HivNCT04036851
Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women
A study testing Peer support intervention in people with Hiv, run by University of Cape Town at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 24 years, women only
- Conditions the study is for
- Hiv
- What is being tested?
- Peer support intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Africa
- Study dates
- 30 Aug 2019to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Gugulethu Community Health Centre
Cape Town, Western Cape, 7750
About this study
Official title: Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women: A Pilot Study
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.
- Conditions
- Hiv
- Being tested
- Peer support intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Peer support intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 6 months of follow-up
Secondary outcomes (5)
Psychosocial outcomes
Psychosocial outcomes, including perceived social support and adherence self-efficacy, assessed using self-report questionnaires
Measured: 6 months
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
Measured: 6 months
Acceptability of the intervention
Acceptability of the peer support intervention, assessed as utilization and during in-depth interviews in a subset of participants
Measured: 6 months
Health status
Maternal and infant health status, assessed using self-report and routine medical records
Measured: 6 months
Health service use
Maternal and infant routine medical service use, assessed using self-report and routine medical records
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start30 Aug 2019
- Primary completion1 Aug 2020
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Landon Myer, University of Cape Town
- Investigators
- Landon Myer, MBChB, PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036851
- Sponsor's protocol ID
- 267/2019
- Status last verified
- May 2022
- First submitted
- 16 Jul 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT04036851
- Acronym / sponsor ID
- 267/2019
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Peer support interventionWomen will be invited to attend monthly peer support groups during pregnancy and postpartum, separate from any routine health services. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer support interventionPeer 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. | Behavioural | Peer support intervention |
Primary outcome
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.
5 secondary outcomes
Psychosocial outcomes
Time frame: 6 months
Implementation of the intervention
Time frame: 6 months
Acceptability of the intervention
Time frame: 6 months
Health status
Time frame: 6 months
Health service use
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 36102063Brittain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Landon Myer, MBChB, PhD principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support intervention in people with Hiv, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention and viral suppression (time frame: After 6 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04036851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.