Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women

NCT07064928 | Enrolling By Invitation

• 1 other identifier: 1R01TW012893-01
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; HIV - Human Immunodeficiency Virus; Postpartum; Pregnancy; Mental Health (Depression); Mental Health; Depression - Major Depressive Disorder; Stigma; Stigma, Social; Pyschological Distress

Keywords

stigma; hiv; self stigma; anticipated stigma; enacted stigma; stigma interventions; therapy; counseling; peer interventions; postpartum women; pregnant women; women living with HIV

Outcome Measures

Primary Outcomes (2)

• Mean change in anticipated HIV-related scale score

  Anticipated HIV-related stigma will be measured using Anticipated stigma scale. Response options range from 0-36 with higher scores indicating greater anticipated stigma.

  Baseline and 12 weeks

• Mean change in internalized HIV-related scale score

  Internalized HIV-related stigma will be measured using 10 items Internalized Stigma Scale (ISAT). Response options range from 10-50 with higher scores indicating greater internalized stigma

  Baseline and 12 weeks

Secondary Outcomes (3)

• Mean change in Edinburgh Postnatal Depression Scale (EPDS) score

  Baseline and 12 weeks

• Mean change in Center for Support Evaluation (CASE) scale score

  Baseline and 12 weeks

• Presence or Absence of tenofovir (TFV) in Urine

  Baseline and 12 weeks

Study Arms (1)

Adapted Project Accept PTSS Module

EXPERIMENTAL

The adapted Project Accept's Post-Test Support Services (PTSS) Module 3 specifically designed to reduce HIV-related stigma, encourage HIV treatment adherence, and improve quality of life among those living with HIV.

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

Interventions

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

Adapted Project Accept's Post-Test Support Services (PTSS) Module 3 for the Ghanaian context, and among pregnant and/or postpartum women living with HIV

Adapted Project Accept PTSS Module

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: Women who are pregnant and/or postpartum living with HIV as identified in the local Ghanian context.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with HIV
• Between 24-36 weeks gestation at enrollment
• Willing to participate during the postpartum period
• Recruitment process:
• Approached during a prenatal visit by a nurse/midwife
• Interested women will be connected with a trained research assistant (RA)
• RA will explain the study to potential participants

You may not qualify if:

• Critically ill and hospitalized pregnant WLWH
• Pregnant WLWH not planning to live in the region for at least 6 months after childbirth
• Pregnant WLWH under 13 years old, under parental supervision, and attending mandatory school
• Eligibility of healthcare providers:
• All providers at the four sites invited to a session at their site
• Providers eligible if they have worked with WLWH or pregnant/postpartum women for at least 2 months
• Providers who do not consent to be interviewed will not be included

Sponsors & Collaborators

• University of California, San Francisco: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Africa Interdisciplinary Research Institute: collaborator

Study Sites (1)

Ashaiman Polyclinic

Accra, Ghana

Location

Related Publications (9)

• Nakimuli-Mpungu E, Okello J, Kinyanda E, Alderman S, Nakku J, Alderman JS, Pavia A, Adaku A, Allden K, Musisi S. The impact of group counseling on depression, post-traumatic stress and function outcomes: a prospective comparison study in the Peter C. Alderman trauma clinics in northern Uganda. J Affect Disord. 2013 Oct;151(1):78-84. doi: 10.1016/j.jad.2013.05.055. Epub 2013 Jun 17.

  PMID: 23787406 BACKGROUND

• Uthman OA, Magidson JF, Safren SA, Nachega JB. Depression and adherence to antiretroviral therapy in low-, middle- and high-income countries: a systematic review and meta-analysis. Curr HIV/AIDS Rep. 2014 Sep;11(3):291-307. doi: 10.1007/s11904-014-0220-1.

  PMID: 25038748 BACKGROUND

• Sakyi KS, Lartey MY, Kennedy CE, Denison JA, Sacks E, Owusu PG, Hurley EA, Mullany LC, Surkan PJ. Stigma toward small babies and their mothers in Ghana: A study of the experiences of postpartum women living with HIV. PLoS One. 2020 Oct 16;15(10):e0239310. doi: 10.1371/journal.pone.0239310. eCollection 2020.

  PMID: 33064737 BACKGROUND

• Khumalo-Sakutukwa G, Morin SF, Fritz K, Charlebois ED, van Rooyen H, Chingono A, Modiba P, Mrumbi K, Visrutaratna S, Singh B, Sweat M, Celentano DD, Coates TJ; NIMH Project Accept Study Team. Project Accept (HPTN 043): a community-based intervention to reduce HIV incidence in populations at risk for HIV in sub-Saharan Africa and Thailand. J Acquir Immune Defic Syndr. 2008 Dec 1;49(4):422-31. doi: 10.1097/QAI.0b013e31818a6cb5.

  PMID: 18931624 BACKGROUND

• Coates TJ, Kulich M, Celentano DD, Zelaya CE, Chariyalertsak S, Chingono A, Gray G, Mbwambo JK, Morin SF, Richter L, Sweat M, van Rooyen H, McGrath N, Fiamma A, Laeyendecker O, Piwowar-Manning E, Szekeres G, Donnell D, Eshleman SH; NIMH Project Accept (HPTN 043) study team. Effect of community-based voluntary counselling and testing on HIV incidence and social and behavioural outcomes (NIMH Project Accept; HPTN 043): a cluster-randomised trial. Lancet Glob Health. 2014 May;2(5):e267-77. doi: 10.1016/S2214-109X(14)70032-4. Epub 2014 Apr 8.

  PMID: 25103167 BACKGROUND

• Turan JM, Nyblade L. HIV-related stigma as a barrier to achievement of global PMTCT and maternal health goals: a review of the evidence. AIDS Behav. 2013 Sep;17(7):2528-39. doi: 10.1007/s10461-013-0446-8.

  PMID: 23474643 BACKGROUND

• Valencia-Garcia D, Rao D, Strick L, Simoni JM. Women's experiences with HIV-related stigma from health care providers in Lima, Peru: "I would rather die than go back for care". Health Care Women Int. 2017 Feb;38(2):144-158. doi: 10.1080/07399332.2016.1217863. Epub 2016 Aug 2.

  PMID: 27485767 BACKGROUND

• Tran BX, Phan HT, Latkin CA, Nguyen HLT, Hoang CL, Ho CSH, Ho RCM. Understanding Global HIV Stigma and Discrimination: Are Contextual Factors Sufficiently Studied? (GAPRESEARCH). Int J Environ Res Public Health. 2019 May 29;16(11):1899. doi: 10.3390/ijerph16111899.

  PMID: 31146379 BACKGROUND

• Turan B, Stringer KL, Onono M, Bukusi EA, Weiser SD, Cohen CR, Turan JM. Linkage to HIV care, postpartum depression, and HIV-related stigma in newly diagnosed pregnant women living with HIV in Kenya: a longitudinal observational study. BMC Pregnancy Childbirth. 2014 Dec 3;14:400. doi: 10.1186/s12884-014-0400-4.

  PMID: 25467187 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Psychological Well-Being; Depression; Social Stigma

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; Personal Satisfaction; Behavior; Behavioral Symptoms; Social Behavior

Study Officials

• Jerry J Ouner, PhD, RN, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigators will randomize 90 pregnant women 1:1 to intervention or standard care controls to assess F\&A of the intervention and preliminary impact on outcomes. Our primary outcomes are anticipated and internalized HIV-related stigma. Secondary outcomes include ART adherence and mental health symptoms of anxiety and depression.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 15, 2025
• Study Start: November 28, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)