Monitoring Pre-exposure Prophylaxis for Young Adult Women

NCT02915367 | Completed Results

• 1 other identifier: R01MH109309
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

HIV/AIDS; Adherence

Keywords

HIV/AIDS; adherence; women; real time monitoring; risk; SMS; mHealth

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring

  Month 1

• USD Per Month

  two years

Other Outcomes (3)

• Risk Perception

  up to 2 years follow-up

• Adherence Measure Performance

  up to 2 years follow-up

• Pregnancy Outcomes

  6 months post-partum or end of the study

Study Arms (2)

SMS Reminders

EXPERIMENTAL

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

Behavioral: SMS Reminders

No Reminders

NO INTERVENTION

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

Interventions

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).

SMS Reminders

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Washington: collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (2)

KEMRI

Kisumu, Kenya

Location

KEMRI

Thika, Kenya

Location

Related Publications (2)

• 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.

  PMID: 35147580 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.

  PMID: 33662265 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Jessica Haberer
• Organization: Massachusetts General Hospital

jhaberer@partners.org

617-643-9195

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 27, 2016
• Study Start: December 21, 2016
• Primary Completion: March 20, 2020
• Study Completion: April 30, 2020
• Last Updated: May 31, 2023
• Results First Posted: April 8, 2022

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within 12 months of publishing primary results
• Access Criteria: Data use agreement

Locations

KE (2)