The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retention in HIV Care

NCT ID: NCT02474992

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-06-30

Brief Summary

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

This arm is eligible for participation in the Microclinic intervention, a social network-based educational program.

Group Type: EXPERIMENTAL

Microclinic

Intervention Type: BEHAVIORAL

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.

Comparison

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Microclinic

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Kanyakla

Eligibility Criteria

Inclusion Criteria

• Must be currently receiving combination antiretroviral therapy (cART) or co-trimoxozole prophylaxis from one of the eligible study clinics:

• 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
• Initiates pre-ART or ART care for the first time at a study clinic during the six month study recruitment period, OR
• 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
• Must currently reside on Mfangano, Remba or Ringiti Island.
• 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).
• Must be ≥18 years of age as of the date of study eligibility.

Exclusion Criteria

• 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.
• Participants planning on moving permanently out of the study area within the next six months will be excluded.
• Participants who, should they be randomized to the intervention arm, would be unwilling to participate in a microclinic will be excluded from study enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organic Health Response

OTHER

Sponsor Role: collaborator

Microclinic International

OTHER

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig R Cohen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Elizabeth A Bukusi, MBChB, M.Med, PhD

Role: PRINCIPAL_INVESTIGATOR

Kenya Medical Research Institute

Matthew D Hickey, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Charles R Salmen, MD, MPhil

Role: PRINCIPAL_INVESTIGATOR

Organic Health Response

Locations

Ekialo Kiona Center

Mfangano Island, Homa Bay County, Kenya

Countries

Kenya

References

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.

Reference Type: DERIVED

PMID: 39516844 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34516557 (View on PubMed)

Other Identifiers

OHR006

Identifier Type: -

Identifier Source: org_study_id