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

Study Overview
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Brief Summary
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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.

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

Conditions
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Correct Consistent Condom Use

Intervention / Treatment
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* Behavioral: Homework Intervention Strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homework Intervention Strategy<br> | Behavioral: Homework Intervention Strategy<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 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 self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale(CCUSES) at 7 months. |  | 30 days |