Trial Outcomes & Findings for Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System (NCT NCT03729570)
NCT ID: NCT03729570
Last Updated: 2024-10-18
Results Overview
Measurements TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP is ingested over approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be medication levels indicating \>4 doses/wk. For participants taking emtricitabine/tenofovir disoproxil fumarate, this will be TFV-DP levels: \>1000 femtomole per blood spot (fmol/punch). For participants taking emtricitabine/tenofovir alafenamide this will be TFV-DP levels: \>140 femtomole per blood spot (fmol/punch).
COMPLETED
NA
217 participants
6-month follow up
2024-10-18
Participant Flow
Participants recruited online in Georgia, North Carolina, Alabama, and Mississippi. Participating universities: Rollins School of Public Health in Atlanta, Georgia; University of North Carolina in Chapel Hill, North Carolina; University of Alabama in Birmingham, Alabama; and University of Mississippi Medical Center in Jackson, Mississippi. Enrollment began on May 28, 2019, and follow-up was complete by May 31, 2022. Study completion is defined as enrolled persons completing their 6-month survey.
Participant milestones
| Measure |
ePrEP
Participants will receive the ePrEP home care system for telemedicine PrEP, permitting initiation and persistence in PrEP care. The ePrEP home care system consists of: a smartphone application (app) for video-based telemedicine PrEP consultations with a clinician; secure messaging; a system to track shipments to \& from participants; and behavioral risk surveys that are complemented by home specimen kits. Self-collected specimens will be mailed to laboratories for routine, guideline-based testing for PrEP care. Home specimen collection will be used to determine the primary study outcome of tenofovir-diphosphate levels.
ePrEP: Participants will have a baseline teleconsultation with a site study clinician who will be responsible for prescribing PrEP as indicated. They will be offered a 1-month check-in and telemedicine consultations at 3, 6, 9 and 12 months. Participants will complete home specimen collection for laboratory tests for each consultation. The virtual study visit consists of surveys, specimen collection, and a telemedicine consultation.
|
Standard of Care
Participants will be referred to a publicly available website that geolocates the nearest PrEP provider. They will receive standard of care, defined as what a member of the general public would be able to access for PrEP services. Home specimen self-collection will be used to determine the primary study outcome of tenofovir-diphosphate levels. Additional research assessments will include quarterly surveys.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
109
|
|
Overall Study
COMPLETED
|
80
|
84
|
|
Overall Study
NOT COMPLETED
|
28
|
25
|
Reasons for withdrawal
| Measure |
ePrEP
Participants will receive the ePrEP home care system for telemedicine PrEP, permitting initiation and persistence in PrEP care. The ePrEP home care system consists of: a smartphone application (app) for video-based telemedicine PrEP consultations with a clinician; secure messaging; a system to track shipments to \& from participants; and behavioral risk surveys that are complemented by home specimen kits. Self-collected specimens will be mailed to laboratories for routine, guideline-based testing for PrEP care. Home specimen collection will be used to determine the primary study outcome of tenofovir-diphosphate levels.
ePrEP: Participants will have a baseline teleconsultation with a site study clinician who will be responsible for prescribing PrEP as indicated. They will be offered a 1-month check-in and telemedicine consultations at 3, 6, 9 and 12 months. Participants will complete home specimen collection for laboratory tests for each consultation. The virtual study visit consists of surveys, specimen collection, and a telemedicine consultation.
