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Increasing Condom Use in People at Risk for HIV Infection

NCT ID: NCT00080093

Last Updated: 2008-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-12-31

Brief Summary

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This study will evaluate a new program designed to increase condom use in both women and men.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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Condom HIV Seronegativity HIV Prevention Behavioral Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4

Group Type EXPERIMENTAL

Individual feedback and specially-tailored manuals

Intervention Type BEHAVIORAL

Individual feedback and specially-tailored manuals

2

Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4

Group Type EXPERIMENTAL

General HIV information feedback and the best-available information

Intervention Type BEHAVIORAL

General HIV information feedback and the best-available information

Interventions

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Individual feedback and specially-tailored manuals

Individual feedback and specially-tailored manuals

Intervention Type BEHAVIORAL

General HIV information feedback and the best-available information

General HIV information feedback and the best-available information

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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University of Rhode Island

Principal Investigators

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Patricia Morokoff, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rhode Island

References

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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.

Reference Type RESULT

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.

Reference Type RESULT

Other Identifiers

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R01AI041323

Identifier Type: NIH

Identifier Source: secondary_id

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R01AI041323

Identifier Type: NIH

Identifier Source: org_study_id

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