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Completed

NCT Number: NCT00849823

HIV Prevention Program for African American Teen Males

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Male Sexual Health Program

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Incidence rate of laboratory-confirmed STIs

    Time frame: 2- and 6-month follow-up, as well as 12-month follow-up medical records review

  2. Self-report of unprotected penetrative sex (past 30 days)

    Time frame: 2- and 6-month follow-up

  3. Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days)

    Time frame: 2 and 6-month follow-up

  4. Self-report of negative experiences with the correct use of condoms (past 30 days)

    Time frame: 2- and 6-month follow-up

Sponsors and collaborators

Lead sponsor

Richard Crosby

Other

Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 24, 2009
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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