|
Standard of Care
Participants will be referred to a publicly available website that geolocates the nearest PrEP provider. They will receive standard of care, defined as what a member of the general public would be able to access for PrEP services. Home specimen self-collection will be used to determine the primary study outcome of tenofovir-diphosphate levels. Additional research assessments will include quarterly surveys.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
20
|
|
Overall Study
Seroconversion
|
5
|
0
|
|
Overall Study
Moved out of the city
|
1
|
0
|
|
Overall Study
Time Conflict
|
1
|
0
|
|
Overall Study
Time Commitment
|
2
|
0
|
|
Overall Study
Bad Experience
|
0
|
1
|
|
Overall Study
No reason provided
|
2
|
1
|
|
Overall Study
Family Conflict
|
0
|
1
|
|
Overall Study
Did not want to continue taking medications
|
0
|
1
|
|
Overall Study
Found another PrEP provider
|
1
|
0
|
|
Overall Study
Did not enjoy being in the control group
|
0
|
1
|
Baseline Characteristics
Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System
Baseline characteristics by cohort
| Measure |
ePrEP
n=108 Participants
Participants will receive the ePrEP home care system for telemedicine PrEP, permitting initiation and persistence in PrEP care. The ePrEP home care system consists of: a smartphone application (app) for video-based telemedicine PrEP consultations with a clinician; secure messaging; a system to track shipments to \& from participants; and behavioral risk surveys that are complemented by home specimen kits. Self-collected specimens will be mailed to laboratories for routine, guideline-based testing for PrEP care. Home specimen collection will be used to determine the primary study outcome of tenofovir-diphosphate levels.
ePrEP: Participants will have a baseline teleconsultation with a site study clinician who will be responsible for prescribing PrEP as indicated. They will be offered a 1-month check-in and telemedicine consultations at 3, 6, 9 and 12 months. Participants will complete home specimen collection for laboratory tests for each consultation. The virtual study visit consists of surveys, specimen collection, and a telemedicine consultation.
|
Standard of Care
n=109 Participants
Participants will be referred to a publicly available website that geolocates the nearest PrEP provider. They will receive standard of care, defined as what a member of the general public would be able to access for PrEP services. Home specimen self-collection will be used to determine the primary study outcome of tenofovir-diphosphate levels. Additional research assessments will include quarterly surveys.
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.29 years
STANDARD_DEVIATION 3.11 • n=99 Participants
|
23.49 years
STANDARD_DEVIATION 3.24 • n=107 Participants
|
23.39 years
STANDARD_DEVIATION 3.17 • n=206 Participants
|
|
Age, Customized
18 to 21 YO
|
36 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Age, Customized
22 to 25 YO
|
42 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Age, Customized
26 to 29 YO
|
30 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
62 Participants
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
|
108 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
217 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
46 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
50 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American/Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
108 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
217 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6-month follow upPopulation: Participants with biomarker data indicating adherent daily PrEP dosing. For participants either reporting the use of both medications in the period or not reporting which medication they used during this period, investigators used decision rules to determine adherence. For instance, if a participant had a TFV-DP level above both cutpoints, they were classified as adherent.
Measurements TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP is ingested over approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be medication levels indicating \>4 doses/wk. For participants taking emtricitabine/tenofovir disoproxil fumarate, this will be TFV-DP levels: \>1000 femtomole per blood spot (fmol/punch). For participants taking emtricitabine/tenofovir alafenamide this will be TFV-DP levels: \>140 femtomole per blood spot (fmol/punch).
Outcome measures
| Measure |
ePrEP
n=31 Participants
Participants will receive the ePrEP home care system for telemedicine PrEP, permitting initiation and persistence in PrEP care. The ePrEP home care system consists of: a smartphone application (app) for video-based telemedicine PrEP consultations with a clinician; secure messaging; a system to track shipments to \& from participants; and behavioral risk surveys that are complemented by home specimen kits. Self-collected specimens will be mailed to laboratories for routine, guideline-based testing for PrEP care. Home specimen collection will be used to determine the primary study outcome of tenofovir-diphosphate levels.
ePrEP: Participants will have a baseline teleconsultation with a site study clinician who will be responsible for prescribing PrEP as indicated. They will be offered a 1-month check-in and telemedicine consultations at 3, 6, 9 and 12 months. Participants will complete home specimen collection for laboratory tests for each consultation. The virtual study visit consists of surveys, specimen collection, and a telemedicine consultation.
|
Standard of Care
n=26 Participants
Participants will be referred to a publicly available website that geolocates the nearest PrEP provider. They will receive standard of care, defined as what a member of the general public would be able to access for PrEP services. Home specimen self-collection will be used to determine the primary study outcome of tenofovir-diphosphate levels. Additional research assessments will include quarterly surveys.
|
|---|---|---|
|
Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up
|
17 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 12-month follow upPopulation: Participants with biomarker data indicating adherent daily PrEP dosing. For participants either reporting the use of both medications in the period or not reporting which medication they used during this time, investigators used decision rules to determine adherence. For instance, if a participant had a TFV-DP level above both cutpoints, they would be classified as adherent.
