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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036851
• Other study ID #: 267/2019
• Status: Completed
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: May 2022
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 1, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

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.

Locations

Country	Name	City	State
South Africa	Gugulethu Community Health Centre	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Psychosocial outcomes	Psychosocial outcomes, including perceived social support and adherence self-efficacy, assessed using self-report questionnaires	6 months
Secondary	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
Secondary	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
Secondary	Health status	Maternal and infant health status, assessed using self-report and routine medical records	6 months
Secondary	Health service use	Maternal and infant routine medical service use, assessed using self-report and routine medical records	6 months