Strengthening Families Living With HIV in Kenya (NCT04588883) | Clinical Trial Compass
CompletedNot Applicable
Strengthening Families Living With HIV in Kenya
Kenya843 participantsStarted 2021-09-28
Plain-language summary
This study seeks to use a group-based microfinance/internal lending model to develop social capital among people with HIV in Kenya. This will create a context to deliver validated curriculum targeting intimate partner violence, positive parenting, agriculture, small business entrepreneurship, group-interpersonal therapy, and other determinants of well-being and ART adherence among people with HIV. The primary outcomes are viral suppression, ART adherence, and common mental disorders.
Who can participate
Age range
13 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:
Criteria for inclusion of subjects include:
* testing positive for HIV, confirmed by the Ministry of Health clinics
* being at or older than 13 years of age
* initiating care at a qualified Ministry of Health clinic in the catchment area, or intending to initiate care at such a clinic (see below for definition)
* Any gender, age (13+ years), and comorbid disease states
* Provide informed consent if adult, emancipated minor or mature minor
* Provide assent if minor with guardian, who must provide informed consent
Qualified clinical locations include
* those with accessible and usable public land to convene weekly meetings,
* no current program targeting families with HIV known to the Ministry of Health
Exclusion Criteria:
* Refusal to participate
* Current participation in a similar program
* Residing in a location with a similar program targeting patients with HIV
* Not covered by inclusion criteria.
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.
What they're measuring
1
Viral Suppression
Timeframe: Change from baseline to 3 years
2
Anti-retroviral therapy Adherence
Timeframe: Change from baseline to 3 years
3
Depression
Timeframe: Change from baseline to 3 years
4
Anxiety
Timeframe: Change from baseline to 3 years
5
Post-Traumatic Stress Disorder
Timeframe: Change from baseline to 3 years
Trial details
NCT IDNCT04588883
SponsorThe University of Texas Medical Branch, Galveston