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.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD070720-03
Application #
8475632
Study Section
Special Emphasis Panel (ZHD1-DSR-M (17))
Program Officer
Haverkos, Lynne
Project Start
2011-09-22
Project End
2016-12-31
Budget Start
2014-01-01
Budget End
2014-12-31
Support Year
3
Fiscal Year
2014
Total Cost
$558,020
Indirect Cost
$62,187
Name
Johns Hopkins University
Department
Type
Schools of Public Health
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218