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HIV Prevention Program for African American Teen Males

Primary Purpose

HIV Infections, Sexually Transmitted Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Male Sexual Health Program
Focus on the Future Program
Sponsored by
Richard Crosby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring African American, Men, Condoms, Randomization, Brief Intervention, HIV, HIV Seronegativity

Eligibility Criteria

15 Years - 23 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Adolescent Medicine Program, LSU School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Male Sexual Health Program

Focus on the Future Program

Arm Description

Outcomes

Primary Outcome Measures

Incidence rate of laboratory-confirmed STIs
Self-report of unprotected penetrative sex (past 30 days)
Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days)
Self-report of negative experiences with the correct use of condoms (past 30 days)

Secondary Outcome Measures

Full Information

First Posted
February 23, 2009
Last Updated
July 11, 2017
Sponsor
Richard Crosby
Collaborators
Louisiana State University Health Sciences Center in New Orleans
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1. Study Identification

Unique Protocol Identification Number
NCT00849823
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Richard Crosby
Collaborators
Louisiana State University Health Sciences Center in New Orleans

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Infections
Keywords
African American, Men, Condoms, Randomization, Brief Intervention, HIV, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Male Sexual Health Program
Arm Type
Active Comparator
Arm Title
Focus on the Future Program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Male Sexual Health Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Focus on the Future Program
Intervention Description
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 Outcome Measure Information:
Title
Incidence rate of laboratory-confirmed STIs
Time Frame
2- and 6-month follow-up, as well as 12-month follow-up medical records review
Title
Self-report of unprotected penetrative sex (past 30 days)
Time Frame
2- and 6-month follow-up
Title
Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days)
Time Frame
2 and 6-month follow-up
Title
Self-report of negative experiences with the correct use of condoms (past 30 days)
Time Frame
2- and 6-month follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Pasternak, MD, MPH
Organizational Affiliation
Louisiana State University Health Sciences Center in New Orleans
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard A Crosby, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adolescent Medicine Program, LSU School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29534210
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.
Results Reference
derived
PubMed Identifier
29419709
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.
Results Reference
derived
PubMed Identifier
24898858
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.
Results Reference
derived

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HIV Prevention Program for African American Teen Males

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