HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

NCT ID: NCT01401335

Last Updated: 2011-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-06-30

Brief 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.

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.

Conditions

Acquired Immunodeficiency Syndrome; Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Trauma counseling

Group Type: OTHER

Questionnaires

Intervention Type: BEHAVIORAL

questionnaires at entry, month 4, 8 and 12

Interventions

Questionnaires

questionnaires at entry, month 4, 8 and 12

Intervention Type: BEHAVIORAL

Other Intervention Names

trauma counseling

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Rwanda

OTHER_GOV

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Stanford University School of Medicine

Principal Investigators

Andrew R Zolopa

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Uyisenga N

Kigali, KG, Rwanda

Countries

United States; Rwanda

Other Identifiers

IRB# 17289

Identifier Type: OTHER

Identifier Source: secondary_id

SU-12082010-7279

Identifier Type: -

Identifier Source: org_study_id