Trial Outcomes & Findings for eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men (NCT NCT03654690)
NCT ID: NCT03654690
Last Updated: 2025-04-10
Results Overview
We used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A dummy-coded covariate indicating whether participants reported testing fewer than three times in the 3 years prior to enrolling was included in all models of HIV testing. We fit longitudinal mixed effects models for two outcomes, HIV testing and high-risk CAS events within a given follow-up period, given that these outcomes varied within participants across the study period. We specified distributions appropriate for each outcome (logistic for HIV testing and negative binomial for high-risk CAS events) with suitable link functions, unstructured covariance structures and robust standard errors. Time was included as a continuous covariate. A covariate reflecting pre-enrolment HIV testing and baseline CAS events were included in these models. We used an intent-to-treat approach for all analyses. Missing data were considered missing at random.
COMPLETED
NA
811 participants
12 month study period
2025-04-10
Participant Flow
Participant milestones
| Measure |
Control
Participants will receive SMS text message reminders to get tested for HIV in a clinic.
|
Standard Self-Testing
Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
|
Enhanced Self-Testing
Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
Counseling: Post-Test HIV Risk ReductionCounseling
|
|---|---|---|---|
|
Overall Study
STARTED
|
271
|
265
|
275
|
|
Overall Study
COMPLETED
|
270
|
265
|
275
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Control
Participants will receive SMS text message reminders to get tested for HIV in a clinic.
|
Standard Self-Testing
Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
|
Enhanced Self-Testing
Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
Counseling: Post-Test HIV Risk ReductionCounseling
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men
Baseline characteristics by cohort
| Measure |
Control
n=270 Participants
Participants will receive SMS text message reminders to get tested for HIV in a clinic.
|
Standard Self-Testing
n=265 Participants
Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
|
Enhanced Self-Testing
n=275 Participants
Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
Counseling: Post-Test HIV Risk ReductionCounseling
|
Total
n=810 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
34.6 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
35.2 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
34.7 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
|
Sex/Gender, Customized
Male
|
269 Participants
n=99 Participants
|
258 Participants
n=107 Participants
|
268 Participants
n=206 Participants
|
795 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Trans/Other gender identity
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
95 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
277 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
175 Participants
n=99 Participants
|
181 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
533 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
72 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
85 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
179 Participants
n=99 Participants
|
169 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
520 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
270 participants
n=99 Participants
|
265 participants
n=107 Participants
|
275 participants
n=206 Participants
|
810 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 month study periodWe used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A dummy-coded covariate indicating whether participants reported testing fewer than three times in the 3 years prior to enrolling was included in all models of HIV testing. We fit longitudinal mixed effects models for two outcomes, HIV testing and high-risk CAS events within a given follow-up period, given that these outcomes varied within participants across the study period. We specified distributions appropriate for each outcome (logistic for HIV testing and negative binomial for high-risk CAS events) with suitable link functions, unstructured covariance structures and robust standard errors. Time was included as a continuous covariate. A covariate reflecting pre-enrolment HIV testing and baseline CAS events were included in these models. We used an intent-to-treat approach for all analyses. Missing data were considered missing at random.
Outcome measures
| Measure |
Control
n=270 Participants
Participants will receive SMS text message reminders to get tested for HIV in a clinic.
|
Standard Self-Testing
n=265 Participants
Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
|
Enhanced Self-Testing
n=275 Participants
Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
Counseling: Post-Test HIV Risk ReductionCounseling
|
|---|---|---|---|
|
Model Adjusted Probability of Any HIV Testing
|
57.0 percent probability
Interval 51.0 to 62.9
|
91.0 percent probability
Interval 87.9 to 94.6
|
89.4 percent probability
Interval 86.2 to 93.3
|
PRIMARY outcome
Timeframe: 12 monthsWe used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A dummy-coded covariate indicating whether participants reported testing fewer than three times in the 3 years prior to enrolling was included in all models of HIV testing. We fit longitudinal mixed effects models for two outcomes, HIV testing and high-risk CAS events within a given follow-up period, given that these outcomes varied within participants across the study period. We specified distributions appropriate for each outcome (logistic for HIV testing and negative binomial for high-risk CAS events) with suitable link functions, unstructured covariance structures and robust standard errors. Time was included as a continuous covariate. A covariate reflecting pre-enrolment HIV testing and baseline CAS events were included in these models. We used an intent-to-treat approach for all analyses. Missing data were considered missing at random.
