HIV/AIDS Orphaned and Vulnerable Children Public Health Evaluation (PHE)

Tulane University School of Social Work

Status: Completed

Conditions: Risk Reduction Behavior; Stress, Psychological; Adolescent Behavior

Treatments: Behavioral: Vhutshilo 2; Behavioral: Interpersonal Psychotherapy for Groups (IPTG)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02386878

PHE# ZA.09.0257

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,302 patients

Sex: All

Ages: 14 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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2,302 participants in 4 patient groups

Interpersonal Psychotherapy for Groups (IPTG)

Experimental group

Description:

The intervention consists of 16 weekly 60 to 90 minute psychotherapy sessions, implemented once a week by a trained lay facilitator.

Treatment:

Behavioral: Interpersonal Psychotherapy for Groups (IPTG)

Vhutshilo 2

Experimental group

Description:

The intervention consists of 13 group sessions, implemented once a week by a trained lay facilitator.

Treatment:

Behavioral: Vhutshilo 2

IPTG and Vhutshilo

Experimental group

Description:

Participants receive the IPTG intervention first, followed by Vhutshilo 2.

Treatment:

Behavioral: Vhutshilo 2

Behavioral: Interpersonal Psychotherapy for Groups (IPTG)

No Intervention

No Intervention group

Description:

No intervention