Rapid HIV Testing and Counseling in Drug Abuse Treatment

NCT ID: NCT00809445

Last Updated: 2015-10-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

On-site HIV rapid test and brief, prevention counseling

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

On- site HIV rapid test & information

Intervention Type BEHAVIORAL

Participants will be offered an on-site oral fluid HIV rapid test with basic info.

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.

Group Type ACTIVE_COMPARATOR

Referral for off-site HIV testing

Intervention Type BEHAVIORAL

Participants will be offered a referral list of HIV testing agencies in the community.

Interventions

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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.

Intervention Type BEHAVIORAL

On- site HIV rapid test & information

Participants will be offered an on-site oral fluid HIV rapid test with basic info.

Intervention Type BEHAVIORAL

Referral for off-site HIV testing

Participants will be offered a referral list of HIV testing agencies in the community.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Daniel J Feaster

Associate Professor of Biostatistics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Metsch, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Grant Colfax, M.D.

Role: PRINCIPAL_INVESTIGATOR

PATH

Locations

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La Frontera Center, Inc.

Tucson, Arizona, United States

Site Status

Midwestern Connecticut Council on Alcoholism

Danbury, Connecticut, United States

Site Status

Wheeler Clinic

Plainville, Connecticut, United States

Site Status

Glenwood Life Counseling Center

Baltimore, Maryland, United States

Site Status

Gibson Recover Centers

Cape Girardeau, Missouri, United States

Site Status

The Life Link

Santa Fe, New Mexico, United States

Site Status

Daymark Recovery Services, Inc.

Salisbury, North Carolina, United States

Site Status

CODA

Portland, Oregon, United States

Site Status

Addiction Medicine Services (Western Psychiatric Institute)

Pittsburgh, Pennsylvania, United States

Site Status

Morris Village Alcohol and Drug Treatment Center

Columbia, South Carolina, United States

Site Status

Lexington / Richland Alcohol and Drug Abuse Council

Columbia, South Carolina, United States

Site Status

Chesterfield CSB Substance Abuse Service

Chesterfield, Virginia, United States

Site Status

Countries

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United States

References

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Metsch LR, Feaster DJ, Gooden L, Matheson T, Mandler RN, Haynes L, Tross S, Kyle T, Gallup D, Kosinski AS, Douaihy A, Schackman BR, Das M, Lindblad R, Erickson S, Korthuis PT, Martino S, Sorensen JL, Szapocznik J, Walensky R, Branson B, Colfax GN. Implementing rapid HIV testing with or without risk-reduction counseling in drug treatment centers: results of a randomized trial. Am J Public Health. 2012 Jun;102(6):1160-7. doi: 10.2105/AJPH.2011.300460. Epub 2012 Apr 19.

Reference Type RESULT
PMID: 22515871 (View on PubMed)

Schackman BR, Metsch LR, Colfax GN, Leff JA, Wong A, Scott CA, Feaster DJ, Gooden L, Matheson T, Haynes LF, Paltiel AD, Walensky RP. The cost-effectiveness of rapid HIV testing in substance abuse treatment: results of a randomized trial. Drug Alcohol Depend. 2013 Feb 1;128(1-2):90-7. doi: 10.1016/j.drugalcdep.2012.08.009. Epub 2012 Sep 9.

Reference Type RESULT
PMID: 22971593 (View on PubMed)

Schackman BR, Leff JA, Barter DM, DiLorenzo MA, Feaster DJ, Metsch LR, Freedberg KA, Linas BP. Cost-effectiveness of rapid hepatitis C virus (HCV) testing and simultaneous rapid HCV and HIV testing in substance abuse treatment programs. Addiction. 2015 Jan;110(1):129-43. doi: 10.1111/add.12754.

Reference Type DERIVED
PMID: 25291977 (View on PubMed)

Other Identifiers

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U10DA013720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20080379

Identifier Type: -

Identifier Source: org_study_id

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