The Effectiveness of Two Promising Interventions for Reducing HIV Risk and Improving the Wellbeing of Orphaned and Vulnerable Adolescents in the Eastern Cape of South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,302
- 主要终点
- Change in Sexual Risk Behavior
研究概览
简要总结
The PHE study is a two-year longitudinal study evaluating two interventions for reducing depression and HIV risk behaviors among highly vulnerable adolescents in the Eastern Cape of South Africa. Research suggests that children affected by AIDS are at heightened risk of HIV infection relative to their peers; however, evidence on how best to address HIV prevention and psychological health among this population is lacking. This study examines the efficacy of both a psychological and behavioral intervention, alone and in combination, on related outcomes among vulnerable youth age 14-17. A mixed methods approach is applied, including a community-randomized controlled trial with a factorial design, a cost-effectiveness analysis, and a qualitative component. At baseline data collection in January 2012, more than 1000 adolescents and their caregivers were interviewed; these participants were invited to take part in two more survey rounds designed to examine both the immediate and long term effects of the interventions. Support for this research was provided by USAID under Grant No. GHH-I-00-007-00069-00.
详细描述
The study will apply a mixed-methods approach involving two primary components: 1) an impact evaluation using a community-randomized controlled trial (CRCT); and 2) a detailed analysis of intervention costs, linked to the impact evaluation to determine the cost-effectiveness of these interventions.
For the CRCT, sixty World Vision drop-in centers which deliver standard care were randomly assigned to one of four study conditions: IPTG, Vhutshilo, IPTG+Vhutshilo, and control. Approximately 1600 adolescent OVC aged 14-17 years (current beneficiaries at the drop-in centers) and their caregivers were eligible to participate in the study at baseline.
Participants were visited three times including the baseline survey. Follow-up data collection was conducted in two rounds. The first round took place 8 months after the baseline survey and immediately following intervention exposure. A second follow-up round took place a year later, allowing assessment of both the immediate and longer-term impact of the interventions.
Participants were interviewed at home in Xhosa or Sesotho. Caregivers in the sample completed face-to-face interviews with trained interviewers, while adolescents complete surveys used a mix of face-to-face interviewing and audio computer-assisted self-interview technology (ACASI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 14-17 years old as of January 1, 2012;
- •Enrolled in a selected World Vision site;
- •Willing and able to assent to study participation; and
- •Consent given by the parent or guardian for the adolescent to participate in the study.
排除标准
- •Are not able to give informed assent due to known or recognizable cognitive or psychiatric impairment.
结局指标
主要结局
Change in Sexual Risk Behavior
时间窗: Baseline, 0 months post-intervention, 12 months post intervention
Adolescent self-report of key sexual behaviors including age at sexual debut; the number of sexual partners; and whether condoms were used consistently in the last 6 months.
Change in Depressive Symptoms
时间窗: Baseline, 0 months post-intervention, 12 months post intervention
Adolescent self-report of the 20-item Center for Epidemiologic Studies Depression Scale for children (CES-DC). The response options used for the CES-DC are on a 4-point scale (not at all; a little; some; a lot).
次要结局
- Change in HIV knowledge(Baseline, 0 months post-intervention, 12 months post intervention)
- Change in Condom Knowledge and Attitudes(Baseline, 0 months post-intervention, 12 months post intervention)
- Change in Peer Norms(Baseline, 0 months post-intervention, 12 months post intervention)
- Change in Self-Efficacy(Baseline, 0 months post-intervention, 12 months post intervention)
- Change in Social Support(Baseline, 0 months post-intervention, 12 months post intervention)
- Change in Future Expectations(Baseline, 0 months post-intervention, 12 months post intervention)
- Change in Alcohol Use(Baseline, 0 months post-intervention, 12 months post intervention)
- Change in VCT(Baseline, 0 months post-intervention, 12 months post intervention)
- Change in STI(Baseline, 0 months post-intervention, 12 months post intervention)
研究者
Tonya Renee Thurman
Principle Investigator
Tulane University School of Social Work