Monitoring Pre-exposure Prophylaxis for Young Adult Women (MPYA)

Mass General Brigham

Status: Completed

Conditions: Adherence; HIV/AIDS

Treatments: Behavioral: SMS Reminders

Study type: Interventional

Funder types: Other

Identifiers

NCT02915367

R01MH109309

Details and patient eligibility

About

Next generation real-time monitoring for PrEP adherence in young Kenyan women

Full 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.

Enrollment: 348 patients

Sex: Female

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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348 participants in 2 patient groups

SMS Reminders

Experimental group

Description:

Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.

Treatment:

Behavioral: SMS Reminders

No Reminders

No Intervention group

Description:

Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.