Making ART Work Among Brazilian Youth (NCT06056037) | Clinical Trial Compass
RecruitingNot Applicable
Making ART Work Among Brazilian Youth
Brazil72 participantsStarted 2023-10-01
Plain-language summary
This study seeks to develop and pilot test a theory-based, integrated technology and counseling intervention to improve ART adherence among sexual and gender minority (SGM) young people living with HIV (ages 18-24) in Rio de Janeiro, Brazil. The intervention aims to improve social support, self-efficacy for taking ART, and teach skills for problem-solving barriers to promote better adherence.
Who can participate
Age range
18 Years – 24 Years
Sex
MALE
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:
* between 18 and 24 years of age
* assigned male sex at birth
* identify as a gay or bisexual man, or a transgender woman or another gender identity along the feminine spectrum
* self-report living with HIV, and verified by medical chart review,
* self-report currently taking or prescribed ART for \> 3 months
* self-report missing 2 or more doses of ART medications in any given week in the past month OR not virally suppressed (i.e., \>40 copies/mL in past 3 months; via national outpatient data \[SISCEL\] or plasma viral load testing)
* owns a cell phone or willing to use one as part of the study
Exclusion Criteria:
* unable to give informed consent due to cognitive limitation, severe mental/physical illness or intoxication
* unable to read and/or write to an extent that would limit their ability to comprehend the informed consent
* lived in the greater Rio de Janeiro area for \< 3 months or planning to move outside the area within the next year
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
Feasibility: number of participants who have at least one follow up visit
Timeframe: 6 months
2
Feasibility: mean number of intervention sessions attended
Timeframe: 3 months
3
Acceptability: mean score on the Client Satisfaction Questionnaire scale (CSQ-8)
Timeframe: 3 months
4
Medication adherence - proportion of participants with presence of tenofovir in urine using a point-of-care lateral flow immunoassay (LFA) method
Timeframe: 6 months
5
Medication adherence - proportion who have received all ART prescriptions over the course of follow up according to pharmacy dispensing records (SICLOM national registry)