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

University of Miami

Status: Completed

Conditions: Adherence, Medication

Treatments: Behavioral: Lifesteps for PrEP; Behavioral: Daily text message reminders

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04316715

20190646

R01MH118043 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 300 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Life-Steps for PreP

Experimental group

Description:

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.

Treatment:

Behavioral: Daily text message reminders

Behavioral: Lifesteps for PrEP

Standard of Care

No Intervention group

Description:

Participants in this group will not receive an intervention outside the standard of care.