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Completed

NCT Number: NCT01401335

HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires

Behavioral

questionnaires at entry, month 4, 8 and 12

Other names: trauma counseling

Primary outcomes

  1. psychosocial interventions

    Time frame: 1 year

    Trauma symptoms and PTSD questionnaires.

Secondary outcomes

  1. HIV treatment adherence and medical follow-up adherence questionnaires

    Time frame: 1 year

    HIV treatment adherence questionnaires, medical follow-up questionnaires

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Ministry of Health, Rwanda

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jul 25, 2011
Registry last updated
Jul 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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