Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
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  
Number of Participants  
[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  
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 [2]
[units: sex acts]
Least Squares Mean ± Standard Deviation
  34.6  ± 1.0809     33.4  ± 1.0431     34.0  ± 0.751  
# of unprotected sex acts [2]
[units: unprotected sex acts]
Least Squares Mean ± Standard Deviation
  23.9  ± 0.9578     22.6  ± 0.9068     23.3  ± 0.6594  
# of partners [2]
[units: partners]
Least Squares Mean ± Standard Deviation
  4.7  ± 0.1141     4.6  ± 0.1135     4.6  ± 0.08047  
# of unprotected partners [2]
[units: unprotected partners]
Least Squares Mean ± Standard Deviation
  2.1  ± 0.05812     2.1  ± 0.05696     2.1  ± 0.04069  
[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.
[2] 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:

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