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

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01536730
• Collaborator: (none)
• Enrollment: 193
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 10.2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Correct Consistent Condom Use	Behavioral: Homework Intervention Strategy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 193 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Self-Guided Intervention to Promote Condom Use Among African American Males
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change from baseline in number of unprotected sex events at 2 months [30 days]

2. Change from baseline in number of unprotected sex events at 4 months [30 days]

3. Change from baseline in number of unprotected sex events at 7 months [30 days]

Secondary Outcome Measures

1. Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 2 months. [30 days]

2. Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 4 months. [30 days]

3. Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 7 months. [30 days]

4. 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. [30 days]

5. 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. [30 days]

6. 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. [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 24 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Bell Flower Clinic	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

• Principal Investigator: Stephanie A Sanders, Ph.D., Indiana University
• Principal Investigator: William L Yarber, Ph.D., Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephanie Sanders, Professor Department of Gender Studies and Associate Director The Kinsey Institute, Indiana University
• ClinicalTrials.gov Identifier: NCT01536730
• Other Study ID Numbers: 5R21MH090892-02
• First Posted: Feb 22, 2012
• Last Update Posted: Sep 18, 2018
• Last Verified: Sep 1, 2018

Study Results

No Results Posted as of Sep 18, 2018