HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

Not Applicable

Completed

• Conditions: Acquired Immunodeficiency Syndrome; Stress Disorders, Post-Traumatic
• Interventions: Behavioral: Questionnaires

• Registration Number: NCT01401335
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-12
• Study Completion: 2011-06
• Status Verified: 2011-07
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-21
• Last Update Submitted: 2011-07-21
• Study First Posted: 2011-07-25
• Last Update Posted: 2011-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trauma counseling	Questionnaires	-

Primary Outcome Measures

Name	Time	Method
psychosocial interventions	1 year	Trauma symptoms and PTSD questionnaires.

Secondary Outcome Measures

Name	Time	Method
HIV treatment adherence and medical follow-up adherence questionnaires	1 year	HIV treatment adherence questionnaires, medical follow-up questionnaires

Trial Locations

Locations (2)

Uyisenga N; 🇷🇼 Kigali, KG, Rwanda

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States