HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth
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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 |
- psychosocial interventions [ Time Frame: 1 year ] [ Designated as safety issue: No ]Trauma symptoms and PTSD questionnaires.
- 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 |
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| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Rwanda | |
| Uyisenga N | |
| Kigali, KG, Rwanda | |
| 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 May 16, 2013