HIV Prevention Program for African American Teen Males

NCT00849823 | Completed DMC

• 2 other identifiers: 080666NIH Grant # 1R01MH083621
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Sexually Transmitted Infections

Keywords

African American; Men; Condoms; Randomization; Brief Intervention; HIV; HIV Seronegativity

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Male Sexual Health Program

ACTIVE COMPARATOR

Behavioral: Male Sexual Health Program

Focus on the Future Program

EXPERIMENTAL

Behavioral: Focus on the Future Program

Interventions

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.

Male Sexual Health Program

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.

Focus on the Future Program

Eligibility Criteria

• Age: 15 Years - 23 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• self-report of being HIV positive

Sponsors & Collaborators

• Richard Crosby: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Adolescent Medicine Program, LSU School of Medicine

New Orleans, Louisiana, 70118, United States

Location

Related Publications (3)

• 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.

  PMID: 29534210 DERIVED

• 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.

  PMID: 29419709 DERIVED

• 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.

  PMID: 24898858 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Ryan Pasternak, MD, MPH

  Louisiana State University Health Sciences Center in New Orleans

  PRINCIPAL INVESTIGATOR

• Richard A Crosby, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair-Department of Health Behavior

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 24, 2009
• Study Start: February 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 14, 2017

Record last verified: 2017-07

Locations

US (1)