Clinical trial NCT00849823: HIV Prevention Program for African American Teen Males
Official title: A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Infections
Keywords: African American
Men
Condoms
Randomization
Brief Intervention
HIV
HIV Seronegativity
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2009-02-24
Enrollment: 840
Sex: MALE
Minimum age (years): 15
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Incidence rate of laboratory-confirmed STIs
timeFrame: 2- and 6-month follow-up, as well as 12-month follow-up medical records review
measure: Self-report of unprotected penetrative sex (past 30 days)
timeFrame: 2- and 6-month follow-up
measure: Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days)
timeFrame: 2 and 6-month follow-up
measure: Self-report of negative experiences with the correct use of condoms (past 30 days)
timeFrame: 2- and 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Adolescent Medicine Program, LSU School of Medicine
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: Ryan Pasternak, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Richard A Crosby, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crosby RA, Mena L, Smith RV. Promoting positive condom use experiences among young black MSM: a randomized controlled trial of a brief, clinic-based intervention. Health Educ Res. 2018 Jun 1;33(3):197-204. doi: 10.1093/her/cyy010.
citation: Crosby RA, Mena L, Salazar LF, Hardin JW, Brown T, Vickers Smith R. Efficacy of a Clinic-Based Safer Sex Program for Human Immunodeficiency Virus-Uninfected and Human Immunodeficiency Virus-Infected Young Black Men Who Have Sex With Men: A Randomized Controlled Trial. Sex Transm Dis. 2018 Mar;45(3):169-176. doi: 10.1097/OLQ.0000000000000721.
citation: Crosby R, Salazar LF. Reduction of condom use errors from a brief, clinic-based intervention: a secondary analysis of data from a randomised, controlled trial of young black males. Sex Transm Infect. 2015 Mar;91(2):111-5. doi: 10.1136/sextrans-2013-051492. Epub 2014 Jun 4.