Rapid HIV Testing and Counseling in Drug Abuse Treatment

Substance-Related Disorders Clinical Trial

Official title:

HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809445
• Other study ID #: 20080379
• Secondary ID: U10DA013720
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2008
• Last updated: October 13, 2015
• Start date: January 2009
• Est. completion date: February 2010

Study information

• Verified date: September 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1281
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

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.
• On- site HIV rapid test & information
Participants will be offered an on-site oral fluid HIV rapid test with basic info.
• Referral for off-site HIV testing
Participants will be offered a referral list of HIV testing agencies in the community.

Locations

Country	Name	City	State
United States	Glenwood Life Counseling Center	Baltimore	Maryland
United States	Gibson Recover Centers	Cape Girardeau	Missouri
United States	Chesterfield CSB Substance Abuse Service	Chesterfield	Virginia
United States	Lexington / Richland Alcohol and Drug Abuse Council	Columbia	South Carolina
United States	Morris Village Alcohol and Drug Treatment Center	Columbia	South Carolina
United States	Midwestern Connecticut Council on Alcoholism	Danbury	Connecticut
United States	Addiction Medicine Services (Western Psychiatric Institute)	Pittsburgh	Pennsylvania
United States	Wheeler Clinic	Plainville	Connecticut
United States	CODA	Portland	Oregon
United States	Daymark Recovery Services, Inc.	Salisbury	North Carolina
United States	The Life Link	Santa Fe	New Mexico
United States	La Frontera Center, Inc.	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	National Institute on Drug Abuse (NIDA), University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Impleme — View Citation

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 Depe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Sharing of Needles Used in Drug Use	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.	Six months	No
Secondary	Self-Report of Ever Having Been Tested	The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.	1 month post-randomization	No