Clinical trial NCT01401335: HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth
Official title: A PILOT STUDY Integrating HIV Prevention and Care With Treatment of Psychological Trauma in Vulnerable Rwandan Youth: A Community-based Pilot Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Immunodeficiency Syndrome
Stress Disorders, Post-Traumatic
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Rwanda
First posted: 2011-07-25
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: psychosocial interventions
timeFrame: 1 year
Secondary outcomes:
measure: HIV treatment adherence and medical follow-up adherence questionnaires
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Kigali
country: Rwanda
facility: Uyisenga N
state: KG
Study officials:
affiliation: Stanford University
name: Andrew R Zolopa
role: PRINCIPAL_INVESTIGATOR
References: