Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women

Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women: A Pilot Study

Young pregnant and postpartum women living with HIV are at the greatest risk of disengagement from HIV services and suboptimal adherence to antiretroviral therapy (ART). Among young women, stigma is a major barrier to retention in services and adherence to ART, and interventions are needed to combat stigma and improve ART outcomes. The investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in this population.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Behavioral: Peer support intervention

Detailed Description

Despite major reductions in mother-to-child HIV transmission (MTCT), young pregnant and postpartum women living with HIV remain a vulnerable group and experience the greatest risk of disengagement from services and suboptimal adherence to antiretroviral therapy (ART). HIV-related and intersectional stigmas are major barriers to uptake and retention in prevention of mother-to-child transmission (PMTCT) services and drive suboptimal adherence, and young women experience unique stigmas. Despite this, there are no evidence-based interventions to combat stigma and improve ART outcomes in this group. Peer support group interventions have shown promise in other populations, but have not been examined in young pregnant and postpartum women living with HIV. The investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in young pregnant and postpartum women living with HIV in South Africa. Participants will be allocated to the standard of care, in which no standardized peer support groups exist for this patient population, or to a peer support intervention.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7750
      • Gugulethu Community Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Aged 16-24 years
• Documented HIV infection
• Confirmed pregnant or recently postpartum
• Accessing antenatal or immediate postpartum PMTCT services at the study site
• Planning on remaining a resident of Cape Town for at least 6 months after enrolment
• Able to provide informed consent for research

Exclusion Criteria:

• Significant pre-existing psychiatric comorbidity that may impact ability to consent
• Stated intention to move outside of Cape Town during the 6 months after enrolment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Local standard of care; Women receive integrated antenatal and HIV services during pregnancy and are referred to general adult HIV services after delivery; no standardized peer support groups exist for this patient population.
Experimental: Peer support intervention; Women will be invited to attend monthly peer support groups during pregnancy and postpartum, separate from any routine health services.	Behavioral: Peer support intervention; Peer support groups will meet monthly for the duration of follow-up, with separate groups for pregnant and postpartum women. Groups will be facilitated by women who are living with HIV and have experience of PMTCT services in this setting. Group sessions will include brief information and a structured discussion about a relevant topic, followed by opportunities for unstructured discussion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention and viral suppression	Combined endpoint of (i) retention in HIV services and (ii) HIV viral suppression. Women will be considered to have achieved the primary outcome if they are both retained in care and virally suppressed.	After 6 months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychosocial outcomes	Psychosocial outcomes, including perceived social support and adherence self-efficacy, assessed using self-report questionnaires	6 months
Implementation of the intervention	Implementation of the peer support intervention including standardization, assessed using logs and process notes completed by counsellors who will deliver the intervention	6 months
Acceptability of the intervention	Acceptability of the peer support intervention, assessed as utilization and during in-depth interviews in a subset of participants	6 months
Health status	Maternal and infant health status, assessed using self-report and routine medical records	6 months
Health service use	Maternal and infant routine medical service use, assessed using self-report and routine medical records	6 months

Collaborators and Investigators

• Sponsor: University of Cape Town
• Investigators: Principal Investigator: Landon Myer, MBChB, PhD, University of Cape Town

Publications and helpful links

General Publications

• Brittain K, Gomba Y, Noholoza S, Pellowski J, Mellins CA, Bekker LG, Kagee A, Remien RH, Abrams EJ, Myer L. HIV-related stigma, disclosure and social support: experiences among young pregnant and postpartum women living with HIV in South Africa. AIDS Care. 2022 Sep 14:1-7. doi: 10.1080/09540121.2022.2121957. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2019
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 267/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No