HIV Prevention Program for African American Teen Males

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849823
• Other study ID #: 080666
• Secondary ID: NIH Grant # 1R01
• Status: Completed
• Phase: N/A
• First received: February 23, 2009
• Last updated: July 11, 2017
• Start date: February 2009
• Est. completion date: September 2013

Study information

• Verified date: July 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 23 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

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
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.

Locations

Country	Name	City	State
United States	Adolescent Medicine Program, LSU School of Medicine	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Richard Crosby	Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of laboratory-confirmed STIs		2- and 6-month follow-up, as well as 12-month follow-up medical records review
Primary	Self-report of unprotected penetrative sex (past 30 days)		2- and 6-month follow-up
Primary	Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days)		2 and 6-month follow-up
Primary	Self-report of negative experiences with the correct use of condoms (past 30 days)		2- and 6-month follow-up