Trial Outcomes & Findings for Adolescent Wellness Visits in Tanzania (NCT NCT05306938)
NCT ID: NCT05306938
Last Updated: 2026-03-25
Results Overview
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.
COMPLETED
NA
1095 participants
between Baseline and Endline, approximately 2.5 years
2026-03-25
Participant Flow
1095 participants in 20 schools were recruited.
Unit of analysis: Schools
Participant milestones
| Measure |
Intervention
Adolescents in this arm will receive the Adolescent Wellness Visit intervention.
Adolescent Wellness Visit: Adolescent Wellness Visits (AWVs) are 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. 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.
|
Control
Adolescents in this arm will not receive the Adolescent Wellness Visit intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
509 10
|
586 10
|
|
Overall Study
Follow-up 1
|
480 10
|
563 10
|
|
Overall Study
Follow-up 2
|
455 10
|
562 10
|
|
Overall Study
COMPLETED
|
473 10
|
556 10
|
|
Overall Study
NOT COMPLETED
|
36 0
|
30 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adolescent Wellness Visits in Tanzania
Baseline characteristics by cohort
| Measure |
Intervention
n=509 Participants
Adolescents in this arm will receive the Adolescent Wellness Visit intervention.
Adolescent Wellness Visit: 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.
|
Control
n=586 Participants
Adolescents in this arm will not receive the Adolescent Wellness Visit intervention.
|
Total
n=1095 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.5 years
STANDARD_DEVIATION 1.2 • n=138 Participants
|
13.4 years
STANDARD_DEVIATION 1.2 • n=62 Participants
|
13.4 years
STANDARD_DEVIATION 1.2 • n=123 Participants
|
|
Sex: Female, Male
Female
|
283 Participants
n=138 Participants
|
286 Participants
n=62 Participants
|
569 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
226 Participants
n=138 Participants
|
300 Participants
n=62 Participants
|
526 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
509 Participants
n=138 Participants
|
586 Participants
n=62 Participants
|
1095 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
509 Participants
n=138 Participants
|
586 Participants
n=62 Participants
|
1095 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Region of Enrollment
Tanzania
|
509 Participants
n=138 Participants
|
586 Participants
n=62 Participants
|
1095 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: between Baseline and Endline, approximately 2.5 yearsPopulation: Excludes participants who were known to be HIV positive at Baseline.
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.
Outcome measures
| Measure |
Intervention
n=504 Participants
Adolescents in this arm will receive the Adolescent Wellness Visit intervention.
Adolescent Wellness Visit: 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.
|
Control
n=584 Participants
Adolescents in this arm will not receive the Adolescent Wellness Visit intervention.
|
|---|---|---|
|
Number of Adolescents Who Self-reported HIV Testing and Counseling, Inclusive of the Adolescent Wellness Visit
|
234 Participants
|
86 Participants
|
PRIMARY outcome
Timeframe: between Baseline and Endline, approximately 2.5 yearsPopulation: Excludes participants who were known to be HIV positive at Baseline.
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.
Outcome measures
| Measure |
Intervention
n=504 Participants
Adolescents in this arm will receive the Adolescent Wellness Visit intervention.
Adolescent Wellness Visit: 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.
|
Control
n=584 Participants
Adolescents in this arm will not receive the Adolescent Wellness Visit intervention.
|
|---|---|---|
|
Number of Adolescents Who Self-reported HIV Testing and Counseling, Exclusive of the Adolescent Wellness Visit
|
101 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: between Baseline and Endline, approximately 2.5 yearsPopulation: Only includes participants who reported having sex during the study period.
Number who self-reported contraceptive use at most recent sex, among participants who reported having sex during the study.
Outcome measures
| Measure |
Intervention
n=66 Participants
Adolescents in this arm will receive the Adolescent Wellness Visit intervention.
Adolescent Wellness Visit: 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.
|
Control
n=89 Participants
Adolescents in this arm will not receive the Adolescent Wellness Visit intervention.
|
|---|---|---|
|
Number Who Reported Contraceptive Use
|
32 Participants
|
54 Participants
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joy Noel Baumgartner, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place