Trial Outcomes & Findings for Pre-exposure Prophylaxis (PrEP) at Home (NCT NCT03569813)
NCT ID: NCT03569813
Last Updated: 2024-09-26
Results Overview
Adherence to study medications was measured using blood TFV-DP levels. For participants taking emtricitabine/tenofovir disoproxil fumarate, TFV-DP levels \>1000 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. For those taking emtricitabine/tenofovir alafenamide, TFV-DP levels \>140 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. Participants achieving these levels were considered to have adhered appropriately (\>4 doses per week). Researchers used decision rules to determine adherence for participants who either reported using both medications in the period or did not report which medication they used. For instance, if a participant had a TFV-DP level above both cut points, they would be considered adherent to treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
318 participants
Primary outcome timeframe
Month 6
Results posted on
2024-09-26
Participant Flow
PrEP@Home study participants were recruited predominantly online in the study cities of Atlanta, GA, Boston, MA, Cleveland, OH, Jackson, MS, and St. Louis, MO. Participant enrollment began April 26, 2019, and all follow-up was complete by April 15, 2023. Study completion is defined as enrolled persons completing their online survey.
Participant milestones
| Measure |
PrEP@Home System
The experimental group will be assigned to the remote care system for one year of follow-up PrEP care to include home test kits, behavioral surveillance, and telemedicine visits as needed.
PrEP@Home System: The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit has components for self-collection of urine, rectal and pharyngeal swabs, microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up (FU) visits will be done on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of emtricitabine triphosphate (FTC-TP).
The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly FU visits (sexual risk, illicit substance use, PrEP adherence, side effects).
Study Clinicians will review Lab and survey results and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as needed.
|
Standard of Care
The comparator group will receive active linkage to a local PrEP provider for clinic-based PrEP follow-up. Participants in this study arm will be seen quarterly by a health care provider, per standard of care when taking PrEP.
Standard of Care: Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, emtricitabine triphosphate (FTC-TP).
|
|---|---|---|
|
Overall Study
STARTED
|
211
|
107
|
|
Overall Study
COMPLETED
|
126
|
62
|
|
Overall Study
NOT COMPLETED
|
85
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-exposure Prophylaxis (PrEP) at Home
Baseline characteristics by cohort
| Measure |
PrEP@Home System
n=211 Participants
The experimental group will be assigned to the remote care system for one year of follow-up PrEP care to include home test kits, behavioral surveillance, and telemedicine visits as needed.
PrEP@Home System: The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit has components for self-collection of urine, rectal and pharyngeal swabs, microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up (FU) visits will be done on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of emtricitabine triphosphate (FTC-TP).
The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly FU visits (sexual risk, illicit substance use, PrEP adherence, side effects).
Study Clinicians will review Lab and survey results and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as needed.
|
Standard of Care
n=107 Participants
The comparator group will receive active linkage to a local PrEP provider for clinic-based PrEP follow-up. Participants in this study arm will be seen quarterly by a health care provider, per standard of care when taking PrEP.
Standard of Care: Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, emtricitabine triphosphate (FTC-TP).
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.12 years
STANDARD_DEVIATION 7.16 • n=99 Participants
|
29.31 years
STANDARD_DEVIATION 7.38 • n=107 Participants
|
29.58 years
STANDARD_DEVIATION 7.30 • n=206 Participants
|
|
Age, Customized
Between 18-24 years
|
63 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Age, Customized
Between 25-34 years
|
105 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
162 Participants
n=206 Participants
|
|
Age, Customized
Between 35-44 years
|
29 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Age, Customized
Between 45-49 years
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
20 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
|
211 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
318 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
192 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
281 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander/Asian
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
69 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
119 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
211 participants
n=99 Participants
|
107 participants
n=107 Participants
|
318 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: This analysis includes participants who submitted a dry blood spot card that had an adequate size of the blood sample for analysis.
Adherence to study medications was measured using blood TFV-DP levels. For participants taking emtricitabine/tenofovir disoproxil fumarate, TFV-DP levels \>1000 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. For those taking emtricitabine/tenofovir alafenamide, TFV-DP levels \>140 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. Participants achieving these levels were considered to have adhered appropriately (\>4 doses per week). Researchers used decision rules to determine adherence for participants who either reported using both medications in the period or did not report which medication they used. For instance, if a participant had a TFV-DP level above both cut points, they would be considered adherent to treatment.
Outcome measures
| Measure |
PrEP@Home System
n=113 Participants
The experimental group will be assigned to the remote care system for one year of follow-up PrEP care to include home test kits, behavioral surveillance, and telemedicine visits as needed.
PrEP@Home System: The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit has components for self-collection of urine, rectal and pharyngeal swabs, microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up (FU) visits will be done on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of emtricitabine triphosphate (FTC-TP).
The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly FU visits (sexual risk, illicit substance use, PrEP adherence, side effects).
