HIV Prevention Program for African American Teen Males

Sponsor

Richard Crosby (Other)

Overall Status

Completed

CT.gov ID

NCT00849823

Collaborator

Louisiana State University Health Sciences Center in New Orleans (Other)

840

Enrollment

Location

Arms

Duration (Months)

15.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV Infections Sexually Transmitted Infections	Behavioral: Male Sexual Health Program Behavioral: Focus on the Future Program	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

840 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Incidence rate of laboratory-confirmed STIs [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) [2- and 6-month follow-up]
Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days) [2 and 6-month follow-up]
Self-report of negative experiences with the correct use of condoms (past 30 days) [2- and 6-month follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 23 Years

Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	Adolescent Medicine Program, LSU School of Medicine	New Orleans	Louisiana	United States	70118

Sponsors and Collaborators

Richard Crosby
Louisiana State University Health Sciences Center in New Orleans

Investigators

Principal Investigator: Ryan Pasternak, MD, MPH, Louisiana State University Health Sciences Center in New Orleans
Principal Investigator: Richard A Crosby, PhD, University of Kentucky