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The PrEP (Pre-exposure Prophylaxis) SMART Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038060
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : August 2, 2019
Sponsor:
Collaborators:
Wits Reproductive Health and HIV Institute
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Connie Celum, University of Washington

Study Description
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Brief Summary:
The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: WhatsApp Group Behavioral: 2-way SMS Behavioral: Drug level feedback Behavioral: Monthly counseling sessions Phase 4

Detailed Description:
Women enrolled in the study will be randomized to standard of care adherence support (brief counseling) and either WhatsApp groups or weekly two-way SMS messages. Two months after PrEP initiation, tenofovir drug levels will be measured to determine if participants have achieved high adherence based on their initial randomization. Women with high adherence (i.e., TFV-DP >/=500 fmol/punch from dried blood spots [DBS]) will continue with the adherence support to which they were initially randomized. Participants with low adherence (i.e., TFV-DP <500 fmol/punch from DBS) will continue initial randomization (WhatsApp or two-way SMS) plus be randomized to more one of two more intensive adherence support interventions - continued monthly visits with adherence and problem-focused counseling at months 3-8 or quarterly visits between months 3-9 with feedback about adherence based on drug levels at months 3 and 6.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential multiple assignment randomized trial (SMART)
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of Stepped PrEP (Pre-exposure Prophylaxis) Adherence Support for Young South African Women Using a SMART Design
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: WhatsApp Group
Participants will be assigned to participate in a WhatsApp Group
 Behavioral: WhatsApp Group
Participants will receive peer adherence support through WhatsApp groups
Experimental: 2-way SMS
Participants will be assigned to receive weekly 2-way SMS initiated by the study team
 Behavioral: 2-way SMS
Participants will receive healthcare worker adherence support through 2-way SMS
Experimental: 2-way SMS and monthly counseling sessions
Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions
 Behavioral: 2-way SMS
Participants will receive healthcare worker adherence support through 2-way SMS

Behavioral: Monthly counseling sessions
Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence
Experimental: 2-way SMS and drug level feedback
Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback
 Behavioral: 2-way SMS
Participants will receive healthcare worker adherence support through 2-way SMS

Behavioral: Drug level feedback
Participants will receive adherence counseling based on tenofovir drug levels
Experimental: WhatsApp Group and monthly counseling sessions
Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
 Behavioral: WhatsApp Group
Participants will receive peer adherence support through WhatsApp groups

Behavioral: Monthly counseling sessions
Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence
Experimental: WhatsApp Group and drug level feedback
Participants will be assigned to participate in a WhatsApp Group and drug level feedback
 Behavioral: WhatsApp Group
Participants will receive peer adherence support through WhatsApp groups

Behavioral: Drug level feedback
Participants will receive adherence counseling based on tenofovir drug levels


Outcome Measures
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Primary Outcome Measures :
  1. PrEP Adherence [ Time Frame: 9 months ]
    Evaluation of the proportion of young women who adhere well to PrEP in each of the intervention arms.


Secondary Outcome Measures :
  1. PrEP persistence [ Time Frame: 12 months ]
    Assessment of the proportion of young women who achieve high adherence.

  2. Correlates of PrEP adherence [ Time Frame: 12 months ]
    Assessment of the correlates of PrEP adherence, after adjusting for study arm.

  3. PrEP discontinuation [ Time Frame: 12 months ]
    Assessment of the timing of PrEP discontinuation in young women who discontinue PrEP.

  4. PrEP decision making [ Time Frame: 12 months ]
    Qualitative exploration of the factors that influence women's decisions to adhere to PrEP.

  5. Intervention satisfaction [ Time Frame: 12 months ]
    Qualitative exploration of women's satisfaction with their assigned intervention(s).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female at birth
  • Age 18-25 years
  • Per participant report, sexually active, defined as having vaginal or anal intercourse at least once in the month prior to screening
  • Literate in one or more of the study languages
  • Willing and able to provide informed consent
  • Able and willing to provide adequate locator information
  • Regular access to a mobile phone with SMS and WhatsApp capacity
  • Agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation

Exclusion Criteria:

  • Planning to relocate in the next 12 months
  • Has a job or other obligations that would require long absences from the area (> 4 weeks at a time) for 12 months
  • A reactive or positive HIV test at Enrollment
  • Any reported PrEP use within the last 6 months
  • Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents
  • Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial
  • Positive pregnancy test
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038060


Contacts
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Contact: Jennifer Morton, MPH, MSW 12065203832 jfmorton@uw.edu
Contact: Jennifer Velloza, PhD, MPH 206-520-3800 jvelloza@uw.edu

Locations
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South Africa
Wits Reproductive Health and HIV Institute Recruiting
Johannesburg, South Africa
Contact: Sinead Delany-Moretlwe, MBHcB, PhD         
Sponsors and Collaborators
University of Washington
Wits Reproductive Health and HIV Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Connie Celum, MD, MPH University of Washington
Principal Investigator: Sinead Delany-Moretlwe, MBChB, PhD Wits Reproductive Health and HIV Institute
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Responsible Party: Connie Celum, Prof of Medicine & Global Health, Adjunct Prof of Epidemiology, University of Washington
ClinicalTrials.gov Identifier: NCT04038060    
Other Study ID Numbers: STUDY00006439
R01MH114544 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from the PrEP SMART Study will be available at the end of the project by contacting the Principal Investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Connie Celum, University of Washington:
pre-exposure prophylaxis
young women
HIV infections/prevention
SMART design