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Rapid HIV Testing and Counseling
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), January 2009
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
University of Miami
University of California, San Francisco
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00809445
  Purpose

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

MedlinePlus related topics: AIDS
U.S. FDA Resources
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.

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Use of injection drugs [ Time Frame: Six months ] [ Designated as safety issue: No ]

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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809445

Contacts
Contact: Lauren K Gooden, MPH, CHES 305-243-9844 LGooden@med.miami.edu

Locations
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    
Sponsors and Collaborators
University of Miami
University of California, San Francisco
Investigators
Principal Investigator: Lisa Metsch, Ph.D. University of Miami
Principal Investigator: Grant Colfax, M.D. City/County of San Francisco Public Health Department
  More Information

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

Study placed in the following topic categories:
Antibodies
HIV Antibodies
Mental Disorders
HIV Infections
Acquired Immunodeficiency Syndrome
Substance-Related Disorders
Disorders of Environmental Origin
Immunoglobulins

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009