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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

811 participants

Primary outcome timeframe

12 month study period

Results posted on

2025-04-10

Participant Flow

Participant milestones

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

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

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 period

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.

Outcome measures

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 months

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.

Outcome measures

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 months

count of participants who were ultimately diagnosed with HIV during the course of the study

Outcome measures

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 period

We 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

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 months

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. 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

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 months

We 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Self-Testing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Enhanced Self-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

Dr. Tyler Wray

Brown University

Phone: 4018636659

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place