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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborator:
Serenity Harm Reduction Programme Zambia (SHARPZ)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT02054780
First received: September 17, 2013
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Risk Behavior
Mental Health Impairment
Behavioral: Trauma-Focused Cognitive Behavioral Therapy
Behavioral: Psychosocial Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Ways to Improve OVC HIV Prevention and Well-being

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Change in HIV Risk Behavior as measured by the World Aids Foundation (WAF) survey [ Time Frame: Baseline, 0 months post-intervention, 6-months post-intervention, 12 months post-intervention ] [ Designated as safety issue: No ]
    The primary outcome is reported HIV risk behaviors, primarily those related to risky sexual behaviors


Secondary Outcome Measures:
  • Change in Mental Health and Well-being [ Time Frame: Baseline, 0 months post-intervention, 6 months post-intervention, 12 months post-intervention ] [ Designated as safety issue: No ]
    Child trauma symptoms will be assessed through the Child PTSD Symptom Scale (CPSS) and internalizing and externalizing symptoms will be assessed through the Youth Self Report (YSR) screening tool.

  • Change in Caregiver mental health and well-being [ Time Frame: Baseline, 0 months post treatment, 6 months follow up, 12 months follow up ] [ Designated as safety issue: No ]
    Caregiver mental health and well-being will be assessed through the World Aids Foundation (WAF) questionnaire and a caregiver functioning scale (developed through previous qualitative research in Zambia).


Estimated Enrollment: 750
Study Start Date: February 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Psychosocial Counseling
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
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.
Experimental: Trauma-Focused Cognitive Behavioral Therapy
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 MH 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
We propose using TF-CBT to address stress related problems (SRP) and reduce HIV risk behaviors. The rationale is that OVC lack behavioral and cognitive skills and intention necessary to use the available information and resources to prevent HIV. For example, internalizing problems (e.g., depression, anxiety) 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 more overlap between evidence-based MH 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 13-17 year olds
  • Live in the compounds served by HBCW's of the Archdiocese (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 (see definition above)
  • Adolescent assents to participate and caregiver provides permission for the adolescent to participate as well as consents to his/her own participation in project

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054780

Contacts
Contact: Laura Murray, PhD 9176170234 lamurray@jhsph.edu

Locations
Zambia
Serenity Harm Reduction Programme Zambia (SHARPZ) Recruiting
Lusaka, Zambia
Contact: Stephanie Skavenski, MPH, MA       sskavenski@yahoo.com   
Sub-Investigator: Stephanie Skavenski, MA, MPH         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Serenity Harm Reduction Programme Zambia (SHARPZ)
Investigators
Principal Investigator: Laura Murray, PhD Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Paul Bolton, MBBS, MPH, MSc Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02054780     History of Changes
Other Study ID Numbers: 5R01HD070720
Study First Received: September 17, 2013
Last Updated: August 28, 2014
Health Authority: United States: Institutional Review Board
Zambia: Ministry of Health
Zambia: Research Ethics Committee

ClinicalTrials.gov processed this record on August 28, 2014