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

CompletedNA

Sponsor: University of Miami

Conditions: Adherence, Medication

Interventions: Lifesteps for PrEP, Daily text message reminders

Countries: United States

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

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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)

Locations (2)

Miami, Florida, United States
Boston, Massachusetts, United States