Increasing Condom Use in People at Risk for HIV Infection
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individual feedback and specially-tailored manuals
General HIV information feedback and the best-available information
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Condom, HIV Seronegativity, HIV Prevention, Behavioral Intervention
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4
Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4
Outcomes
Primary Outcome Measures
Frequency of condom use
Number of occurances of unprotected sex
Stage of change for condom use with main and nonmain partners, and men and women
Secondary Outcome Measures
Frequency of condom use with main and nonmain partners, and men and women
Number and ratios of protected sex occasions with main and nonmain partners, and men and women
Stage of change for condom use with main and nonmain partners, and men and women
Full Information
NCT ID
NCT00080093
First Posted
March 23, 2004
Last Updated
September 25, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00080093
Brief Title
Increasing Condom Use in People at Risk for HIV Infection
Official Title
Increasing Condom Use With a Stage-Matched Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
This study will evaluate a new program designed to increase condom use in both women and men.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Condom, HIV Seronegativity, HIV Prevention, Behavioral Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
534 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4
Intervention Type
Behavioral
Intervention Name(s)
Individual feedback and specially-tailored manuals
Intervention Description
Individual feedback and specially-tailored manuals
Intervention Type
Behavioral
Intervention Name(s)
General HIV information feedback and the best-available information
Intervention Description
General HIV information feedback and the best-available information
Primary Outcome Measure Information:
Title
Frequency of condom use
Time Frame
At 30 days and 2 months before each assessment
Title
Number of occurances of unprotected sex
Time Frame
At 30 days before each assessment
Title
Stage of change for condom use with main and nonmain partners, and men and women
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Frequency of condom use with main and nonmain partners, and men and women
Time Frame
Throughout Study
Title
Number and ratios of protected sex occasions with main and nonmain partners, and men and women
Time Frame
Throughout study
Title
Stage of change for condom use with main and nonmain partners, and men and women
Time Frame
Throughout Study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Morokoff, PhD
Organizational Affiliation
University of Rhode Island
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Learn more about this trial
Increasing Condom Use in People at Risk for HIV Infection
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