Trial record 15 of 28 for:    " June 29, 2011":" July 29, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


Condition Intervention
Acquired Immunodeficiency Syndrome
Stress Disorders, Post-Traumatic
Behavioral: Questionnaires

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • psychosocial interventions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Trauma symptoms and PTSD questionnaires.


Secondary Outcome Measures:
  • 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


Enrollment: 120
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Trauma counseling Behavioral: Questionnaires
questionnaires at entry, month 4, 8 and 12
Other Name: trauma counseling

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.

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401335

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Rwanda
Uyisenga N
Kigali, KG, Rwanda
Sponsors and Collaborators
Stanford University
Ministry of Health, Rwanda
Investigators
Principal Investigator: Andrew R Zolopa Stanford University
  More Information

No publications provided

Responsible Party: Andrew R Zolopa, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01401335     History of Changes
Other Study ID Numbers: SU-12082010-7279, IRB# 17289
Study First Received: July 19, 2011
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014