Measurement of TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP is ingested over approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be medication levels indicating \>4 doses/wk. For participants taking emtricitabine/tenofovir disoproxil fumarate, this will be TFV-DP levels: \>1000 femtomole per blood spot (fmol/punch). For participants taking emtricitabine/tenofovir alafenamide this will be TFV-DP levels: \>140 femtomole per blood spot (fmol/punch).
Outcome measures
| Measure |
ePrEP
n=37 Participants
Participants will receive the ePrEP home care system for telemedicine PrEP, permitting initiation and persistence in PrEP care. The ePrEP home care system consists of: a smartphone application (app) for video-based telemedicine PrEP consultations with a clinician; secure messaging; a system to track shipments to \& from participants; and behavioral risk surveys that are complemented by home specimen kits. Self-collected specimens will be mailed to laboratories for routine, guideline-based testing for PrEP care. Home specimen collection will be used to determine the primary study outcome of tenofovir-diphosphate levels.
ePrEP: Participants will have a baseline teleconsultation with a site study clinician who will be responsible for prescribing PrEP as indicated. They will be offered a 1-month check-in and telemedicine consultations at 3, 6, 9 and 12 months. Participants will complete home specimen collection for laboratory tests for each consultation. The virtual study visit consists of surveys, specimen collection, and a telemedicine consultation.
|
Standard of Care
n=48 Participants
Participants will be referred to a publicly available website that geolocates the nearest PrEP provider. They will receive standard of care, defined as what a member of the general public would be able to access for PrEP services. Home specimen self-collection will be used to determine the primary study outcome of tenofovir-diphosphate levels. Additional research assessments will include quarterly surveys.
|
|---|---|---|
|
Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 12 Months Follow-up
|
15 Participants
|
20 Participants
|
Adverse Events
ePrEP
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ePrEP
n=108 participants at risk
Participants will receive the ePrEP home care system for telemedicine PrEP, permitting initiation and persistence in PrEP care. The ePrEP home care system consists of: a smartphone application (app) for video-based telemedicine PrEP consultations with a clinician; secure messaging; a system to track shipments to \& from participants; and behavioral risk surveys that are complemented by home specimen kits. Self-collected specimens will be mailed to laboratories for routine, guideline-based testing for PrEP care. Home specimen collection will be used to determine the primary study outcome of tenofovir-diphosphate levels.
ePrEP: Participants will have a baseline teleconsultation with a site study clinician who will be responsible for prescribing PrEP as indicated. They will be offered a 1-month check-in and telemedicine consultations at 3, 6, 9 and 12 months. Participants will complete home specimen collection for laboratory tests for each consultation. The virtual study visit consists of surveys, specimen collection, and a telemedicine consultation.
|
Standard of Care
n=109 participants at risk
Participants will be referred to a publicly available website that geolocates the nearest PrEP provider. They will receive standard of care, defined as what a member of the general public would be able to access for PrEP services. Home specimen self-collection will be used to determine the primary study outcome of tenofovir-diphosphate levels. Additional research assessments will include quarterly surveys.
|
|---|---|---|
|
Renal and urinary disorders
Increase in serum creatinine level
|
0.93%
1/108 • Information on adverse events was collected beginning at the time consent to participate in the study was given, during study participation up to 12 months.
|
0.00%
0/109 • Information on adverse events was collected beginning at the time consent to participate in the study was given, during study participation up to 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place