Trial Outcomes & Findings for Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study) (NCT NCT01161446)
NCT ID: NCT01161446
Last Updated: 2017-06-07
Results Overview
Number of HIV tests during follow-up reported by participants at end-of-study visit
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
230 participants
Primary outcome timeframe
15 months
Results posted on
2017-06-07
Participant Flow
Participant milestones
| Measure |
Home Testing
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
|
Standard Testing
HIV testing as usual.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
114
|
|
Overall Study
COMPLETED
|
98
|
99
|
|
Overall Study
NOT COMPLETED
|
18
|
15
|
Reasons for withdrawal
| Measure |
Home Testing
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
|
Standard Testing
HIV testing as usual.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
18
|
14
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)
Baseline characteristics by cohort
| Measure |
Home Testing
n=116 Participants
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
|
Standard Testing
n=114 Participants
HIV testing as usual.
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 years
n=99 Participants
|
37.5 years
n=107 Participants
|
36 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
230 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
116 participants
n=99 Participants
|
114 participants
n=107 Participants
|
230 participants
n=206 Participants
|
|
Education
High school or less
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Education
Some college, Associate's, or technical training
|
44 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Education
Bachelor's degree or more
|
57 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Education
Unknown or not reported
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Living Situation
Alone in a house or apartment
|
40 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Living Situation
With a sex partner, lover, or spouse
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Living Situation
With friends or roommates
|
46 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Living Situation
With parents, guardians, or other relatives
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Living Situation
In school or university dormitories
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Living Situation
No regular place to stay, couch surfing, homeless
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Living Situation
Unknown or not reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Number of HIV tests in last year
|
2 HIV tests
n=99 Participants
|
2.5 HIV tests
n=107 Participants
|
2 HIV tests
n=206 Participants
|
|
Currently tests for HIV on regular basis
Yes
|
66 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Currently tests for HIV on regular basis
No
|
50 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Currently tests for HIV on regular basis
Unknown or not reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ever used a home HIV test
Yes
|
2 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ever used a home HIV test
No
|
113 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
217 Participants
n=206 Participants
|
|
Ever used a home HIV test
Unknown or not reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Gender of sex partners in last 3 months
Men
|
107 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
|
Gender of sex partners in last 3 months
Women
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Gender of sex partners in last 3 months
Both men and women
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Gender of sex partners in last 3 months
Unknown or not reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of male sex partners in last 3 months
|
5 partners
n=99 Participants
|
5.5 partners
n=107 Participants
|
5 partners
n=206 Participants
|
|
Number of male condomless anal intercourse partners in last 3 months
|
1 partners
n=99 Participants
|
1 partners
n=107 Participants
|
1 partners
n=206 Participants
|
|
Any condomless anal intercourse with an HIV-discordant partner in last 3 months
Yes
|
37 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Any condomless anal intercourse with an HIV-discordant partner in last 3 months
No
|
70 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
144 Participants
n=206 Participants
|
|
Any condomless anal intercourse with an HIV-discordant partner in last 3 months
Unknown or not reported
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Methamphetamine use in last 3 months
Yes
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Methamphetamine use in last 3 months
No
|
103 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Methamphetamine use in last 3 months
Unknown or not reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Inhaled nitrite use in last 3 months
Yes
|
39 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Inhaled nitrite use in last 3 months
No
|
77 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
|
Diagnosis of bacterial sexually transmitted infection at enrollment visit
Yes
|
9 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Diagnosis of bacterial sexually transmitted infection at enrollment visit
No
|
107 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
202 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 15 monthsNumber of HIV tests during follow-up reported by participants at end-of-study visit
Outcome measures
| Measure |
Home Testing
n=98 Participants
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
|
Standard Testing
n=99 Participants
HIV testing as usual.
|
|---|---|---|
|
HIV Testing Frequency
|
5.3 HIV tests
Interval 4.7 to 6.0
|
3.6 HIV tests
Interval 3.2 to 4.0
|
SECONDARY outcome
Timeframe: From 6 to 9 months and 12 to 15 months of follow-upPopulation: Included "Overall Number of Participants Analyzed" as number who completed follow-up. However, only participants who responded to the question regarding non-concordant condomless anal intercourse in the last 3 months were included in this analysis for each time point.
Outcome measures
| Measure |
Home Testing
n=98 Participants
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
|
Standard Testing
n=99 Participants
HIV testing as usual.
|
|---|---|---|
|
Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months
Measured at 9 months
|
16 Participants
|
17 Participants
|
|
Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months
Measured at end of study (15 months)
|
26 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Assessed at 15 monthsPopulation: Includes only participants who received screening for sexually transmitted infections at the end-of-study visit.
Includes syphilis, gonorrhea, and chlamydial infection
Outcome measures
| Measure |
Home Testing
n=93 Participants
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
|
Standard Testing
n=90 Participants
HIV testing as usual.
|
|---|---|---|
|
Bacterial Sexually Transmitted Infections
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From 6 to 9 and 12 to 15 monthsPopulation: Included "Overall Number of Participants Analyzed" as number who completed follow-up. However, only participants who responded to the question regarding condomless anal intercourse partners in the last 3 months were included in this analysis for each time point.
Outcome measures
| Measure |
Home Testing
n=98 Participants
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
|
Standard Testing
n=99 Participants
HIV testing as usual.
|
|---|---|---|
|
Number of Male Condomless Anal Intercourse Partners in Last 3 Months
Measured at 9 months
|
1.375 number of partners
Standard Error 0.207
|
2.050 number of partners
Standard Error 0.313
|
|
Number of Male Condomless Anal Intercourse Partners in Last 3 Months
Measured at end of study (15 months)
|
2.337 number of partners
Standard Error 0.355
|
2.141 number of partners
Standard Error 0.314
|
Adverse Events
Home Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place