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

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

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

Conditions
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Adherence, Medication

Intervention / Treatment
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* Behavioral: Lifesteps for PrEP
* Behavioral: Daily text message reminders


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Life-Steps for PreP<br>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<br>* 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.<br>Behavioral: Daily text message reminders<br>* Participants get daily text messages on their cell phone reminding them to take their PrEP medication.<br>|
| No Intervention: Standard of Care<br>Participants in this group will not receive an intervention outside the standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TFV-DP concentrations | Medication adherence as reported by Tenofovir diphosphate (TFV-DP) concentrations measured using dried blood spot (DBS) testing. | 3, 6, 9, 12, 15, and 18 months | 
| Wilson Medication Adherence self-report | 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. | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in PrEP care | The percentage of participant attendance at follow up visits over 18 month study participation | 3, 6, 9, 12, 15, and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Life-Steps, HIV Prevention