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OpenTrials
Completed

NCT Number: NCT04316715

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

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

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Key information

Conditions

Adherence, Medication Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 years or older
  • Male sex at birth or trans man (current gender identity is male) assigned female sex at birth
  • Self-reports as a person who has sex with men
  • PrEP naïve or is currently prescribed PrEP and reports uncertainty about future adherence
  • 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
  • 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)

Treatment and study plan

Lifesteps for PrEP

Behavioral

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.

Daily text message reminders

Behavioral

Participants get daily text messages on their cell phone reminding them to take their PrEP medication.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2020
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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