NCT00809445

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,281

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

September 17, 2014

Completed
Last Updated

October 14, 2015

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

December 16, 2008

Results QC Date

August 28, 2014

Last Update Submit

October 13, 2015

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (2)

  • Self-Report Receipt of HIV Test Results

    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.

    One month post-randomization

  • Number of Risky Sexual Behaviors

    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).

    Six months post-randomization

Secondary Outcomes (2)

  • Sharing of Needles Used in Drug Use

    Six months

  • Self-Report of Ever Having Been Tested

    1 month post-randomization

Study Arms (3)

HIV rapid test & counseling

EXPERIMENTAL

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

HIV rapid test and info

EXPERIMENTAL

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

HIV testing referral

ACTIVE COMPARATOR

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

Interventions

On-site HIV rapid test and brief, prevention counselingBEHAVIORAL

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 & counseling
On- site HIV rapid test & informationBEHAVIORAL

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

HIV rapid test and info
Referral for off-site HIV testingBEHAVIORAL

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

HIV testing referral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

La Frontera Center, Inc.

Tucson, Arizona, 85713, United States

Location

Midwestern Connecticut Council on Alcoholism

Danbury, Connecticut, 06818, United States

Location

Wheeler Clinic

Plainville, Connecticut, 06062, United States

Location

Glenwood Life Counseling Center

Baltimore, Maryland, 21212, United States

Location

Gibson Recover Centers

Cape Girardeau, Missouri, 63703, United States

Location

The Life Link

Santa Fe, New Mexico, 87505, United States

Location

Daymark Recovery Services, Inc.

Salisbury, North Carolina, 28146, United States

Location

CODA

Portland, Oregon, 97214, United States

Location

Addiction Medicine Services (Western Psychiatric Institute)

Pittsburgh, Pennsylvania, 15213, United States

Location

Morris Village Alcohol and Drug Treatment Center

Columbia, South Carolina, 29203, United States

Location

Lexington / Richland Alcohol and Drug Abuse Council

Columbia, South Carolina, 29250, United States

Location

Chesterfield CSB Substance Abuse Service

Chesterfield, Virginia, 23832, United States

Location

Related Publications (3)

  • 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.

    PMID: 22515871RESULT

  • 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.

    PMID: 22971593RESULT

  • 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.

    PMID: 25291977DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Results Point of Contact

Title
Dr. Lisa Metsch
Organization
Columbia University, Mailman School of Public Health
lm2892@columbia.edu
212-305-3577

Study Officials

  • Lisa Metsch, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Grant Colfax, M.D.

    PATH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Biostatistics

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 17, 2008

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

October 14, 2015

Results First Posted

September 17, 2014

Record last verified: 2014-09

Locations

US(12)