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Increasing Condom Use in People at Risk for HIV Infection

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ClinicalTrials.gov Identifier: NCT00080093
Recruitment Status : Unknown
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was:  Active, not recruiting
First Posted : March 24, 2004
Last Update Posted : September 26, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
This study will evaluate a new program designed to increase condom use in both women and men.

Condition or disease Intervention/treatment
HIV Infections Behavioral: Individual feedback and specially-tailored manuals Behavioral: 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Increasing Condom Use With a Stage-Matched Intervention
Study Start Date : January 2006
Primary Completion Date : October 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
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
Experimental: 2
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


Outcome Measures

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

Secondary Outcome Measures :
  1. Frequency of condom use with main and nonmain partners, and men and women [ Time Frame: Throughout Study ]
  2. Number and ratios of protected sex occasions with main and nonmain partners, and men and women [ Time Frame: Throughout study ]
  3. Stage of change for condom use with main and nonmain partners, and men and women [ Time Frame: Throughout Study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080093


Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Patricia Morokoff, PhD University of Rhode Island
More Information

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.

Responsible Party: Patricia Morokoff, PhD, University of Rhode Island
ClinicalTrials.gov Identifier: NCT00080093     History of Changes
Other Study ID Numbers: R01AI041323 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2004    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008

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

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases