HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S. (Aware)

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ClinicalTrials.gov Identifier: NCT01154296

Recruitment Status : Completed

First Posted : June 30, 2010

Results First Posted : September 29, 2014

Last Update Posted : September 29, 2014

Sponsor:

Collaborators:

National Institute on Drug Abuse (NIDA)

University of Pittsburgh

University of California, San Francisco

Oregon Health and Science University

Medical University of South Carolina

Research Foundation for Mental Hygiene, Inc.

Duke University

The Emmes Company, LLC

San Francisco Department of Public Health

University of California

Weill Medical College of Cornell University

Information provided by (Responsible Party):

Lisa Metsch, Columbia University

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Screening
Conditions	HIV/AIDS Sexually Transmitted Infections
Intervention	Behavioral: RESPECT-2 Counseling
Enrollment	5012

Participant Flow

Recruitment Details	Individuals seeking services at 9 sexually transmitted disease (STD) clinics across the U.S. were recruited, screened and randomized between April 2010 - December 2010.
Pre-assignment Details	Study personnel made 14,948 approaches to STD clinic patients; some were approached multiple times. Of the 6,239 consenting to be screened, 5028 were eligible (80.6%); 16 of these were not randomized due to: decision to decline (n=3), not returning (n=11), not testing with HIV/STD battery (n=1) and not completing baseline activities (n=1).


Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description	Individuals who screen as eligible ...	Individuals who screen as eligible ...
Arm/Group Description	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Period Title: Randomization and Intervention
Started	2505	2507
Completed	2500	2505
Not Completed	5	2
Reason Not Completed
Decided to decline	1	1
Declined by staff	1	0
Did not return	1	0
Left before test	0	1
Left clinic early	2	0
Period Title: 6-month Follow-up
Started	2505	2507
Completed	2177	2179
Not Completed	328	328
Reason Not Completed
Lost contact	269	275
Incarcerated	37	32
Withdrew consent	14	15
Death	3	2
Declined by Study Coordinator	5	4

Baseline Characteristics

Arm/Group Title		Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)	Total
Arm/Group Description		Individuals who screen as eligible ...	Individuals who screen as eligible ...	Total of all reporting groups
Arm/Group Description		Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.	Total of all reporting groups
Overall Number of Baseline Participants		2505	2507	5012
Baseline Analysis Population Description		...
Baseline Analysis Population Description		6,239 patients approached provided consent to be screened. Of these, 5,028 were eligible (80.6%) and 5012 (99.5% of those eligible) were randomized; 16 screened eligible, but were not randomized due to: decision to decline (3), not returning (11), not testing with HIV/STD battery (1) and not completing baseline activities (1).
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	2505 participants	2507 participants	5012 participants
<25 years		1705	1727	3432
>=25 years		800	780	1580
Sex/Gender, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	2505 participants	2507 participants	5012 participants
Male sex		1655	1653	3308
Female sex		850	854	1704
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	2505 participants	2507 participants	5012 participants
Black		1045	1053	2098
Hispanic		382	385	767
White		798	794	1592
Other		280	275	555
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	2505 participants	2507 participants	5012 participants
United States		2505	2507	5012
Men who have sex with men (MSM), # ^[1] Measure Type: Number Unit of measure: Participants
	Number Analyzed	2505 participants	2507 participants	5012 participants
		689	711	1400
		[1] Measure Description: Men were classified as MSM if, at study intake, they reported any previous anal or oral sex with males or if on the baseline sexual risk behavior questions they reported having anal or oral sexwith another male at any time during the study. All men who did not meet the definition of MSM were classified as men who have sex with women.
Any STI, # Measure Type: Number Unit of measure: Participants
	Number Analyzed	2505 participants	2507 participants	5012 participants
		1049	1092	2141
Any STI excluding trichomoniasis, # Measure Type: Number Unit of measure: Participants
	Number Analyzed	2505 participants	2507 participants	5012 participants
		1016	1070	2086
Gonorrhea, # Measure Type: Number Unit of measure: Participants
	Number Analyzed	2505 participants	2507 participants	5012 participants
		137	145	282
Chlamydia, # Measure Type: Number Unit of measure: Participants
	Number Analyzed	2505 participants	2507 participants	5012 participants
		238	254	492
Trichomoniasis, # Measure Type: Number Unit of measure: Participants
	Number Analyzed	2505 participants	2507 participants	5012 participants
		126	119	245
Syphilis, # Measure Type: Number Unit of measure: Participants
	Number Analyzed	2505 participants	2507 participants	5012 participants
		28	35	63
HSV-2, # Measure Type: Number Unit of measure: Participants
	Number Analyzed	2505 participants	2507 participants	5012 participants
		758	793	1551
HIV, # Measure Type: Number Unit of measure: Participants
	Number Analyzed	2505 participants	2507 participants	5012 participants
		29	24	53
# of sex acts ^[1] Least Squares Mean (Standard Deviation) Unit of measure: Sex acts
	Number Analyzed	2505 participants	2507 participants	5012 participants
		34.6 (1.0809)	33.4 (1.0431)	34.0 (0.751)
		[1] Measure Description: Note that standard errors (not standard deviations) are presented below with the least squares means.
# of unprotected sex acts ^[1] Least Squares Mean (Standard Deviation) Unit of measure: Unprotected sex acts
	Number Analyzed	2505 participants	2507 participants	5012 participants
		23.9 (0.9578)	22.6 (0.9068)	23.3 (0.6594)
		[1] Measure Description: Note that standard errors (not standard deviations) are presented below with the least squares means.
# of partners ^[1] Least Squares Mean (Standard Deviation) Unit of measure: Partners
	Number Analyzed	2505 participants	2507 participants	5012 participants
		4.7 (0.1141)	4.6 (0.1135)	4.6 (0.08047)
		[1] Measure Description: Note that standard errors (not standard deviations) are presented below with the least squares means.
# of unprotected partners ^[1] Least Squares Mean (Standard Deviation) Unit of measure: Unprotected partners
	Number Analyzed	2505 participants	2507 participants	5012 participants
		2.1 (0.05812)	2.1 (0.05696)	2.1 (0.04069)
		[1] Measure Description: Note that standard errors (not standard deviations) are presented below with the least squares means.

Outcome Measures

1.Primary Outcome


Title	STI Incidence
Description	Composite STI incidence (Yes/No) at 6-month follow-up in which a perso...
Description	Composite STI incidence (Yes/No) at 6-month follow-up in which a person is considered positive for STIs if they are positive on any tested STI.
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description:	Individuals who screen as eligible ...	Individuals who screen as eligible ...
Arm/Group Description:	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed	2039	2032
Measure Type: Number Unit of Measure: participants
	250	226

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments	A total of 2039/2505 participants randomized to the counseling group and 2032/2507 to the information-only group had complete follow-up STI data. Cumulative STI incidence was 250/2039 (12.3%) in the counseling group and 226/2032 (11.1%) in the information-only group (aRR, 1.12; 95%CI, 0.94-1.33).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.
	Method	Mantel Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	adjusted risk ratio (aRR)
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95% 0.94 to 1.33
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Sexual Risk Behavior -- # of Sex Acts
Description	Self-reported continuous variables to determine number of (vaginal and...
Description	Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts.
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description:	Individuals who screen as eligible ...	Individuals who screen as eligible ...
Arm/Group Description:	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed	2505	2507
Least Squares Mean (Standard Error) Unit of Measure: sex acts
	28.6 (1.1312)	29.1 (1.1553)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments	Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Incidence rate ratio (IRR)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95% 0.90 to 1.09
	Estimation Comments	In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.

3.Secondary Outcome


Title	Sexual Risk Behavior -- # of Unprotected Sex Acts
Description	Self-reported continuous variables to determine number of unprotected ...
Description	Self-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description:	Individuals who screen as eligible ...	Individuals who screen as eligible ...
Arm/Group Description:	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed	2505	2507
Least Squares Mean (Standard Error) Unit of Measure: unprotected sex acts
	17.4 (0.9791)	18.3 (1.0381)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments	Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Incidence Rate Ratio (IRR)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95% 0.86 to 1.13
	Estimation Comments	In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.

4.Secondary Outcome


Title	Sexual Risk Behavior -- # of Partners
Description	Self-reported continuous variables to determine number of partners wit...
Description	Self-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex.
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description:	Individuals who screen as eligible ...	Individuals who screen as eligible ...
Arm/Group Description:	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed	2505	2507
Least Squares Mean (Standard Error) Unit of Measure: partners
	2.7 (0.07454)	3.0 (0.08386)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments	Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Incidence Rate Ratio (IRR)
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95% 0.82 to 0.94
	Estimation Comments	In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.

5.Secondary Outcome


Title	Sexual Risk Behavior -- # of Unprotected Partners
Description	Self-reported continuous variables to determine number of partners wit...
Description	Self-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex.
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description:	Individuals who screen as eligible ...	Individuals who screen as eligible ...
Arm/Group Description:	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed	2505	2507
Least Squares Mean (Standard Error) Unit of Measure: unprotected partners
	1.1 (0.03749)	1.1 (0.03845)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments	Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Incidence Rate Ratio (IRR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95% 0.90 to 1.05
	Estimation Comments	In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.

6.Secondary Outcome


Title	Sexual Risk Behavior -- # of Sex Acts With Substance Use
Description	Self-reported continuous variables to determine number of (vaginal and...
Description	Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts in which the participant reported using substances before the sex act.
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description:	Individuals who screen as eligible ...	Individuals who screen as eligible ...
Arm/Group Description:	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Overall Number of Participants Analyzed	952	952
Measure Type: Number Unit of Measure: sex acts with substance use
	115	106

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.
	Method	Mantel Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Adjusted Risk Ratio (aRR)
	Estimated Value	1.14
	Confidence Interval	95% 0.89 to 1.46
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Adverse events were captured post-randomization and were collected at each research visit. Other safety information is based on spontaneous reports and not specifically required by the study team.
Adverse Event Reporting Description	Only the following events were required for reporting as AEs: medical events that are directly related to the collection of the HIV and STI test samples (e.g. irritation at the testing site); additional AE were assessed based on report of untoward events that participant or investigator believes are a direct result of the study.

Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)		Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description	Individuals who screen as eligible ...		Individuals who screen as eligible ...
Arm/Group Description	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.		Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
All-Cause Mortality
	Rapid HIV Testing w/ Counseling (Group 1)		Rapid HIV Testing & Information Only (Group 2)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Rapid HIV Testing w/ Counseling (Group 1)		Rapid HIV Testing & Information Only (Group 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/2505 (0.12%)		2/2507 (0.08%)
Cardiac disorders
Heart failure ^* 1	0/2505 (0.00%)	0	1/2507 (0.04%)	1
General disorders
Death, cause unknown ^* 1 [1]	1/2505 (0.04%)	1	0/2507 (0.00%)	0
victim of homicide, secondary to robbery ^* 1 [2]	1/2505 (0.04%)	1	0/2507 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer ^* 1	1/2505 (0.04%)	1	0/2507 (0.00%)	0
Metastatic colon cancer ^* 1	0/2505 (0.00%)	0	1/2507 (0.04%)	1
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA (Unspecified) [1] "General disorders" selected as default; cause of death is unknown [2] "General disorders" selected as default; cause is homicide
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Rapid HIV Testing w/ Counseling (Group 1)		Rapid HIV Testing & Information Only (Group 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2505 (0.00%)		0/2507 (0.00%)

Limitations and 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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Lisa Metsch, PhD, Stephen Smith Professor and Chair of Sociomedical Sciences
Organization:	Department of Sociomedical Sciences/Mailman School of Public Health/Columbia University
Phone:	212-305-3577
EMail:	lm2892@columbia.edu

Publications of Results:

Metsch LR, Feaster DJ, Gooden L, Schackman BR, Matheson T, Das M, Golden MR, Huffaker S, Haynes LF, Tross S, Malotte CK, Douaihy A, Korthuis PT, Duffus WA, Henn S, Bolan R, Philip SS, Castro JG, Castellon PC, McLaughlin G, Mandler RN, Branson B, Colfax GN. Effect of risk-reduction counseling with rapid HIV testing on risk of acquiring sexually transmitted infections: the AWARE randomized clinical trial. JAMA. 2013 Oct 23;310(16):1701-10. doi: 10.1001/jama.2013.280034.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Alcaide ML, Feaster DJ, Duan R, Cohen S, Diaz C, Castro JG, Golden MR, Henn S, Colfax GN, Metsch LR. The incidence of Trichomonas vaginalis infection in women attending nine sexually transmitted diseases clinics in the USA. Sex Transm Infect. 2016 Feb;92(1):58-62. doi: 10.1136/sextrans-2015-052010. Epub 2015 Jun 12.

Layout table for additonal information

Responsible Party:	Lisa Metsch, Columbia University
ClinicalTrials.gov Identifier:	NCT01154296
Other Study ID Numbers:	AAAK3153 1RC2DA028973-01 ( U.S. NIH Grant/Contract )
First Submitted:	June 29, 2010
First Posted:	June 30, 2010
Results First Submitted:	July 29, 2014
Results First Posted:	September 29, 2014
Last Update Posted:	September 29, 2014

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