Study Clinicians will review Lab and survey results and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as needed.
|
Standard of Care
n=63 Participants
The comparator group will receive active linkage to a local PrEP provider for clinic-based PrEP follow-up. Participants in this study arm will be seen quarterly by a health care provider, per standard of care when taking PrEP.
Standard of Care: Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, emtricitabine triphosphate (FTC-TP).
|
|---|---|---|
|
Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up
|
78 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Up to Month 6Population: Participants with self-report data indicating adherent daily PrEP dosing.
Retention in PrEP care is based on participant self-report of taking PrEP at least 4 days per week in the last week as measured at the 6 months.
Outcome measures
| Measure |
PrEP@Home System
n=155 Participants
The experimental group will be assigned to the remote care system for one year of follow-up PrEP care to include home test kits, behavioral surveillance, and telemedicine visits as needed.
PrEP@Home System: The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit has components for self-collection of urine, rectal and pharyngeal swabs, microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up (FU) visits will be done on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of emtricitabine triphosphate (FTC-TP).
The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly FU visits (sexual risk, illicit substance use, PrEP adherence, side effects).
Study Clinicians will review Lab and survey results and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as needed.
|
Standard of Care
n=77 Participants
The comparator group will receive active linkage to a local PrEP provider for clinic-based PrEP follow-up. Participants in this study arm will be seen quarterly by a health care provider, per standard of care when taking PrEP.
Standard of Care: Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, emtricitabine triphosphate (FTC-TP).
|
|---|---|---|
|
Retention in PrEP Care
|
132 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: This analysis includes participants who submitted a dry blood spot card that had an adequate size of the blood sample for analysis.
Adherence to study medications was measured using blood TFV-DP levels. For participants taking emtricitabine/tenofovir disoproxil fumarate, TFV-DP levels \>1000 femtomole per blood spot (fmol/punch) indicated adherence \>4 doses per week. For those taking emtricitabine/tenofovir alafenamide, TFV-DP levels \>140 femtomole per blood spot (fmol/punch) indicated adherence \>4 doses per week. Participants achieving these levels were considered to have adhered appropriately (\>4 doses per week). For participants who either reported using both medications in the period or did not report which medication they used, the researchers used decision rules to determine adherence. For instance, if a participant had a TDF-DP level above both cutpoints, they would be considered adherent to treatment.
Outcome measures
| Measure |
PrEP@Home System
n=86 Participants
The experimental group will be assigned to the remote care system for one year of follow-up PrEP care to include home test kits, behavioral surveillance, and telemedicine visits as needed.
PrEP@Home System: The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit has components for self-collection of urine, rectal and pharyngeal swabs, microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up (FU) visits will be done on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of emtricitabine triphosphate (FTC-TP).
The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly FU visits (sexual risk, illicit substance use, PrEP adherence, side effects).
Study Clinicians will review Lab and survey results and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as needed.
|
Standard of Care
n=56 Participants
The comparator group will receive active linkage to a local PrEP provider for clinic-based PrEP follow-up. Participants in this study arm will be seen quarterly by a health care provider, per standard of care when taking PrEP.
Standard of Care: Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, emtricitabine triphosphate (FTC-TP).
|
|---|---|---|
|
Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 12-month Follow-up
|
56 Participants
|
36 Participants
|
Adverse Events
PrEP@Home System
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PrEP@Home System
n=211 participants at risk
The experimental group will be assigned to the remote care system for one year of follow-up PrEP care to include home test kits, behavioral surveillance, and telemedicine visits as needed.
PrEP@Home System: The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit has components for self-collection of urine, rectal and pharyngeal swabs, microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up (FU) visits will be done on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of emtricitabine triphosphate (FTC-TP).
The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly FU visits (sexual risk, illicit substance use, PrEP adherence, side effects).
Study Clinicians will review Lab and survey results and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as needed.
|
Standard of Care
n=107 participants at risk
The comparator group will receive active linkage to a local PrEP provider for clinic-based PrEP follow-up. Participants in this study arm will be seen quarterly by a health care provider, per standard of care when taking PrEP.
Standard of Care: Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, emtricitabine triphosphate (FTC-TP).
|
|---|---|---|
|
Infections and infestations
STI
|
1.4%
3/211 • Number of events 3 • 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%
0/107 • 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
|
|
Gastrointestinal disorders
Traveler's diarrhea
|
0.47%
1/211 • Number of events 1 • 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%
0/107 • 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
|
|
Psychiatric disorders
Exacerbation of Depression
|
0.47%
1/211 • Number of events 1 • 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
|
0.93%
1/107 • Number of events 1 • 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
|
|
Musculoskeletal and connective tissue disorders
Fracture of Ankle
|
0.47%
1/211 • Number of events 1 • 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%
0/107 • 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
|
|
General disorders
Rash
|
0.47%
1/211 • Number of events 1 • 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%
0/107 • 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