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

Not Applicable

Active, not recruiting

• Conditions: Adherence, Medication
• Interventions: Behavioral: Lifesteps for PrEP; Behavioral: Daily text message reminders

• Registration Number: NCT04316715
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-20
• Study Start: 2020-09-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 250

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Life-Steps for PreP	Lifesteps for PrEP	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.
Life-Steps for PreP	Daily text message reminders	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.

Primary Outcome Measures

Name	Time	Method
TFV-DP concentrations	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	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 Outcome Measures

Name	Time	Method
Retention in PrEP care	3, 6, 9, 12, 15, and 18 months	The percentage of participant attendance at follow up visits over 18 month study participation

Trial Locations

Locations (2)

Fenway Health; 🇺🇸 Boston, Massachusetts, United States

University of Miami; 🇺🇸 Miami, Florida, United States