Rapid HIV Testing and Counseling
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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. |
- Receipt of HIV test results [ Time Frame: One month post-randomization ] [ Designated as safety issue: No ]
- Number of risky sexual behaviors [ Time Frame: Six months post-randomization ] [ Designated as safety issue: No ]
- Use of injection drugs [ Time Frame: Six months ] [ Designated as safety issue: No ]
| Enrollment: | 1281 |
| Study Start Date: | January 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: HIV rapid test & counseling |
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 |
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 |
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 |
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| 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 | |
| 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. | University of Miami |
| Principal Investigator: | Grant Colfax, M.D. | City/County of San Francisco Public Health Department |
More Information
No publications provided
| Responsible Party: | Lisa R Metsch, Professor, University of Miami |
| ClinicalTrials.gov Identifier: | NCT00809445 History of Changes |
| Other Study ID Numbers: | NIDA-CTN-0032, U10DA013720 |
| Study First Received: | December 16, 2008 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders HIV Antibodies |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013