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临床试验/NCT03231358
NCT03231358已完成3 期

Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa

Brown University2 个研究点 分布在 1 个国家目标入组 1,758 人开始时间: 2018年11月21日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
1,758
试验地点
2
主要终点
Depressive Symptoms

研究概览

简要总结

The purpose of this study is to test the efficacy of Our Family Our Future, an integrated intervention for preventing HIV and depression onset among adolescents.

详细描述

Adolescent human immunodeficiency virus (HIV) and depression present significant public health challenges for South Africa, a country with the largest HIV epidemic globally and where structural factors including violence and poverty increase susceptibility for poor mental health. In families already experiencing psychological distress, adolescents face elevated risk for sexually transmitted infections (STIs) including HIV and depression. Preventive interventions are urgently needed during adolescence when risks for HIV, STIs, and depression in-crease exponentially. Preventive intervention strategies for adolescents should substantively involve families who can tailor prevention content to meet the unique needs of individual adolescents and reinforce formation and habituation of prevention behaviors. Moreover, evidence indicates common family risk and protective factors for adolescent HIV/STI risk behaviors and depression, underscoring the need for a family prevention approach. However, key gaps exist in family prevention science. In South Africa, few empirically supported family interventions integrate prevention of HIV/STI with depression for adolescents. This intervention (called Our Family Our Future) uses a resilience-oriented approach engages families in adolescent prevention from low-resource settings facing high adversity. The study will focus on adolescents (14-16 years) who are at an ideal developmental transition for family engagement in prevention. The age- and developmentally-tailored intervention - called Our Family Our Future - is based off of two empirically supported interventions that have been integrated and adapted to South Africa. In a pilot randomized trial, Our Family Our Future exhibited outstanding acceptability, feasibility and promising direction of effects including reductions of depressive symptoms; lower rates of sex; decreased unprotected sex; increased HIV testing; increased knowledge, motivation, intentions and self-efficacy for protective HIV/STI behaviors; improved family interactions; and increased resilience. Now investigators propose the next phase of this research program, an efficacy study of Our Family Our Future with three aims: (1) test the efficacy of the Our Family Our Future intervention in preventing HIV/STI acquisition among adolescents (14-16) with depressive symptoms by reducing HIV/STI risk behavior, and reducing depressive symptoms. The project will randomize N=880 adolescents to Our Family Our Future intervention or usual care with 6- and 12-month outcome assessments; (2) examine the extent to which the impact of the Our Family Our Future intervention is a) mediated by changes in resilience; behavioral skills; norms and attitudes relating to sex, condom use, gender; and family communication and functioning and b) moderated by the effect of sociodemographics, family HIV, and social protections; (3) identify barriers and facilitators to implementing Our Family Our Future within a large community-based organization setting with wide reach to provide data for future dissemination and scale-up.

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
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 14-16 years
  • adolescent concurs that the adult identified is their parent (to also include primary caregivers in the pa-rental role)
  • when more than one child in the family falls within the eligible age range, one child will be chosen at random
  • lives in the household at least 4 days a week

排除标准

  • no or low symptoms (<6) or clinically significant thresholds of depression (16+)

结局指标

主要结局

Depressive Symptoms

时间窗: 12 months

We will examine whether the intervention produces reductions in depressive symptoms. Depressive symptoms will be measured through symptom scores on the Center for Epidemiologic Studies Depression Scale. Scores are summed, and range from 0 to 60. Higher scores correspond with worse depressive symptoms. There are ranges for the severity of depressive symptoms and these are as follows: 0-15: May indicate no or low levels of depressive symptoms. 16 or higher: Suggests a risk for clinically significant depressive symptoms.

Prevalence of HIV and/or Chlamydia and/or Gonorrhoeae

时间窗: 12 months

We will examine whether the intervention produces reductions in HIV and STI prevalence using biological tests for HIV, Chlamydia trachomatis, and Neisseria gonorrhoeae. We report on the prevalence of any HIV or STI (positive for one or more of HIV and/or Chlamydia and/or Neisseria).

Number of Participants Engaged In Vaginal Sex

时间窗: 12 months

We will examine whether the intervention produces reductions in the number of participants engaged in vaginal sex and condom use.

次要结局

未报告次要终点

研究者

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

Caroline Kuo

Assistant Professor

Brown University

研究点 (2)

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