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

NCT01536730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2018-09-18

No results posted yet for this study

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.

Conditions

  • Correct Consistent Condom Use

Interventions

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.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Stephanie A Sanders, Ph.D. · Indiana University

  • William L Yarber, Ph.D. · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01536730 on ClinicalTrials.gov