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

No results posted yet for this study

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
  • Johns Hopkins University

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841797 on ClinicalTrials.gov