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Completed

NCT Number: NCT04036851

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gugulethu Community Health Centre

Cape Town, Western Cape, 7750, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer Support Intervention

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.

Primary outcomes

  1. Retention and viral suppression

    Time frame: After 6 months of follow-up

    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.

Secondary outcomes

  1. Psychosocial outcomes

    Time frame: 6 months

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

  2. Implementation of the intervention

    Time frame: 6 months

    Implementation of the peer support intervention including standardization, assessed using logs and process notes completed by counsellors who will deliver the intervention

  3. Acceptability of the intervention

    Time frame: 6 months

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

  4. Health status

    Time frame: 6 months

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

  5. Health service use

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 30, 2019
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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