HIV Prevention Program for African American Teen Males

This study has been completed.
Sponsor:
Collaborator:
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
Richard Crosby, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00849823
First received: February 23, 2009
Last updated: December 13, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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
Study Completion Date: September 2013
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849823

Locations
United States, Louisiana
Adolescent Medicine Program, LSU School of Medicine
New Orleans, Louisiana, United States, 70118
Sponsors and Collaborators
University of Kentucky
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
  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: December 13, 2013
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:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014