search
Back to results

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

Primary Purpose

HIV/AIDS

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WISH Adherence
WISH Parenting
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 16 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

Exclusion Criteria:

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • MedStar Health Research InstituteRecruiting
  • Emory UniversityRecruiting
  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adherence

Parenting

Arm Description

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 ART adherence and engagement in HIV care.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Viral Suppression up to 1 year postpartum
Viral Load ≤ 50 copies/mL using the last available VL up to 180 days before the end of the postpartum year.

Full Information

First Posted
November 8, 2019
Last Updated
March 15, 2023
Sponsor
University of Pennsylvania
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT04168008
Brief Title
A Peer-Led Intervention to Improve Postpartum Retention in HIV Care
Official Title
A Randomized Controlled Trial of Women Involved in Supporting Health (WISH), a Peer-Led Intervention to Improve Postpartum Retention in HIV Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Despite significant progress in the reduction of perinatal transmission of HIV, there has been less attention to retaining women living with HIV (WLH) in care in the postpartum period. Retention in care particularly affects black and Hispanic women as they are disproportionately affected by the HIV epidemic in the United States (U.S.). In preliminary work, the investigators used HIV surveillance data from the Philadelphia Department of Public Health to examine the HIV care continuum of 561 women, 78% of whom were black, during pregnancy and up to two years postpartum (2005-2011). Only 38% of women received HIV care within 3 months after delivery, and retention remained poor at 1 (39%) and 2 (25%) years postpartum. Poor maternal retention in care also occurs in Mississippi, Georgia, and New York, demonstrating that this break in the HIV care continuum is widespread. Retaining WLH in care positively impacts their well-being and health postpartum and for years to come, which promotes not only their health but that of their newborns. Therefore, the long-term goal of this study is to decrease HIV disparities by increasing WLH's retention in care in the postpartum period. Presently, there are a limited number of evidence-based interventions aimed at improving retention in care for WLH. Through a critical review of research literature, the investigators found that interventions to improve retention in care have been implemented in low-resource countries, but studies in high-resource countries are lacking. In sub-Saharan Africa, the use of peers has resulted in significantly higher maternal retention and viral suppression compared to standard of care. Peers are WLH who remained engaged in HIV care postpartum, and provide education and support to WLH in the prenatal and postpartum periods. The investigators also conducted a series of qualitative interviews with WLH in the U.S. to evaluate factors contributing to poor retention in care postpartum, and to assess the acceptability and feasibility of a peer intervention in meeting women's needs. The results showed that women's primary motivation to engage in prenatal care is to keep their infant healthy, but that many of them experience significant life challenges that impede their ability to engage in care postpartum. However, they expressed great interest in receiving support from a peer to motivate sustained engagement in care postpartum. The investigators propose to test the efficacy of a theory-driven peer intervention, based on the integrated model of health behavior. The peer intervention, Women Involved in Supporting Health (WISH), 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 three face-to-face prenatal sessions, starting in early third trimester, and two face-to-face postpartum sessions scheduled up to three months postpartum. The prenatal sessions focus on knowledge that will address barriers to outcome expectancies and self-efficacy, and the postpartum sessions build on outcome expectancy and knowledge to develop skills tailored to adherence to antiretroviral therapy and engagement in HIV care. Between the sessions, the peer and the WLH will communicate via text messages, phone calls and/or video chat. The randomized controlled trial (RCT) will take place across Center for AIDS Research sites in Philadelphia, the District of Columbia, Atlanta, and Birmingham, where HIV infection rates remain disproportionally high among black and Hispanic women. A total of 260 pregnant WLH will be randomized to either WISH adherence or an attention-matched WISH parenting control group. The impact of this research will be the development of the first evidence-based peer intervention to address the pressing need to improve postpartum retention in HIV care and viral suppression of WLH in the U.S.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned in equal proportions to either the WISH Adherence arm or to the WISH Parenting arm
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adherence
Arm Type
Experimental
Arm Description
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 ART adherence and engagement in HIV care.
Arm Title
Parenting
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
WISH Adherence
Intervention Description
The educational sessions will consist of an adherence-centered curriculum.
Intervention Type
Behavioral
Intervention Name(s)
WISH Parenting
Intervention Description
The educational sessions will focus on parenting and baby care.
Primary Outcome Measure Information:
Title
Retention in Care up to 1 year postpartum
Description
≥1 visit with an HIV provider in each 6-month interval of the postpartum year with ≥60 days between visits.
Time Frame
Baseline through 1 year after delivery
Secondary Outcome Measure Information:
Title
Viral Suppression up to 1 year postpartum
Description
Viral Load ≤ 50 copies/mL using the last available VL up to 180 days before the end of the postpartum year.
Time Frame
Baseline through 1 year after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 16 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 Exclusion Criteria: planning to relocate outside the country within the year following delivery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florence Momplaisir, MD
Phone
215-746-8555
Email
florence.momplaisir@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aadia Rana
Facility Name
MedStar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Scott
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anandi Sheth
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Momplaisir, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs