Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
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 Corporation
San Francisco Department of Public Health
University of California
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Lisa Metsch, Columbia University
ClinicalTrials.gov Identifier:
NCT01154296
First received: June 29, 2010
Last updated: September 23, 2014
Last verified: September 2014
Results First Received: July 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Screening
Conditions: HIV/AIDS
Sexually Transmitted Infections
Intervention: Behavioral: RESPECT-2 Counseling

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Rapid HIV Testing w/ Counseling (Group 1)

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.

Rapid HIV Testing & Information Only (Group 2) 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.

Participant Flow for 2 periods

Period 1:   Randomization and Intervention
    Rapid HIV Testing w/ Counseling (Group 1)   Rapid HIV Testing & Information Only (Group 2)
STARTED   2505   2507 
COMPLETED   2500   2505 
NOT COMPLETED   5   2 
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 2:   6-month Follow-up
    Rapid HIV Testing w/ Counseling (Group 1)   Rapid HIV Testing & Information Only (Group 2)
STARTED   2505   2507 
COMPLETED   2177   2179 
NOT COMPLETED   328   328 
Lost contact                269                275 
Incarcerated                37                32 
Withdrew consent                14                15 
Death                3                2 
Declined by Study Coordinator                5                4 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Rapid HIV Testing w/ Counseling (Group 1)

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.

Rapid HIV Testing & Information Only (Group 2) 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 Total of all reporting groups

Baseline Measures
   Rapid HIV Testing w/ Counseling (Group 1)   Rapid HIV Testing & Information Only (Group 2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 2505   2507   5012 
Age, Customized 
[Units: Participants]
     
<25 years   1705   1727   3432 
>=25 years   800   780   1580 
Gender, Customized 
[Units: Participants]
     
Male sex   1655   1653   3308 
Female sex   850   854   1704 
Race/Ethnicity, Customized 
[Units: Participants]
     
Black   1045   1053   2098 
Hispanic   382   385   767 
White   798   794   1592 
Other   280   275   555 
Region of Enrollment 
[Units: Participants]
     
United States   2505   2507   5012 
Men who have sex with men (MSM), # [1] 
[Units: Participants]
 689   711   1400 
[1] 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, # 
[Units: Participants]
 1049   1092   2141 
Any STI excluding trichomoniasis, # 
[Units: Participants]
 1016   1070   2086 
Gonorrhea, # 
[Units: Participants]
 137   145   282 
Chlamydia, # 
[Units: Participants]
 238   254   492 
Trichomoniasis, # 
[Units: Participants]
 126   119   245 
Syphilis, # 
[Units: Participants]
 28   35   63 
HSV-2, # 
[Units: Participants]
 758   793   1551 
HIV, # 
[Units: Participants]
 29   24   53 
# of sex acts [1] 
[Units: Sex acts]
Least Squares Mean (Standard Deviation)
 34.6  (1.0809)   33.4  (1.0431)   34.0  (0.751) 
[1] Note that standard errors (not standard deviations) are presented below with the least squares means.
# of unprotected sex acts [1] 
[Units: Unprotected sex acts]
Least Squares Mean (Standard Deviation)
 23.9  (0.9578)   22.6  (0.9068)   23.3  (0.6594) 
[1] Note that standard errors (not standard deviations) are presented below with the least squares means.
# of partners [1] 
[Units: Partners]
Least Squares Mean (Standard Deviation)
 4.7  (0.1141)   4.6  (0.1135)   4.6  (0.08047) 
[1] Note that standard errors (not standard deviations) are presented below with the least squares means.
# of unprotected partners [1] 
[Units: Unprotected partners]
Least Squares Mean (Standard Deviation)
 2.1  (0.05812)   2.1  (0.05696)   2.1  (0.04069) 
[1] Note that standard errors (not standard deviations) are presented below with the least squares means.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   STI Incidence   [ Time Frame: 6 months post randomization ]

2.  Secondary:   Sexual Risk Behavior -- # of Sex Acts   [ Time Frame: 6 months post randomization ]

3.  Secondary:   Sexual Risk Behavior -- # of Unprotected Sex Acts   [ Time Frame: 6 months post randomization ]

4.  Secondary:   Sexual Risk Behavior -- # of Partners   [ Time Frame: 6 months post randomization ]

5.  Secondary:   Sexual Risk Behavior -- # of Unprotected Partners   [ Time Frame: 6 months post randomization ]

6.  Secondary:   Sexual Risk Behavior -- # of Sex Acts With Substance Use   [ Time Frame: 6 months post randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide 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:  
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
e-mail: lm2892@columbia.edu


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

Responsible Party: Lisa Metsch, Columbia University
ClinicalTrials.gov Identifier: NCT01154296     History of Changes
Other Study ID Numbers: AAAK3153
1RC2DA028973-01 ( US NIH Grant/Contract Award Number )
Study First Received: June 29, 2010
Results First Received: July 29, 2014
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board