Trial Outcomes & Findings for HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S. (NCT NCT01154296)
NCT ID: NCT01154296
Last Updated: 2014-09-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5012 participants
Primary outcome timeframe
6 months post randomization
Results posted on
2014-09-29
Participant Flow
Individuals seeking services at 9 sexually transmitted disease (STD) clinics across the U.S. were recruited, screened and randomized between April 2010 - December 2010.
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).
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Randomization and Intervention
STARTED
|
2505
|
2507
|
|
Randomization and Intervention
COMPLETED
|
2500
|
2505
|
|
Randomization and Intervention
NOT COMPLETED
|
5
|
2
|
|
6-month Follow-up
STARTED
|
2505
|
2507
|
|
6-month Follow-up
COMPLETED
|
2177
|
2179
|
|
6-month Follow-up
NOT COMPLETED
|
328
|
328
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Randomization and Intervention
Decided to decline
|
1
|
1
|
|
Randomization and Intervention
Declined by staff
|
1
|
0
|
|
Randomization and Intervention
Did not return
|
1
|
0
|
|
Randomization and Intervention
Left before test
|
0
|
1
|
|
Randomization and Intervention
Left clinic early
|
2
|
0
|
|
6-month Follow-up
Lost contact
|
269
|
275
|
|
6-month Follow-up
Incarcerated
|
37
|
32
|
|
6-month Follow-up
Withdrew consent
|
14
|
15
|
|
6-month Follow-up
Death
|
3
|
2
|
|
6-month Follow-up
Declined by Study Coordinator
|
5
|
4
|
Baseline Characteristics
HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.
Baseline characteristics by cohort
| Measure |
Rapid HIV Testing w/ Counseling (Group 1)
n=2505 Participants
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)
n=2507 Participants
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
n=5012 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<25 years
|
1705 participants
n=99 Participants
|
1727 participants
n=107 Participants
|
3432 participants
n=206 Participants
|
|
Age, Customized
>=25 years
|
800 participants
n=99 Participants
|
780 participants
n=107 Participants
|
1580 participants
n=206 Participants
|
|
Sex/Gender, Customized
Male sex
|
1655 participants
n=99 Participants
|
1653 participants
n=107 Participants
|
3308 participants
n=206 Participants
|
|
Sex/Gender, Customized
Female sex
|
850 participants
n=99 Participants
|
854 participants
n=107 Participants
|
1704 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
1045 participants
n=99 Participants
|
1053 participants
n=107 Participants
|
2098 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
382 participants
n=99 Participants
|
385 participants
n=107 Participants
|
767 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
798 participants
n=99 Participants
|
794 participants
n=107 Participants
|
1592 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
280 participants
n=99 Participants
|
275 participants
n=107 Participants
|
555 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2505 participants
n=99 Participants
|
2507 participants
n=107 Participants
|
5012 participants
n=206 Participants
|
|
Men who have sex with men (MSM), #
|
689 participants
n=99 Participants
|
711 participants
n=107 Participants
|
1400 participants
n=206 Participants
|
|
Any STI, #
|
1049 participants
n=99 Participants
|
1092 participants
n=107 Participants
|
2141 participants
n=206 Participants
|
|
Any STI excluding trichomoniasis, #
|
1016 participants
n=99 Participants
|
1070 participants
n=107 Participants
|
2086 participants
n=206 Participants
|
|
Gonorrhea, #
|
137 participants
n=99 Participants
|
145 participants
n=107 Participants
|
282 participants
n=206 Participants
|
|
Chlamydia, #
|
238 participants
n=99 Participants
|
254 participants
n=107 Participants
|
492 participants
n=206 Participants
|
|
Trichomoniasis, #
|
126 participants
n=99 Participants
|
119 participants
n=107 Participants
|
245 participants
n=206 Participants
|
|
Syphilis, #
|
28 participants
n=99 Participants
|
35 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
HSV-2, #
|
758 participants
n=99 Participants
|
793 participants
n=107 Participants
|
1551 participants
n=206 Participants
|
|
HIV, #
|
29 participants
n=99 Participants
|
24 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
# of sex acts
|
34.6 sex acts
STANDARD_DEVIATION 1.0809 • n=99 Participants
|
33.4 sex acts
STANDARD_DEVIATION 1.0431 • n=107 Participants
|
34.0 sex acts
STANDARD_DEVIATION 0.751 • n=206 Participants
|
|
# of unprotected sex acts
|
23.9 unprotected sex acts
STANDARD_DEVIATION 0.9578 • n=99 Participants
|
22.6 unprotected sex acts
STANDARD_DEVIATION 0.9068 • n=107 Participants
|
23.3 unprotected sex acts
STANDARD_DEVIATION 0.6594 • n=206 Participants
|
|
# of partners
|
4.7 partners
STANDARD_DEVIATION 0.1141 • n=99 Participants
|
4.6 partners
STANDARD_DEVIATION 0.1135 • n=107 Participants
|
4.6 partners
STANDARD_DEVIATION 0.08047 • n=206 Participants
|
|
# of unprotected partners
|
2.1 unprotected partners
STANDARD_DEVIATION 0.05812 • n=99 Participants
|
2.1 unprotected partners
STANDARD_DEVIATION 0.05696 • n=107 Participants
|
2.1 unprotected partners
STANDARD_DEVIATION 0.04069 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months post randomizationComposite 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.
