CompletedNot Applicable

Adolescent Wellness Visits in Tanzania

Tanzania1,095 participantsStarted 2022-05-17

Plain-language summary

This study evaluates the impact of clinic-based 'Adolescent Wellness Visits' (AWVs) coordinated with primary schools that offer a package of evidence-based adolescent-friendly preventative services on HIV testing uptake in Tanzania. Participants: The clinical trial participants are approximately 1500 adolescents in their final year of primary school who will be enrolled in this cluster randomized controlled trial (RCT) from 20 primary schools and followed up for two years post-primary school. \[Qualitative data from approximately 250 adult stakeholders will also be collected via focus group discussions (FGDs) and in-depth interviews (IDIs) for implementation science, non-trial related study aims\] . Procedures: Adolescent data will include surveys with self-report measures and reviews of their medical records (using REDCap). The adult qualitative data will be in the form of translated and transcribed FGD and IDI transcripts as Word documents.

Who can participate

Age range

10 Years – 17 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: * At enrollment, must be a student in the seventh and final year of primary school. Exclusion Criteria: * Youth that are out of school at the time of enrollment.

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

Number of Adolescents Who Self-reported HIV Testing and Counseling, Inclusive of the Adolescent Wellness Visit

Timeframe: between Baseline and Endline, approximately 2.5 years

Number of Adolescents Who Self-reported HIV Testing and Counseling, Exclusive of the Adolescent Wellness Visit

Timeframe: between Baseline and Endline, approximately 2.5 years

Trial details

NCT IDNCT05306938

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-28

Results submitted2026-02-13

View on ClinicalTrials.gov More HIV Testing trials

Plain-language summary

Who can participate

Age range

10 Years – 17 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: * At enrollment, must be a student in the seventh and final year of primary school. Exclusion Criteria: * Youth that are out of school at the time of enrollment.

What they're measuring

Number of Adolescents Who Self-reported HIV Testing and Counseling, Inclusive of the Adolescent Wellness Visit

Timeframe: between Baseline and Endline, approximately 2.5 years

Number of Adolescents Who Self-reported HIV Testing and Counseling, Exclusive of the Adolescent Wellness Visit

Timeframe: between Baseline and Endline, approximately 2.5 years