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

  • End date
    Aug 1, 2024
  • participants needed
  • sponsor
    University of Miami
Updated on 26 January 2021


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 Noncompliance with medication regimen
Treatment Lifesteps for PrEP, Daily text message reminders
Clinical Study IdentifierNCT04316715
SponsorUniversity of Miami
Last Modified on26 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have Noncompliance with medication regimen?
Do you have any of these conditions: Do you have Noncompliance with medication regimen??
Age: 18 years or older
Male sex at birth
Self-reports as a man who has sex with men
PrEP nave (started PrEP in the past month, or restarting after not taking for 6 months or more)
Medical providers at each site will determine that the participant is indicated for PrEP per Centers for Disease Control (CDC) guidelines
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
Owns a cell phone that has texting and internet / data capacity

Exclusion Criteria

Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
Has lived in the greater Boston or Miami areas for less than three months (as a means to enhance participant retention)
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)
Laboratory or clinical findings that would preclude PrEP initiation (e.g. decreased creatinine clearance)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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