Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya
NCT05841797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-12-05
Summary
This study includes secondary quantitative analysis, qualitative methods, and hybrid type 2 implementation-effectiveness pilot trial. The overall goal of this protocol is to determine whether risk stratification of PWLWH in conjunction with a tailored psychosocial support intervention can optimize health outcomes for the vulnerable women and infants. This study will be conducted in high-volume, low-resource health facilities in Kisumu County, Kenya, which is a priority area for research among WLWH and one of the highest HIV burden counties.
Conditions
- Human Immunodeficiency Virus
Interventions
- BEHAVIORAL
-
In-Person Program Management Plus (PM+)
PM+ sessions conducted in-person by mentor mothers
- BEHAVIORAL
-
Mobile Program Management Plus (mHealth PM+)
PM+ sessions conducted via phone
Sponsors & Collaborators
-
University of Alabama at Birmingham
collaborator OTHER -
Kenya Medical Research Institute
collaborator OTHER - collaborator OTHER
-
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Lisa Abuogi, MD, MSc · University of Colorado, Denver
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-05
- Primary Completion
- 2025-08-12
- Completion
- 2025-08-12
Countries
- Kenya
Study Locations
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