- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00947947
Computerized HIV/Sexually Transmitted Disease (STD) Prevention Program (TIPSS)
Enhancing Message Design in Tailored, Computerized HIV/STI Interventions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proposed study will involve the development and pilot testing of an interactive computerized tailored intervention program for HIV/STI prevention among at-risk heterosexually active African-American STI clinic patients, aged 18-29. The Attitude-Social-Influence Efficacy (ASE) model will serve as a conceptual foundation for the intervention and tailored feedback, which will assess and give feedback to participants separately for main/steady and other/casual partners. Individual modules will be developed for key theoretical concepts and subsequently tied together into an integrated system. The tailored feedback will additionally be enhanced by crafting intervention messages to be high in message sensation value and by developing interactive intervention activities for skill-building, which will be guided by both Social Cognitive Theory and skills training principles. The computerized intervention will be developed and guided using data collected from the target audience to ensure an empirically-based approach to tailoring. The intervention will also be developed with input from the target audience in order to maximize the appropriateness and persuasiveness of the feedback and the program, including interactive components. The final year of the project will entail a pilot test of the intervention in order to gather preliminary data on the acceptability and efficacy of such an intervention for increasing safer sexual behaviors among at-risk heterosexually active African-Americans.
The specific aims of the study are: 1) to develop tailored feedback on HIV/STI prevention based on the ASE model, including condom attitudes, social influences, self-efficacy including communication / negotiation skills, partner and behavioral risk, correct condom use, and condom stages of change; 2) to enhance the delivery of the tailored messages using sensation-seeking targeting (SENTAR) and skill-building using interactive activities guided by Social Cognitive Theory (SCT) and skills training principles; 3) to tie the individual theoretical modules together and develop a computerized intervention program for HIV/STI prevention, which provides tailored risk reduction messages to participants based upon an assessment of participant characteristics; 4) to develop empirically sound cutpoints, specific to the target audience, to guide the message tailoring; and 5) in a wait-list control group design, to pilot test the intervention for acceptability and efficacy in increasing condom use with main and casual partners among at-risk heterosexually active African-Americans, relative to a "usual care" comparison condition.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40204
- Specialty Clinic, Louisville Metro Health Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- African American
- Aged 18-29
- Heterosexually active in past 3 months
- NOT knowingly HIV positive
- Not pregnant or planning on becoming pregnant/impregnating partner in next 3 months
- Client of the STI clinic where study is being conducted
- Not currently enrolled in another condom study at the clinic
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention media condition
Received a stage tailored DVD-based intervention
|
Health communication intervention delivered on a laptop computer to increase positive perceptions of condoms and increase skills to use condoms.
Other Names:
|
Placebo Comparator: standard of care
received only clinical standard of care
|
Health communication intervention delivered on a laptop computer to increase positive perceptions of condoms and increase skills to use condoms.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Condom use with main and casual sexual partners
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard Crosby, Ph.D., Department of Communication, University of Kentucky
- Principal Investigator: Seth M. Noar, PhD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- R34MH077507 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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