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

Journal: Contemporary clinical trials

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Affiliated Institutions:  Department of Health Policy and Organization, School of Public Health, The University of Alabama at Birmingham, University Blvd, Birmingham, , AL, United States; Sparkman Center for Global Health, School of Public Health, The University of Alabama at Birmingham, University Blvd, Birmingham, , AL, United States. Electronic address: ahelova@uab.edu. Centre for Microbiology Research, Kenya Medical Research Institute, Karume Road/ Jairo Street Junction, Kisumu, Kenya. Centre for Microbiology Research, Kenya Medical Research Institute, Karume Road/ Jairo Street Junction, Kisumu, Kenya. Electronic address: eouma@kargeno-hub.org. Department of Pediatrics, School of Medicine, University of Colorado Denver, East th Avenue Box , Aurora, , CO, United States. Electronic address: RABBIA.IMRAN@CUANSCHUTZ.EDU. Department of International Health, Johns Hopkins Bloomberg School of Public Health, N. Wolfe Street, Baltimore, , MD, United States. Electronic address: lberes@jhu.edu. Department of OB-GYN-Gyn & OB Health, School of Medicine, University of Colorado Denver, E. Montview Blvd., Suite , A, Aurora, CO, United States. Electronic address: KAREN.HAMPANDA@CUANSCHUTZ.EDU. Sparkman Center for Global Health, School of Public Health, The University of Alabama at Birmingham, University Blvd, Birmingham, , AL, United States; Department of Biostatistics, School of Public Health, The University of Alabama at Birmingham, University Blvd, Birmingham, , AL, United States. Electronic address: kowuor@uab.edu. Department of Biostatistics, School of Public Health, The University of Alabama at Birmingham, University Blvd, Birmingham, , AL, United States. Electronic address: jszychow@uab.edu. Centre for Clinical Research, Kenya Medical Research Institute, Mbagathi way, - , Nairobi, Kenya. Department of Pediatrics, School of Medicine, University of Colorado Denver, East th Avenue Box , Aurora, , CO, United States. Electronic address: lisa.abuogi@childrenscolorado.org. Department of Health Policy and Organization, School of Public Health, The University of Alabama at Birmingham, University Blvd, Birmingham, , AL, United States; Sparkman Center for Global Health, School of Public Health, The University of Alabama at Birmingham, University Blvd, Birmingham, , AL, United States. Electronic address: jmturan@uab.edu.

Abstract summary 

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.

Authors & Co-authors:  Helova Anna A Onono Maricianah M Ogolla-Onyando Mercelline M Ouma Emmah E Imran Rabbia R Beres Laura K LK Hampanda Karen K Owuor Kevin K Szychowski Jeff M JM Ongeri Linnet L Abuogi Lisa L LL Turan Janet M JM

Study Outcome 

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Citations : 
Authors :  12
Identifiers
Doi : 10.1016/j.cct.2025.107838
SSN : 1559-2030
Study Population
Female,Women
Mesh Terms
Other Terms
African region;HIV;Mental health;Pregnancy;Prevention of perinatal HIV transmission;Problem management plus
Study Design
Randomized Control Trial
Study Approach
Country of Study
Kenya
Publication Country
United States