Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-24 @ 2:23 AM
Study NCT ID:
NCT02474992
Status:
COMPLETED
Last Update Posted:
2019-08-08
First Post:
2015-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retention in HIV Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2015-06-16', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disengagement from care', 'timeFrame': '12 months', 'description': 'Incidence of 90-day absence from care following a missed appointment'}, {'measure': 'Disengagement from care', 'timeFrame': '12 months', 'description': 'Proportion of time eligible for HIV care that patient is adherent to clinic appointment schedules. Calculated by subtracting the sum of all gaps in care from the total time eligible for care, and dividing by total time eligible for care. Gaps in care are defined as the number of days between a missed appointment and subsequent return to any clinic in the study area to access HIV care.'}], 'secondaryOutcomes': [{'measure': 'Virologic suppression', 'timeFrame': '12 months', 'description': 'Proportion of patients who are virologically suppressed 12 months after randomization'}, {'measure': 'HIV-related stigma', 'timeFrame': '12 months', 'description': 'Reduction in stigma as compared to baseline, measured by the Earnshaw HIV Stigma Framework'}, {'measure': 'Re-engagement in care', 'timeFrame': '12 months', 'description': 'Incidence of re-engagement in care following missed visit at time of study enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Social network', 'Social support', 'Disclosure', 'Stigma', 'Kenya'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '39516844', 'type': 'DERIVED', 'citation': 'Zoughbie DE, Huddleston D, Watson K, Ding EL. HIV Social-network intervention more effective in older populations in Kenya. BMC Public Health. 2024 Nov 9;24(1):3098. doi: 10.1186/s12889-024-20315-0.'}, {'pmid': '34516557', 'type': 'DERIVED', 'citation': 'Hickey MD, Ouma GB, Mattah B, Pederson B, DesLauriers NR, Mohamed P, Obanda J, Odhiambo A, Njoroge B, Otieno L, Zoughbie DE, Ding EL, Fiorella KJ, Bukusi EA, Cohen CR, Geng EH, Salmen CR. The Kanyakla study: Randomized controlled trial of a microclinic social network intervention for promoting engagement and retention in HIV care in rural western Kenya. PLoS One. 2021 Sep 13;16(9):e0255945. doi: 10.1371/journal.pone.0255945. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized controlled trial is to compare a social network-based behavioral intervention known as microclinics to standard HIV clinical care alone in helping patients receiving HIV care on Mfangano, Remba and Ringiti Islands, Kenya remain adherent to clinic appointments. The study is designed to evaluate the effectiveness of microclinics on reducing gaps in clinical care, HIV viral load and HIV-related stigma, compared to standard HIV clinical care alone. By doing this research study, the investigators hope to learn whether microclinics are a useful social strategy for improving delivery of HIV treatment in rural Kenya.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be currently receiving combination antiretroviral therapy (cART) or co-trimoxozole prophylaxis from one of the eligible study clinics:\n\n * Is currently in care at study baseline, defined as having ≥1 medical care visit to receive medications (cART or prophylaxis) during the six months preceeding initiation of study enrollment, OR\n * Initiates pre-ART or ART care for the first time at a study clinic during the six month study recruitment period, OR\n * Transfers from a clinic outside the study area and receives pre-ART or ART care for the first time from a study clinic during the six month recruitment period\n* Participants become eligible for study inclusion on the 4th day following a missed clinic appointment, provided the patient has not transferred care to another clinic prior to the 4th day, moved outside the study area or died. Participants who miss a study visit by \\>3 days but return to clinic before recruitment takes place are still eligible for study enrollment. Missed visits must have occurred within the previous 90 days at the time of eligibility assessment to meet this inclusion criteria.\n* Must currently reside on Mfangano, Remba or Ringiti Island.\n* Must be conversant with one of the commonly spoken languages within the study area (i.e. DhoLuo, Swahili or English; prior experience indicates that this represents \\>99% of the adult population).\n* Must be ≥18 years of age as of the date of study eligibility.\n\nExclusion Criteria:\n\n* Eligible participants who reside in the Mfangano East sub-location will be excluded from participation in this study. Many of these patients have already participated in the microclinic intervention as part of the Mfangano Island Healthy Network Impact Study.\n* Participants planning on moving permanently out of the study area within the next six months will be excluded.\n* Participants who, should they be randomized to the intervention arm, would be unwilling to participate in a microclinic will be excluded from study enrollment.'}, 'identificationModule': {'nctId': 'NCT02474992', 'briefTitle': 'The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retention in HIV Care', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retention in HIV Care', 'orgStudyIdInfo': {'id': 'OHR006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This arm is eligible for participation in the Microclinic intervention, a social network-based educational program.', 'interventionNames': ['Behavioral: Microclinic']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison', 'description': 'This arm is not eligible for participation in the intervention during the first twelve months of the study. Following collection of the primary study endpoints, this arm will also be invited to participate in a Microclinic group. Participants in this arm will still have access to standard HIV care at the facility of their choice. At time of recruitment into the study, prior to randomization, all eligible participants will be counseled on the importance of returning to their clinic for ongoing HIV care.'}], 'interventions': [{'name': 'Microclinic', 'type': 'BEHAVIORAL', 'otherNames': ['Kanyakla'], 'description': 'Individuals randomized to this arm will be invited to recruit members of their social network to form a health team, or microclinic. These groups will proceed through a discussion-based health education curriculum led by local community health workers. Topics will include HIV biology, medications, the importance of social support, and community outreach for reducing HIV stigma. The curriculum will conclude with an opportunity for all group members to disclose their HIV status to one another.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mfangano Island', 'state': 'Homa Bay County', 'country': 'Kenya', 'facility': 'Ekialo Kiona Center'}], 'overallOfficials': [{'name': 'Craig R Cohen, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Elizabeth A Bukusi, MBChB, M.Med, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kenya Medical Research Institute'}, {'name': 'Matthew D Hickey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Charles R Salmen, MD, MPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Organic Health Response'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Organic Health Response', 'class': 'OTHER'}, {'name': 'Microclinic International', 'class': 'OTHER'}, {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}