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Increasing Condom Use in People at Risk for HIV Infection

This study is ongoing, but not recruiting participants.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00080093
  Purpose

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


Condition Intervention
HIV Infections
Behavioral: Individual feedback and specially-tailored manuals
Behavioral: General HIV information feedback and the best-available information

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Increasing Condom Use With a Stage-Matched Intervention

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Frequency of condom use [ Time Frame: At 30 days and 2 months before each assessment ] [ Designated as safety issue: No ]
  • Number of occurances of unprotected sex [ Time Frame: At 30 days before each assessment ] [ Designated as safety issue: No ]
  • Stage of change for condom use with main and nonmain partners, and men and women [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of condom use with main and nonmain partners, and men and women [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]
  • Number and ratios of protected sex occasions with main and nonmain partners, and men and women [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Stage of change for condom use with main and nonmain partners, and men and women [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]

Enrollment:   534
Study Start Date:   January 2006
Estimated Study Completion Date:   December 2008
Primary Completion Date:   October 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4
Behavioral: Individual feedback and specially-tailored manuals
Individual feedback and specially-tailored manuals
2: Experimental
Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4
Behavioral: General HIV information feedback and the best-available information
General HIV information feedback and the best-available information

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.

  Eligibility
Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080093

Sponsors and Collaborators

Investigators
Principal Investigator:     Patricia Morokoff, PhD     University of Rhode Island    
  More Information


Publications of Results:
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.
 

Responsible Party:   University of Rhode Island ( Patricia Morokoff, PhD )
Study ID Numbers:   R01AI41323, R01 AI41323
First Received:   March 23, 2004
Last Updated:   September 25, 2008
ClinicalTrials.gov Identifier:   NCT00080093
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Condom  
HIV Seronegativity  
HIV Prevention  
Behavioral Intervention  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on November 19, 2008




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