Rapid HIV Testing and Counseling

This study has been completed.
Sponsor:
Collaborators:
University of California, San Francisco
Information provided by (Responsible Party):
Lisa R Metsch, University of Miami
ClinicalTrials.gov Identifier:
NCT00809445
First received: December 16, 2008
Last updated: January 26, 2012
Last verified: January 2012
  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 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.

Resource links provided by NLM:


Further study details as provided by University of Miami:

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 ]

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
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

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
Chemically-Induced Disorders
Mental Disorders
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014