Monitoring Pre-exposure Prophylaxis for Young Adult Women

NCT ID: NCT02915367

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-21
• Study Completion Date: 2020-04-30

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.

Conditions

HIV/AIDS; Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

SMS Reminders

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

Group Type: EXPERIMENTAL

SMS Reminders

Intervention Type: 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).

No Reminders

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jessica Haberer, MD

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Haberer, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Massachussetts General Hospital

Jared Baeten, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Nelly Mugo

Role: STUDY_DIRECTOR

Kenya Medical Research Institute

Elizabeth Bukusi

Role: STUDY_DIRECTOR

Kenya Medical Research Institute

Locations

KEMRI

Kisumu, , Kenya

KEMRI

Thika, , Kenya

Countries

Kenya

References

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.

Reference Type: DERIVED

PMID: 35147580 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33662265 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01MH109309

Identifier Type: NIH

Identifier Source: org_study_id

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