Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Level 5, Falmouth Building, Anzio Road, Cape Town, South Africa.
ICAP at Columbia University, Mailman School of Public Health, New York, USA.
Trials. 2021 Dec 27;22(1):956. doi: 10.1186/s13063-021-05943-w.
Adolescents and youth living with HIV (AYAHIV) have worse HIV outcomes than other age groups, particularly in sub-Saharan Africa (SSA). AYAHIV in SSA face formidable health system, interpersonal- and individual-level barriers to retention in HIV care, uptake of ART, and achievement of viral suppression (VS), underscoring an urgent need for multi-component interventions to address these challenges. This cluster-randomized control trial (cRCT) aims to evaluate the effectiveness and monitor implementation of a community-informed multi-component intervention ("CombinADO strategy") addressing individual-, facility-, and community-level factors to improve health outcomes for AYAHIV.
This trial will be conducted in 12 clinics in Nampula Province, Northern Mozambique. All clinics will implement an optimized standard of care (control) including (1) billboards/posters and radio shows, (2) healthcare worker (HCW) training, (3) one-stop adolescent and youth-friendly services, (4) information/motivation walls, (5) pill containers, and (6) tools to be used by HCW during clinical visits. The CombinADO strategy (intervention) will be superadded to control conditions at 6 randomly selected clinics. It will include five additional components: (1) peer support, (2) informational/motivational video, (3) support groups for AYAHIV caregivers, (4) AYAHIV support groups, and (5) mental health screening and linkage to adolescent-focused mental health support. The study conditions will be in place for 12 months; all AYAHIV (ages 10-24 years, on ART) seeking care in the participating sites will be exposed to either the control or intervention condition based on the clinic they attend. The primary outcome is VS (viral load < 50 copies/mL) at 12 months among AYAHIV attending participating clinics. Secondary outcomes include ART adherence (self-reported and TDF levels) and retention in care (engagement in the preceding 90 days). Uptake, feasibility, acceptability, and fidelity of the CombinADO strategy during implementation will be measured. Trial outcomes will be assessed in AYAHIV, caregivers, healthcare workers, and key informants. Statistical analyses will be conducted and reported in line with CONSORT guidelines for cRCTs.
The CombinADO study will provide evidence on effectiveness and inform implementation of a novel community-informed multi-component intervention to improve retention, adherence, and VS among AYAHIV. If found effective, results will strengthen the rationale for scale up in SSA.
ClinicalTrials.gov NCT04930367 . Registered on 18 June 2021.
与 HIV 共存的青少年和青年（AYAHIV）的 HIV 结局比其他年龄组更差，尤其是在撒哈拉以南非洲（SSA）。SSA 的 AYAHIV 面临着严峻的卫生系统、人际和个人层面的障碍，难以保持 HIV 护理的连续性、接受抗逆转录病毒治疗（ART）以及实现病毒抑制（VS），这凸显了迫切需要采取多组分干预措施来应对这些挑战。这项整群随机对照试验（cRCT）旨在评估一种基于社区的多组分干预措施（“CombinADO 策略”）的有效性和实施情况，该策略针对个人、医疗设施和社区层面的因素，以改善 AYAHIV 的健康结果。
这项试验将在莫桑比克北部楠普拉省的 12 个诊所进行。所有诊所都将实施优化的标准护理（对照组），包括（1）广告牌/海报和广播节目，（2）医护人员（HCW）培训，（3）一站式青少年友好服务，（4）信息/激励墙，（5）药盒，以及（6）HCW 在临床访视中使用的工具。CombinADO 策略（干预组）将在随机选择的 6 个诊所的对照组条件上增加。它将包括五个额外的组成部分：（1）同伴支持，（2）信息/激励视频，（3）AYAHIV 照顾者支持小组，（4）AYAHIV 支持小组，以及（5）心理健康筛查和与青少年为重点的心理健康支持的联系。研究条件将持续 12 个月；所有在参与地点寻求护理的 AYAHIV（年龄在 10-24 岁，正在接受 ART 治疗）将根据他们就诊的诊所，接触到对照组或干预组的条件。主要结局是在 12 个月时接受治疗的 AYAHIV 的 VS（病毒载量<50 拷贝/mL）。次要结局包括 ART 依从性（自我报告和 TDF 水平）和护理保留（在前 90 天内参与）。将在实施过程中测量 CombinADO 策略的实施、可行性、可接受性和保真度。试验结果将在 AYAHIV、照顾者、医护人员和关键信息提供者中进行评估。统计分析将按照 CONSORT 指南进行 cRCT。
CombinADO 研究将提供有效性证据，并为改善 AYAHIV 的保留、依从性和 VS 提供新的基于社区的多组分干预措施的实施信息。如果发现有效，结果将为 SSA 的扩大提供依据。
ClinicalTrials.gov NCT04930367。于 2021 年 6 月 18 日注册。
