Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-05 @ 12:43 AM
Study NCT ID:
NCT04036851
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2019-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2019-07-16', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention and viral suppression', 'timeFrame': 'After 6 months of follow-up', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Psychosocial outcomes', 'timeFrame': '6 months', 'description': 'Psychosocial outcomes, including perceived social support and adherence self-efficacy, assessed using self-report questionnaires'}, {'measure': 'Implementation of the intervention', 'timeFrame': '6 months', 'description': 'Implementation of the peer support intervention including standardization, assessed using logs and process notes completed by counsellors who will deliver the intervention'}, {'measure': 'Acceptability of the intervention', 'timeFrame': '6 months', 'description': 'Acceptability of the peer support intervention, assessed as utilization and during in-depth interviews in a subset of participants'}, {'measure': 'Health status', 'timeFrame': '6 months', 'description': 'Maternal and infant health status, assessed using self-report and routine medical records'}, {'measure': 'Health service use', 'timeFrame': '6 months', 'description': 'Maternal and infant routine medical service use, assessed using self-report and routine medical records'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hiv']}, 'referencesModule': {'references': [{'pmid': '36102063', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 16-24 years\n* Documented HIV infection\n* Confirmed pregnant or recently postpartum\n* Accessing antenatal or immediate postpartum PMTCT services at the study site\n* Planning on remaining a resident of Cape Town for at least 6 months after enrolment\n* Able to provide informed consent for research\n\nExclusion Criteria:\n\n* Significant pre-existing psychiatric comorbidity that may impact ability to consent\n* Stated intention to move outside of Cape Town during the 6 months after enrolment'}, 'identificationModule': {'nctId': 'NCT04036851', 'briefTitle': 'Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Cape Town'}, 'officialTitle': 'Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women: A Pilot Study', 'orgStudyIdInfo': {'id': '267/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Local standard of care', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Peer support intervention', 'description': 'Women will be invited to attend monthly peer support groups during pregnancy and postpartum, separate from any routine health services.', 'interventionNames': ['Behavioral: Peer support intervention']}], 'interventions': [{'name': 'Peer support intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Peer support intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7750', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Gugulethu Community Health Centre', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Landon Myer, MBChB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cape Town'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cape Town', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor Landon Myer', 'investigatorAffiliation': 'University of Cape Town'}}}}