London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, UK.
Biomedical Research and Training Institute, 10 Seagrave Road, Avondale, Harare, Zimbabwe.
Implement Sci. 2018 May 23;13(1):70. doi: 10.1186/s13012-018-0762-5.
Community health worker (CHW)-delivered support visits to children living with HIV and their caregivers significantly reduced odds of virological failure among the children in the ZENITH trial conducted in Zimbabwe. We conducted a process evaluation to assess fidelity, acceptability, and feasibility of this intervention to identify lessons that could inform replication and scale-up of this approach.
Field manuals kept by each CHW, records from monthly supervisory meetings, and participant data collected throughout the trial were used to assess the intervention's implementation. Data extracted from field manuals included visit type, content, and duration. Minutes from monthly supervisory meetings were used to capture CHW attendance.
The trial enrolled 172 participants in the intervention arm of whom 5 subsequently refused all visits, 1 died before the intervention could be delivered, and 1 could not be located. Manuals for 8 participants were not returned, 3 were incorrectly entered, and 1 manual was lost. We had 154 manuals available for analysis. A total of 1553 visits were successfully conducted (median 11 per participant, range 1-20). Additionally, CHWs made 85 visits where they were unable to make contact with the family. Thirteen (8.4%) participants received 5 or fewer visits, 10 moved out of the study area, and 3 died. CHWs discussed disclosure with the child/family for over 89% of participants and assisted clients with developing and reviewing their personal treatment plan with over 85% of participants. Of the 20 CHWs (3 male, 17 female) selected to implement the intervention, 19 were retained at the end of the trial.
The intervention was acceptable to participants with most receiving and accepting the required number of visits. Key strenghts were high staff retention and fidelity to the intervention. This community-based intervention was an acceptable and feasible approach to reduce virological failure among children living with HIV.
The ZENITH trial was registered on 25 October 2012 in the Pan African Clinical Trials Registry under the trial registration number PACTR201212000442288 . It can be found at http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201212000442288 .
在津巴布韦开展的 ZENITH 试验中,社区卫生工作者(CHW)为感染艾滋病毒的儿童及其照顾者提供的支持访问显著降低了儿童病毒学失败的几率。我们进行了一项过程评估,以评估该干预措施的忠实性、可接受性和可行性,以确定可以为该方法的复制和扩大提供信息的经验教训。
每位 CHW 保存的现场手册、每月监督会议记录以及试验期间收集的参与者数据用于评估干预措施的实施情况。从现场手册中提取的访问类型、内容和持续时间的数据。每月监督会议记录用于记录 CHW 的出席情况。
该试验在干预组招募了 172 名参与者,其中 5 名随后拒绝了所有访问,1 名在干预措施实施前死亡,1 名无法找到。8 名参与者的手册未归还,3 名手册录入错误,1 名手册丢失。我们有 154 份手册可供分析。共成功进行了 1553 次访问(中位数为每名参与者 11 次,范围为 1-20 次)。此外,CHWs 进行了 85 次无法与家庭取得联系的访问。13 名(8.4%)参与者接受了 5 次或更少的访问,10 名搬离了研究区域,3 名死亡。CHWs 与超过 89%的参与者讨论了披露问题,并帮助客户制定和审查了他们个人的治疗计划,超过 85%的参与者接受了治疗计划。在 20 名被选中实施该干预措施的 CHWs(3 名男性,17 名女性)中,有 19 名在试验结束时保留了下来。
该干预措施为参与者所接受,大多数参与者接受并接受了所需的访问次数。该干预措施的主要优点是工作人员保留率高且对干预措施的忠实性高。这种基于社区的干预措施是减少艾滋病毒感染儿童病毒学失败的一种可接受且可行的方法。
ZENITH 试验于 2012 年 10 月 25 日在泛非临床试验注册中心注册,试验注册编号为 PACTR201212000442288。可在 http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201212000442288 找到。