deltatrials
Completed NA INTERVENTIONAL 2-arm NCT00109421

Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females

PROJECT ÒRÉ: An Innovative Friendship Based HIV/STI Intervention for High Risk African American Females

Sponsor: National Institute of Mental Health (NIMH)

Interventions Project ÒRÉ
Updated 6 times since 2017 Last updated: Feb 27, 2017 Started: Nov 30, 2004 Primary completion: Nov 30, 2009 Completion: Nov 30, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00109421, this NA trial focuses on HIV Infections and Sexual Behavior and remains completed. Sponsored by National Institute of Mental Health (NIMH), it has been updated 6 times since 2004, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Study Description(click to expand)

A group-randomized controlled design to test the efficacy of the Project ÒRÉ intervention, a community-based adolescent social network HIV/STI intervention tailored to African American culture. Four community based organization sites (CBOs) will be randomly assigned to an experimental or attention control condition. In both conditions, sexually experienced African American adolescent females will recruit members of their friendship group for the five-hour program. In the experimental condition, the intervention group will receive the half-day Project ÒRÉ 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. In the experimental condition, a subset of groups will participate in a process evaluation focus group immediately following the program.

A group-randomized controlled design to test the efficacy of the Project ÒRÉ intervention, a community-based adolescent social network HIV/STI intervention tailored to African American culture. Four community based organization sites (CBOs) will be randomly assigned to an experimental or attention control condition. In both conditions, sexually experienced African American adolescent females will recruit members of their friendship group for the five-hour program. In the experimental condition, the intervention group will receive the half-day Project ÒRÉ 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. In the experimental condition, a subset of groups will participate in a process evaluation focus group immediately following the program.

Status Flow

~Jan 2017 – ~Mar 2017 · 59 days · monthly snapshotCompleted~Mar 2017 – ~Jun 2018 · 15 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed NA

  2. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  3. Jan 2021 — Jul 2024 [monthly]

    Completed NA

  4. Jun 2018 — Jan 2021 [monthly]

    Completed NA

  5. Mar 2017 — Jun 2018 [monthly]

    Completed NA

Show 1 earlier version
  1. Jan 2017 — Mar 2017 [monthly]

    Completed NA

    First recorded

Nov 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institute on Drug Abuse (NIDA)
  • University of North Carolina, Chapel Hill
Data source: University of North Carolina, Chapel Hill

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations