Increasing Condom Use in People at Risk for HIV Infection
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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 |
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
More Information
Publications:
| 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:
|
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 |
ClinicalTrials.gov processed this record on May 23, 2013