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

NCT02054780 | Completed

• 1 other identifier: 5R01HD070720
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in HIV Risk Behavior as measured by the World Aids Foundation (WAF) survey

  The primary outcome is reported HIV risk behaviors, primarily those related to risky sexual behaviors

  Baseline, 0 months post-intervention, 6-months post-intervention, 12 months post-intervention

Secondary Outcomes (3)

• Change in Mental Health and Well-being

  Baseline, 0 months post-intervention, 6 months post-intervention, 12 months post-intervention

• Change in Caregiver mental health and well-being

  Baseline, 0 months post-intervention, 6 months post-intervention, 12 months post-intervention

• Cost Effectiveness of TF-CBT and PC

  Baseline, 0 months post-intervention, 6 months post-intervention, 12 months post-intervention

Study Arms (2)

Psychosocial Counseling

ACTIVE COMPARATOR

The curriculum "Psychosocial Care and Counseling" (PC) 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. PC is considered an "enhanced" model of a Psychosocial Support program for OVC.

Behavioral: Psychosocial Counseling

Trauma-Focused Cognitive Behavioral Therapy

EXPERIMENTAL

We propose using TF-CBT to address stress related problems (SRP) and reduce HIV risk behaviors. Given evidence on the link between abuse/trauma and elevated HIV risk, researchers have called for more overlap between evidence-based mental health treatments like TF-CBT and HIV prevention programs. Recent trials have provided direct evidence that CBT may be effective in HIV prevention. TF-CBT has eight components including: Psychoeducation, Relaxation, Affective Modulation, Cognitive Coping, Trauma Narrative, In-vivo Exposure (if needed), Conjoint parent-child session, and Enhancing Safety Skills. This cognitive behavioral therapy teaches skills such as how to think about situations differently in order to feel better. It also includes helping a child face the fear and anxiety of the traumatic situations, rather than avoid them. Based on earlier pilot projects, the MoH has endorsed TF-CBT in Zambia.

Behavioral: Trauma-Focused Cognitive Behavioral Therapy

Interventions

Trauma-Focused Cognitive Behavioral Therapy BEHAVIORAL

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.

Trauma-Focused Cognitive Behavioral Therapy

Psychosocial Counseling BEHAVIORAL

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.

Psychosocial Counseling

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• year olds
• Live in one of the 16 compounds that serve as our study sites (i.e., not staying temporarily)
• Both OVC and caretaker speak English, Nyanja, or Bemba.
• Responses to the screening measure suggest the presence of behaviors that increase risk of HIV.
• Responds "yes" to one of the study criteria for an orphaned or vulnerable child
• Adolescent assents to participate and caregiver provides permission for the adolescent to participate as well as consents to his/her own participation in project
• This study will also enroll adolescents who do not have a primary caretaker or who live in child headed households. In these situations the person that is the caretaker has to declare that he/she is the principal caregiver or they have been charged with the responsibility of making sure the adolescent receives care. For any child headed households or street youth, the ministry of community and social welfare should be contacted. In these cases the ministry usually has the adolescent themselves consent before they could be involved.

You may not qualify if:

• Currently on an unstable psychiatric drug regimen (i.e., regimen altered in last 2 months)
• Suicide attempt or suicidal ideation with intent or plan, or self-harm in the past month.
• A current psychotic disorder (identified by OVC STEPS programming or other sources).
• Serious developmental disorder (e.g., mental retardation, autism) that would preclude participation in cognitive-behavioral oriented skills intervention

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• SHARPZ (Serenity Harm Reduction Programme Zambia): collaborator

Study Sites (1)

Serenity Harm Reduction Programme Zambia (SHARPZ)

Lusaka, Zambia

Location

Related Publications (1)

• Kane JC, Figge C, Paniagua-Avila A, Michaels-Strasser S, Akiba C, Mwenge M, Munthali S, Bolton P, Skavenski S, Paul R, Simenda F, Whetten K, Cohen J, Metz K, Murray LK. Effectiveness of trauma-focused cognitive behavioral therapy compared to psychosocial counseling in reducing HIV risk behaviors, substance use, and mental health problems among orphans and vulnerable children in Zambia: a community-based randomized controlled trial. AIDS Behav. 2024 Jan;28(1):245-263. doi: 10.1007/s10461-023-04179-w. Epub 2023 Oct 9.

  PMID: 37812272 DERIVED

MeSH Terms

Conditions

Risk-Taking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Laura Murray, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Paul Bolton, MBBS, MPH, MSc

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: February 4, 2014
• Study Start: February 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

ZA (1)