Adolescent Wellness Visits in Tanzania (VITAA)

March 5, 2026 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  1. To assess the impact of Adolescent Wellness Visits on HTC (for all adolescents; primary outcome) and contraceptive uptake (for a sexually active subset) up to two years post-primary school via a cluster randomized controlled trial (20 school-clinic pairs: 10 intervention + 10 control; n= approximately 1500 adolescents);
  2. To evaluate factors that support or limit implementation of the AWV model and fidelity/adherence to implementation of the proposed package of evidence-based practices included in the AWV by utilizing 24 focus group discussions (FGDs) with implementers and 60 semi-structured interviews (IDIs) with key informants; and
  3. To evaluate the cost-effectiveness of AWVs on two key health behavioral outcomes: uptake of HTC for all adolescents, and reductions in unmet need for contraception among sexually active adolescents.

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.

Study Type

Interventional

Enrollment (Actual)

1095

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Dar es Salaam, Tanzania
        • Muhimbili University of Health and Allied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Adolescents in this arm will receive the Adolescent Wellness Visit intervention.
Behavioral: 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.
No Intervention: Control
Adolescents in this arm will not receive the Adolescent Wellness Visit intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adolescents Who Self-reported HIV Testing and Counseling, Inclusive of the Adolescent Wellness Visit
Time Frame: between Baseline and Endline, approximately 2.5 years
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
Time Frame: between Baseline and Endline, approximately 2.5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number Who Reported Contraceptive Use
Time Frame: between Baseline and Endline, approximately 2.5 years
Number who self-reported contraceptive use at most recent sex, among participants who reported having sex during the study.
between Baseline and Endline, approximately 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Duke University
Arizona State University
Muhimbili University of Health and Allied Sciences

Investigators

  • Principal Investigator: Joy Noel Baumgartner, PhD, MSSW, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Actual)

May 28, 2025

Study Completion (Actual)

May 28, 2025

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-1198
  • 5R01HD102279 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

9 to 36 months following publication or per NIH requirements

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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