Clinical trial NCT02474992: The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retention in HIV Care
Official title: The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retention in HIV Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Social network
Social support
Disclosure
Stigma
Kenya
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Organic Health Response
name: Microclinic International
name: Kenya Medical Research Institute
First posted: 2015-06-18
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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.
* 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.

Primary outcomes:
measure: Disengagement from care
timeFrame: 12 months
measure: Disengagement from care
timeFrame: 12 months
Secondary outcomes:
measure: Virologic suppression
timeFrame: 12 months
measure: HIV-related stigma
timeFrame: 12 months
measure: Re-engagement in care
timeFrame: 12 months
Other outcomes:
Locations:
city: Mfangano Island
country: Kenya
facility: Ekialo Kiona Center
state: Homa Bay County
Study officials:
affiliation: University of California, San Francisco
name: Craig R Cohen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenya Medical Research Institute
name: Elizabeth A Bukusi, MBChB, M.Med, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Matthew D Hickey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Organic Health Response
name: Charles R Salmen, MD, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
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.