HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A PILOT STUDY Integrating HIV Prevention and Care With Treatment of Psychological Trauma in Vulnerable Rwandan Youth: A Community-based Pilot Intervention

Conditions
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Acquired Immunodeficiency Syndrome, Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trauma counseling<br> | Behavioral: Questionnaires<br>* questionnaires at entry, month 4, 8 and 12<br>* Other names: trauma counseling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychosocial interventions | Trauma symptoms and PTSD questionnaires. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV treatment adherence and medical follow-up adherence questionnaires | HIV treatment adherence questionnaires, medical follow-up questionnaires | 1 year |