban and periurban communities in Harare and Mashonaland East, Zimbabwe DESIGN: Population-based cross-sectional study PARTICIPANTS: Young people aged 13-24 years living in households in the study areas., Outcome Measures: The primary outcome was the proportion of participants screening positive for probable CMDs defined as a Shona Symptoms Questionnaire (SSQ) score ≥8. Secondary outcomes were emotional and behavioural disorders measured using the Strength and Difficulties Questionnaire (SDQ), and adjusted ORs for factors associated with CMD., Results: Out of 634 young people, 37.4% (95% CI 33.0% to 42.0%) screened positive for probable CMDs, 9.8% (95% CI 7.5% to 12.7%) reported perceptual symptoms and 11.2% (95% CI 9.0% to 13.8%) reported suicidal ideation. Using UK norms to define normal, borderline and abnormal scores for each of the SDQ domains, a high proportion (15.8%) of Zimbabwean young people had abnormal scores for emotional symptoms and a low proportion had abnormal scores for hyperactivity/inattention scores (2.8%) and prosocial scores (7.1%). We created local cut-offs for the emotional symptoms, hyperactivity/attention and prosocial SDQ domains. The odds of probable CMDs increased with each year of age (OR 1.09, p<0.001) and was higher among those who were out of school and not working compared with those in school or working (adj. OR 1.67 (1.07, 2.62), p=0.04). One in five participants (22.1%) were referred immediately for further clinical assessment but uptake of referral services was low., Conclusions: We observed a high prevalence of symptoms of CMDs among general population urban and peri-urban young people especially among those with no employment. There is a need for more accessible and acceptable youth-friendly mental health services., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objectives: While integral to women's physical and mental well-being, achieving good menstrual health (MH) remains a challenge for many women. This study investigated the effectiveness of a comprehensive MH intervention on menstrual knowledge, perceptions and practices among women aged 16-24 years in Harare, Zimbabwe., Design: A mixed-methods prospective cohort study with pre-post evaluation of an MH intervention., Setting: Two intervention clusters in Harare, Zimbabwe., Participants: Overall, 303 female participants were recruited, of whom 189 (62.4%) were seen at midline (median follow-up 7.0; IQR 5.8-7.7 months) and 184 (60.7%) were seen at endline (median follow-up 12.4; IQR 11.9-13.8 months). Cohort follow-up was greatly affected by COVID-19 pandemic and associated restrictions., Intervention: The MH intervention provided MH education and support, analgesics, and a choice of menstrual products in a community-based setting to improve MH outcomes among young women in Zimbabwe., Primary and Secondary Outcomes: Effectiveness of a comprehensive MH intervention on improving MH knowledge, perceptions, and practices among young women over time. Quantitative questionnaire data were collected at baseline, midline, and endline. At endline, thematic analysis of four focus group discussions was used to further explore participants' menstrual product use and experiences of the intervention., Results: At midline, more participants had correct/positive responses for MH knowledge (adjusted OR (aOR)=12.14; 95% CI: 6.8 to 21.8), perceptions (aOR=2.85; 95% CI: 1.6 to 5.1) and practices for reusable pads (aOR=4.68; 95% CI: 2.3 to 9.6) than at baseline. Results were similar comparing endline with baseline for all MH outcomes. Qualitative findings showed that sociocultural norms, stigma and taboos around menstruation, and environmental factors such as limited access to water, sanitation and hygiene facilities affected the effect of the intervention on MH outcomes., Conclusions: The intervention improved MH knowledge, perceptions and practices among young women in Zimbabwe, and the comprehensive nature of the intervention was key to this. MH interventions should address interpersonal, environmental and societal factors., Trial Registration Number: NCT03719521., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objective: Post-randomisation exclusions in randomised controlled trials are common and may include participants identified as not meeting trial eligibility criteria after randomisation. We report how a decision might be reached and reported on, to include or exclude these participants. We illustrate using a motivating scenario from the BREATHE trial (Trial registration ClinicalTrials.gov, NCT02426112) evaluating azithromycin for the treatment of chronic lung disease in people aged 6-19 years with HIV in Zimbabwe and Malawi., Key Points: Including all enrolled and randomised participants in the primary analysis of a trial ensures an unbiased estimate of the intervention effect using intention-to-treat principles, and minimises the effects of confounding through balanced allocation to trial arm. Ineligible participants are sometimes enrolled, due to measurement or human error. Of 347 participants enrolled into the BREATHE trial, 11 (3.2%) were subsequently found to be ineligible based on lung function criteria. We assumed no safety risk of azithromycin treatment; their inclusion in the trial and subsequent analysis of the intervention effect therefore mirrors clinical practice. Senior trial investigators considered diurnal variations in the measurement of lung function, advantages of retaining a higher sample size and advice from the Data Safety and Monitoring Board and Trial Steering Committee, and decided to include these participants in primary analysis. We planned and reported analyses including and excluding these participants, and in our case the interpretation of treatment effect was consistent., Conclusion: The decision, by senior investigators, on whether to exclude enrolled participants, should reflect issues of safety, treatment efficacy, statistical power and measurement error. As long as decisions are made prior to finalising the statistical analysis plan for the trial, the risk of exclusions creating bias should be minimal. The decision taken should be transparently reported and a sensitivity analysis can present