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Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care

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. Identifier: NCT04316715
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : September 14, 2022
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven Safren, University of Miami

Brief Summary:
The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.

Condition or disease Intervention/treatment Phase
Adherence, Medication Behavioral: Lifesteps for PrEP Behavioral: Daily text message reminders Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2024

Arm Intervention/treatment
Experimental: Life-Steps for PreP
Participants in this group will receive standard of care treatment plus daily text message reminders. A subset of participants who demonstrate continued adherence challenges will also receive 4-6 weekly sessions of the Lifesteps for PrEP intervention.
Behavioral: Lifesteps for PrEP
Four weekly nurse delivered counseling sessions plus two optional booster sessions. Sessions last approximately 40-50 minutes each. Sessions employ cognitive behavioral (CBT) techniques, motivational interviewing (MI), and psychoeducation.

Behavioral: Daily text message reminders
Participants get daily text messages on their cell phone reminding them to take their PrEP medication.

No Intervention: Standard of Care
Participants in this group will not receive an intervention outside the standard of care.

Primary Outcome Measures :
  1. TFV-DP concentrations [ Time Frame: 3, 6, 9, 12, 15, and 18 months ]
    Medication adherence as reported by Tenofovir diphosphate (TFV-DP) concentrations measured using dried blood spot (DBS) testing.

  2. Wilson Medication Adherence self-report [ Time Frame: up to 18 months ]
    Medication adherence as reported by the Wilson Medication Adherence self-report. The questionnaire has a total score ranging from 0-40, with a higher score indicating greater adherence.

Secondary Outcome Measures :
  1. Retention in PrEP care [ Time Frame: 3, 6, 9, 12, 15, and 18 months ]
    The percentage of participant attendance at follow up visits over 18 month study participation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age: 18 years or older
  2. Male sex at birth or trans man (current gender identity is male) assigned female sex at birth
  3. Self-reports as a person who has sex with men
  4. PrEP naïve or is currently prescribed PrEP and reports uncertainty about future adherence
  5. Medical providers at each site will determine that the participant is indicated for PrEP per Centers for Disease Control (CDC) guidelines
  6. Screens in for currently having one or more of the following psychosocial syndemic problems: depression; heavy alcohol use; problematic substance use or polydrug use; history of trauma or abuse; and/or current interpersonal violence
  7. Owns a cell phone that has texting and internet / data capacity

Exclusion Criteria:

  1. Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
  2. Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of enrollment (these patients will be referred immediately for treatment, but may join the study when this is resolved)
  3. Laboratory or clinical findings that would preclude PrEP initiation (e.g. decreased creatinine clearance)

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 identifier (NCT number): NCT04316715

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Contact: Marc Puccinelli, Ph.D. 3052433508

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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Marc Puccinelli, Ph.D.    305-243-3508   
Principal Investigator: Steven A Safren, Ph.D.         
United States, Massachusetts
Fenway Health Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jairan Sadeghi, BSN    857-313-6978   
Principal Investigator: Kenneth Mayer, MD         
Sponsors and Collaborators
University of Miami
National Institute of Mental Health (NIMH)
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Principal Investigator: Steven A Safren, Ph.D. University of Miami
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Responsible Party: Steven Safren, Professor, University of Miami Identifier: NCT04316715    
Other Study ID Numbers: 20190646
R01MH118043 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Steven Safren, University of Miami:
HIV Prevention