Correct Consistent Condom Use
Conditions
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.
Interventions
BEHAVIORALHomework 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
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
15 Years to 24 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in number of unprotected sex events at 2 months | 30 days |
| Change from baseline in number of unprotected sex events at 4 months | 30 days |
| Change from baseline in number of unprotected sex events at 7 months | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 2 months. | 30 days |
| 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 |
| 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 |
| Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 4 months. | 30 days |
| Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 7 months. | 30 days |
Countries
United States
Outcome results
None listed