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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: WISH Parenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted19 Nov 2019
- Study start3 Mar 2020
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Florence Momplaisir, MD, University of Pennsylvania
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
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Women Involved in Supporting Health (WISH), a Peer-Led Intervention to Improve Postpartum Retention in HIV Care
- ClinicalTrials.gov ID
- NCT04168008
- Acronym / sponsor ID
- 833893
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Posted 3 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned in equal proportions to either the WISH Adherence arm or to the WISH Parenting arm
| Arm | Type | Receives |
|---|---|---|
| Adherence | Experimental | Behavioral: WISH AdherenceWomen 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. |
| Parenting | Active comparator | Behavioral: WISH ParentingWomen 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- planning to relocate outside the country within the year following delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WISH AdherenceThe educational sessions will consist of an adherence-centered curriculum. | Behavioural | Adherence |
| WISH ParentingThe educational sessions will focus on parenting and baby care. | Behavioural | Parenting |
Primary outcome
Retention in Care up to 1 Year Postpartum
Time frame: Baseline through 1 year after delivery
≥1 visit with an HIV provider in each 6-month interval of the postpartum year with ≥60 days between visits.
1 secondary outcome
Viral Suppression up to 1 Year Postpartum
Time frame: Baseline through 1 year after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
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.