NCT04316715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 3, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2025

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

4.8 years

First QC Date

March 19, 2020

Last Update Submit

August 19, 2025

Conditions

Adherence, Medication

Keywords

Life-StepsHIV Prevention

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Retention in PrEP care

    3, 6, 9, 12, 15, and 18 months

Study Arms (2)

Life-Steps for PreP

EXPERIMENTAL

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 PrEPBehavioral: Daily text message reminders

Standard of Care

NO INTERVENTION

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

Interventions

Lifesteps for PrEPBEHAVIORAL

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.

Life-Steps for PreP
Daily text message remindersBEHAVIORAL

Participants get daily text messages on their cell phone reminding them to take their PrEP medication.

Life-Steps for PreP

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

Fenway Health

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Steven A Safren, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 20, 2020

Study Start

September 3, 2020

Primary Completion

July 8, 2025

Study Completion

August 1, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)