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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00109421
First received: April 27, 2005
Last updated: June 23, 2014
Last verified: April 2014

April 27, 2005
June 23, 2014
November 2004
November 2009   (final data collection date for primary outcome measure)
Conduct elicitation research in the study community [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
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
  • HIV/STI related knowledge
  • perceived risk and peer norms
  • intentions for future sexual behavior and communication with sexual partners
Complete list of historical versions of study NCT00109421 on ClinicalTrials.gov Archive Site
  • Test the efficacy of the intervention [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    To use a group-randomized controlled design to conduct a test of the efficacy of the Project ÒRÉ intervention.
  • Conduct a qualitative process evaluation [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    To conduct a qualitative process evaluation to assess the acceptability of the experimental intervention in a new community using a subset of the participants in the experimental condition.
  • condom use
  • numbers of sexual partners
  • frequency of follow-up HIV/STI testing
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Sexual Behavior
  • Sexually Transmitted Diseases
  • HIV Infections
Behavioral: Project ÒRÉ
Community-based adolescent social network HIV/STI intervention tailored to African American culture
Other Name: ÒRÉ
  • Experimental: Experimental arm
    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.
    Intervention: Behavioral: Project ÒRÉ
  • No Intervention: Attention control group
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Female
14 Years to 21 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00109421
ATN 034
No
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: M. Margaret Dolcini, Ph.D. University of California, San Francisco
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP