HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth
| Tracking Information | |||||
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| First Received Date ICMJE | July 19, 2011 | ||||
| Last Updated Date | July 21, 2011 | ||||
| Start Date ICMJE | October 2009 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
psychosocial interventions [ Time Frame: 1 year ] [ Designated as safety issue: No ] Trauma symptoms and PTSD questionnaires. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01401335 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth | ||||
| Official Title ICMJE | A PILOT STUDY Integrating HIV Prevention and Care With Treatment of Psychological Trauma in Vulnerable Rwandan Youth: A Community-based Pilot Intervention | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Questionnaires
questionnaires at entry, month 4, 8 and 12
Other Name: trauma counseling |
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| Study Arm (s) | Trauma counseling
Intervention: Behavioral: Questionnaires |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 120 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years to 25 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Rwanda | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01401335 | ||||
| Other Study ID Numbers ICMJE | SU-12082010-7279, IRB# 17289 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Andrew R Zolopa, Stanford University School of Medicine | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | Ministry of Health, Rwanda | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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