Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 17 of 92 for:    "health promotion" AND (woman OR women OR female)

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
  Purpose

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.


Condition Intervention
Sexual Behavior
Sexually Transmitted Diseases
HIV Infections
Behavioral: Project ÒRÉ

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PROJECT ÒRÉ: An Innovative Friendship Based HIV/STI Intervention for High Risk African American Females

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 420
Study Start Date: November 2004
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Project ÒRÉ
Community-based adolescent social network HIV/STI intervention tailored to African American culture
Other Name: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109421

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Investigators
Principal Investigator: M. Margaret Dolcini, Ph.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00109421     History of Changes
Other Study ID Numbers: ATN 034
Study First Received: April 27, 2005
Last Updated: June 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
adolescent
female
community-based
social network
HIV/STI intervention
High HIV-risk African American adolescent females

Additional relevant MeSH terms:
Genital Diseases, Female
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Sexually Transmitted Diseases
Genital Diseases, Male
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014