Nakimuli-Mpungu Etheldreda, Wamala Kizito, Nalugya Joyce Sserunjoji, Nakanyike Caroline, Iya Jane, Bakeera Kitaka Sabrina, Diana Namuli Justine, Akimana Benedict, Nachega Jean B, Mills Edward J, Seggane Musisi
Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.
Department of Paediatrics and Childhealth, MakCHS, SEEK Group Support Psychotherapy Initiative Limited, Kampala, Uganda.
Front Health Serv. 2023 Apr 5;3:1011898. doi: 10.3389/frhs.2023.1011898. eCollection 2023.
Several studies have demonstrated an association between psychological risk factors and HIV disease progression. However, there is limited information on the use of psychological interventions to improve HIV treatment outcomes in young people living with HIV.
This pilot trial aims to evaluate the feasibility, acceptability and preliminary effectiveness of group support psychotherapy in improving adherence to anti-retroviral therapy and viral suppression in young people living with HIV in Uganda.
We recruited 120 young people with HIV, aged 10-18 years, who had non-viral suppression 6 months after initiating first-line anti-retroviral therapy (ART) from community based HIV clinics in Kitgum district, northern Uganda. Participants were randomly assigned to receive GSP plus IAC ( = 60) or IAC alone ( = 60). Primary outcomes will be indicators of feasibility and acceptability as well as preliminary effectiveness of GSP in improving ART adherence and viral suppression analysed by intention to treat using cluster-adjusted t tests and permutation tests. Secondary outcomes will be measures of depression, anxiety and cost-effectiveness.
The trial has been approved by the Makerere College of Health Sciences School of Health Sciences Research Ethics Committee, and the Uganda National Council of Science and Technology. Recruitment began in June 2021 and 120 young people living with HIV with their adult caregivers have been recruited to the trial. An analysis of baseline and 6-month data is in progress. The results of this trial will not only be presented at national and international conferences but also submitted for publication in peer-reviewed journals and as a report to the funding agencies.
This pilot trial will provide critical evidence to support the ongoing mental health integration into routine HIV care in Uganda.
Pan African Clinical Trials Registry (PACTR): 202006601935462.
多项研究表明心理风险因素与艾滋病病毒（HIV）疾病进展之间存在关联。然而，关于采用心理干预措施改善HIV感染青年的治疗效果的信息有限。
这项试点试验旨在评估团体支持心理治疗在提高乌干达HIV感染青年对抗逆转录病毒疗法的依从性和病毒抑制方面的可行性、可接受性和初步效果。
我们从乌干达北部基特古姆区的社区HIV诊所招募了120名年龄在10至18岁之间、在开始一线抗逆转录病毒疗法（ART）6个月后病毒未得到抑制的HIV感染青年。参与者被随机分配接受团体支持心理治疗加强化咨询（IAC）（n = 60）或仅接受强化咨询（n = 60）。主要结局将是可行性和可接受性指标，以及通过使用聚类调整t检验和置换检验进行意向性分析来分析团体支持心理治疗在改善ART依从性和病毒抑制方面的初步效果。次要结局将是抑郁、焦虑和成本效益的测量指标。
该试验已获得马凯雷雷健康科学学院健康科学研究伦理委员会以及乌干达国家科学技术委员会的批准。招募工作于2021年6月开始，120名HIV感染青年及其成年照料者已被纳入该试验。对基线数据和6个月数据的分析正在进行中。该试验的结果不仅将在国内和国际会议上展示，还将提交给同行评审期刊发表，并作为报告提交给资助机构。
这项试点试验将提供关键证据，以支持乌干达正在进行的将心理健康纳入常规HIV护理的工作。
泛非临床试验注册中心（PACTR）：202006601935462。
