Adolescent Wellness Visits in Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,095
- 试验地点
- 1
- 主要终点
- Proportion of adolescents who self-reported HIV testing and counseling over 24-month follow-up, inclusive of the Adolescent Wellness Visit
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statisticians will be blinded to the intervention status of individuals and schools.
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At enrollment, must be a student in the seventh and final year of primary school.
排除标准
- •Youth that are out of school at the time of enrollment.
结局指标
主要结局
Proportion of adolescents who self-reported HIV testing and counseling over 24-month follow-up, inclusive of the Adolescent Wellness Visit
时间窗: Approximately 24 months, inclusive of AWV.
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 follow-up 3/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.
Proportion of adolescents who self-reported HIV testing and counseling over 24-months follow-up, exclusive of the Adolescent Wellness Visit
时间窗: Approximately 24 months, excluding AWV.
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 follow-up 3/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.
次要结局
未报告次要终点