HIV Prevention Program for African American Teen Males
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00849823|
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Sexually Transmitted Infections||Behavioral: Male Sexual Health Program Behavioral: Focus on the Future Program||Not Applicable|
Based on the observation that African Americans are vastly more likely than their white and Hispanic counterparts to be infected by the human immunodeficiency virus (HIV), the Centers for Disease Control and Prevention (CDC) has termed AIDS a "health crisis" for African Americans and has called for a heightened national response to this glaring racial disparity. The crisis is especially dramatic in the Southern United States. Thus, the search for effective interventions tailored to this population is a national priority. This study expands upon a previous study conducted among young African American men. In the previous study we developed and tested the efficacy of a brief, clinic-based, program designed to interactively promote safer sex for African American men (18 to 29 years of age) engaging in sex with women. Adjusted findings from the previous study provided relatively robust support for program efficacy, with men who received the intervention program being about two-thirds less likely, than controls, to acquire an STI during a 6-month period. This study expands on the work performed in the previous study by developing and testing a version for younger African American males (i.e., teen males).
The purpose of this study is to test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STI incidence among African American teen (15 to 20 years old) males presenting themselves for STI testing.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||840 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
|Active Comparator: Male Sexual Health Program||
Behavioral: Male Sexual Health Program
An attention equivalent control condition entailing a 60-minute one-to-one session that will didactically teach teens about several aspects of male sexual health. The content and objectives are related only to knowledge acquisition. In addition to this program, teens randomized to the control condition will receive standard-of-care services from the clinic. This involves the provision of free condoms (one size "fits all" condoms) and a brief (nurse-delivered) counseling message to practice safer sex.
|Experimental: Focus on the Future Program||
Behavioral: Focus on the Future Program
A 60-minute, theory-guided program designed to increase the quality and frequency of teens' condom use within the context of making safer choices regarding partners and sexual behaviors. The program is explicitly designed to increase the quality and frequency of teen's condom use.
- Incidence rate of laboratory-confirmed STIs [ Time Frame: 2- and 6-month follow-up, as well as 12-month follow-up medical records review ]
- Self-report of unprotected penetrative sex (past 30 days) [ Time Frame: 2- and 6-month follow-up ]
- Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days) [ Time Frame: 2 and 6-month follow-up ]
- Self-report of negative experiences with the correct use of condoms (past 30 days) [ Time Frame: 2- and 6-month follow-up ]
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): NCT00849823
|United States, Louisiana|
|Adolescent Medicine Program, LSU School of Medicine|
|New Orleans, Louisiana, United States, 70118|
|Principal Investigator:||Ryan Pasternak, MD, MPH||Louisiana State University Health Sciences Center in New Orleans|
|Principal Investigator:||Richard A Crosby, PhD||University of Kentucky|