Rapid HIV Testing and Counseling in Drug Abuse Treatment

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT00809445
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), University of California, San Francisco (Other)
• Enrollment: 1,281
• Locations: 12
• Arms: 3
• Duration (Months): 13
• Patients Per Site: 106.8
• Patients Per Site Per Month: 8.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1281 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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 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; Participants will be offered an on-site oral fluid HIV rapid test with basic info.
Active Comparator: 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.	Behavioral: Referral for off-site HIV testing; Participants will be offered a referral list of HIV testing agencies in the community.

Outcome Measures

Primary Outcome Measures

1. Self-Report Receipt of HIV Test Results [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.

2. Number of Risky Sexual Behaviors [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).

Secondary Outcome Measures

1. Sharing of Needles Used in Drug Use [Six months]

   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.

2. Self-Report of Ever Having Been Tested [1 month post-randomization]

   The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

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

Sponsors and Collaborators

• University of Miami
• National Institute on Drug Abuse (NIDA)
• University of California, San Francisco

Investigators

• Principal Investigator: Lisa Metsch, Ph.D., Columbia University
• Principal Investigator: Grant Colfax, M.D., PATH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel J Feaster, Associate Professor of Biostatistics, University of Miami
• ClinicalTrials.gov Identifier: NCT00809445
• Other Study ID Numbers: 20080379; U10DA013720
• First Posted: Dec 17, 2008
• Last Update Posted: Oct 14, 2015
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

Participant Flow

Recruitment Details	Adults receiving drug abuse treatment in drug treatment clinics were recruited, screened for eligibility, and randomized from Jan - May 2009 into 1 of 3 arms: 1) on-site HIV rapid testing with counseling; 2) on-site HIV rapid testing with information only; and 3) referral for off-site HIV testing. Participants were then followed at 1 and 6 months.
Pre-assignment Detail	2473 patients were assessed for eligibility. Of these, 1313 were eligible and 1281 were randomized; 32 screened eligible, but were not randomized due to: failure to return to the study (n=30), lying about HIV status (n=1) and completing the baseline after the enrollment period closed (n=1).

Arm/Group Title	HIV Testing Referral	HIV Rapid Test & Counseling	HIV Rapid Test and Info
Arm/Group Description	Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.	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.
Period Title: 1 Month Follow-up
STARTED	429	433	419
COMPLETED	427	429	415
NOT COMPLETED	2	4	4
Period Title: 1 Month Follow-up
STARTED	429	433	419
COMPLETED	405	410	395
NOT COMPLETED	24	23	24

Baseline Characteristics

Arm/Group Title	HIV Testing Referral	HIV Rapid Test & Counseling	HIV Rapid Test and Info	Total
Arm/Group Description	Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.	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.	Total of all reporting groups
Overall Participants	429	433	419	1281
Age (Count of Participants)
<=18 years	1 0.2%	0 0%	1 0.2%	2 0.2%
Between 18 and 65 years	425 99.1%	429 99.1%	415 99%	1269 99.1%
>=65 years	3 0.7%	4 0.9%	3 0.7%	10 0.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.81 (10.76)	39.62 (11.19)	39.56 (11.77)	40.00 (11.35)
Sex: Female, Male (Count of Participants)
Female	173 40.3%	170 39.3%	160 38.2%	503 39.3%
Male	256 59.7%	263 60.7%	259 61.8%	778 60.7%
Race/Ethnicity, Customized (participants) [Number]
Black or African American	89 20.7%	88 20.3%	86 20.5%	263 20.5%
White	278 64.8%	277 64%	271 64.7%	826 64.5%
American Indian/Alaskan Native	9 2.1%	13 3%	11 2.6%	33 2.6%
Mixed race	34 7.9%	34 7.9%	30 7.2%	98 7.7%
Other	19 4.4%	21 4.8%	21 5%	61 4.8%
Hispanic	51 11.9%	49 11.3%	47 11.2%	147 11.5%
Region of Enrollment (participants) [Number]
United States	429 100%	433 100%	419 100%	1281 100%

Outcome Measures

1. Primary Outcome

Title	Self-Report Receipt of HIV Test Results
Description	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.
Time Frame	One month post-randomization

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HIV Testing Referral	HIV Rapid Test & Counseling	HIV Rapid Test and Info
Arm/Group Description	Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.	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.
Measure Participants	424	424	409
Number [participants]	78 18.2%	338 78.1%	347 82.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HIV Testing Referral, HIV Rapid Test & Counseling, HIV Rapid Test and Info
	Comments	Hypothesis: The HIV rapid testing arms would have a higher rate of HIV testing than the HIV testing referral arm. Thus there is one comparison: HIV rapid test & counseling+HIV rapid test and info versus HIV testing referral.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	a-prior threshold for statistical significance is .025
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	4.52
	Confidence Interval	(2-Sided) 97.5%; 3.57 to 5.72
	Parameter Dispersion	Type: Value:
	Estimation Comments	The numerator is the two HIV rapid testing arms The denominator is the HIV testing referral arm

