NCT00109421

Brief Summary

The Project ÒRÉ intervention is a half-day community-based HIV/STI intervention program for friendship groups of adolescents that is tailored to African American culture. The four participating community sites will be assigned to either the Project ÒRÉ intervention or a standard health promotion program. Sexually experienced African American adolescent females will recruit members of their friendship group for the five-hour program. All participants will complete questionnaires before and immediately following the programs and another one 3 months later. Immediately following the program some of the Project ÒRÉ groups will also participate in a focus group to provide feedback about the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

November 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2016

Enrollment Period

5 years

First QC Date

April 27, 2005

Last Update Submit

February 27, 2017

Conditions

Sexual BehaviorSexually Transmitted DiseasesHIV Infections

Keywords

adolescentfemalecommunity-basedsocial networkHIV/STI interventionHigh HIV-risk African American adolescent females

Outcome Measures

Primary Outcomes (1)

  • Conduct elicitation research in the study community

    To conduct elicitation research in the study community to: assess the applicability of the existing Project ÒRÉ intervention modules, modify the intervention for the specific populations that are targeted in the current study, and incorporate local data in the production of three brief videos involving youth in the study community

    18 Months

Secondary Outcomes (2)

  • Test the efficacy of the intervention

    18 Months

  • Conduct a qualitative process evaluation

    18 Months

Study Arms (2)

Experimental arm

EXPERIMENTAL

In the experimental condition, the intervention group will receive the half-day Project ÒRÉ intervention. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires. A subset of groups will participate in a process evaluation focus group immediately following the program.

Behavioral: Project ÒRÉ

Attention control group

NO INTERVENTION

The attention control group will receive a standard health promotion control program which has been used previously with similar populations. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires.

Interventions

Project ÒRÉBEHAVIORAL

Community-based adolescent social network HIV/STI intervention tailored to African American culture

Also known as: ÒRÉ
Experimental arm

Eligibility Criteria

Age14 Years - 21 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female
  • Between the ages of 14-18
  • Self-identifies as African American
  • Sexually experienced
  • Willing to participate in a single five-hour workshop and a one-hour follow-up session
  • Willing to nominate 2-5 close female friends ages 14-21 to participate in the study with her
  • Lives in the experimental intervention community
  • Ability to obtain permission from parent or legal guardian and assent from minors or consent from those above age of majority

You may not qualify if:

  • Individual reports predominantly same gender sexual behavior
  • Recent homelessness
  • Visibly distraught or unstable (i.e. suicidal, manic, exhibiting violent behavior, etc.)
  • Intoxicated or under the influence of psychoactive agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Sexual BehaviorSexually Transmitted DiseasesHIV Infections

Condition Hierarchy (Ancestors)

BehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • M. Margaret Dolcini, Ph.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2005

First Posted

April 28, 2005

Study Start

November 1, 2004

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 28, 2017

Record last verified: 2016-02

Locations

US(1)