Evaluation of risk stratification and problem management plus (PM+) for pregnant women with HIV in Kenya (Tatua study): Protocol paper

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-06 DOI:10.1016/j.cct.2025.107838

Anna Helova , Maricianah Onono , Mercelline Ogolla-Onyando , Emmah Ouma , Rabbia Imran , Laura K. Beres , Karen Hampanda , Kevin Owuor , Jeff M. Szychowski , Linnet Ongeri , Lisa L. Abuogi , Janet M. Turan

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引用次数: 0

Abstract

Background

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.

Objective

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.

Methods

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.

Expected study outcomes

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.

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肯尼亚感染艾滋病毒孕妇的风险分层和问题管理（PM+）评估（Tatua研究）：议定书文件。

背景：虽然非洲区域许多感染艾滋病毒的孕妇和产后妇女成功地参与了艾滋病毒护理，但仍有相当数量的人面临重大障碍，包括精神健康状况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诊所就诊依从性差，健康状况不佳，包括病毒载量未受抑制，以及艾滋病毒围产期传播风险增加。为了在资源有限的卫生系统内有效改善健康结果，迫切需要采取反应迅速和有效的干预措施，以支持面临次优结果风险最高的妇女。目的：确定PPWH的风险分层结合基于证据的、量身定制的、非专业卫生工作者提供的心理干预是否可以优化PPWH及其婴儿的健康结局。方法：采用以人为本的设计，我们将采用问题管理+ (PM+)与PPWH进行面对面和移动交付形式，以防止肯尼亚基苏木PPWH的次优治疗依从性和艾滋病毒护理脱离。我们将在120名PPWH中测试适应性PM+干预，这些PPWH按1:1:1随机分为标准护理、现场PM+或移动PM+，这是一项混合2型实施效果试点试验。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。预期研究结果：我们预计，经过调整的PM+干预措施将是高度可接受和可行的，并有可能有效减少PPWH患者的护理脱离、病毒血症和心理困扰。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.