HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth
|ClinicalTrials.gov Identifier: NCT01401335|
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : July 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Acquired Immunodeficiency Syndrome Stress Disorders, Post-Traumatic||Behavioral: Questionnaires||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PILOT STUDY Integrating HIV Prevention and Care With Treatment of Psychological Trauma in Vulnerable Rwandan Youth: A Community-based Pilot Intervention|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||June 2011|
questionnaires at entry, month 4, 8 and 12
Other Name: trauma counseling
- psychosocial interventions [ Time Frame: 1 year ]Trauma symptoms and PTSD questionnaires.
- HIV treatment adherence and medical follow-up adherence questionnaires [ Time Frame: 1 year ]HIV treatment adherence questionnaires, medical follow-up questionnaires
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401335
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Kigali, KG, Rwanda|
|Principal Investigator:||Andrew R Zolopa||Stanford University|