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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Miami University of California, San Francisco |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00809445 |
This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV risk behaviors.
Condition | Intervention | Phase |
---|---|---|
Substance-Related Disorders |
Behavioral: On-site HIV rapid test and brief, prevention counseling Behavioral: On- site HIV rapid test & information Behavioral: Referral for off-site HIV testing |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment |
Official Title: | HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S. |
Estimated Enrollment: | 1272 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
HIV rapid test & counseling: Experimental |
Behavioral: On-site HIV rapid test and brief, prevention counseling
Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
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HIV rapid test and info: Experimental |
Behavioral: On- site HIV rapid test & information
Participants will be offered an on-site oral fluid HIV rapid test with basic info.
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HIV testing referral: Active Comparator |
Behavioral: Referral for off-site HIV testing
Participants will be offered a referral list of HIV testing agencies in the community.
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This is a randomized controlled clinical trial in which individuals receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of HIV test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV sexual risk behaviors. Injection drug risk behavior will be a secondary outcome. Participants will complete a baseline assessment to report their demographics, HIV testing history and sexual and drug-using risk behaviors, and will be randomized to one of three groups. At one month post-randomization, participants will complete a follow-up assessment to determine whether or not they received their HIV test results. At six months post-randomization, participants will complete a follow-up assessment to assess any changes in their HIV sexual risk behaviors.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Lauren K Gooden, MPH, CHES | 305-243-9844 | LGooden@med.miami.edu |
United States, Arizona | |
La Frontera Center, Inc. | Not yet recruiting |
Tucson, Arizona, United States, 85713 | |
Contact: Penn Pat, Ph.D. 520-838-5520 ppenn@lafrontera.org | |
United States, Connecticut | |
Midwestern Connecticut Council on Alcoholism | Not yet recruiting |
Danbury, Connecticut, United States, 06818 | |
Contact: Avila David, LCSW 203-792-4515 ext 1109 davila@mccaonline.com | |
Wheeler Clinic | Not yet recruiting |
Plainville, Connecticut, United States, 06062 | |
Contact: Ray Muszynski, MS 860-793-3500 rmuszynski@Wheelerclinic.org | |
United States, Maryland | |
Glenwood Life Counseling Center | Not yet recruiting |
Baltimore, Maryland, United States, 21212 | |
Contact: Robert Schwartz, MD 410-823-5116 rschwartz@sorosny.org | |
United States, Missouri | |
Gibson Recover Centers | Not yet recruiting |
Cape Girardeau, Missouri, United States, 63703 | |
Contact: Scott Doty 573-332-0416 dotys@gibsonrecovery.org | |
United States, New Mexico | |
The Life Link | Not yet recruiting |
Santa Fe, New Mexico, United States, 87505 | |
Contact: Michael DeBernardi, MD 505-438-0010 drdebernardi@thelifelink.org | |
United States, North Carolina | |
Daymark Recovery Services, Inc. | Not yet recruiting |
Salisbury, North Carolina, United States, 28146 | |
Contact: Robert Werstlein, Ph.D. 704-939-1156 rwerstlein@daymarkrecovery.org | |
United States, Oregon | |
CODA | Not yet recruiting |
Portland, Oregon, United States, 97214 | |
Contact: Katharina Wiest, Ph.D. 503-494-3165 KatharinaWiest@codainc.org | |
United States, Pennsylvania | |
Addiction Medicine Services (Western Psychiatric Institute) | Not yet recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Antoine Douaihy, MPH, CHES 412-246-5937 douaihya@upmc.edu | |
United States, South Carolina | |
Morris Village Alcohol and Drug Treatment Center | Recruiting |
Columbia, South Carolina, United States, 29203 | |
Contact: Louise Haynes, MSW 803-256-3100 ext 120 LGooden@med.miami.edu | |
Lexington / Richland Alcohol and Drug Abuse Council | Not yet recruiting |
Columbia, South Carolina, United States, 29250 | |
Contact: Louise Haynes, MSW 803-256-3100 ext 120 LGooden@med.miami.edu | |
United States, Virginia | |
Chesterfield CSB Substance Abuse Service | Not yet recruiting |
Chesterfield, Virginia, United States, 23832 | |
Contact: Lauren K Gooden, MPH, CHES 305-243-9844 LGooden@med.miami.edu |
Principal Investigator: | Lisa Metsch, Ph.D. | University of Miami |
Principal Investigator: | Grant Colfax, M.D. | City/County of San Francisco Public Health Department |
Responsible Party: | University of Miami ( Lisa Metsch, Ph.D. ) |
Study ID Numbers: | NIDA-CTN-0032 |
Study First Received: | December 16, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00809445 |
Health Authority: | United States: Federal Government |
Antibodies HIV Antibodies Mental Disorders HIV Infections |
Acquired Immunodeficiency Syndrome Substance-Related Disorders Disorders of Environmental Origin Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |