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Increasing Condom Use in People at Risk for HIV Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00080093
First received: March 23, 2004
Last updated: September 25, 2008
Last verified: September 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Increasing Condom Use With a Stage-Matched Intervention

Resource links provided by NLM:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: R01AI41323, R01 AI41323
Study First Received: March 23, 2004
Last Updated: September 25, 2008
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 27, 2014