Adolescent Wellness Visits in Tanzania

NCT05306938 | Completed Results DMC

• 2 other identifiers: 21-11985R01HD102279
• Study Type: interventional
• Target: 1,095
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Testing; Contraceptive Usage

Keywords

HIV testing and counseling; Adolescent health; Mental health; Contraception

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  between Baseline and Endline, approximately 2.5 years

Secondary Outcomes (1)

• Number Who Reported Contraceptive Use

  between Baseline and Endline, approximately 2.5 years

Study Arms (2)

Intervention

EXPERIMENTAL

Adolescents in this arm will receive the Adolescent Wellness Visit intervention.

Behavioral: Adolescent Wellness Visit

Control

NO INTERVENTION

Adolescents in this arm will not receive the Adolescent Wellness Visit intervention.

Interventions

Adolescent Wellness Visit BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• At enrollment, must be a student in the seventh and final year of primary school.

You may not qualify if:

• Youth that are out of school at the time of enrollment.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Muhimbili University of Health and Allied Sciences: collaborator
• Duke University: collaborator
• Arizona State University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location

Related Publications (1)

• Alexander K, Gitagno D, Mtei RJ, Minja A, Lema I, Egger JR, Van Praag E, Kaaya S, Baumgartner JN. Caregiver attitudes towards HIV testing and contraceptive services for adolescents in Tanzania. AIDS Care. 2026 Jan;38(1):83-96. doi: 10.1080/09540121.2025.2569975. Epub 2025 Oct 15.

  PMID: 41093752 DERIVED

MeSH Terms

Conditions

Contraception Behavior; Psychological Well-Being

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior; Personal Satisfaction

Results Point of Contact

• Title: Joy Noel Baumgartner, PhD
• Organization: University of North Carolina at Chapel Hill

joy.baumgartner@unc.edu

919-923-8534

Study Officials

• Joy Noel Baumgartner, PhD, MSSW

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statisticians will be blinded to the intervention status of individuals and schools.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cluster randomized control trial, with randomization occurring at the school level into one of two arms: intervention or control.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: May 17, 2022
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

TA (1)