Trial Outcomes & Findings for Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women (NCT NCT02584140)
NCT ID: NCT02584140
Last Updated: 2021-07-08
Results Overview
Adherence is measured by TFV-DP (tenofovir diphosphate) concentrations in Dried Blood Spots (DBS) suggestive of 6-7 doses per week.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
136 participants
Primary outcome timeframe
Week 4 to Week 48
Results posted on
2021-07-08
Participant Flow
Participant milestones
| Measure |
AEGIS
All participants will be assigned to this arm of the study.
Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.
Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of \<1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of \<1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.
Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
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|---|---|
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Overall Study
STARTED
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136
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Overall Study
COMPLETED
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83
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Overall Study
NOT COMPLETED
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53
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women
Baseline characteristics by cohort
| Measure |
AEGIS
n=136 Participants
All participants will be assigned to this arm of the study.
Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.
Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of \<1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of \<1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.
Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
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|---|---|
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Age, Continuous
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39.16 years
STANDARD_DEVIATION 9.98 • n=39 Participants
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Sex: Female, Male
Female
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136 Participants
n=39 Participants
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Sex: Female, Male
Male
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0 Participants
n=39 Participants
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Race/Ethnicity, Customized
Non-Hispanic White
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30 Participants
n=39 Participants
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Race/Ethnicity, Customized
Non-Hispanic Black
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52 Participants
n=39 Participants
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|
Race/Ethnicity, Customized
Latina
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26 Participants
n=39 Participants
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Race/Ethnicity, Customized
Other
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28 Participants
n=39 Participants
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Region of Enrollment
United States
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136 participants
n=39 Participants
|
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Education
High school or less
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61 Participants
n=39 Participants
|
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Education
Some college or more
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75 Participants
n=39 Participants
|
|
Monthly Income
$2,000 or less
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74 Participants
n=39 Participants
|
|
Monthly Income
More than $2,000
|
35 Participants
n=39 Participants
|
|
Monthly Income
No response
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27 Participants
n=39 Participants
|
|
Relationship
Divorced/Widowed/Separated
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17 Participants
n=39 Participants
|
|
Relationship
Married/Monogamous
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53 Participants
n=39 Participants
|
|
Relationship
Single/Open
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63 Participants
n=39 Participants
|
|
Relationship
No response
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3 Participants
n=39 Participants
|
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Employment
Full/Part time/Retired
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68 Participants
n=39 Participants
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Employment
Unemployed/Unable to work
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60 Participants
n=39 Participants
|
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Employment
No response
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8 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Week 4 to Week 48Adherence is measured by TFV-DP (tenofovir diphosphate) concentrations in Dried Blood Spots (DBS) suggestive of 6-7 doses per week.
Outcome measures
| Measure |
AEGIS
n=136 Participants
All participants will be assigned to this arm of the study.
Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.
Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of \<1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of \<1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.
Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
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|---|---|
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Adherence to PrEP
Week 12 · 2-3 doses (350 - 699 fmol/punch)
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19 Participants
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Adherence to PrEP
Week 12 · 4-5 doses (700 - 1049 fmol/punch)
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17 Participants
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Adherence to PrEP
Week 48 · 2-3 doses (350 - 699 fmol/punch)
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8 Participants
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Adherence to PrEP
Week 48 · 4-5 doses (700 - 1049 fmol/punch)
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17 Participants
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Adherence to PrEP
Week 48 · 6-7 doses (≥ 1050 fmol/punch)
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25 Participants
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Adherence to PrEP
Week 48 · Missed Visit, Withdrawal, Off PrEP
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70 Participants
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Adherence to PrEP
Week 12 · 6-7 doses (≥ 1050 fmol/punch)
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45 Participants
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Adherence to PrEP
Week 12 · Missed Visit, Withdrawal, Off PrEP
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34 Participants
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Adherence to PrEP
Week 24 · <2 doses (BLQ - 349 fmol/punch)
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15 Participants
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Adherence to PrEP
Week 24 · 2-3 doses (350 - 699 fmol/punch)
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11 Participants
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Adherence to PrEP
Week 24 · 4-5 doses (700 - 1049 fmol/punch)
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25 Participants
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Adherence to PrEP
Week 24 · 6-7 doses (≥ 1050 fmol/punch)
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29 Participants
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Adherence to PrEP
Week 24 · Missed Visit, Withdrawal, Off PrEP
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56 Participants
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Adherence to PrEP
Week 36 · <2 doses (BLQ - 349 fmol/punch)
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16 Participants
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Adherence to PrEP
Week 36 · 2-3 doses (350 - 699 fmol/punch)
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8 Participants
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Adherence to PrEP
Week 36 · 4-5 doses (700 - 1049 fmol/punch)
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17 Participants
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Adherence to PrEP
Week 36 · 6-7 doses (≥ 1050 fmol/punch)
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28 Participants
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Adherence to PrEP
Week 36 · Missed Visit, Withdrawal, Off PrEP
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67 Participants
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Adherence to PrEP
Week 48 · <2 doses (BLQ - 349 fmol/punch)
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16 Participants
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Adherence to PrEP
Week 4 · <2 doses (BLQ - 349 fmol/punch)
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22 Participants
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Adherence to PrEP
Week 4 · 2-3 doses (350 - 699 fmol/punch)
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11 Participants
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Adherence to PrEP
Week 4 · 4-5 doses (700 - 1049 fmol/punch)
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30 Participants
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Adherence to PrEP
Week 4 · 6-7 doses (≥ 1050 fmol/punch)
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54 Participants
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Adherence to PrEP
Week 4 · Missed Visit, Withdrawal, Off PrEP
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19 Participants
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Adherence to PrEP
Week 12 · <2 doses (BLQ - 349 fmol/punch)
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21 Participants
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SECONDARY outcome
Timeframe: Baseline to Week 48Describe the safety and tolerability of daily emtricitabine/tenofovir disoproxil fumarate TDF/FTC given for PrEP including discontinuation for any adverse event, serious adverse events and adverse events (grade 2 or higher).
