ClinicalTrials.gg
CompletedNCT04036851Updated May 18, 2022

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

An interventional study of Peer support intervention in Hiv, sponsored by University of Cape Town. Completed at 1 site in South Africa. Open to female participants aged 16 Years to 24 Years. Per ClinicalTrials.gov, last updated 2022-05-18.

Sponsored by University of Cape Town · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
16 Years to 24 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

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In context

Acquired Immunodeficiency Syndrome

2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.

This study's enrollment of 120 is above the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

University of Cape Town is the lead sponsor of 116 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 24 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralPeer 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: After 6 months of follow-up

Secondary outcomes

  1. Psychosocial outcomes

    Psychosocial outcomes, including perceived social support and adherence self-efficacy, assessed using self-report questionnaires

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. Acceptability of the intervention

    Acceptability of the peer support intervention, assessed as utilization and during in-depth interviews in a subset of participants

    Time frame: 6 months

  4. Health status

    Maternal and infant health status, assessed using self-report and routine medical records

    Time frame: 6 months

  5. Health service use

    Maternal and infant routine medical service use, assessed using self-report and routine medical records

    Time frame: 6 months

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Study locations

1 site
  • Gugulethu Community Health Centre
    Cape Town, Western Cape 7750, South Africa
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References and documents

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. 2023 Mar;35(3):399-405. doi: 10.1080/09540121.2022.2121957. Epub 2022 Sep 14. PubMed 36102063 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04036851
Responsible party
Professor Landon Myer (Professor, University of Cape Town) — Principal investigator
First posted
Jul 30, 2019
Start date
Aug 30, 2019
Primary completion
Aug 1, 2020
Completion
Nov 1, 2021
Last update
May 18, 2022

Study contacts

Landon Myer, MBChB, PhD
principal investigator · University of Cape Town

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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