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

Adherence, Medication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04316715
• Other study ID #: 20190646
• Secondary ID: R01MH118043
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2023
• Source: University of Miami
• Contact: Marc Puccinelli, Ph.D.
• Phone: 3052433508
• Email: mpuccinelli[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adherence, Medication

Intervention

Behavioral:
• Lifesteps for PrEP
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.
• Daily text message reminders
Participants get daily text messages on their cell phone reminding them to take their PrEP medication.

Locations

Country	Name	City	State
United States	Fenway Health	Boston	Massachusetts
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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