HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401335
• Other study ID #: SU-12082010-7279
• Secondary ID: IRB# 17289
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: July 21, 2011
• Start date: October 2009
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Questionnaires
questionnaires at entry, month 4, 8 and 12

Locations

Country	Name	City	State
Rwanda	Uyisenga N	Kigali	KG
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Ministry of Health, Rwanda

Countries where clinical trial is conducted

United States,  Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychosocial interventions	Trauma symptoms and PTSD questionnaires.	1 year	No
Secondary	HIV treatment adherence and medical follow-up adherence questionnaires	HIV treatment adherence questionnaires, medical follow-up questionnaires	1 year	No