HIV Prevention Program for African American Teen Males
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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 21 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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males |
- Incidence rate of laboratory-confirmed STIs [ Time Frame: 2- and 6-month follow-up, as well as 12-month follow-up medical records review ] [ Designated as safety issue: No ]
- Self-report of unprotected penetrative sex (past 30 days) [ Time Frame: 2- and 6-month follow-up ] [ Designated as safety issue: No ]
- Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days) [ Time Frame: 2 and 6-month follow-up ] [ Designated as safety issue: No ]
- Self-report of negative experiences with the correct use of condoms (past 30 days) [ Time Frame: 2- and 6-month follow-up ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| 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.
|
Detailed Description:
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 23 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- at least 15, but not more than 23 years of age
- attending the clinic for the expressed purpose of being tested for sexually transmitted infections
- engaging in penetrative sex (penile-vaginal or penile-anal) at least once in the past 2 months
- willingness to return for the two planned follow-up assessments
Exclusion Criteria:
- self-report of being HIV positive
Contacts and Locations| Contact: Richard A Crosby, PhD | 859-218-2039 | rcros2@email.uky.edu |
| Contact: Ivy Wilson Terrell, MPH | (504)717-9415 | iwils1@lsuhsc.edu |
| United States, Louisiana | |
| Adolescent Medicine Program, LSU School of Medicine | Recruiting |
| New Orleans, Louisiana, United States, 70118 | |
| Contact: Ryan Pasternak, MD, MPH 504-919-9640 rpaste@lsuhsc.edu | |
| Principal Investigator: Ryan Pasternak, MD, MPH | |
| Principal Investigator: | Ryan Pasternak, MD, MPH | Louisiana State University Health Sciences Center in New Orleans |
| Principal Investigator: | Richard A Crosby, PhD | University of Kentucky |
More Information
No publications provided
| Responsible Party: | Richard Crosby, Chair-Department of Health Behavior, University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00849823 History of Changes |
| Other Study ID Numbers: | 080666, NIH Grant # 1R01MH083621 |
| Study First Received: | February 23, 2009 |
| Last Updated: | June 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Kentucky:
|
African American Men Condoms Randomization |
Brief Intervention HIV HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Infection Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on March 14, 2013