2. Primary Outcome

Title	Number of Risky Sexual Behaviors
Description	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).
Time Frame	Six months post-randomization

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	HIV Testing Referral	HIV Rapid Test & Counseling	HIV Rapid Test and Info
Arm/Group Description	Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.	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.
Measure Participants	387	385	371
Mean (Standard Deviation) [number of unprotected sex acts]	20.5 (49.8)	21.3 (47.6)	21.3 (44.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HIV Testing Referral, HIV Rapid Test & Counseling, HIV Rapid Test and Info
	Comments	Hypothesis: The HIV rapid testing arms would have a lower rate of unprotected sexual episodes than the HIV testing referral arm. Thus there is one comparison: HIV rapid test & counseling+HIV rapid test and info versus HIV testing referral.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.39
	Comments	a-priori threshold for statistical significance is .025
	Method	generalized estimating equations (GEE)
	Comments
Method of Estimation	Estimation Parameter	incidence rate raios (IRR)
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 97.5%; 0.95 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	Numerator includes the two HIV rapid testing groups Denominator is the HIV testing referral group

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	HIV Rapid Test & Counseling, HIV Rapid Test and Info
	Comments	The data analysis information presented is for the comparison of the 2 on-site testing groups. Hypothesis: HIV rapid test and counseling group will have fewer unprotected sexual acts than will HIV rapid test and info group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.81
	Comments	a-priori threshold for statistical significance is .025
	Method	Generalized estimating equations (GEE)
	Comments
Method of Estimation	Estimation Parameter	Incidence rate ratio (IRR)
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 97.5%; 0.84 to 1.26
	Parameter Dispersion	Type: Value:
	Estimation Comments	Numerator is the HIV rapid test and counseling arm Denominator is the HIV rapid test and info arm

3. Secondary Outcome

Title	Sharing of Needles Used in Drug Use
Description	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.
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HIV Testing Referral	HIV Rapid Test & Counseling	HIV Rapid Test and Info
Arm/Group Description	Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.	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.
Measure Participants	401	402	385
Number discontinuing sharing	17	32	24
Number initiating sharing	2	1	6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HIV Testing Referral, HIV Rapid Test & Counseling, HIV Rapid Test and Info
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.044
	Comments	a priori threshold for significance was .05
	Method	Chi-squared
	Comments	Note that this is a 3 by 3 chi-square: the 3 conditions by discontinued sharing needles /no change in sharing needles/initiated sharing needles

4. Secondary Outcome

Title	Self-Report of Ever Having Been Tested
Description	The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.
Time Frame	1 month post-randomization

Outcome Measure Data

Analysis Population Description

Number reporting having taken an HIV test, whether they received results or not, at one month follow-up. 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

Arm/Group Title	HIV Testing Referral	HIV Rapid Test & Counseling	HIV Rapid Test and Info
Arm/Group Description	Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.	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.
Measure Participants	424	424	409
Number [participants]	103 24%	344 79.4%	352 84%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HIV Testing Referral, HIV Rapid Test & Counseling, HIV Rapid Test and Info
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	a-priori threshold for statistical significance is .05
	Method	Chi-squared
	Comments	chi-square = 428.2466, Df=2

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.
Adverse Event Reporting Description	Research staff will use a standard checklist to document adverse events at each research visit following randomization. This information will be collected and documented in the study database via CRF.
Arm/Group Title	HIV Testing Referral		HIV Rapid Test & Counseling		HIV Rapid Test and Info
Arm/Group Description	Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.		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.
All Cause Mortality
	HIV Testing Referral		HIV Rapid Test & Counseling		HIV Rapid Test and Info
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	HIV Testing Referral		HIV Rapid Test & Counseling		HIV Rapid Test and Info
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/429 (0.5%)		2/433 (0.5%)		2/419 (0.5%)
Cardiac disorders
Myocardial infarction	1/429 (0.2%)	1	1/433 (0.2%)	1	0/419 (0%)	0
General disorders
Overdose	0/429 (0%)	0	0/433 (0%)	0	2/419 (0.5%)	2
Death	0/429 (0%)	0	1/433 (0.2%)	1	0/419 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm	2/429 (0.5%)	2	0/433 (0%)	0	0/419 (0%)	0
Other (Not Including Serious) Adverse Events
	HIV Testing Referral		HIV Rapid Test & Counseling		HIV Rapid Test and Info
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/429 (0%)		0/433 (0%)		0/419 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.