Outcome measures
| Measure |
Control
n=270 Participants
Participants will receive SMS text message reminders to get tested for HIV in a clinic.
|
Standard Self-Testing
n=265 Participants
Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
|
Enhanced Self-Testing
n=275 Participants
Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
Counseling: Post-Test HIV Risk ReductionCounseling
|
|---|---|---|---|
|
Model Adjusted Probabilities of Repeat HIV Testing (>1)
|
31.3 percent probability
Interval 25.7 to 36.9
|
79.4 percent probability
Interval 74.5 to 84.3
|
80.4 percent probability
Interval 75.7 to 85.1
|
PRIMARY outcome
Timeframe: 12 monthscount of participants who were ultimately diagnosed with HIV during the course of the study
Outcome measures
| Measure |
Control
n=270 Participants
Participants will receive SMS text message reminders to get tested for HIV in a clinic.
|
Standard Self-Testing
n=265 Participants
Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
|
Enhanced Self-Testing
n=275 Participants
Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
Counseling: Post-Test HIV Risk ReductionCounseling
|
|---|---|---|---|
|
HIV Diagnoses
|
0 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 month study periodWe used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A binary variable reflecting whether participants had ever had a PrEP prescription in the past was included for the PrEP prescription model. We specified two-way interactions between these covariates and condition assignment in all models, but none were significant and were excluded.
Outcome measures
| Measure |
Control
n=270 Participants
Participants will receive SMS text message reminders to get tested for HIV in a clinic.
|
Standard Self-Testing
n=265 Participants
Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
|
Enhanced Self-Testing
n=275 Participants
Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
Counseling: Post-Test HIV Risk ReductionCounseling
|
|---|---|---|---|
|
Model Predicted Probability of Receipt of a Prescription for Pre-exposure Prophylaxis (PrEP)
|
20 percent probability
Interval 15.0 to 25.0
|
15 percent probability
Interval 10.0 to 19.0
|
15 percent probability
Interval 10.0 to 19.0
|
SECONDARY outcome
Timeframe: 12 monthsWe used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A dummy-coded covariate indicating whether participants reported testing fewer than three times in the 3 years prior to enrolling was included in all models of HIV testing. A similar covariate for STI testing was included in the STI testing model. We specified two-way interactions between these covariates and condition assignment in all models, but none were significant and were excluded.
Outcome measures
| Measure |
Control
n=270 Participants
Participants will receive SMS text message reminders to get tested for HIV in a clinic.
|
Standard Self-Testing
n=265 Participants
Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
|
Enhanced Self-Testing
n=275 Participants
Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
Counseling: Post-Test HIV Risk ReductionCounseling
|
|---|---|---|---|
|
Model Predicted Probability of Receipt of Testing for Other Sexually-transmitted Infections
|
46 percent probability
Interval 40.0 to 52.0
|
49 percent probability
Interval 43.0 to 55.0
|
50 percent probability
Interval 44.0 to 56.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsWe used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. We specified two-way interactions between these covariates and condition assignment in all models, but none were significant and were excluded. We fit longitudinal mixed effects models for two outcomes, HIV testing and high-risk CAS events within a given follow-up period, given that these outcomes varied within participants across the study period. We specified distributions appropriate for each outcome (logistic for HIV testing and negative binomial for high-risk CAS events) with suitable link functions, unstructured covariance structures and robust standard errors. Time was included as a continuous covariate. A covariate reflecting pre-enrolment HIV testing and baseline CAS events were included in these models.
Outcome measures
| Measure |
Control
n=270 Participants
Participants will receive SMS text message reminders to get tested for HIV in a clinic.
|
Standard Self-Testing
n=265 Participants
Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
|
Enhanced Self-Testing
n=275 Participants
Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test.
HIV self-test: Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
Counseling: Post-Test HIV Risk ReductionCounseling
|
|---|---|---|---|
|
Average Predicted Number of High-risk Casual Anal Sex (CAS) Events With Partners of Unknown HIV and PrEP Status
|
2.03 events
Interval 0.5 to 3.6
|
2.01 events
Interval 0.5 to 3.5
|
1.46 events
Interval 0.3 to 2.6
|
Adverse Events
Control
Standard Self-Testing
Enhanced Self-Testing
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