Outcome measures
| Measure |
Rapid HIV Testing w/ Counseling (Group 1)
n=2039 Participants
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)
n=2032 Participants
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.
|
|---|---|---|
|
STI Incidence
|
250 participants
|
226 participants
|
SECONDARY outcome
Timeframe: 6 months post randomizationSelf-reported continuous variables to determine number of (vaginal and/or anal) sex acts.
Outcome measures
| Measure |
Rapid HIV Testing w/ Counseling (Group 1)
n=2505 Participants
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)
n=2507 Participants
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.
|
|---|---|---|
|
Sexual Risk Behavior -- # of Sex Acts
|
28.6 sex acts
Standard Error 1.1312
|
29.1 sex acts
Standard Error 1.1553
|
SECONDARY outcome
Timeframe: 6 months post randomizationSelf-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts
Outcome measures
| Measure |
Rapid HIV Testing w/ Counseling (Group 1)
n=2505 Participants
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)
n=2507 Participants
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.
|
|---|---|---|
|
Sexual Risk Behavior -- # of Unprotected Sex Acts
|
17.4 unprotected sex acts
Standard Error 0.9791
|
18.3 unprotected sex acts
Standard Error 1.0381
|
SECONDARY outcome
Timeframe: 6 months post randomizationSelf-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex.
Outcome measures
| Measure |
Rapid HIV Testing w/ Counseling (Group 1)
n=2505 Participants
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)
n=2507 Participants
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.
|
|---|---|---|
|
Sexual Risk Behavior -- # of Partners
|
2.7 partners
Standard Error 0.07454
|
3.0 partners
Standard Error 0.08386
|
SECONDARY outcome
Timeframe: 6 months post randomizationSelf-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex.
Outcome measures
| Measure |
Rapid HIV Testing w/ Counseling (Group 1)
n=2505 Participants
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)
n=2507 Participants
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.
|
|---|---|---|
|
Sexual Risk Behavior -- # of Unprotected Partners
|
1.1 unprotected partners
Standard Error 0.03749
|
1.1 unprotected partners
Standard Error 0.03845
|
SECONDARY outcome
Timeframe: 6 months post randomizationSelf-reported continuous variables to determine number of (vaginal and/or anal) sex acts in which the participant reported using substances before the sex act.
Outcome measures
| Measure |
Rapid HIV Testing w/ Counseling (Group 1)
n=952 Participants
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)
n=952 Participants
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.
|
|---|---|---|
|
Sexual Risk Behavior -- # of Sex Acts With Substance Use
|
115 sex acts with substance use
|
106 sex acts with substance use
|
Adverse Events
Rapid HIV Testing w/ Counseling (Group 1)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Rapid HIV Testing & Information Only (Group 2)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rapid HIV Testing w/ Counseling (Group 1)
n=2505 participants at risk
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)
n=2507 participants at risk
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.
|
|---|---|---|
|
General disorders
Death, cause unknown
|
0.04%
1/2505 • Number of events 1 • 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.
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.
|
0.00%
0/2507 • 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.
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.
|
|
General disorders
victim of homicide, secondary to robbery
|
0.04%
1/2505 • Number of events 1 • 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.
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.
|
0.00%
0/2507 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.04%
1/2505 • Number of events 1 • 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.
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.
|
0.00%
0/2507 • 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.
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.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/2505 • 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.
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.
|
0.04%
1/2507 • Number of events 1 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic colon cancer
|
0.00%
0/2505 • 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.
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.
|
0.04%
1/2507 • Number of events 1 • 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.
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Lisa Metsch, PhD, Stephen Smith Professor and Chair of Sociomedical Sciences
Department of Sociomedical Sciences/Mailman School of Public Health/Columbia University
Phone: 212-305-3577
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place