the opposite decision., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Introduction: In April 2019, 14 children were diagnosed with HIV infection by a private healthcare provider in Larkana district, Sindh province, Pakistan. Over the next 3 months, 930 individuals were diagnosed with HIV, >80% below 16 years, the largest ever outbreak of HIV in children in Pakistan. In this protocol paper, we describe research methods for assessing likely modes of HIV transmission in this outbreak and investigate spatial and molecular epidemiology., Methods and Analysis: A matched case-control study will be conducted with 406 cases recruited. Cases will be children aged below 16 years registered for care at the HIV treatment centre at Shaikh Zayed Children Hospital in Larkana City. Controls will be children who are HIV-uninfected (confirmed by a rapid HIV test) matched 1:1 by age (within 1 year), sex and neighbourhood. Following written informed consent from the guardian, a structured questionnaire will be administered to collect data on sociodemographic indices and exposure to risk factors for parenteral, vertical and sexual (only among those aged above 10 years) HIV transmission. A blood sample will be collected for hepatitis B and C serology (cases and controls) and HIV lineage studies (cases only). Mothers of participants will be tested for HIV to investigate the possibility of mother-to-child transmission. Conditional logistic regression will be used to investigate the association of a priori defined risk factors with HIV infection. Phylogenetic analyses will be conducted. Global positioning system coordinates of participants' addresses will be collected to investigate concordance between the genetic and spatial epidemiology., Ethics and Dissemination: Ethical approval was granted by the Ethics Review Committee of the Aga Khan University, Karachi. Study results will be shared with Sindh and National AIDS Control Programs, relevant governmental and non-governmental organisations, presented at national and international research conferences and published in international peer-reviewed scientific journals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The scale-up of antiretroviral therapy (ART) across sub-Saharan Africa (SSA) has reduced mortality so that increasing numbers of children with HIV (CWH) are surviving to adolescence. However, they experience a range of morbidities due to chronic HIV infection and its treatment. Impaired linear growth (stunting) is a common manifestation, affecting up to 50% of children. However, the effect of HIV on bone and muscle development during adolescent growth is not well characterised. Given the close link between pubertal timing and musculoskeletal development, any impairments in adolescence are likely to impact on future adult musculoskeletal health. We hypothesise that bone and muscle mass accrual in CWH is reduced, putting them at risk of reduced bone mineral density (BMD) and muscle function and increasing fracture risk. This study aims to determine the impact of HIV on BMD and muscle function in peripubertal children on ART in Zimbabwe., Methods and Analysis: Children with (n=300) and without HIV (n=300), aged 8-16 years, established on ART, will be recruited into a frequency-matched prospective cohort study and compared. Musculoskeletal assessments including dual-energy X-ray absorptiometry, peripheral quantitative computed tomography, grip strength and standing long jump will be conducted at baseline and after 1 year. Linear regression will be used to estimate mean size-adjusted bone density and Z-scores by HIV status (ie, total-body less-head bone mineral content for lean mass adjusted for height and lumbar spine bone mineral apparent density. The prevalence of low size-adjusted BMD (ie, Z-scores <-2) will also be determined., Ethics and Dissemination: Ethical approval for this study has been granted by the Medical Research Council of Zimbabwe and the London School of Hygiene and Tropical Medicine Ethics Committee. Baseline and longitudinal analyses will be published in peer-reviewed journals and disseminated to research communities., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Introduction: The number of new paediatric infections per year has declined in sub-Saharan Africa due to prevention-of-mother-to-child HIV transmission programmes; many children and adolescents living with HIV remain undiagnosed. In this protocol paper, we describe the methodology for evaluating an index-linked HIV testing approach for children aged 2-18 years in health facility and community settings in Zimbabwe., Methods and Analysis: Individuals attending for HIV care at selected primary healthcare clinics (PHCs) will be asked if they have any children aged 2-18 years in their households who have not been tested for HIV. Three options for HIV testing for these children will be offered: testing at the PHC; home-based testing performed by community workers; or an oral mucosal HIV test given to the caregiver to test the children at home. All eligible children will be followed-up to ascertain whether HIV testing occurred. For those who did not test, reasons will be determined, and for those who tested, the HIV test result will be recorded. The primary outcome will be uptake of HIV testing. The secondary outcomes will be preferred HIV testing method, HIV yield, prevalence and proportion of those testing positive linking to care and having an undetectable viral load at 12 months. HIV test results will be stratified by sex and age group, and factors associated with uptake of HIV testing and choice of HIV testing method will be investigated., Ethics and Dissemination: Ethical approval for this study was granted by the Medical Research Council of Zimbabwe, the London School of Hygiene and Tropical Medicine and the Institutional Review Board of the Biomedical Research and Training Institute. Study results will be presented at national policy meetings and national and international research conferences. Results will also be published in international peer-reviewed scientific journals and disseminated to study communities at the end of study., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)