NCT01401335

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 15 Years – 25 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Questionnaires	questionnaires at entry, month 4, 8 and 12

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-12-01
• Completion: 2011-06-01
• First posted: 2011-07-25
• Last updated: 2011-07-25

Locations

2 sites across 2 countries: United States, Rwanda