Trial Outcomes & Findings for Evaluation of Rapid HIV Self-testing Among MSM (eSTAMP) (NCT NCT02067039)
NCT ID: NCT02067039
Last Updated: 2020-03-31
Results Overview
Frequency of HIV testing \>=3 times reported by participants over a 12-month follow-up period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2665 participants
Primary outcome timeframe
12 months
Results posted on
2020-03-31
Participant Flow
Recruitment occurred from 3/2015 through 8/2015. Subjects were recruited online from internet (websites and music) catering to MSM.
Participants who did not provide contact information, complete and submit their baseline interview online, provided fraudulent information or later reported an HIV diagnoses before study enrollment were excluded.
Participant milestones
| Measure |
Self-testing
The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing. Participants had access to telephone consultation from study staff and a web-link to obtain HIV testing services in their community.
OraQuick in home \& Sure Check HIV tests: Provision of OraQuick in home \& Sure Check HIV tests
|
Control
All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing. Participants had access to telephone consultation from study staff and a web-link to obtain HIV testing services in their community.
|
|---|---|---|
|
Overall Study
STARTED
|
1325
|
1340
|
|
Overall Study
3 Month Survey
|
824
|
766
|
|
Overall Study
6 Month Survey
|
735
|
756
|
|
Overall Study
9 Month Survey
|
748
|
838
|
|
Overall Study
COMPLETED
|
752
|
832
|
|
Overall Study
NOT COMPLETED
|
573
|
508
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Rapid HIV Self-testing Among MSM (eSTAMP)
Baseline characteristics by cohort
| Measure |
HIV Self-testing
n=1325 Participants
The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
OraQuick in home \& Sure Check HIV tests: Provision of OraQuick in home \& Sure Check HIV tests
|
Information Only
n=1340 Participants
All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
|
Total
n=2665 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age-group · 18-29 years
|
752 Participants
n=93 Participants
|
775 Participants
n=4 Participants
|
1527 Participants
n=27 Participants
|
|
Age, Customized
Age-group · >=30 years
|
573 Participants
n=93 Participants
|
565 Participants
n=4 Participants
|
1138 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Male Gender
|
1325 Participants
n=93 Participants
|
1340 Participants
n=4 Participants
|
2665 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic white
|
773 Participants
n=93 Participants
|
767 Participants
n=4 Participants
|
1540 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic black
|
133 Participants
n=93 Participants
|
128 Participants
n=4 Participants
|
261 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
296 Participants
n=93 Participants
|
324 Participants
n=4 Participants
|
620 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other/mixed
|
123 Participants
n=93 Participants
|
121 Participants
n=4 Participants
|
244 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
1325 participants
n=93 Participants
|
1340 participants
n=4 Participants
|
2665 participants
n=27 Participants
|
|
Recruitment site
Music
|
510 Participants
n=93 Participants
|
553 Participants
n=4 Participants
|
1063 Participants
n=27 Participants
|
|
Recruitment site
Dating
|
754 Participants
n=93 Participants
|
763 Participants
n=4 Participants
|
1517 Participants
n=27 Participants
|
|
Recruitment site
Social network
|
61 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
85 Participants
n=27 Participants
|
|
HIV testing experience at enrollment
Never tested
|
230 Participants
n=93 Participants
|
213 Participants
n=4 Participants
|
443 Participants
n=27 Participants
|
|
HIV testing experience at enrollment
Tested in past 12 months
|
813 Participants
n=93 Participants
|
795 Participants
n=4 Participants
|
1608 Participants
n=27 Participants
|
|
HIV testing experience at enrollment
Tested more than 12 months ago
|
282 Participants
n=93 Participants
|
332 Participants
n=4 Participants
|
614 Participants
n=27 Participants
|
|
At least 3 HIV tests in past year
Yes
|
243 Participants
n=93 Participants
|
218 Participants
n=4 Participants
|
461 Participants
n=27 Participants
|
|
At least 3 HIV tests in past year
No
|
1082 Participants
n=93 Participants
|
1122 Participants
n=4 Participants
|
2204 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: percent of MSM who reported testing at least three times over the course of the RCT
Frequency of HIV testing \>=3 times reported by participants over a 12-month follow-up period.
Outcome measures
| Measure |
HIV Self-testing
n=1014 Participants
The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
OraQuick in home \& Sure Check HIV tests: Provision of OraQuick in home \& Sure Check HIV tests
|
Information Only
n=977 Participants
All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
|
|---|---|---|
|
Frequency of HIV Testing by Internet-recruited MSM.
|
777 Participants
|
215 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Persons who reported initiating linkage to care following an HIV positive test
MSM who report accessing supplemental testing and care following a positive rapid HIV test results.
Outcome measures
| Measure |
HIV Self-testing
n=25 Participants
The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
OraQuick in home \& Sure Check HIV tests: Provision of OraQuick in home \& Sure Check HIV tests
|
Information Only
n=11 Participants
All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
|
|---|---|---|
|
Linkage to HIV Testing and Care Services Following a Positive Rapid Test Result.
Linked to care
|
16 Participants
|
10 Participants
|
|
Linkage to HIV Testing and Care Services Following a Positive Rapid Test Result.
not linked to care
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All persons assigned to study.
Report of positive HIV test result (self-test or provider testing)
Outcome measures
| Measure |
HIV Self-testing
n=1325 Participants
The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
OraQuick in home \& Sure Check HIV tests: Provision of OraQuick in home \& Sure Check HIV tests
|
Information Only
n=1340 Participants
All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
|
|---|---|---|
|
Newly Identified HIV Infections
|
25 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Number of social network associates who used a study HIV self-test and received a new HIV diagnosis
Number of social network associates (N=2150)who received a study self-test from ST participants (N=1325) and who reported a positive HIV self-test result. Sample size for this analyses is 2150.
Outcome measures
| Measure |
HIV Self-testing
n=2150 Participants
The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
OraQuick in home \& Sure Check HIV tests: Provision of OraQuick in home \& Sure Check HIV tests
|
Information Only
All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
|
|---|---|---|
|
HIV Infections Among Social Network Associates
|
34 social network members
|
—
|
Adverse Events
OraQuick in Home & Sure Check HIV Tests
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Information Only
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