The impact of community-based integrated HIV and sexual and reproductive health services for youth on population-level HIV viral load and sexually transmitted infections in Zimbabwe: protocol for the CHIEDZA cluster-randomised trial

<ns4:p><ns4:bold>Background: </ns4:bold>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.</ns4:p><ns4:p> </ns4:p><ns4:p> <ns4:bold>Protocol: </ns4:bold>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.</ns4:p><ns4:p> </ns4:p><ns4:p> Outcomes will be ascertained through a population-based survey of 18–24-year-olds. The primary outcome is HIV viral load &lt;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.</ns4:p><ns4:p> </ns4:p><ns4:p> <ns4:bold>Ethics and Dissemination: </ns4:bold>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 &amp; 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.</ns4:p><ns4:p> </ns4:p><ns4:p> <ns4:bold>Trial Registration </ns4:bold></ns4:p><ns4:p> <ns4:ext-link xmlns:ns5="http://www.w3.org/1999/xlink" ext-link-type="uri" ns5:href="https://clinicaltrials.gov/">https://clinicaltrials.gov/</ns4:ext-link>: NCT03719521</ns4:p>