Computerized HIV/Sexually Transmitted Disease (STD) Prevention Program (TIPSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00947947
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : November 15, 2013
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

July 24, 2009
July 28, 2009
November 15, 2013
February 2010
May 2012   (Final data collection date for primary outcome measure)
Condom use with main and casual sexual partners [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00947947 on Archive Site
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Computerized HIV/Sexually Transmitted Disease (STD) Prevention Program
Enhancing Message Design in Tailored, Computerized HIV/STI Interventions
The purpose of the current study is to test a computerized HIV/STD prevention program with heterosexual African Americans. The hypothesis is that those exposed to the program will increase their correct and consistent use of condoms compared to those not exposed to the program.

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.

Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
Behavioral: Tailored Information Program for Safer Sex
Health communication intervention delivered on a laptop computer to increase positive perceptions of condoms and increase skills to use condoms.
Other Name: Computerized health intervention
  • Experimental: intervention media condition
    Received a stage tailored DVD-based intervention
    Intervention: Behavioral: Tailored Information Program for Safer Sex
  • Placebo Comparator: standard of care
    received only clinical standard of care
    Intervention: Behavioral: Tailored Information Program for Safer Sex
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2012
May 2012   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
18 Years to 29 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R34MH077507( U.S. NIH Grant/Contract )
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University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
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Principal Investigator: Richard Crosby, Ph.D. Department of Communication, University of Kentucky
Principal Investigator: Seth M. Noar, PhD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP