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

NCT ID: NCT04036851

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2021-11-01

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.

Conditions

Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Peer support intervention

Women will be invited to attend monthly peer support groups during pregnancy and postpartum, separate from any routine health services.

Group Type: EXPERIMENTAL

Peer support intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Professor Landon Myer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Landon Myer, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Locations

Gugulethu Community Health Centre

Cape Town, Western Cape, South Africa

Countries

South Africa

References

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. 2023 Mar;35(3):399-405. doi: 10.1080/09540121.2022.2121957. Epub 2022 Sep 14.

Reference Type: DERIVED

PMID: 36102063 (View on PubMed)

Other Identifiers

267/2019

Identifier Type: -

Identifier Source: org_study_id