Randomized Controlled Trial of Ways to Improve OVC HIV Prevention and Well-being

Summary

The purpose of this study is to compare the effectiveness of two types of counseling, Psychosocial Counseling (PC) and Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), in addressing outcomes of orphans and vulnerable children (OVC) including mental and behavioral health, well-being, social support, and HIV risk behaviors. The study will be conducted in Lusaka, Zambia.

Conditions

• Risk Behavior
• Mental Health Impairment

Interventions

BEHAVIORAL

Trauma-Focused Cognitive Behavioral Therapy

We propose using TF-CBT to address stress related problems (SRP) and reduce HIV risk behaviors. OVC lack behavioral and cognitive skills and intention necessary to use the available information and resources to prevent HIV. For example, internalizing problems are related to HIV risk through low self-efficacy, poor assertiveness skills, and reduced ability to negotiate safe sex. Given evidence on the link between abuse/trauma and elevated HIV risk, researchers have called for overlap between evidence-based mental health treatments like TF-CBT and HIV prevention programs. Some studies have found that skills-oriented interventions reduced HIV-risk behaviors among minority and troubled youths. An intervention study using CBT increased condom use and decreased high-risk sexual behaviors among runaway youths in a short-term follow-up evaluation. However, these studies were done in Western countries; their relevance to OVC in Africa is unproven.

BEHAVIORAL

Psychosocial Counseling

The curriculum "Psychosocial Care and Counseling" was developed for HIV Infected Children and Adolescents. The goal is to enable health care providers to provide safe supportive counseling and support services to HIV infected youth and their families. The course materials are designed to be adapted to different cultures and needs. The 14 modules cover child development, family systems, communicating with children, disclosure and adherence and legal/ethical issues. The course teaches basic counseling skills with children such as listening and play. It explores and challenges barriers to care such as caregivers' fear and reluctance to disclose an HIV positive diagnosis to a child, discussing adolescent sexuality, and practical issues such as inadequate legislation governing child rights. The curriculum was adapted for Zambia and endorsed by the MoH.

Sponsors & Collaborators

• SHARPZ (Serenity Harm Reduction Programme Zambia)

  collaborator UNKNOWN

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Laura Murray, PhD · Johns Hopkins Bloomberg School of Public Health

• Paul Bolton, MBBS, MPH, MSc · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2017-11-30

Completion

2017-11-30

Countries

• Zambia

Study Locations