An interventional study of Adolescent Wellness Visit in HIV Testing and Contraceptive Usage, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in Tanzania. Open to participants aged 10 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
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.
In most low-resource country settings, there is no routine clinic-based adolescent health check-up after the recommended child wellness visits end at age 5. Adolescents in low-resource settings need a preventative health service platform applicable for all young people that promotes a culture of health-seeking behavior. This study evaluates the impact of Adolescent Wellness Visits (AWVs), a new health service platform, for reaching young adolescents with HIV testing and counseling (HTC) and other evidence-based prevention services which are clinic-based and school-facilitated. AWVs could meet the reproductive health needs of at-risk adolescents and have a larger public health impact for all adolescents on access to traditionally neglected and under-treated health conditions such as poor nutrition, and vision, dental, and mental health problems at the time of delivery as well as in the future as adolescents continue with more timely service utilization.
The AWV is designed to be delivered during the last year of primary school when school attendance is high, and adolescents are on the cusp of puberty (mean age 13). This project is a collaboration between the University of North Carolina at Chapel Hill in the United States (prime), Muhimbili University of Health and Allied Sciences in Dar es Salaam, Tanzania, and Duke University in the United States.
Specific Aims are:
Methodology:
Participants: Up to 1,500 adolescents in the seventh and final grade of primary school; about 650 for each randomized study arm (10 intervention schools + 10 control schools).
Study design: Investigators will implement this cluster RCT with 10 intervention schools and 10 control schools. Randomization occurs at the school level and both adolescent assent and parental consent will be obtained for all participants. There are 4 data collection timepoints (baseline, follow-up 1, follow-up 2, follow-up 3/endline). At baseline, for control schools, adolescents will be interviewed at their schools or in the community while for intervention schools, adolescents will be interviewed before and after their AWV at the clinic. The AWV intervention will involve a single adolescent wellness visit to a public health facility within a walking distance (1 Km) that offers a package of government-approved, evidence-based youth-friendly services (screenings for nutrition, vision, dental pain, mental health, puberty and contraception information and counseling, syndromic sexually transmitted infection screening, and optional HIV testing) in Dar es Salaam and Pwani regions in Tanzania. All children (intervention and control) will be given a Tanzanian government endorsed Puberty Book and encouraged to ask questions to teachers/parents and guardians (intervention participants will also have the opportunity to ask questions with clinical staff during AWV). Follow-interviews with adolescents will be community-based.
Direct observations coupled with FGDs and IDIs (perspectives of parents, direct providers of health and education services and other key stakeholders), will describe factors that support or limit implementation of the AWV model including fidelity/adherence to components of the evidence-based package.
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's enrollment of 1,095 is above the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Adolescents in this arm will receive the Adolescent Wellness Visit intervention.
Behavioral: Adolescent Wellness Visit
Adolescents in this arm will not receive the Adolescent Wellness Visit intervention.
Adolescent Wellness Visits (AWVs) are a new health service platform for reaching young adolescents with HTC and other evidence-based prevention services which are clinic-based and school-facilitated. The AWVs bundle the following health screenings, education, and counseling on: nutrition, vision, dental, mental health (depression), contraception, sexually transmitted infections, and optional HIV testing.
Number of Adolescents Who Self-reported HIV Testing and Counseling, Inclusive of the Adolescent Wellness Visit
Data will be collected at four time points via individual interviews between the adolescent and a research assistant at the AWV (baseline), and at follow-up 1, follow-up 2, and endline. At each time point, the adolescent will be asked whether they have had an HIV test since the previous interview. The AWV intervention is delivered concurrently with baseline data collection.
Time frame: between Baseline and Endline, approximately 2.5 years
Number of Adolescents Who Self-reported HIV Testing and Counseling, Exclusive of the Adolescent Wellness Visit
Data will be collected at four time points via individual interviews between the adolescent and a research assistant at the AWV (baseline), and at follow-up 1, follow-up 2, and endline. At each time point, the adolescent will be asked whether they have had an HIV test since the previous interview. The AWV intervention is delivered concurrently with baseline data collection.
Time frame: between Baseline and Endline, approximately 2.5 years
Number Who Reported Contraceptive Use
Number who self-reported contraceptive use at most recent sex, among participants who reported having sex during the study.
Time frame: between Baseline and Endline, approximately 2.5 years
1095 participants in 20 schools were recruited.
| Milestone | Intervention | Control |
|---|---|---|
| Started | 509 | 586 |
| Follow-up 1 | 480 | 563 |
| Follow-up 2 | 455 | 562 |
| Completed | 473 | 556 |
| Not completed | 36 | 30 |
Data will be collected at four time points via individual interviews between the adolescent and a research assistant at the AWV (baseline), and at follow-up 1, follow-up 2, and endline. At each time point, the adolescent will be asked whether they have had an HIV test since the previous interview. The AWV intervention is delivered concurrently with baseline data collection.
| Participants | Intervention | Control |
|---|---|---|
| Number of Adolescents Who Self-reported HIV Testing and Counseling, Inclusive of the Adolescent Wellness Visit | 234 | 86 |
Data will be collected at four time points via individual interviews between the adolescent and a research assistant at the AWV (baseline), and at follow-up 1, follow-up 2, and endline. At each time point, the adolescent will be asked whether they have had an HIV test since the previous interview. The AWV intervention is delivered concurrently with baseline data collection.
| Participants | Intervention | Control |
|---|---|---|
| Number of Adolescents Who Self-reported HIV Testing and Counseling, Exclusive of the Adolescent Wellness Visit | 101 | 86 |
Number who self-reported contraceptive use at most recent sex, among participants who reported having sex during the study.
| Participants | Intervention | Control |
|---|---|---|
| Number Who Reported Contraceptive Use | 32 | 54 |
Collected over From Baseline interview until endline interview, an average of 2.5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 1/509 (0.2%) | 0/509 (0%) | 0/509 (0%) |
| Control | 0/586 (0%) | 0/586 (0%) | 0/586 (0%) |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 13.5 ± 1.2 | 13.4 ± 1.2 | 13.4 ± 1.2 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 283 | 286 | 569 |
| Male | 226 | 300 | 526 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 509 | 586 | 1095 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 509 | 586 | 1095 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Tanzania | 509 | 586 | 1095 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified individual data that supports the results will be shared per NIH requirements in the public repository and no later than 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol, Statistical analysis plan
Time frame: 9 to 36 months following publication or per NIH requirements
Access criteria: Investigator proposing to use the data has IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC or publicly available via NIH repository.
Ran from May 2022 to primary completion in May 2025, 36 months.
Results were first posted in Mar 2026, 9 months after primary completion.
Of 64 non-industry interventional studies with no phase under Contraception Behavior, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 40. This study's 36 months is above that.
Counting every sponsor, half of 64 studies reached it within 20 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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