Adolescent Wellness Visits in Tanzania

Contraceptive Usage Clinical Trial

— VITAA  

Official title:

Adolescent Wellness Visits in Tanzania

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05306938
• Other study ID #: 21-1198
• Secondary ID: 5R01HD102279
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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 5 data collection timepoints (baseline, 6, 12, 18 and 24 months). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1095
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraceptive Usage
• HIV Testing

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.

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health and Allied Sciences	Dar es Salaam

Sponsors (5)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Arizona State University, Duke University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of adolescents who self-reported HIV testing and counseling over 24-month follow-up, inclusive of the Adolescent Wellness Visit	Data will be collected at five time points via individual interviews between the adolescent and a research assistant at the AWV (baseline), and at months 6, 12, 18, and approximately 24. 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.	Approximately 24 months, inclusive of AWV.
Primary	Proportion of adolescents who self-reported HIV testing and counseling over 24-months follow-up, exclusive of the Adolescent Wellness Visit	Data will be collected at five time points via individual interviews between the adolescent and a research assistant at the AWV (baseline), and at months 6, 12, 18, and approximately 24. 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.	Approximately 24 months, excluding AWV.