HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

A PILOT STUDY Integrating HIV Prevention and Care With Treatment of Psychological Trauma in Vulnerable Rwandan Youth: A Community-based Pilot Intervention

The investigators propose a prospective single arm pilot cohort study of 100 youth (ages 15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a district of the Southern province, in Rwanda.

Study Overview

• Status: Completed
• Conditions: Acquired Immunodeficiency Syndrome; Stress Disorders, Post-Traumatic
• Intervention / Treatment: Behavioral: Questionnaires

Detailed Description

The investigators propose a prospective single arm pilot cohort study of 100 youth (ages 15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a district of the Southern province, in Rwanda. UYISENGA N'MANZI identified 400 youths in Nyanza region, organized in 4 groups, each of them between 160 to 100 youths. Many of those orphans go to school in any school in the country. This situation will be taken into account for the calendar of activities and for organization of the regular interviews and evaluations.

Random selection of the participant will be ensured by choosing study subjects from a list and attributing them an arbitrary number. The random selection will be weighted by the size of the household group across the 4 groups in the Nyanza region. Selection will also be in proportion of sex and age groups. In this manner 100 youth will be picked with 20 "backup" to account for refusals and drop-outs. Those selected youth will be asked to participate to the pilot study and will fill the consent form under the guidance of an external observer (not one of the service providers of the project to avoid consent obtained by social pressure).

Once enrolled, the subjects will be followed during 1 year with serial evaluations at baseline, 3, 6, 9 and 12 months.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Rwanda
  • KG
    • Kigali, KG, Rwanda
      • Uyisenga N
• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 100 orphans/vulnerable youth aged 15 to 25 will be recruited through their participation at the day care center, on a voluntary basis.

Exclusion Criteria:

• Age less than 15 or greater than 25 and not participating in the day care center

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trauma counseling	Behavioral: Questionnaires; questionnaires at entry, month 4, 8 and 12; Other Names: trauma counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
psychosocial interventions	Trauma symptoms and PTSD questionnaires.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV treatment adherence and medical follow-up adherence questionnaires	HIV treatment adherence questionnaires, medical follow-up questionnaires	1 year

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Ministry of Health, Rwanda
• Investigators: Principal Investigator: Andrew R Zolopa, Stanford University

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 25, 2011

Study Record Updates

• Last Update Posted (Estimate): July 25, 2011
• Last Update Submitted That Met QC Criteria: July 21, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Trauma and Stressor Related Disorders; Slow Virus Diseases; Stress Disorders, Traumatic; HIV Infections; Stress Disorders, Post-Traumatic; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Psychological Trauma
• Other Study ID Numbers: SU-12082010-7279; IRB# 17289 (Other Identifier: Stanford University)