Clinical Trial: HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 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. 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.


Sponsor: Stanford University

Current Primary Outcome: psychosocial interventions [ Time Frame: 1 year ]

Trauma symptoms and PTSD questionnaires.


Original Primary Outcome: Same as current

Current Secondary Outcome: HIV treatment adherence and medical follow-up adherence questionnaires [ Time Frame: 1 year ]

HIV treatment adherence questionnaires, medical follow-up questionnaires


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: July 19, 2011
Date Started: October 2009
Date Completion:
Last Updated: July 21, 2011
Last Verified: July 2011