NCT05841797

Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya

Piloting Risk Stratification and Tailored Interventions With Pregnant and Postpartum Women With HIV in Kenya to Prevent Disengagement From Care and Viral Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Among pregnant/postpartum women living with HIV (PWLWH) in low resource, high HIV prevalence settings, access to antiretroviral treatment (ART) has increased dramatically and mother-to-child transmission (MTCT) of HIV has decreased substantially, yet successful outcomes are not universal. Despite a 52% decline in new HIV infections among children under five from 2010-2019, recent UNAIDS data indicate global targets were missed by wide margins, with an estimated 160,000 new pediatric HIV infections annually. Sub-optimal retention of PWLWH is a major contributor to new pediatric infections. 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. As PMTCT programs in sub-Saharan Africa (SSA) aim for the elimination of MTCT in the context of decreased funding, there is need for research geared towards identifying and supporting the most vulnerable PWLWH with tailored interventions that can be implemented using available resources. This study aims to build on a previous study, Mother and Infant Visit Adherence and Treatment Engagement Study (MOTIVATE, R01HD080477), to develop and implement interventions that can promote proper taking of HIV drugs among PWLWH, namely a risk calculator to identify women at high risk for treatment failure and an adapted Problem Management Plus (PM+) intervention specifically geared towards women identified as high risk. Such interventions are critical in order to identify the most vulnerable PWLWH as early as possible to intervene with effective targeted interventions that will help improve maternal and child health outcomes.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-05
• Primary completion: 2025-08-12
• Completion: 2025-08-12
• First posted: 2023-05-03
• Last updated: 2025-12-05

Locations

1 site across 1 country: Kenya