NCT04036851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 30, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

July 16, 2019

Last Update Submit

May 17, 2022

Conditions

Hiv

Outcome Measures

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.

    After 6 months of follow-up

Secondary Outcomes (5)

  • Psychosocial outcomes

    6 months

  • Implementation of the intervention

    6 months

  • Acceptability of the intervention

    6 months

  • Health status

    6 months

  • Health service use

    6 months

Study Arms (2)

Local standard of care

NO INTERVENTION

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.

Peer support intervention

EXPERIMENTAL

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

Peer support interventionBEHAVIORAL

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.

Peer support intervention

Eligibility Criteria

Age16 Years - 24 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gugulethu Community Health Centre

Cape Town, Western Cape, 7750, South Africa

Location

Related Publications (1)

  • 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.

    PMID: 36102063DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Landon Myer, MBChB, PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 30, 2019

Study Start

August 30, 2019

Primary Completion

August 1, 2020

Study Completion

November 1, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

ZA(1)