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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04036851
Enrollment
120
Registered
2019-07-30
Start date
2019-08-30
Completion date
2021-11-01
Last updated
2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

Brief summary

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.

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.

Interventions

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.

Sponsors

University of Cape Town
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 24 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Retention and viral suppressionAfter 6 months of follow-upCombined 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.

Secondary

MeasureTime frameDescription
Psychosocial outcomes6 monthsPsychosocial outcomes, including perceived social support and adherence self-efficacy, assessed using self-report questionnaires
Implementation of the intervention6 monthsImplementation of the peer support intervention including standardization, assessed using logs and process notes completed by counsellors who will deliver the intervention
Acceptability of the intervention6 monthsAcceptability of the peer support intervention, assessed as utilization and during in-depth interviews in a subset of participants
Health status6 monthsMaternal and infant health status, assessed using self-report and routine medical records
Health service use6 monthsMaternal and infant routine medical service use, assessed using self-report and routine medical records

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026