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

NCT05841797 | Completed

• 1 other identifier: 22-1946
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV Transmission; Prevention of Mother to Child Transmission; Linkage to care; Retention in care; Community Mentor Mothers; Mobile intervention; Antiretroviral therapy adherence; Infant Health; Maternal CD4/viral loads; Early infant diagnosis; Acceptability of interventions; Vertical transmission; Mental health

Outcome Measures

Primary Outcomes (1)

• Combined retention and treatment failure outcome

  Failure will be outcome of a missed visit (\>30 days) OR treatment failure (elevated VL\>= 200 copies/ml among PWLWH assessed through medical records from baseline to 6 months postpartum.

  Baseline, 3 months postpartum, 6 months postpartum

Secondary Outcomes (6)

• Depression

  Baseline, 3 months postpartum, 6 months postpartum

• Psychological Outcome Profiles

  Baseline, 3 months postpartum, 6 months postpartum

• Fidelity - Content

  6 months postpartum

• Fidelity - Coverage

  6 months postpartum

• Feasibility - Recruitment

  Enrollment

Study Arms (3)

Standard of Care (SOC)

NO INTERVENTION

Standard of Care (SOC): For Arm 1 of the pilot trial, SOC will be implemented. SOC for PWLWH in Kenya is carried out according Kenyan National Guidelines and includes integration of antenatal care, HIV care, and HIV-exposed infant follow up within the maternal-child health clinic through 18-24 months postpartum. Provision of ART, HIV education, and adherence counseling is routinely provided. Psychosocial support is provided by either peer educators or lay health workers. WLWH who miss visits are followed up by phone and then traced in the community to encourage return to care. PWLWH undergo routine VL testing six months after ART initiation or at confirmation of pregnancy if already on ART. VLs are performed every six months through breastfeeding. Women with VL 200 copies/ml undergo enhanced adherence counseling with repeat VL in three months. While routine screening for IPV and depression are recommended per National Guidelines, they are incompletely implemented.

In-Person Program Management Plus (PM+)

EXPERIMENTAL

For Arm 2, the investigators will implement the adapted PM+ utilizing the complete manual of operations and adaptation lessons learned in the non-clinical trial portion of the study. The investigators will train mentor mothers to serve as PM+ Helpers. In-person sessions will likely be delivered at home. Sessions will continue after the birth if not completed during pregnancy. PM+ Helpers will debrief regularly on the progress of participants with clinically trained supervisors - both for their own psychological well-being and to ensure that participants receive adequate care.

Behavioral: In-Person Program Management Plus (PM+)

Mobile Program Management Plus (mHealth PM+)

EXPERIMENTAL

For Arm 3, the investigators will implement the adapted PM+ utilizing the complete manual of operations and adaptation lessons learned in the non-clinical trial portion of the study. The investigators will train mentor mothers to serve as PM+ Helpers. In the mHealth delivered version of PM+, PM+ Helpers will conduct PM+ virtually after an initial meeting to create rapport. Sessions will be delivered by either 1) a PM+ Helper- initiated phone call or 2) a participant-initiated call via a call-in help line. Airtime will be provided so that participation will be free of charge. Sessions will continue after the birth if not completed during pregnancy. PM+ Helpers will debrief regularly on the progress of participants with clinically trained supervisors - both for their own psychological well-being and to ensure that participants receive adequate care.

Behavioral: Mobile Program Management Plus (mHealth PM+)

Interventions

Mobile Program Management Plus (mHealth PM+) BEHAVIORAL

PM+ sessions conducted via phone

Mobile Program Management Plus (mHealth PM+)

In-Person Program Management Plus (PM+) BEHAVIORAL

PM+ sessions conducted in-person by mentor mothers

In-Person Program Management Plus (PM+)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant woman living with HIV attending an ANC clinic in Kisumu County, on/initiating ART
• At least 15 years of age
• At least 20 weeks estimated gestational age
• At moderate or critical risk of the combined outcome of treatment disengagement or viral failure according to the risk calculator
• Access to a cell phone (for those who share phones, have disclosed their HIV status to whomever individuals share the phone with.

You may not qualify if:

• Imminent plans of suicide and severe impairment due to severe mental, neurological or substance use disorders
• Less than 15 years of age
• Less than 20 weeks estimated gestational age or not currently pregnant
• Not HIV-infected at time of first ANC visit

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Alabama at Birmingham: collaborator
• Kenya Medical Research Institute: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Kenya Medical Research Institute

Nairobi, Kenya

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Psychological Well-Being

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Personal Satisfaction; Behavior

Study Officials

• Lisa Abuogi, MD, MSc

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and care providers will not be blinded to study arm, however investigators and analyst will be.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will conduct a pilot hybrid type 2 effectiveness-implementation trial in which pregnant women at higher risk for missed visits and treatment failure are randomized to one of three study arms 1:1:1 standard of care, mHealth PM+, or in-person PM+ and followed through 6 months postpartum. Feasibility, acceptability, intervention satisfaction, and preliminary efficacy on mental health and HIV outcomes (combined outcome of continuous viral suppression and engagement in care) will be assessed.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 3, 2023
• Study Start: June 5, 2023
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

KE (1)