The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retent… (NCT02474992) | Clinical Trial Compass
CompletedNot Applicable
The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retention in HIV Care
Kenya304 participantsStarted 2016-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* Elig…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.