Clinical trial NCT04036851: Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women
Official title: Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Retention and viral suppression
timeFrame: After 6 months of follow-up
Secondary outcomes:
measure: Psychosocial outcomes
timeFrame: 6 months
measure: Implementation of the intervention
timeFrame: 6 months
measure: Acceptability of the intervention
timeFrame: 6 months
measure: Health status
timeFrame: 6 months
measure: Health service use
timeFrame: 6 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Gugulethu Community Health Centre
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Landon Myer, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.