NCT07064928: WAT

Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women

ENROLLING BY INVITATION NA Last updated 20 July 2025

What this trial tests

NA trial testing Adapted Project Accept's Post-Test Support Services (PTSS) Module 3 in HIV in 175 participants. Enrolling by invitation.

Timeline

28 November 2024

Primary endpoint
31 July 2027

31 July 2027

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	175
Start date	28 November 2024
Primary completion	31 July 2027
Estimated completion	31 July 2027
Sites	1 location across Ghana

Drugs / interventions tested

• Adapted Project Accept's Post-Test Support Services (PTSS) Module 3

Conditions studied

• HIV — all drugs for HIV →
• HIV - Human Immunodeficiency Virus — all drugs for HIV - Human Immunodeficiency Virus →
• Postpartum — all drugs for Postpartum →
• Pregnancy — all drugs for Pregnancy →

Sponsor

University of California, San Francisco

Who can join

14 and older, female only, with HIV or HIV - Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Purpose of this Study:

The main purpose of this study is to adapt an existing evidence-based intervention, Project Accept Post-Test Support Services (PTSS) Module 3, specifically for pregnant and postpartum women living with HIV (WLWH) in Ghana. The adapted intervention aims to reduce HIV-related stigma and improve adherence to antiretroviral therapy (ART) and mental health symptoms, such as depression and anxiety, among this vulnerable population.

Why was this study done? (Background):

HIV-related stigma is a major obstacle for women living with HIV, particularly pregnant women in Sub-Saharan Africa (SSA), hindering their engagement in HIV care and adherence to ART. This contributes to poor health outcomes, including inadequate viral suppression, depression, and an ongoing risk of HIV transmission to their children and sexual partners. While effective HIV stigma-reduction interventions exist for the general adult population living with HIV, there is a critical lack of tailored interventions for pregnant and postpartum WLWH in SSA. This study addresses this gap by adapting a proven intervention (Project Accept PTSS Module 3), which has shown success in reducing stigma and improving outcomes in other populations, for this specific group in Ghana, where HIV-related stigma remains disproportionately high.

Who participated in this study? (Target Population):

This study will involve several groups:

Pregnant and postpartum women living with HIV: 30 women will participate in in-depth interviews to share their experiences with stigma and HIV care.

HIV care providers: 20 providers will participate in in-depth interviews to offer their perspectives on stigma and care provision.

Stakeholders: This group will include HIV care providers, program administrators/directors, and pregnant and postpartum women. They will collaborate in the iterative process of adapting the intervention.

Pregnant women living with HIV (for feasibility testing): 90 pregnant women will be randomized, with half receiving the adapted intervention and half receiving standard care, to assess the intervention's feasibility, acceptability, and preliminary impact.

What happened in this study? (Intervention/Methods):

This 3-year study has three main aims:

Understanding Stigma Experiences: Researchers will describe the experiences of stigma and HIV care from the perspectives of pregnant and postpartum WLWH and compare them with providers' experiences. This will involve longitudinal data collection and in-depth interviews to understand how stigma affects women's health, clinical care (e.g., provider discrimination, ART adherence), and mental health over time.

Intervention Adaptation: Project Accept PTSS Module 3 will be adapted specifically for pregnant and postpartum WLWH using the ADAPT-ITT framework. This involves an iterative process with stakeholders to ensure the intervention is culturally and gender-appropriate, enhancing its acceptability for the target population.

Feasibility and Preliminary Impact Assessment: The study will assess the feasibility and acceptability of the adapted intervention. Ninety pregnant women will be randomly assigned to either receive the intervention or continue with standard care. Researchers will then estimate the intervention's potential impact on anticipated and internalized HIV-related stigma (primary outcomes), as well as ART adherence and symptoms of anxiety and depression (secondary outcomes).

What were the results of this study? (Outcomes):

As a preliminary and adaptation study, this research aims to:

Provide essential data to inform and justify a larger, fully-powered randomized clinical trial to rigorously evaluate the adapted intervention's effectiveness.

Identify potential indicators associated with mother-to-child transmission of HIV.

Develop a model that can be applied to other Sub-Saharan African countries facing similar challenges.

Foster new collaborations focused on HIV-related stigma among women in Ghana. Build research capacity among researchers in sub-Saharan Africa.

What are the side effects of the treatments in this study? (Safety):

This study focuses on a behavioral intervention (a support and counseling module) rather than a drug or medical treatment. Therefore, typical physical side effects associated with medications are not expected. The intervention aims to improve well-being and health outcomes by addressing psychosocial factors. Any adverse events or discomfort experienced by participants will be carefully monitored and addressed in accordance with ethical guidelines.

What are the conclusions of this study? (Implications/Future Plans):

The findings from this study are expected to demonstrate the feasibility and potential impact of a culturally and gender-tailored HIV stigma-reduction intervention for pregnant and postpartum WLWH in Ghana. This research will be foundational for launching a larger-scale clinical trial to definitively test the intervention's efficacy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.