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临床试验/NCT03307226
NCT03307226已完成不适用

Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 1,260 人开始时间: 2018年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,260
试验地点
2
主要终点
Proportion With STIs From Baseline to Follow-up Assessments

研究概览

简要总结

This study examines the impact and cost associated with Suubi4Her, an innovative combination intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly assigned at the school level into one of three study conditions: 1) Savings (Youth Development Accounts - YDA) - with a 1:1 incentive match rate - for education and microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3) Control condition receiving standard health and sex education provided in schools. The intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and 36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections during the study period, and for HIV+ participants markers for ART adherence. The study aims to examine the impact of the Suubi4Her intervention on behavioral health functioning, and protecting adolescent girls against known HIV risk factors. The study will also examine the cost-effectiveness of each intervention condition.

详细描述

Aligned with the NIH priority of addressing disparities in new HIV infections and the UNAIDS call for implementing combination HIV prevention approaches, the proposed study will examine the impact and cost associated with Suubi4Her, an innovative combination intervention that aims to prevent HIV risk behaviors among 14-17 year-old girls living in communities heavily affected by poverty and HIV/AIDS in Uganda. In sub-Saharan Africa (SSA), family financial stress can compromise the support available to adolescents, with girls living in poverty exhibiting higher rates of risky sexual behavior increasing their vulnerability in acquiring HIV and other STIs. At the same time, internalizing mental health disorders such as depression and low self-esteem disproportionately affect girls and may be contributing to HIV risk behavior. Against that backdrop, support over and above health and sex education is needed to help adolescent girls in SSA successfully transition into young adulthood. The proposed study is informed by two previously tested interventions - asset-based matched savings accounts (YDA) and family strengthening through Multiple Family Groups (MFG) which have successfully been implemented with younger primary school-going adolescents. Suubi4Her will test the theory that youth cognitive and behavioral change is influenced by economic stability while examining if enhanced intra-familial support and communication are needed to maintain positive behavioral health functioning and reinforce engagement in protective health behaviors. Nested within 47 secondary schools across four districts of Uganda heavily impacted by HIV/AIDS, 1260 older girls (ages 14-17 at enrollment) will be randomly assigned (at school level) to one of three study conditions: 1) Savings (Youth Development Accounts - YDA)- with a 1:1 incentive match rate - for education and microenterprise development; 2) Savings (YDA) + MFG intervention; 3) Control condition receiving standard health and sex education provided in schools. The intervention will be provided for 24 months. Assessments at baseline,12, 24, and 36-months will include biomedical data to measure our primary sexual-risk outcome:1) proportion of girls' biologically confirmed STIs (Gonorrhea, Trichomonas and Chlamydia); and secondary outcomes: 2) the proportion of new HIV infections during the study period, and 3) for HIV+ girls, viral load and CD4 as markers of ART adherence. The study aims are to: 1) Examine whether the Suubi4Her intervention is effective in protecting adolescent girls against known HIV risk factors (including economically-motivated sex and intimate partner violence). 2) Elucidate the effects of the Suubi4Her intervention on behavioral health functioning (i.e., depression, self-efficacy and hopelessness) and examine the effects of these variables as potential mechanisms of change, mediating the relationship between each intervention and HIV risk reduction. 3) Evaluate the cost-effectiveness of each intervention condition. The study will also use the Child Depression Index and Beck Hopelessness Scale to examine the efficacy of interventions in improving mental health in this vulnerable population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • (1) female; (2) enrolled in first year of secondary school in Rakai, Masaka, Lwengo or Kalungu districts; (3) age 14-17 years; (4) living within a family (broadly defined and not an institution or orphanage, as those in institutions have different familial needs)

排除标准

  • (5) they have a cognitive or severe psychiatric impairment that would prevent comprehension of study procedures as assessed during the Informed Consent process or; (6) they are unwilling or unable to commit to completing the study.
  • We will not exclude girls because of their HIV, STI and/or pregnancy status. Analysis will be adjusted to account for these baseline factors. Girls testing positive for HIV, STI or pregnancy will be referred for care and support.

结局指标

主要结局

Proportion With STIs From Baseline to Follow-up Assessments

时间窗: 12 months

Proportion of girls biologically confirmed STIs (Gonorrhea, Trichomonas, and Chlamydia) or positive pregnancy test at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)

次要结局

  • Change in Adherence to HIV Treatment From Baseline to Follow-up Assessments(baseline)
  • Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)(12 months)
  • Cost-Effectiveness Analyses(Every year for five years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fred Ssewamala

Professor

Washington University School of Medicine

研究点 (2)

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