Clinical trial NCT02915367: Monitoring Pre-exposure Prophylaxis for Young Adult Women
Official title: Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Adherence
Keywords: HIV/AIDS
adherence
women
real time monitoring
risk
SMS
mHealth
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Kenya Medical Research Institute
First posted: 2016-09-27
Enrollment: 348
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
timeFrame: up to 2 years follow-up
Secondary outcomes:
measure: Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring
timeFrame: Month 1
measure: USD Per Month
timeFrame: two years
Other outcomes:
measure: Risk Perception
timeFrame: up to 2 years follow-up
measure: Adherence Measure Performance
timeFrame: up to 2 years follow-up
measure: Pregnancy Outcomes
timeFrame: 6 months post-partum or end of the study
Locations:
city: Kisumu
country: Kenya
facility: KEMRI
city: Thika
country: Kenya
facility: KEMRI
Study officials:
affiliation: Massachussetts General Hospital
name: Jessica Haberer, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Jared Baeten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenya Medical Research Institute
name: Nelly Mugo
role: STUDY_DIRECTOR
affiliation: Kenya Medical Research Institute
name: Elizabeth Bukusi
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.