Rapid HIV Testing and Counseling in Drug Abuse Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00809445|
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : September 17, 2014
Last Update Posted : October 14, 2015
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||1281 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||February 2010|
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.
- Self-Report Receipt of HIV Test Results [ Time Frame: One month post-randomization ]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 ]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).
- Sharing of Needles Used in Drug Use [ Time Frame: Six months ]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 ]The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809445
|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|
|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|
|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.||Columbia University|
|Principal Investigator:||Grant Colfax, M.D.||PATH|