Trial Outcomes & Findings for Rapid HIV Testing and Counseling in Drug Abuse Treatment (NCT NCT00809445)
NCT ID: NCT00809445
Last Updated: 2015-10-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1281 participants
Primary outcome timeframe
One month post-randomization
Results posted on
2015-10-14
Participant Flow
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.
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).
Participant milestones
| Measure |
HIV Testing Referral
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
|
HIV Rapid Test & Counseling
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.
|
HIV Rapid Test and Info
On- site HIV rapid test \& information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
|
|---|---|---|---|
|
1 Month Follow-up
STARTED
|
429
|
433
|
419
|
|
1 Month Follow-up
COMPLETED
|
427
|
429
|
415
|
|
1 Month Follow-up
NOT COMPLETED
|
2
|
4
|
4
|
|
6 Month Follow-up
STARTED
|
429
|
433
|
419
|
|
6 Month Follow-up
COMPLETED
|
405
|
410
|
395
|
|
6 Month Follow-up
NOT COMPLETED
|
24
|
23
|
24
|
Reasons for withdrawal
| Measure |
HIV Testing Referral
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
|
HIV Rapid Test & Counseling
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.
|
HIV Rapid Test and Info
On- site HIV rapid test \& information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
|
|---|---|---|---|
|
1 Month Follow-up
Lost contact
|
1
|
2
|
1
|
|
1 Month Follow-up
Withdrew consent
|
1
|
1
|
1
|
|
1 Month Follow-up
Death
|
0
|
1
|
1
|
|
1 Month Follow-up
Incarcerated
|
0
|
0
|
1
|
|
6 Month Follow-up
Lost contact
|
16
|
14
|
14
|
|
6 Month Follow-up
Death
|
2
|
1
|
1
|
|
6 Month Follow-up
Incarcerated
|
6
|
8
|
8
|
|
6 Month Follow-up
Withdrew consent
|
0
|
0
|
1
|
Baseline Characteristics
Rapid HIV Testing and Counseling in Drug Abuse Treatment
Baseline characteristics by cohort
| Measure |
HIV Testing Referral
n=429 Participants
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
|
HIV Rapid Test & Counseling
n=433 Participants
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.
|
HIV Rapid Test and Info
n=419 Participants
On- site HIV rapid test \& information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
|
Total
n=1281 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
425 Participants
n=5 Participants
|
429 Participants
n=7 Participants
|
415 Participants
n=5 Participants
|
1269 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Continuous
|
40.81 years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
39.62 years
STANDARD_DEVIATION 11.19 • n=7 Participants
|
39.56 years
STANDARD_DEVIATION 11.77 • n=5 Participants
|
40.00 years
STANDARD_DEVIATION 11.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
503 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
256 Participants
n=5 Participants
|
263 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
778 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
89 participants
n=5 Participants
|
88 participants
n=7 Participants
|
86 participants
n=5 Participants
|
263 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
278 participants
n=5 Participants
|
277 participants
n=7 Participants
|
271 participants
n=5 Participants
|
826 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
9 participants
n=5 Participants
|
13 participants
n=7 Participants
|
11 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
34 participants
n=5 Participants
|
34 participants
n=7 Participants
|
30 participants
n=5 Participants
|
98 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
51 participants
n=5 Participants
|
49 participants
n=7 Participants
|
47 participants
n=5 Participants
|
147 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
429 participants
n=5 Participants
|
433 participants
n=7 Participants
|
419 participants
n=5 Participants
|
1281 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One month post-randomizationPopulation: 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
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.
Outcome measures
| Measure |
HIV Testing Referral
n=424 Participants
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
|
HIV Rapid Test & Counseling
n=424 Participants
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.
|
HIV Rapid Test and Info
n=409 Participants
On- site HIV rapid test \& information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
|
|---|---|---|---|
|
Self-Report Receipt of HIV Test Results
|
78 participants
|
338 participants
|
347 participants
|
PRIMARY outcome
Timeframe: Six months post-randomizationPopulation: 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.
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).
Outcome measures
| Measure |
HIV Testing Referral
n=387 Participants
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
|
HIV Rapid Test & Counseling
n=385 Participants
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.
|
HIV Rapid Test and Info
n=371 Participants
On- site HIV rapid test \& information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
|
|---|---|---|---|
|
Number of Risky Sexual Behaviors
|
20.5 number of unprotected sex acts
Standard Deviation 49.8
|
21.3 number of unprotected sex acts
Standard Deviation 47.6
|
21.3 number of unprotected sex acts
Standard Deviation 44.8
|
SECONDARY outcome
Timeframe: Six monthsChange 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.
Outcome measures
| Measure |
HIV Testing Referral
n=401 Participants
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
|
HIV Rapid Test & Counseling
n=402 Participants
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.
|
HIV Rapid Test and Info
n=385 Participants
On- site HIV rapid test \& information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
|
|---|---|---|---|
|
Sharing of Needles Used in Drug Use
Number discontinuing sharing
|
17 n of people changing needle sharing
|
32 n of people changing needle sharing
|
24 n of people changing needle sharing
|
|
Sharing of Needles Used in Drug Use
Number initiating sharing
|
2 n of people changing needle sharing
|
1 n of people changing needle sharing
|
6 n of people changing needle sharing
|
SECONDARY outcome
Timeframe: 1 month post-randomizationPopulation: 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
The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.
Outcome measures
| Measure |
HIV Testing Referral
n=424 Participants
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
|
HIV Rapid Test & Counseling
n=424 Participants
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.
|
HIV Rapid Test and Info
n=409 Participants
On- site HIV rapid test \& information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
|
|---|---|---|---|
|
Self-Report of Ever Having Been Tested
|
103 participants
|
344 participants
|
352 participants
|
Adverse Events
HIV Testing Referral
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Rapid Test & Counseling
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Rapid Test and Info
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV Testing Referral
n=429 participants at risk
Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
|
HIV Rapid Test & Counseling
n=433 participants at risk
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.
|
HIV Rapid Test and Info
n=419 participants at risk
On- site HIV rapid test \& information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.23%
1/429 • Number of events 1 • 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.
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.
|
0.23%
1/433 • Number of events 1 • 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.
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.
|
0.00%
0/419 • 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.
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.
|
|
General disorders
Overdose
|
0.00%
0/429 • 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.
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.
|
0.00%
0/433 • 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.
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.
|
0.48%
2/419 • Number of events 2 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.47%
2/429 • Number of events 2 • 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.
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.
|
0.00%
0/433 • 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.
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.
|
0.00%
0/419 • 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.
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.
|
|
General disorders
Death
|
0.00%
0/429 • 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.
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.
|
0.23%
1/433 • Number of events 1 • 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.
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.
|
0.00%
0/419 • 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.
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lisa Metsch
Columbia University, Mailman School of Public Health
Phone: 212-305-3577
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place