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Clinical Trials/NCT01401335
NCT01401335CompletedNot Applicable

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

Stanford University2 sites in 2 countries120 target enrollmentStarted: October 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
2
Primary Endpoint
psychosocial interventions

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
15 Years to 25 Years (Child, Adult)
Sex
All
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

Arms & Interventions

Trauma counseling

Other

Intervention: Questionnaires (Behavioral)

Outcomes

Primary Outcomes

psychosocial interventions

Time Frame: 1 year

Trauma symptoms and PTSD questionnaires.

Secondary Outcomes

  • HIV treatment adherence and medical follow-up adherence questionnaires(1 year)

Investigators

Sponsor Class
Other

Study Sites (2)

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