A Self-Guided Intervention to Promote Condom Use Among African American Males

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Indiana University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Stephanie Sanders, Indiana University
ClinicalTrials.gov Identifier:
NCT01536730
First received: July 20, 2011
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

The Centers for Disease Control and Prevention has declared that AIDS is a "state of emergency" in the US for African Americans - young African American men are especially vulnerable in this epidemic. Thus, the development of effective interventions tailored to this population is a national priority. The investigators previous preliminary studies suggest that a brief, clinic-initiated, home-based, self-guided condom use program may effectively promote the acceptance of condom use and increase the quality and consistency of condom-protected sexual behaviors. This pilot study will (1) develop and test the feasibility of this program (Homework Intervention Strategy, HIS) for young African American men attending an urban STD clinic and (2) identify variables that may mediate the efficacy of the program. The HIS has the potential to be readily translated into widespread practice, while requiring only minimal resources. Unlike previously tested interventions, the HIS can be applied to all men who use condoms, regardless of the sex of their partners or their HIV/STI status. To develop the HIS to meet the needs of these high-risk men, the proposed study will include a formative phase during which the basic intervention "instructions" which will be delivered by DVD will be refined and tailored for this population.

One hundred young African American men recruited from an urban STD clinic will be randomized to each of two groups (HIS vs. "standard of care") in a randomized 2-arm trial with 5 assessment periods over the course of 6 months. Assessments will compare the groups on frequency of unprotected sex, quality of the condom use experience, experience of condom use errors and problems, attitudes regarding condom use, condom use acceptability, and condom use self-efficacy and confidence.


Condition Intervention
Correct and Consistent Condom Use.
Behavioral: Homework Intervention Strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Self-Guided Intervention to Promote Condom Use Among African American Males

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Change from baseline in number of unprotected sex events at 2 months [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change from baseline in number of unprotected sex events at 4 months [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change from baseline in number of unprotected sex events at 7 months [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 2 months. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 4 months. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 7 months. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale(CCUSES) at 2 months. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale (CCUSES) at 4 months. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale(CCUSES) at 7 months. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Homework Intervention Strategy Behavioral: Homework Intervention Strategy
Participants assigned to intervention will receive a condom "ditty bag" containing 50 condoms (5 each of 10 types), a variety of 50 lubricants, an instructional DVD, and instructions for the intervention.
No Intervention: Control

  Eligibility

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American men
  • 15 to 24 years of age
  • able to read, write and comprehend English
  • have engaged penile-vaginal intercourse (PVI) or insertive penile-anal intercourse (PAI) with a partner at least once in the past 30 days
  • willing to use a condom
  • does not intend to get a partner pregnant in the next 6 months
  • consent to participate in the study
  • client of the Bell Flower Clinic in Indianapolis, IN in the past 12 months
  • has maintained a cell-phone number for the past three months and is willing to use it for data collection and incur fees for voice communication or text messaging it they do not have unlimited plans
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536730

Contacts
Contact: Elizabeth M Webb, MA 812-856-9065 elizwebb@indiana.edu

Locations
United States, Indiana
Bell Flower Clinic Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Elizabeth M Webb, MA    317-775-7337    elizwebb@indiana.edu   
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Stephanie A Sanders, Ph.D. Indiana University
Principal Investigator: William L Yarber, Ph.D. Indiana University
  More Information

No publications provided

Responsible Party: Stephanie Sanders, Professor Department of Gender Studies and Associate Director The Kinsey Institute, Indiana University
ClinicalTrials.gov Identifier: NCT01536730     History of Changes
Other Study ID Numbers: 5R21MH090892-02
Study First Received: July 20, 2011
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014