Randomized Controlled Trial of ways to improve OVC HIV prevention and well being

改善 OVC HIV 预防和福祉方法的随机对照试验

基本信息

批准号：
8208370
负责人：
PAUL Anthony BOLTON
金额：
$ 71.67万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-22 至 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8208370
关键词：
AIDS prevention AIDS/HIV problem Acquired Immunodeficiency Syndrome Address Adolescent Adult Affect Affective Africa Africa South of the Sahara Aftercare Age Attitude Behavior Behavioral Caregivers Caring Child Child Mental Health Childhood Cognitive Cognitive Therapy Commit Communities Coping Skills Counseling Country Data Decision Making Development Distress Education Effectiveness Effectiveness of Interventions Emotional Ensure Ethnic Origin Evidence based treatment Feeling Funding Future Gender HIV Healthcare Home environment Intervention Interview Knowledge Laws Link Literature Measures Mediating Mediator of activation protein Mental Health Orphan Outcome Personal Satisfaction Policies Policy Maker Poverty Prevention Primary Prevention Privacy Problem Solving Psychosocial Assessment and Care Randomized Randomized Controlled Trials Recruitment Activity Religion Reporting Resources Risk Risk Behaviors Risk Reduction Behavior Role Secondary Prevention Self Efficacy Self Perception Services Social support Stigmata Stress Testing Thinking Trauma Visit Youth Zambia base behavioral health compare effectiveness computerized condoms cost effective cost effectiveness design effectiveness trial experience high risk behavior high risk sexual behavior improved physical conditioning programs psychologic psychosocial response sex skills social social stigma standard of care stressor tertiary prevention

项目摘要

DESCRIPTION (provided by applicant): There are millions of youth orphaned by AIDS in sub-Saharan Africa, with numbers predicted to increase. By definition, orphans and vulnerable children (OVC) have and/or are undergoing high levels of stress and trauma. These cause stress-related problems (SRP) - interpersonal and problem-solving skills deficits, unhealthy decision-making, and maladaptive behaviors, thoughts and feelings - which contribute to risky sexual behaviors. Therefore, addressing trauma and stressors and SRP is not only necessary to ensure current and future well-being of OVC, but will also contribute to HIV prevention. Despite funding for psychosocial support programs intended to address SRP there is little evidence on what is effective in enhancing OVC well-being and the potential role of these programs in the prevention of HIV. The literature shows targeted cognitive behavioral therapy (CBT) interventions to be effective in addressing SRP that contribute to HIV risk behaviors. CBT focuses on skill-building and self-efficacy to deal with trauma and stress, thus forming a basis for primary, secondary, and tertiary prevention of HIV and SRP. Recent literature and ongoing studies suggest that CBT, if locally adapted, is feasible, acceptable, and effective in low-resource settings. We will conduct a Randomized Controlled Trial of: 1) an intensive form of psychosocial support, referred to as Psychosocial Counseling (PC), and 2) an evidence-based treatment, Trauma Focused-CBT (TFCBT). Outcomes include HIV risk behaviors, emotional and behavioral health, social support, overall wellbeing, and mental health development of OVC affected by HIV/AIDS. This study has 4 Specific Aims: Aim 1: To compare the effectiveness of PC and TF-CBT in addressing OVC outcomes (SRP) relevant to current and future well-being. Aim 2: To compare the effectiveness of PC and TF-CBT in reducing HIV risk behaviors. Aim 3: To measure influences of theoretically important HIV risk behavior reduction mediators and moderators, and Aim 4: To test and compare the cost effectiveness of TF-CBT and PC. This randomized controlled effectiveness trial will recruit adolescents (13-17 years) who report risky sexual behavior (including recent sex without a condom). We will recruit from the community through integration of the trial with an existing PEPFAR OVC program, and assess adolescents and their caregivers using a computerized interviewing program to enhance privacy and frankness of responses. Assessments will be done prior to treatment and at 0, 6 & 12 months after treatment completion. Results from this trial will contribute to much needed scientific data on which interventions are/are not feasible, effective, and cost-effective to address important problems faced by OVC affected by HIV/AIDS. Therefore, the results will inform future OVC program services addressing OVC psychosocial problems, mental health, and HIV prevention. PUBLIC HEALTH RELEVANCE: Findings from this trial will provide the much needed scientific evidence on feasibility, effectiveness, and cost effectiveness of program-relevant interventions for OVC affected by HIV/AIDS. Results will inform rational and efficient program design, policy, and effectiveness of interventions for the prevention of HIV in OVC in low-resource settings.

描述（由申请人提供）：撒哈拉以南非洲地区有数百万青少年因艾滋病而成为孤儿，而且预计这一数字还会增加。根据定义，孤儿和弱势儿童 (OVC) 已经和/或正在承受高度的压力和创伤。这些会导致与压力相关的问题（SRP）——人际交往和解决问题的技能缺陷、不健康的决策以及适应不良的行为、思想和感受——从而导致危险的性行为。因此，解决创伤和压力源以及 SRP 不仅对于确保 OVC 当前和未来的福祉是必要的，而且还将有助于艾滋病毒的预防。尽管为旨在解决 SRP 问题的心理社会支持计划提供了资金，但几乎没有证据表明什么可以有效提高 OVC 的福祉以及这些计划在预防艾滋病毒方面的潜在作用。文献表明，有针对性的认知行为疗法 (CBT) 干预措施可有效解决导致 HIV 危险行为的 SRP。 CBT 侧重于处理创伤和压力的技能建设和自我效能，从而为 HIV 和 SRP 的一级、二级和三级预防奠定了基础。最近的文献和正在进行的研究表明，CBT 如果适合当地情况，在资源匮乏的环境中是可行的、可接受的和有效的。我们将进行以下随机对照试验：1) 强化形式的社会心理支持，称为社会心理咨询 (PC)，以及 2) 循证治疗，创伤聚焦 CBT (TFCBT)。结果包括受艾滋病毒/艾滋病影响的孤儿群体的艾滋病毒风险行为、情绪和行为健康、社会支持、整体福祉和心理健康发展。本研究有 4 个具体目标：目标 1：比较 PC 和 TF-CBT 在解决与当前和未来福祉相关的 OVC 结果 (SRP) 方面的有效性。目标 2：比较 PC 和 TF-CBT 在减少 HIV 危险行为方面的有效性。目标 3：衡量理论上重要的 HIV 风险行为减少中介因素和调节因素的影响，目标 4：测试和比较 TF-CBT 和 PC 的成本效益。这项随机对照有效性试验将招募报告危险性行为（包括最近不使用安全套的性行为）的青少年（13-17 岁）。我们将通过将该试验与现有的 PEPFAR OVC 计划相结合，从社区招募人员，并使用计算机化访谈程序来评估青少年及其照顾者，以增强回答的隐私性和坦率性。评估将在治疗前以及治疗完成后 0、6 和 12 个月进行。该试验的结果将有助于提供急需的科学数据，这些数据表明干预措施对于解决受艾滋病毒/艾滋病影响的孤儿群体所面临的重要问题是否可行、有效且具有成本效益。因此，研究结果将为未来解决 OVC 心理社会问题、心理健康和艾滋病毒预防的 OVC 项目服务提供信息。公共卫生相关性：本次试验的结果将为受艾滋病毒/艾滋病影响的孤儿和弱势群体实施项目相关干预措施的可行性、有效性和成本效益提供急需的科学证据。结果将为资源匮乏地区的孤儿和弱势群体中艾滋病毒预防干预措施的合理有效的规划设计、政策和有效性提供信息。