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HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Rwanda
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01401335
First received: July 19, 2011
Last updated: July 21, 2011
Last verified: July 2011

July 19, 2011
July 21, 2011
October 2009
December 2010   (final data collection date for primary outcome measure)
psychosocial interventions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Trauma symptoms and PTSD questionnaires.
Same as current
Complete list of historical versions of study NCT01401335 on ClinicalTrials.gov Archive Site
HIV treatment adherence and medical follow-up adherence questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]
HIV treatment adherence questionnaires, medical follow-up questionnaires
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
  • Acquired Immunodeficiency Syndrome
  • Stress Disorders, Post-Traumatic
Behavioral: Questionnaires
questionnaires at entry, month 4, 8 and 12
Other Name: trauma counseling
Trauma counseling
Intervention: Behavioral: Questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
15 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Rwanda
 
NCT01401335
SU-12082010-7279, IRB# 17289
No
Andrew R Zolopa, Stanford University School of Medicine
Stanford University
Ministry of Health, Rwanda
Principal Investigator: Andrew R Zolopa Stanford University
Stanford University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP