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HIV/AIDSNCT04168008

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

A study testing WISH Adherence and WISH Parenting in people with HIV/AIDS, run by University of Pennsylvania at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
HIV/AIDS
What is being tested?
WISH Adherence and WISH Parenting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
7 sitesUnited States
Study dates
3 Mar 2020to 8 Sep 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Emory University

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Montefiore Medical Center/Albert Einstein College of Medicine

    The Bronx, New York, 10466

  • MedStar Health Research Institute

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of Women Involved in Supporting Health (WISH), a Peer-Led Intervention to Improve Postpartum Retention in HIV Care

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.

Read the 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.

Conditions
HIV/AIDS
Being tested
WISH Adherence, WISH Parenting
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WISH AdherenceBehavioural

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

  • WISH ParentingBehavioural

    The educational sessions will focus on parenting and baby care.

Study groups in NCT04168008
Study groupRoleWhat they receive
AdherenceExperimentalWomen 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.
Receives: Behavioral: WISH Adherence
ParentingActive comparatorWomen 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.
Receives: Behavioral: WISH Parenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline through 1 year after delivery

Secondary outcomes (1)
  1. Viral Suppression up to 1 Year Postpartum

    Viral Load ≤ 200 copies/mL using the last available Viral Load up to 180 days before the end of the postpartum year.

    Measured: Baseline through 1 year after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2019
  2. Study start3 Mar 2020
  3. Primary completion8 Sep 2025
  4. Study completion8 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be assigned in equal proportions to either the WISH Adherence arm or to the WISH Parenting arm
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04168008
Sponsor's protocol ID
833893
Other IDs
1R01MD013558
Status last verified
Oct 2026
First submitted
8 Nov 2019
Last updated
3 Nov 2026
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing WISH Adherence and WISH Parenting in people with HIV/AIDS, run by University of Pennsylvania at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention in Care up to 1 Year Postpartum (time frame: Baseline through 1 year after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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