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.
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.
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DOI：
10.12688/wellcomeopenres.17530.2
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发表时间：
2022
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与其他年龄组相比，青年的艾滋病毒相关结果较差。我们描述了一个群集随机试验（CRT）的协议，以评估基于社区的，综合的艾滋病毒和性与生殖健康服务的青年艾滋病毒的结果的有效性。CHIEDZA试验正在津巴布韦的三个省进行，每个省有8个地理划界区域（集群）（共24个集群），按1：1的比例随机分配到标准护理（现有卫生服务）或干预措施。干预措施包括以社区为基础提供艾滋病毒服务，包括检测、抗逆转录病毒治疗、治疗监测和坚持支持以及计划生育、性传播感染综合症管理、月经健康管理、避孕套和艾滋病毒预防以及一般健康咨询。生活在干预集群内的16-24岁青年有资格获得儿童教育和保健中心的服务。在两个省（24个集群中的16个）开展了性传播感染筛查（衣原体、淋病和滴虫病）的CRT。干预措施由一个经过培训和配置的多学科小组在30个月内提供，以提供高质量的青年友好型服务。将通过对18至24岁的人进行人口调查来确定结果。主要结果是HIV病毒载量<1000拷贝/ml的HIV感染者和STI检测阳性的比例（对于巢式试验）。将对试验进行详细的过程和成本评估。试验方案得到津巴布韦医学研究理事会、生物医学研究和培训研究所机构审查委员会和伦敦卫生与热带医学研究伦理委员会的批准。研究结果将提交给开放获取的同行评审期刊，在学术会议上介绍，并与参与社区以及国家和国际决策机构分享。 https://clinicaltrials.gov/：NCT03719521
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. 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 screening (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. 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. https://clinicaltrials.gov/: NCT03719521