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

March 23, 2004
September 25, 2008
January 2006
October 2007   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00080093 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Behavioral: Individual feedback and specially-tailored manuals
    Individual feedback and specially-tailored manuals
  • Behavioral: General HIV information feedback and the best-available information
    General HIV information feedback and the best-available information
  • Experimental: 1
    Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4
    Intervention: Behavioral: 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
    Intervention: Behavioral: General HIV information feedback and the best-available information
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
534
December 2008
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00080093
R01AI41323, R01 AI41323
Not Provided
Patricia Morokoff, PhD, University of Rhode Island
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Patricia Morokoff, PhD University of Rhode Island
National Institute of Allergy and Infectious Diseases (NIAID)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP