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| Sponsor: | University of Kentucky |
|---|---|
| Collaborators: |
Louisiana State University Carolinas Healthcare System |
| Information provided by: | University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00849823 |
Purpose
The purpose of this study is to test if sexual health interventions can reduce the incidence of STIs among African American teens (15 to 20 years old). By doing this study, we hope to help African American teens improve their condom use skills and encourage them to use condoms more frequently. If the number of STIs in this population can be decreased, the health of African American teen males will greatly improve. We also believe that sexual partners (typically African American teen females) will also benefit.
| Condition | Intervention |
|---|---|
|
HIV Infections Sexually Transmitted Infections |
Behavioral: Male Sexual Health Program Behavioral: Focus on the Future Program |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males |
| Estimated Enrollment: | 840 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Male Sexual Health Program: Active Comparator |
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.
|
| Focus on the Future Program: Experimental |
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.
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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.
Eligibility| Ages Eligible for Study: | 15 Years to 20 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Richard A Crosby, PhD | 859-218-2039 | rcros2@email.uky.edu |
| United States, Louisiana | |
| Adolescent Medicine Program, LSU School of Medicine | |
| New Orleans, Louisiana, United States, 70118 | |
| United States, North Carolina | |
| Levine Children's Hospital at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| Principal Investigator: | Ryan Pasternak, MD, MPH | Louisiana State University |
| Principal Investigator: | Kristin Rager, MD, MPH | Levine Children Hospital, Carolinas Medical Center |
| Principal Investigator: | Richard A Crosby, PhD | University of Kentucky |
More Information
| Responsible Party: | University of Kentucky ( Richard A. Crosby ) |
| Study ID Numbers: | 080666, NIH Grant # 1R01MH083621 |
| Study First Received: | February 23, 2009 |
| Last Updated: | March 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00849823 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
African American Men Condoms Randomization |
Brief Intervention HIV HIV Seronegativity |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Genital Diseases, Male Infection |
Immunologic Deficiency Syndromes Genital Diseases, Female Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
