Clinical trial NCT02386878: HIV/AIDS Orphaned and Vulnerable Children Public Health Evaluation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Risk Reduction Behavior
Stress, Psychological
Keywords: Orphans and vulnerable children (OVC)
Program Evaluation
HIV Prevention
Psychosocial Wellbeing
Adolescents
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2015-03-12
Enrollment: 2302
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Are not able to give informed assent due to known or recognizable cognitive or psychiatric impairment.

Primary outcomes:
measure: Change in Sexual Risk Behavior
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Change in Depressive Symptoms
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
Secondary outcomes:
measure: Change in HIV knowledge
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Change in Condom Knowledge and Attitudes
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Change in Peer Norms
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Change in Self-Efficacy
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Change in Social Support
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Change in Future Expectations
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Change in Alcohol Use
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Change in VCT
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Change in STI
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
Other outcomes:
measure: Demographic Information
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Adolescent Education
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Adolescent Health
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Traumatic Events
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Caregiver Health
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Caregiver Psychological Health
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Caregiver Social Relationships
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
measure: Caregiver HIV Knowledge, Attitudes and Communication
timeFrame: Baseline, 0 months post-intervention, 12 months post intervention
Locations:
Study officials:
affiliation: Tulane University School of Social Work
name: Tonya R Thurman, MPH PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thurman TR, Nice J, Taylor TM, Luckett B. Mitigating depression among orphaned and vulnerable adolescents: a randomized controlled trial of interpersonal psychotherapy for groups in South Africa. Child Adolesc Ment Health. 2017 Nov;22(4):224-231. doi: 10.1111/camh.12241. Epub 2017 Sep 26.