Rapid HIV Testing and Counseling
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![](https://webarchive.library.unt.edu/web/20130315211609im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
Official Title: | HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S. |
- Receipt of HIV test results [ Time Frame: One month post-randomization ] [ Designated as safety issue: No ]
- Number of risky sexual behaviors [ Time Frame: Six months post-randomization ] [ Designated as safety issue: No ]
- Use of injection drugs [ Time Frame: Six months ] [ Designated as safety issue: No ]
Enrollment: | 1281 |
Study Start Date: | January 2009 |
Study Completion Date: | January 2010 |
Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: HIV rapid test & counseling |
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.
|
Experimental: HIV rapid test and info |
Behavioral: On- site HIV rapid test & information
Participants will be offered an on-site oral fluid HIV rapid test with basic info.
|
Active Comparator: HIV testing referral |
Behavioral: Referral for off-site HIV testing
Participants will be offered a referral list of HIV testing agencies in the community.
|
Detailed Description:
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.
![](https://webarchive.library.unt.edu/web/20130315211609im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 18 years of age
- HIV-negative or HIV status unknown
- No receipt of results from HIV test initiated within last 12 months
- Be able to communicate in English
![](https://webarchive.library.unt.edu/web/20130315211609im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, Arizona | |
La Frontera Center, Inc. | |
Tucson, Arizona, United States, 85713 | |
United States, Connecticut | |
Midwestern Connecticut Council on Alcoholism | |
Danbury, Connecticut, United States, 06818 | |
Wheeler Clinic | |
Plainville, Connecticut, United States, 06062 | |
United States, Maryland | |
Glenwood Life Counseling Center | |
Baltimore, Maryland, United States, 21212 | |
United States, Missouri | |
Gibson Recover Centers | |
Cape Girardeau, Missouri, United States, 63703 | |
United States, New Mexico | |
The Life Link | |
Santa Fe, New Mexico, United States, 87505 | |
United States, North Carolina | |
Daymark Recovery Services, Inc. | |
Salisbury, North Carolina, United States, 28146 | |
United States, Oregon | |
CODA | |
Portland, Oregon, United States, 97214 | |
United States, Pennsylvania | |
Addiction Medicine Services (Western Psychiatric Institute) | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, South Carolina | |
Morris Village Alcohol and Drug Treatment Center | |
Columbia, South Carolina, United States, 29203 | |
Lexington / Richland Alcohol and Drug Abuse Council | |
Columbia, South Carolina, United States, 29250 | |
United States, Virginia | |
Chesterfield CSB Substance Abuse Service | |
Chesterfield, Virginia, United States, 23832 |
Principal Investigator: | Lisa Metsch, Ph.D. | University of Miami |
Principal Investigator: | Grant Colfax, M.D. | City/County of San Francisco Public Health Department |
![](https://webarchive.library.unt.edu/web/20130315211609im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Lisa R Metsch, Professor, University of Miami |
ClinicalTrials.gov Identifier: | NCT00809445 History of Changes |
Other Study ID Numbers: | NIDA-CTN-0032, U10DA013720 |
Study First Received: | December 16, 2008 |
Last Updated: | January 26, 2012 |
Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
Substance-Related Disorders Mental Disorders HIV Antibodies |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 14, 2013