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

• 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
• 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

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）：在撒哈拉以南非洲，有数百万因艾滋病而成为孤儿的青年，预计人数还会增加。根据定义，孤儿和弱势儿童已经和/或正在经历高度的压力和创伤。这些导致压力相关问题（SRP）-人际关系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-这有助于危险的性行为。因此，解决创伤和压力源以及简化生殖方案不仅对确保孤儿和易受感染儿童当前和未来的福祉是必要的，而且也将有助于预防艾滋病毒。尽管为旨在解决孤儿和易受感染儿童问题的社会心理支助方案提供了资金，但几乎没有证据表明什么能有效地提高孤儿和易受感染儿童的福祉，以及这些方案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）干预措施在解决导致艾滋病毒风险行为的SRP方面是有效的。CBT侧重于技能建设和自我效能，以应对创伤和压力，从而为艾滋病毒和SRP的初级、二级和三级预防奠定基础。最近的文献和正在进行的研究表明，CBT，如果当地适应，是可行的，可接受的，在低资源设置有效。我们将进行一项随机对照试验：1）一种强化形式的心理社会支持，称为心理社会咨询（PC），2）一种循证治疗，创伤集中CBT（TFCBT）。结果包括艾滋病毒的危险行为，情绪和行为健康，社会支持，整体幸福感，和心理健康发展的受艾滋病毒/艾滋病影响的OVC。本研究有4个具体目的：目的1：比较PC和TF-CBT在解决与当前和未来福祉相关的OVC结局（SRP）方面的有效性。目的2：比较PC和TF-CBT在减少HIV危险行为方面的效果。目标三：测量理论上重要的HIV风险行为减少介导因子和调节因子的影响，目的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有危险性行为（包括最近不使用避孕套的性行为）的青少年（13-17岁）。我们将通过将试验与现有的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评估青少年及其照顾者，以提高隐私和反应的坦率性。评估将在治疗前和治疗完成后0、6和12个月进行。这项试验的结果将有助于提供急需的科学数据，说明哪些干预措施对于解决受艾滋病毒/艾滋病影响的孤儿和易受感染儿童所面临的重要问题是可行的、有效的和具有成本效益的。因此，研究结果将为未来的孤儿和易受感染儿童方案服务提供信息，以解决孤儿和易受感染儿童的社会心理问题、心理健康和艾滋病毒预防。 公共卫生关系：这项试验的结果将为受艾滋病毒/艾滋病影响的孤儿和易受感染儿童的方案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。研究结果将为合理和有效的方案设计、政策和干预措施的有效性提供信息，以在资源匮乏的环境中预防孤儿和易受感染儿童感染艾滋病毒。