Outcome measures
| Measure |
AEGIS
n=136 Participants
All participants will be assigned to this arm of the study.
Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.
Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of \<1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of \<1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.
Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
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Number of Participants Experiencing Treatment-Emergent Adverse Events
One of more grade 2+ AEs
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72 Participants
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Number of Participants Experiencing Treatment-Emergent Adverse Events
No grade 2+ AEs reported
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64 Participants
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SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants with one or more follow-up visits were included in this analysis
Number of new HIV infections observed among participants with at least one follow-up visit.
Outcome measures
| Measure |
AEGIS
n=121 Participants
All participants will be assigned to this arm of the study.
Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.
Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of \<1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of \<1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.
Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
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|---|---|
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Number of HIV Infections
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0 infections
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SECONDARY outcome
Timeframe: Baseline to Week 48Self-reported adherence by daily texting through iTAB will be correlated with TFV-DP concentrations in DBS
Outcome measures
| Measure |
AEGIS
n=136 Participants
All participants will be assigned to this arm of the study.
Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.
Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of \<1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of \<1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.
Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
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|---|---|
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Correlates of PrEP Adherence
Week 4 · TFV-DP <1050 fmol/punch (0-5 doses weekly)
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58 Participants
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Correlates of PrEP Adherence
Week 4 · TFV-DP ≥1050 fmol/punch (6-7 doses weekly)
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50 Participants
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Correlates of PrEP Adherence
Week 36 · TFV-DP <1050 fmol/punch (0-5 doses weekly)
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39 Participants
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Correlates of PrEP Adherence
Week 36 · TFV-DP ≥1050 fmol/punch (6-7 doses weekly)
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26 Participants
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Correlates of PrEP Adherence
Week 36 · Missing/Withdrawn/On study, off medication
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71 Participants
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Correlates of PrEP Adherence
Week 48 · TFV-DP <1050 fmol/punch (0-5 doses weekly)
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38 Participants
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Correlates of PrEP Adherence
Week 48 · TFV-DP ≥1050 fmol/punch (6-7 doses weekly)
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23 Participants
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Correlates of PrEP Adherence
Week 48 · Missing/Withdrawn/On study, off medication
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75 Participants
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Correlates of PrEP Adherence
Week 4 · Missing/Withdrawn/On study, off medication
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28 Participants
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Correlates of PrEP Adherence
Week 12 · TFV-DP <1050 fmol/punch (0-5 doses weekly)
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55 Participants
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Correlates of PrEP Adherence
Week 12 · TFV-DP ≥1050 fmol/punch (6-7 doses weekly)
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44 Participants
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Correlates of PrEP Adherence
Week 12 · Missing/Withdrawn/On study, off medication
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37 Participants
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Correlates of PrEP Adherence
Week 24 · TFV-DP <1050 fmol/punch (0-5 doses weekly)
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48 Participants
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Correlates of PrEP Adherence
Week 24 · TFV-DP ≥1050 fmol/punch (6-7 doses weekly)
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28 Participants
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Correlates of PrEP Adherence
Week 24 · Missing/Withdrawn/On study, off medication
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60 Participants
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Adverse Events
AEGIS
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AEGIS
n=136 participants at risk
All participants will be assigned to this arm of the study.
Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.
Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of \<1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of \<1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.
Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
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|---|---|
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Nervous system disorders
Headache
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2.9%
4/136 • Number of events 4 • 48 Weeks
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Gastrointestinal disorders
Abdominal Discomfort
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3.7%
5/136 • Number of events 5 • 48 Weeks
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Investigations
Decreased Creatinine Clearance
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44.9%
61/136 • Number of events 126 • 48 Weeks
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Additional Information
Jill Blumenthal, MD
UCSD Medical Center, Antiviral Research Center
Phone: (619) 471-3913
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place