Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females
|ClinicalTrials.gov Identifier: NCT00109421|
Recruitment Status : Completed
First Posted : April 28, 2005
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sexual Behavior Sexually Transmitted Diseases HIV Infections||Behavioral: Project ÒRÉ||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PROJECT ÒRÉ: An Innovative Friendship Based HIV/STI Intervention for High Risk African American Females|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
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.
- Conduct elicitation research in the study community [ Time Frame: 18 Months ]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
- Test the efficacy of the intervention [ Time Frame: 18 Months ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109421
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||M. Margaret Dolcini, Ph.D.||University of California, San Francisco|