Abstract
Background: Youth have poorer HIV-related outcomes when compared to other age-groups. We describe the protocol for a cluster randomised trial (CRT) to evaluate the effectiveness of community-based, integrated HIV and sexual and reproductive health services for youth on HIV outcomes. Protocol: The CHIEDZA trial is being conducted in three provinces in Zimbabwe, each with eight geographically demarcated areas (clusters) (total 24 clusters) randomised 1:1 to standard of care (existing health services) or to the intervention. The intervention comprises community-based delivery of HIV services including testing, antiretroviral therapy, treatment monitoring and adherence support as well as family planning, syndromic management of sexually transmitted infections (STIs), menstrual health management, condoms and HIV prevention and general health counselling. Youth aged 16-24 years living within intervention clusters are eligible to access CHIEDZA services. A CRT of STI testing (chlamydia, gonorrhoea and trichomoniasis) is nested in two provinces (16 of 24 clusters). The intervention is delivered over a 30-month period by a multidisciplinary team trained and configured to provide high-quality, youth friendly services. Outcomes will be ascertained through a population-based survey of 18–24-year-olds. The primary outcome is HIV viral load <1000 copies/ml in those living with HIV and proportion who test positive for STIs (for the nested trial). A detailed process and cost evaluation of the trial will be conducted. Ethics and Dissemination: The trial 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 policy-making bodies. Trial Registration https://clinicaltrials.gov/: NCT03719521
Highlights
Two-thirds of people living with HIV reside in sub-Saharan Africa (SSA)
The primary outcome is HIV viral load
The primary outcome is the product of the following three secondary outcomes among participants living with HIV: 1. Proportion who are aware of their HIV status
Summary
Two-thirds of people living with HIV reside in sub-Saharan Africa (SSA). While there has been a general global decline in new HIV infections, this has been much less marked in youth. The aim of this trial is to estimate the impact of a comprehensive community-based package of HIV services, integrated with SRH services and general health counselling for youth aged 16–24 years, on population-level HIV viral load. Wide range of services available (see above) C hoice of products where relevant e.g., menstrual management products, contraceptives, All services and commodities free of charge High quality products Trained and mentored providers System to “red-flag” youth with concerns Well-established linkages to other services aBiometrics used for recording service uptake and pseudonyms used for managing STI test results bExcept where required for clinical care e.g., registration with national HIV care programme IEC - Information, Education and Counselling SMS - Short Message Service CAPS - CHIEDZA Adolescent Peer Support. The primary outcome is the product of the following three secondary outcomes among participants living with HIV: 1. Proportion who are aware of their HIV status
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