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

University of Miami2 sites in 1 country300 target enrollmentSeptember 3, 2020

ConditionsAdherence, Medication

Overview

Phase: N/A
Intervention: Not specified
Conditions: Adherence, Medication
Sponsor: University of Miami
Enrollment: 300
Locations: 2
Primary Endpoint: TFV-DP concentrations
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 3, 2020

End Date

August 1, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Steven Safren

Professor

University of Miami

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

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.