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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00947947
First received: July 24, 2009
Last updated: November 13, 2013
Last verified: November 2013

July 24, 2009
November 13, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00947947 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
274
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:

  • None
Both
18 Years to 29 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00947947
R34-MH077507
No
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
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