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

Primary Purpose

Acquired Immunodeficiency Syndrome, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tailored Information Program for Safer Sex
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acquired Immunodeficiency Syndrome focused on measuring condom use, HIV prevention, African American, Behavioral intervention, HIV Seronegativity

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Specialty Clinic, Louisville Metro Health Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

intervention media condition

standard of care

Arm Description

Received a stage tailored DVD-based intervention

received only clinical standard of care

Outcomes

Primary Outcome Measures

Condom use with main and casual sexual partners

Secondary Outcome Measures

Full Information

First Posted
July 24, 2009
Last Updated
November 13, 2013
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT00947947
Brief Title
Computerized HIV/Sexually Transmitted Disease (STD) Prevention Program
Acronym
TIPSS
Official Title
Enhancing Message Design in Tailored, Computerized HIV/STI Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, HIV Infections
Keywords
condom use, HIV prevention, African American, Behavioral intervention, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention media condition
Arm Type
Experimental
Arm Description
Received a stage tailored DVD-based intervention
Arm Title
standard of care
Arm Type
Placebo Comparator
Arm Description
received only clinical standard of care
Intervention Type
Behavioral
Intervention Name(s)
Tailored Information Program for Safer Sex
Other Intervention Name(s)
Computerized health intervention
Intervention Description
Health communication intervention delivered on a laptop computer to increase positive perceptions of condoms and increase skills to use condoms.
Primary Outcome Measure Information:
Title
Condom use with main and casual sexual partners
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Crosby, Ph.D.
Organizational Affiliation
Department of Communication, University of Kentucky
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seth M. Noar, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Specialty Clinic, Louisville Metro Health Department
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40204
Country
United States

12. IPD Sharing Statement

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Computerized HIV/Sexually Transmitted Disease (STD) Prevention Program

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