Increasing Condom Use in People at Risk for HIV Infection
|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
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Individual feedback and specially-tailored manuals Behavioral: General HIV information feedback and the best-available information||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||534 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Increasing Condom Use With a Stage-Matched Intervention|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||October 2007|
|Estimated Study Completion Date :||December 2008|
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
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
- Frequency of condom use [ Time Frame: At 30 days and 2 months before each assessment ]
- Number of occurances of unprotected sex [ Time Frame: At 30 days before each assessment ]
- Stage of change for condom use with main and nonmain partners, and men and women [ Time Frame: Throughout study ]
- Frequency of condom use with main and nonmain partners, and men and women [ Time Frame: Throughout Study ]
- Number and ratios of protected sex occasions with main and nonmain partners, and men and women [ Time Frame: Throughout study ]
- Stage of change for condom use with main and nonmain partners, and men and women [ Time Frame: Throughout Study ]
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
|Principal Investigator:||Patricia Morokoff, PhD||University of Rhode Island|