Rapid HIV Testing and Counseling in Drug Abuse Treatment

This study has been completed.
Sponsor:
Collaborators:
University of California, San Francisco
Information provided by (Responsible Party):
Daniel J Feaster, University of Miami
ClinicalTrials.gov Identifier:
NCT00809445
First received: December 16, 2008
Last updated: September 9, 2014
Last verified: September 2014
  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:
  • Self-Report Receipt of HIV Test Results [ Time Frame: One month post-randomization ] [ Designated as safety issue: No ]
    The HIV testing primary outcome is self-reported receipt of HIV test results. This will be measured at one month post-randomization for all participants. We recognize that there are three potential HIV testing behaviors that could be evaluated in this study: acceptance of HIV testing, completion of HIV testing, and receipt of HIV testing results. Acceptance of testing refers to whether or not a participant would accept the offer of an HIV test. Completion of testing refers to whether or not a participant completes the HIV test. Receipt of HIV test results refers to whether or not a participant self-reports having received the results of the HIV test.

  • Number of Risky Sexual Behaviors [ Time Frame: Six months post-randomization ] [ Designated as safety issue: No ]
    The sexual risk behavior primary outcome is self-reported sexual risk behavior, which will be measured at baseline and six months post-randomization as the self-reported number of unprotected sex acts (vaginal or anal sex without a condom).


Secondary Outcome Measures:
  • Sharing of Needles Used in Drug Use [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Change in sharing of needles. The number of individuals reporting needle sharing at baseline and 6-month follow-up were measured and the change in sharing of needles assessed.

  • Self-Report of Ever Having Been Tested [ Time Frame: 1 month post-randomization ] [ Designated as safety issue: No ]
    The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.


Enrollment: 1281
Study Start Date: January 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV rapid test & counseling
Participants will be offered an oral fluid HIV rapid test (via oral swab) and brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach (Project RESPECT-2 counseling). Prior to receiving testing, study participants must first provide consent for HIV testing. Consent for testing will be obtained through a second consent form required of all participants who wish to proceed with the HIV test.
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
Participants will be offered an oral fluid HIV rapid test (via oral swab). Prior to receiving testing, study participants must first provide consent for HIV testing. Again, consent for testing will be obtained through a second consent form required of all participants who wish to proceed with the HIV test. Participants will receive rapid HIV testing and test results after signing the consent to be tested. In both Groups 1 and 2, participants who test reactive (preliminary positive) will be counseled on the sexual risk behaviors associated with transmission of HIV and the acquisition of STDs, as is current clinical practice with those testing HIV positive. Confirmed positives will be linked to HIV primary care.
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
Participants randomized to group 3 will receive a referral list for HIV community-testing agencies. Each CTP site will have previously prepared an extensive referral list of testing sites in the surrounding geographic area. By virtue of their status as patients in the CTPs, they will receive whatever HIV testing and HIV education referrals the CTPs normally provide to their patients. This is the standard of care at CTPs that do not provide on-site testing.
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
Lexington / Richland Alcohol and Drug Abuse Council
Columbia, South Carolina, United States, 29250
Morris Village Alcohol and Drug Treatment Center
Columbia, South Carolina, United States, 29203
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. Columbia University
Principal Investigator: Grant Colfax, M.D. PATH
  More Information

Publications:
Responsible Party: Daniel J Feaster, Associate Professor of Biostatistics, University of Miami
ClinicalTrials.gov Identifier: NCT00809445     History of Changes
Other Study ID Numbers: 20080379, U10DA013720
Study First Received: December 16, 2008
Results First Received: August 28, 2014
Last Updated: September 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
HIV Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014