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HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01401335
Enrollment
120
Registered
2011-07-25
Start date
2009-10-31
Completion date
2011-06-30
Last updated
2011-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Immunodeficiency Syndrome, Stress Disorders, Post-Traumatic

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.

Interventions

BEHAVIORALQuestionnaires

questionnaires at entry, month 4, 8 and 12

Sponsors

Ministry of Health, Rwanda
CollaboratorOTHER_GOV
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 25 Years
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

Design outcomes

Primary

MeasureTime frameDescription
psychosocial interventions1 yearTrauma symptoms and PTSD questionnaires.

Secondary

MeasureTime frameDescription
HIV treatment adherence and medical follow-up adherence questionnaires1 yearHIV treatment adherence questionnaires, medical follow-up questionnaires

Countries

Rwanda, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026