Adherence, HIV/AIDS
Conditions
Keywords
HIV/AIDS, adherence, women, real time monitoring, risk, SMS, mHealth
Brief summary
Next generation real-time monitoring for PrEP adherence in young Kenyan women
Detailed description
This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered HIV pre-exposure prophylaxis (PrEP) for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive short message service (SMS) reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women. Additionally, SMS will be used for longitudinal assessment of risk perception and its alignment with PrEP adherence.
Interventions
BEHAVIORALSMS 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).
Sponsors
University of Washington
Kenya Medical Research Institute
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* HIV-uninfected (as determined by Kenya national testing algorithms) * Wanting to start PrEP with an initial recommendation of 6 months of use * Clinically safe to receive PrEP, in accordance with Centers for Disease Control and Prevention (CDC) guidelines: * Creatinine clearance \>60 mL/min * Not infected with hepatitis B * No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study * Sexually active (defined as vaginal or anal sex) within the last 3 months * At high risk for HIV infection based on a validated risk score of \>5 or being in an HIV serodiscordant relationship * Not pregnant * Owns a personal cell phone (not shared) compatible with study protocols and the ability to charge it * Ability to send a text message * Intending to stay in the area for at least the next year * Willing to use study criteria
Exclusion criteria
* Unable to provide consent * Breast-feeding (PrEPis not currently approved for use during breast-feeding) * Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months | up to 2 years follow-up | Comparison of average percent adherence (doses taken/doses prescribed) by study arm at each time point among participants choosing to pick up PrEP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring | Month 1 | 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) |
| USD Per Month | two years | Cost estimates (including time and motion studies) and mathematical modeling estimate the cost-effectiveness of Wisepill plus SMS reminders per HIV case averted |
Other
| Measure | Time frame | Description |
|---|---|---|
| Risk Perception | up to 2 years follow-up | Assess self-reported weekly HIV risk perception through an automated SMS survey |
| Adherence Measure Performance | up to 2 years follow-up | Tenofovir concentration in DBS compared to electronic adherence data from the prior 30 days for each participant. |
| Pregnancy Outcomes | 6 months post-partum or end of the study | Descriptive measures of infants exposed to PrEP during gestation |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 173 |
| No Reminders Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device. | 175 |
| Total | 348 |
Baseline characteristics
| Characteristic | No Reminders | Total | SMS Reminders |
|---|---|---|---|
| Age, Categorical <=18 years | 19 Participants | 34 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 156 Participants | 314 Participants | 158 Participants |
| Age, Continuous | 21 years | 21 years | 21 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 175 Participants | 348 Participants | 173 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 175 participants | 348 participants | 173 participants |
| Sex: Female, Male Female | 175 Participants | 348 Participants | 173 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 173 | 0 / 175 |
| other Total, other adverse events | 5 / 173 | 5 / 174 |
| serious Total, serious adverse events | 0 / 173 | 0 / 174 |
Outcome results
Primary
Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
Comparison of average percent adherence (doses taken/doses prescribed) by study arm at each time point among participants choosing to pick up PrEP.
Time frame: up to 2 years follow-up
Population: Number of participants choosing to take PrEP per arm
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SMS Reminders | Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months | Month 24 adherence | 27.0 percentage of adherence |
| SMS Reminders | Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months | Month 6 adherence | 40.2 percentage of adherence |
| No Reminders | Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months | Month 6 adherence | 36.8 percentage of adherence |
| No Reminders | Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months | Month 24 adherence | 26.6 percentage of adherence |
Secondary
Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring
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)
Time frame: Month 1
Population: Participants using the Wisepill adherence monitor
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SMS Reminders | Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring | 141 participants |
| No Reminders | Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring | 142 participants |
p-value: 0.93Chi-squared
Secondary
USD Per Month
Cost estimates (including time and motion studies) and mathematical modeling estimate the cost-effectiveness of Wisepill plus SMS reminders per HIV case averted
Time frame: two years
Population: Costs for study participants in the SMS reminders arm (data were not collected from participants in the No Reminders arm)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SMS Reminders | USD Per Month | Incremental cost per month in USD (Wisepill + SMS) | 12.64 USD per month |
| SMS Reminders | USD Per Month | Incremental cost per month in USD (Wisepill + SMS; at scale) | 7.57 USD per month |
| SMS Reminders | USD Per Month | Incremental cost per month in USD (SMS only) | 7.69 USD per month |
| SMS Reminders | USD Per Month | Incremental cost per month in USD (SMS only; at scale) | 2.76 USD per month |
Other Pre-specified
Adherence Measure Performance
Tenofovir concentration in DBS compared to electronic adherence data from the prior 30 days for each participant.
Time frame: up to 2 years follow-up
Population: Data reflect a 15% random sample.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SMS Reminders | Adherence Measure Performance | 0.56 Correlation coefficient |
| No Reminders | Adherence Measure Performance | 0.66 Correlation coefficient |
Other Pre-specified
Pregnancy Outcomes
Descriptive measures of infants exposed to PrEP during gestation
Time frame: 6 months post-partum or end of the study
Population: Number of pregnancies by arm
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SMS Reminders | Pregnancy Outcomes | live birth | 32 Participants |
| SMS Reminders | Pregnancy Outcomes | pregnancy loss | 15 Participants |
| SMS Reminders | Pregnancy Outcomes | ectopic | 2 Participants |
| SMS Reminders | Pregnancy Outcomes | unknown | 1 Participants |
| No Reminders | Pregnancy Outcomes | unknown | 1 Participants |
| No Reminders | Pregnancy Outcomes | live birth | 46 Participants |
| No Reminders | Pregnancy Outcomes | ectopic | 0 Participants |
| No Reminders | Pregnancy Outcomes | pregnancy loss | 16 Participants |
Other Pre-specified
Risk Perception
Assess self-reported weekly HIV risk perception through an automated SMS survey
Time frame: up to 2 years follow-up
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SMS Reminders | Risk Perception | 88 participants |
| No Reminders | Risk Perception | 82 participants |
p-value: 0.96Chi-squared