A Peer-Led Intervention to Improve Postpartum Retention in HIV Care

NCT04168008 | Completed

• 2 other identifiers: 8338931R01MD013558
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to test the efficacy of a theory-driven peer intervention for pregnant and postpartum women living HIV. The peer intervention is designed to increase self-efficacy, social support, self-regulatory behaviors, and outcome expectancy in order to improve retention in care and viral suppression postpartum. The intervention will consist of face-to-face prenatal educational sessions, starting in early third trimester, and postpartum sessions scheduled up to three months postpartum.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Retention in Care up to 1 year postpartum

  ≥1 visit with an HIV provider in each 6-month interval of the postpartum year with ≥60 days between visits.

  Baseline through 1 year after delivery

Secondary Outcomes (1)

• Viral Suppression up to 1 year postpartum

  Baseline through 1 year after delivery

Study Arms (2)

Adherence

EXPERIMENTAL

Women randomized to the adherence arm will attend 3 prenatal sessions and 2 postpartum sessions with a peer facilitator. Each session will be delivered on an individual basis and consist of structured educational content followed by unstructured conversation, allowing the participant to ask questions and actively engage in formulating her plan to be retained in HIV care. The goal of the prenatal sessions is to introduce the intervention, foster bonding, and address outcome expectancies and self-efficacy regarding retention in HIV care postpartum. The postpartum sessions build on outcome expectancies and self-efficacy to develop skills for Antiretroviral therapy (ART) adherence and engagement in HIV care.

Behavioral: WISH Adherence

Parenting

ACTIVE COMPARATOR

Women randomized to the parenting control arm will also attend 3 prenatal sessions and 2 postpartum sessions with a peer facilitator. The educational sessions will be focused on parenting and baby care.

Behavioral: WISH Parenting

Interventions

WISH Parenting BEHAVIORAL

The educational sessions will focus on parenting and baby care.

Parenting

WISH Adherence BEHAVIORAL

The educational sessions will consist of an adherence-centered curriculum.

Adherence

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• a woman living with HIV in the 2nd or 3rd trimester of pregnancy
• able to provide informed consent including HIPAA authorization to access protected health information
• able to read and speak English
• having access to a cell phone

You may not qualify if:

• planning to relocate outside the country within the year following delivery

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Montefiore Medical Center/Albert Einstein College of Medicine

The Bronx, New York, 10466, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be assigned in equal proportions to either the WISH Adherence arm or to the WISH Parenting arm

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 19, 2019
• Study Start: March 3, 2020
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (7)