Increasing Condom Use in People at Risk for HIV Infection

Increasing Condom Use With a Stage-Matched Intervention

This study will evaluate a new program designed to increase condom use in both women and men.

Study Overview

Detailed Description

As heterosexual HIV transmission increases, effective behavioral interventions to increase condom use are needed. Interventions should be low cost and accessible to large segments of the at-risk population. This study will evaluate the efficacy of a behavioral intervention designed to increase condom use in at-risk, heterosexually active women and men. The intervention is computer-delivered and will be provided in health care settings. The study will also examine additional psychosocial mediators of condom use by testing the predictive efficacy of the Multifaceted Model of HIV Risk.

Participants will be recruited from four health clinic sites that serve local ethnic minority communities. The participants will be randomly assigned to either an individualized intervention designed to increase condom use or to an HIV information comparison group. All participants will receive comparable group-specific informational materials at study entry and at Months 2 and 4. Participants in the intervention group will receive individualized feedback and specially-tailored manuals. Participants in the HIV information comparison group will receive general HIV information feedback and the best-available informational manual.

Assessments for both groups will be conducted at study entry and at Months 6, 12, and 18. At study entry, participants will complete paper and pencil questionnaires lasting about 30 minutes. There will also be computer question sessions at study entry and at Months 2 and 4. Participants will be asked about condom use, contraceptive use, risk behaviors, sexual transmitted disease (STD) history, and personal relationships. Telephone follow-ups at Months 6, 12, and 18 will take approximately 20 to 30 minutes.

Study Type

Interventional

Enrollment (Actual)

534

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • HIV uninfected
  • Sexually active
  • At risk for HIV (as determined by study officials)
  • Speaks English
  • Seen at a participating clinic

Exclusion Criteria

  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4
Individual feedback and specially-tailored manuals
Experimental: 2
Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4
General HIV information feedback and the best-available information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of condom use
Time Frame: At 30 days and 2 months before each assessment
At 30 days and 2 months before each assessment
Number of occurances of unprotected sex
Time Frame: At 30 days before each assessment
At 30 days before each assessment
Stage of change for condom use with main and nonmain partners, and men and women
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of condom use with main and nonmain partners, and men and women
Time Frame: Throughout Study
Throughout Study
Number and ratios of protected sex occasions with main and nonmain partners, and men and women
Time Frame: Throughout study
Throughout study
Stage of change for condom use with main and nonmain partners, and men and women
Time Frame: Throughout Study
Throughout Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patricia Morokoff, PhD, University of Rhode Island

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Cho S, Harlow L, Morokoff P, Redding C, Rossi J, Mayer K, Koblin B. Predicting 3-Wave LGCM of Condom Use in High-Risk Community Sample. Annual Meeting of the American Psychological Association, San Francisco, CA, 2007.
  • Cho S, Morokoff P, Redding C, Harlow L, Rossi J, Mayer K, Koblin B. Empirically Investigating Gender in a Multifaceted Model of HIV Risk. 19th Annual Meeting of the American Psychological Society, Washington, DC, 2007.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

March 23, 2004

First Submitted That Met QC Criteria

March 23, 2004

First Posted (Estimate)

March 24, 2004

Study Record Updates

Last Update Posted (Estimate)

September 26, 2008

Last Update Submitted That Met QC Criteria

September 25, 2008

Last Verified

September 1, 2008

More Information

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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