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| Name | Class |
|---|---|
| University of Washington | OTHER |
| Kenya Medical Research Institute | OTHER |
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Next generation real-time monitoring for PrEP adherence in young Kenyan women
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMS Reminders | Experimental | Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device. |
|
| No Reminders | No Intervention | Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS Reminders | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 2 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Month 1 |
| USD Per Month |
| Measure | Description | Time Frame |
|---|---|---|
| Risk Perception | Assess self-reported weekly HIV risk perception through an automated SMS survey | up to 2 years follow-up |
| Adherence Measure Performance | Tenofovir concentration in DBS compared to electronic adherence data from the prior 30 days for each participant. |
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Haberer, MD, MS | Massachussetts General Hospital | Principal Investigator |
| Jared Baeten, MD, PhD | University of Washington | Principal Investigator |
| Nelly Mugo | Kenya Medical Research Institute | Study Director |
| Elizabeth Bukusi | Kenya Medical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KEMRI | Kisumu | Kenya | ||||
| KEMRI |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35147580 | Derived | Haberer JE, Mugo N, Bukusi EA, Ngure K, Kiptinness C, Oware K, Garrison LE, Musinguzi N, Pyra M, Valenzuela S, Thomas KK, Anderson PL, Thirumurthy H, Baeten JM. Understanding Pre-Exposure Prophylaxis Adherence in Young Women in Kenya. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):251-260. doi: 10.1097/QAI.0000000000002876. | |
| 33662265 | Derived | Haberer JE, Bukusi EA, Mugo NR, Pyra M, Kiptinness C, Oware K, Garrison LE, Thomas KK, Musinguzi N, Morrison S, Anderson PL, Ngure K, Baeten JM; MPYA Study Team. Effect of SMS reminders on PrEP adherence in young Kenyan women (MPYA study): a randomised controlled trial. Lancet HIV. 2021 Mar;8(3):e130-e137. doi: 10.1016/S2352-3018(20)30307-6. |
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De-identified data will be made available at the end of the study upon request.
Data will be available within 12 months of publishing primary results
Data use agreement
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | No Reminders | Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants choosing to take PrEP per arm | Posted | Mean | 95% Confidence Interval | percentage of adherence | up to 2 years follow-up |
|
We attempted to follow all participants for 24 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Social harm | Social circumstances | Non-systematic Assessment | There were five social harms per study arm that were probably or definitely related to study participation, and consisted of verbal or physical abuse with a sexual partner. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Haberer | Massachusetts General Hospital | 617-643-9195 | jhaberer@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 25, 2020 | Sep 16, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 4, 2019 | Sep 16, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
Cost estimates (including time and motion studies) and mathematical modeling estimate the cost-effectiveness of Wisepill plus SMS reminders per HIV case averted |
| two years |
| up to 2 years follow-up |
| Pregnancy Outcomes | Descriptive measures of infants exposed to PrEP during gestation | 6 months post-partum or end of the study |
| Thika |
| Kenya |
| BG001 | No Reminders | Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Reminders | Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device. |
|
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| 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) | Participants using the Wisepill adherence monitor | Posted | Number | participants | Month 1 |
|
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|
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| 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 | Costs for study participants in the "SMS reminders" arm (data were not collected from participants in the "No Reminders" arm) | Posted | Number | USD per month | two years |
|
|
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| Other Pre-specified | Risk Perception | Assess self-reported weekly HIV risk perception through an automated SMS survey | 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) | Posted | Number | participants | up to 2 years follow-up |
|
|
|
|
| Other Pre-specified | Adherence Measure Performance | Tenofovir concentration in DBS compared to electronic adherence data from the prior 30 days for each participant. | Data reflect a 15% random sample. | Posted | Number | Correlation coefficient | up to 2 years follow-up |
|
|
|
| Other Pre-specified | Pregnancy Outcomes | Descriptive measures of infants exposed to PrEP during gestation | Number of pregnancies by arm | Posted | Count of Participants | Participants | 6 months post-partum or end of the study |
|
|
|
| 1 |
| 173 |
| 0 |
| 173 |
| 5 |
| 173 |
| EG001 | No Reminders | Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device. | 0 | 175 | 0 | 174 | 5 | 174 |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
|
| Incremental cost per month in USD (SMS only; at scale) |
|
| ectopic |
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| unknown |
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