Substance-Related DisordersPhase 3NCT00809445

Rapid HIV Testing and Counseling in Drug Abuse Treatment

A Phase 3 study testing On-site HIV rapid test and brief, prevention counseling, On- site HIV rapid test & information and Referral for off-site HIV testing in people with Substance-Related Disorders, run by University of Miami at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Substance-Related Disorders
What is being tested?: On-site HIV rapid test and brief, prevention counseling, On- site HIV rapid test & information and Referral for off-site HIV testing
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,281 participants
Where: 12 sitesUnited States
Study dates: Jan 2009to Feb 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Glenwood Life Counseling Center
Baltimore, Maryland, 21212
Gibson Recover Centers
Cape Girardeau, Missouri, 63703
Chesterfield CSB Substance Abuse Service
Chesterfield, Virginia, 23832
Morris Village Alcohol and Drug Treatment Center
Columbia, South Carolina, 29203
Lexington / Richland Alcohol and Drug Abuse Council
Columbia, South Carolina, 29250
Midwestern Connecticut Council on Alcoholism
Danbury, Connecticut, 06818
Addiction Medicine Services (Western Psychiatric Institute)
Pittsburgh, Pennsylvania, 15213
Wheeler Clinic
Plainville, Connecticut, 06062
CODA
Portland, Oregon, 97214
Daymark Recovery Services, Inc.
Salisbury, North Carolina, 28146
The Life Link
Santa Fe, New Mexico, 87505
La Frontera Center, Inc.
Tucson, Arizona, 85713

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Substance-Related Disorders
Being tested: On-site HIV rapid test and brief, prevention counseling, On- site HIV rapid test & information, Referral for off-site HIV testing
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

On-site HIV rapid test and brief, prevention counselingBehavioural
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 & informationBehavioural
Participants will be offered an on-site oral fluid HIV rapid test with basic info.
Referral for off-site HIV testingBehavioural
Participants will be offered a referral list of HIV testing agencies in the community.

Study groups in NCT00809445
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Behavioral: Referral for off-site HIV testing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: Six months post-randomization

Secondary outcomes (2)

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.
Measured: Six months
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.
Measured: 1 month post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Feb 2010

First posted17 Dec 2008 (estimated)
Study startJan 2009
Primary completionDec 2009
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,281 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00809445
Sponsor's protocol ID: 20080379
Other IDs: U10DA013720
Status last verified: Sep 2014
First submitted: 16 Dec 2008
Last updated: 14 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 22515871
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.
PubMed 22971593
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.
PubMed 25291977

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.
ClinicalTrials.gov ID: NCT00809445
Acronym / sponsor ID: 20080379
Conditions: Substance-Related Disorders
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,281 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), University of California, San Francisco
Study start: Jan 2009
Primary completion: Dec 2009 (actual)
Study completion: Feb 2010 (actual)
First posted: 17 Dec 2008 (estimated)
Results: Posted 17 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
HIV rapid test & counseling	Experimental	Behavioral: On-site HIV rapid test and brief, prevention counselingParticipants 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.
HIV rapid test and info	Experimental	Behavioral: On- site HIV rapid test & informationParticipants 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.
HIV testing referral	Active comparator	Behavioral: Referral for off-site HIV testingParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
On-site HIV rapid test and brief, prevention counselingParticipants 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.	Behavioural	HIV rapid test & counseling
On- site HIV rapid test & informationParticipants will be offered an on-site oral fluid HIV rapid test with basic info.	Behavioural	HIV rapid test and info
Referral for off-site HIV testingParticipants will be offered a referral list of HIV testing agencies in the community.	Behavioural	HIV testing referral

Primary outcome

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).

2 secondary outcomes

Sharing of Needles Used in Drug Use
Time frame: Six months
Self-Report of Ever Having Been Tested
Time frame: 1 month post-randomization

Results and safety

Results posted to the registry on 17 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HIV Testing Referral	429	427
HIV Rapid Test & Counseling	433	429
HIV Rapid Test and Info	419	415

Primary outcome: Self-Report Receipt of HIV Test Results

Time frame: One month post-randomization. Number. Unit: participants

Measure	HIV Testing Referral n = 424	HIV Rapid Test & Counseling n = 424	HIV Rapid Test and Info n = 409
Value	78	338	347

HIV Testing Referral vs HIV Rapid Test & Counseling vs HIV Rapid Test and Info: Risk Ratio (RR): 4.52 (97.5% CI 3.57 to 5.72), p <0.001, Cochran-Mantel-Haenszel

Population analysed: All randomized participants who provided self-report of either receipt or non-receipt of testing results at one month follow-up are included. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively

Primary outcome: Number of Risky Sexual Behaviors

Time frame: Six months post-randomization. Mean (Standard Deviation). Unit: number of unprotected sex acts

Measure	HIV Testing Referral n = 387	HIV Rapid Test & Counseling n = 385	HIV Rapid Test and Info n = 371
Value	20.5 (49.8)	21.3 (47.6)	21.3 (44.8)

HIV Testing Referral vs HIV Rapid Test & Counseling vs HIV Rapid Test and Info: incidence rate raios (IRR): 1.04 (97.5% CI 0.95 to 1.14), p = 0.39, generalized estimating equations (GEE)
HIV Rapid Test & Counseling vs HIV Rapid Test and Info: Incidence rate ratio (IRR): 1.03 (97.5% CI 0.84 to 1.26), p = 0.81, Generalized estimating equations (GEE)

Population analysed: All randomized participants who provided self-report of number of unprotected sex acts (vaginal or anal sex without a condom) at six-month follow-up are included.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE will be reported within 7 days of the site becoming aware of the event. 24 hr expedited reporting is required for reportable serious adverse events. Lead investigators and the NIDA assigned Safety Monitor will be notified within 24 hours.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV Testing Referral	2 of 429 (0.5%)	0 of 429 (0%)	Not reported
HIV Rapid Test & Counseling	2 of 433 (0.5%)	0 of 433 (0%)	Not reported
HIV Rapid Test and Info	2 of 419 (0.5%)	0 of 419 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22515871Metsch 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.
Results publication: PubMed 22971593Schackman 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.
Derived from this study: PubMed 25291977Schackman 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa Metsch, Ph.D. principal investigator

Columbia University

Grant Colfax, M.D. principal investigator

PATH

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Report Receipt of HIV Test Results (time frame: One month post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00809445, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.