Trial Outcomes & Findings for Monitoring Pre-exposure Prophylaxis for Young Adult Women (NCT NCT02915367)
NCT ID: NCT02915367
Last Updated: 2023-05-31
Results Overview
Comparison of average percent adherence (doses taken/doses prescribed) by study arm at each time point among participants choosing to pick up PrEP.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
348 participants
Primary outcome timeframe
up to 2 years follow-up
Results posted on
2023-05-31
Participant Flow
Participant milestones
| Measure |
SMS Reminders
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).
|
No Reminders
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
|
|---|---|---|
|
Overall Study
STARTED
|
173
|
175
|
|
Overall Study
COMPLETED
|
136
|
144
|
|
Overall Study
NOT COMPLETED
|
37
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Monitoring Pre-exposure Prophylaxis for Young Adult Women
Baseline characteristics by cohort
| Measure |
SMS Reminders
n=173 Participants
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).
|
No Reminders
n=175 Participants
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
158 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21 years
n=5 Participants
|
21 years
n=7 Participants
|
21 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
348 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
173 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
348 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
173 participants
n=5 Participants
|
175 participants
n=7 Participants
|
348 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 years follow-upPopulation: Number of participants choosing to take PrEP per arm
Comparison of average percent adherence (doses taken/doses prescribed) by study arm at each time point among participants choosing to pick up PrEP.
Outcome measures
| Measure |
SMS Reminders
n=173 Participants
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).
|
No Reminders
n=175 Participants
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
|
|---|---|---|
|
Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
Month 24 adherence
|
27.0 percentage of adherence
Interval 23.6 to 30.5
|
26.6 percentage of adherence
Interval 23.1 to 30.2
|
|
Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
Month 6 adherence
|
40.2 percentage of adherence
Interval 36.1 to 44.4
|
36.8 percentage of adherence
Interval 32.7 to 40.8
|
SECONDARY outcome
Timeframe: Month 1Population: Participants using the Wisepill adherence monitor
Questionnaire indicating "very interested" in using the Wisepill monitor (a pill box that records the date and time of each opening as a proxy for pill ingestion)
Outcome measures
| Measure |
SMS Reminders
n=173 Participants
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).
|
No Reminders
n=175 Participants
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
|
|---|---|---|
|
Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring
|
141 participants
|
142 participants
|
SECONDARY outcome
Timeframe: two yearsPopulation: Costs for study participants in the "SMS reminders" arm (data were not collected from participants in the "No Reminders" arm)
Cost estimates (including time and motion studies) and mathematical modeling estimate the cost-effectiveness of Wisepill plus SMS reminders per HIV case averted
Outcome measures
| Measure |
SMS Reminders
n=173 Participants
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).
|
No Reminders
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
|
|---|---|---|
|
USD Per Month
Incremental cost per month in USD (Wisepill + SMS)
|
12.64 USD per month
|
—
|
|
USD Per Month
Incremental cost per month in USD (Wisepill + SMS; at scale)
|
7.57 USD per month
|
—
|
|
USD Per Month
Incremental cost per month in USD (SMS only)
|
7.69 USD per month
|
—
|
|
USD Per Month
Incremental cost per month in USD (SMS only; at scale)
|
2.76 USD per month
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2 years follow-upPopulation: Number of participants by arm who reported perceived HIV risk during at least 1 week (among a subset of the participants responding to the SMS surveys)
Assess self-reported weekly HIV risk perception through an automated SMS survey
Outcome measures
| Measure |
SMS Reminders
n=124 Participants
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).
|
No Reminders
n=116 Participants
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
|
|---|---|---|
|
Risk Perception
|
88 participants
|
82 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2 years follow-upPopulation: Data reflect a 15% random sample.
Tenofovir concentration in DBS compared to electronic adherence data from the prior 30 days for each participant.
Outcome measures
| Measure |
SMS Reminders
n=99 Participants
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).
|
No Reminders
n=87 Participants
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
|
|---|---|---|
|
Adherence Measure Performance
|
0.56 Correlation coefficient
|
0.66 Correlation coefficient
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post-partum or end of the studyPopulation: Number of pregnancies by arm
Descriptive measures of infants exposed to PrEP during gestation
Outcome measures
| Measure |
SMS Reminders
n=50 Participants
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).
|
No Reminders
n=63 Participants
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
|
|---|---|---|
|
Pregnancy Outcomes
live birth
|
32 Participants
|
46 Participants
|
|
Pregnancy Outcomes
pregnancy loss
|
15 Participants
|
16 Participants
|
|
Pregnancy Outcomes
ectopic
|
2 Participants
|
0 Participants
|
|
Pregnancy Outcomes
unknown
|
1 Participants
|
1 Participants
|
Adverse Events
SMS Reminders
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
No Reminders
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SMS Reminders
n=173 participants at risk
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).
|
No Reminders
n=174 participants at risk
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
|
|---|---|---|
|
Social circumstances
Social harm
|
2.9%
5/173 • We attempted to follow all participants for 24 months.
|
2.9%
5/174 • We attempted to follow all participants for 24 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place