Helova Anna, Onono Maricianah, Ogolla-Onyando Mercelline, Ouma Emmah, Imran Rabbia, Beres Laura K, Hampanda Karen, Owuor Kevin, Szychowski Jeff M, Ongeri Linnet, Abuogi Lisa L, Turan Janet M
Department of Health Policy and Organization, School of Public Health, The University of Alabama at Birmingham, 1665 University Blvd, Birmingham, 35233, AL, United States; Sparkman Center for Global Health, School of Public Health, The University of Alabama at Birmingham, 1665 University Blvd, Birmingham, 35233, AL, United States.
Centre for Microbiology Research, Kenya Medical Research Institute, Karume Road/ Jairo Street Junction, Kisumu, Kenya.
Contemp Clin Trials. 2025 Apr;151:107838. doi: 10.1016/j.cct.2025.107838. Epub 2025 Feb 6.
While many pregnant and postpartum women with HIV (PPWH) in the African Region successfully engage in HIV care, a substantial number still face significant barriers, including poor mental health and HIV stigma. These psychosocial barriers contribute to poor medication and clinic visit adherence, poor health outcomes, including unsuppressed viral load, and increased risk of perinatal transmission of HIV. To efficiently improve health outcomes within a resource-constrained health system, responsive and effective interventions are urgently needed to support women who are at the highest risk of sub-optimal outcomes.
To determine whether risk stratification of PPWH in conjunction with an evidence-based, tailored, lay health worker-delivered psychological intervention can optimize health outcomes for PPWH and their infants.
Using human-centered design, we will adapt Problem Management Plus (PM+) with PPWH for in-person and mobile delivery formats to prevent sub-optimal treatment adherence and HIV care disengagement among PPWH in Kisumu, Kenya. We will test the adapted PM+ intervention among 120 PPWH randomized 1:1:1 to standard of care, in-person PM+, or mobile PM+ in a hybrid type 2 implementation effectiveness pilot trial. Implementation outcomes, including feasibility, acceptability, and intervention satisfaction, as well as preliminary effectiveness outcomes in mental health and HIV, will be evaluated.
We anticipate that the adapted PM+ intervention will be highly acceptable and feasible to implement and have the potential to be effective at reducing care disengagement, viremia, and psychological distress in PPWH.
虽然非洲地区许多感染艾滋病毒的孕妇和产后妇女(PPWH)成功接受了艾滋病毒治疗,但仍有相当一部分人面临重大障碍,包括心理健康不佳和艾滋病毒污名化。这些社会心理障碍导致药物治疗和门诊就诊依从性差、健康结果不佳,包括病毒载量未得到抑制,以及围产期艾滋病毒传播风险增加。为了在资源有限的卫生系统中有效改善健康结果,迫切需要有针对性和有效的干预措施来支持那些最有可能出现次优结果的妇女。
确定对PPWH进行风险分层并结合基于证据的、量身定制的、由非专业卫生工作者提供的心理干预措施是否能优化PPWH及其婴儿的健康结果。
采用以人为本的设计,我们将对PPWH采用问题管理强化版(PM+),以面对面和移动服务的形式,防止肯尼亚基苏木的PPWH出现次优治疗依从性和艾滋病毒治疗中断的情况。我们将在一项混合型2期实施效果试点试验中,对120名PPWH进行1:1:1随机分组,分别接受标准治疗、面对面PM+或移动PM+,测试经过调整的PM+干预措施。将评估实施结果,包括可行性、可接受性和干预满意度,以及心理健康和艾滋病毒方面的初步有效性结果。
我们预计,经过调整的PM+干预措施将非常易于接受且实施可行,并且有可能有效减少PPWH的治疗中断、病毒血症和心理困扰。