HIV TestingVITAANCT05306938
Adolescent Wellness Visits in Tanzania
A study testing Adolescent Wellness Visit in people with HIV Testing and Contraceptive Usage, run by University of North Carolina, Chapel Hill at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Testing, Contraceptive Usage
- What is being tested?
- Adolescent Wellness Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,095 participants
- Where
- 1 siteTanzania
- Study dates
- 17 May 2022to 28 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At enrollment, must be a student in the seventh and final year of primary school.
Who cannot join
- Youth that are out of school at the time of enrollment.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam
About this study
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.
Read more
[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.
Read the 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:
- 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);
- 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
- 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.
- Conditions
- HIV Testing, Contraceptive Usage
- Being tested
- Adolescent Wellness Visit
- Keywords
- HIV testing and counseling, Adolescent health, Mental health, Contraception
- Medical subject headings
- Contraception Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent Wellness VisitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Adolescents in this arm will receive the Adolescent Wellness Visit intervention. Receives: Behavioral: Adolescent Wellness Visit |
| Control | No intervention | Adolescents in this arm will not receive the Adolescent Wellness Visit intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: between Baseline and Endline, approximately 2.5 years
Secondary outcomes (1)
Number Who Reported Contraceptive Use
Number who self-reported contraceptive use at most recent sex, among participants who reported having sex during the study.
Measured: between Baseline and Endline, approximately 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start17 May 2022
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized control trial, with randomization occurring at the school level into one of two arms: intervention or control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences, Duke University, Arizona State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Joy Noel Baumgartner, PhD, MSSW, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306938
- Sponsor's protocol ID
- 21-1198
- Other IDs
- 5R01HD102279
- Acronym
- VITAA
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2022
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 41093752
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Wellness Visits in Tanzania
- ClinicalTrials.gov ID
- NCT05306938
- Acronym / sponsor ID
- VITAA / 21-1198
- Conditions
- HIV Testing, Contraceptive Usage
- Keywords
- HIV testing and counseling, Adolescent health, Mental health, Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,095 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences, Duke University, Arizona State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Posted 25 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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);
- 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
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a cluster randomized control trial, with randomization occurring at the school level into one of two arms: intervention or control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Adolescent Wellness VisitAdolescents in this arm will receive the Adolescent Wellness Visit intervention. |
| Control | No intervention | –Adolescents in this arm will not receive the Adolescent Wellness Visit intervention. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- At enrollment, must be a student in the seventh and final year of primary school.
Key exclusion criteria (1 listed)
- Youth that are out of school at the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adolescent Wellness VisitAdolescent 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. | Behavioural | Intervention |
Primary outcome
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.
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.
1 secondary outcome
Number Who Reported Contraceptive Use
Time frame: between Baseline and Endline, approximately 2.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41093752Alexander 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy Noel Baumgartner, PhD, MSSW principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adolescent Wellness Visit in people with HIV Testing and Contraceptive Usage, run by University of North Carolina, Chapel Hill at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.