NCT01401335

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

1.2 years

First QC Date

July 19, 2011

Last Update Submit

July 21, 2011

Conditions

Acquired Immunodeficiency SyndromeStress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

  • psychosocial interventions

    Trauma symptoms and PTSD questionnaires.

    1 year

Secondary Outcomes (1)

  • HIV treatment adherence and medical follow-up adherence questionnaires

    1 year

Study Arms (1)

Trauma counseling

OTHER
Behavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

questionnaires at entry, month 4, 8 and 12

Also known as: trauma counseling
Trauma counseling

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • orphans/vulnerable youth aged 15 to 25 will be recruited through their participation at the day care center, on a voluntary basis.

You may not qualify if:

  • Age less than 15 or greater than 25 and not participating in the day care center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Uyisenga N

Kigali, KG, Rwanda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeStress Disorders, Post-Traumatic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Andrew R Zolopa

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 25, 2011

Study Start

October 1, 2009

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

US(1)RW(1)