Adherence, MedicationNCT04316715

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

A study testing Lifesteps for PrEP and Daily text message reminders in people with Adherence, Medication, run by University of Miami at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Adherence, Medication
What is being tested?: Lifesteps for PrEP and Daily text message reminders
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 2 sitesUnited States
Study dates: 3 Sep 2020to 1 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Fenway Health
Boston, Massachusetts, 02215
University of Miami
Miami, Florida, 33136

Other trials in United States

About this study

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

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

Conditions: Adherence, Medication
Being tested: Lifesteps for PrEP, Daily text message reminders
Keywords: Life-Steps, HIV Prevention
Medical subject headings: Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04316715
Study group	Role	What they receive
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. Receives: Behavioral: Lifesteps for PrEP; Behavioral: Daily text message reminders
Standard of Care	No intervention	Participants in this group will not receive an intervention outside the standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants With TFV-DP Concentrations Consistent With Adherence (≥4 Doses/Week)
Medication adherence as reported by Tenofovir diphosphate (TFV-DP) concentrations measured using dried blood spot (DBS) testing. Measured by the concentration of PrEP medication in dried blood spots (DBS), displaying levels consistent with adherence (4+ pills per week). Outcomes reported categorically as "adherent" vs. "not adherent." Count of participants measures participants with TFV-DP concentrations consistent with adherence (4+ pill per week).
Measured: 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 score ranging from 0-1, with a higher score indicating greater adherence.
Measured: 3, 6, 9, 12, 15, and 18 months

Secondary outcomes (1)

Retention in PrEP Care
The number of participants in attendance at each follow up visit over 18 month study participation
Measured: 3, 6, 9, 12, 15, and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 20201 Aug 2025

First posted20 Mar 2020
Study start3 Sep 2020
Primary completion8 Jul 2025
Study completion1 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adherence, MedicationStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04316715
Sponsor's protocol ID: 20190646
Other IDs: R01MH118043
Status last verified: Aug 2026
First submitted: 19 Mar 2020
Last updated: 16 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care
ClinicalTrials.gov ID: NCT04316715
Acronym / sponsor ID: 20190646
Conditions: Adherence, Medication
Keywords: Life-Steps, HIV Prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 3 Sep 2020 (actual)
Primary completion: 8 Jul 2025 (actual)
Study completion: 1 Aug 2025 (actual)
First posted: 20 Mar 2020 (actual)
Results: Posted 16 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Life-Steps for PreP	Experimental	Behavioral: Lifesteps for PrEP, Behavioral: Daily text message remindersParticipants 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.
Standard of Care	No intervention	–Participants in this group will not receive an intervention outside the standard of care.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (3 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lifesteps for PrEPFour 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.	Behavioural	Life-Steps for PreP
Daily text message remindersParticipants get daily text messages on their cell phone reminding them to take their PrEP medication.	Behavioural	Life-Steps for PreP

Primary outcome

Participants With TFV-DP Concentrations Consistent With Adherence (≥4 Doses/Week)
Time frame: 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. Measured by the concentration of PrEP medication in dried blood spots (DBS), displaying levels consistent with adherence (4+ pills per week). Outcomes reported categorically as "adherent" vs. "not adherent." Count of participants measures participants with TFV-DP concentrations consistent with adherence (4+ pill per week).
Wilson Medication Adherence Self-Report
Time frame: 3, 6, 9, 12, 15, and 18 months
Medication adherence as reported by the Wilson Medication Adherence self-report. The questionnaire has a score ranging from 0-1, with a higher score indicating greater adherence.

1 secondary outcome

Retention in PrEP Care
Time frame: 3, 6, 9, 12, 15, and 18 months

Results and safety

Results posted to the registry on 16 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Life-Steps for PreP	151	126
Standard of Care	149	130

Primary outcome: Participants With TFV-DP Concentrations Consistent With Adherence (≥4 Doses/Week)

Time frame: 3, 6, 9, 12, 15, and 18 months. Count of participants. Unit: Participants

Measure	Life-Steps for PreP n = 151	Standard of Care n = 149
3-Month Follow up	62	69
6-Month Follow Up	62	51
9-Month Follow Up	56	51
12-Month Follow Up	61	55
15-Month Follow Up	49	44
18-Month Follow Up	58	51

Life-Steps for PreP vs Standard of Care: Odds Ratio (OR): 1.002 (95% CI 0.893 to 1.125), p = 0.9697, Generalized Estimating Equation

Population analysed: At each time-point, participants who had an analyzable dried blood spot (DBS) sample are included.

Primary outcome: Wilson Medication Adherence Self-Report

Time frame: 3, 6, 9, 12, 15, and 18 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Life-Steps for PreP n = 151	Standard of Care n = 149
3-Month Follow up	0.83 (0.21)	0.81 (0.19)
6-Month Follow Up	0.82 (0.24)	0.82 (0.22)
9-Month Follow Up	0.82 (0.24)	0.77 (0.28)
12-Month Follow Up	0.8 (0.29)	0.78 (0.28)
15-Month Follow Up	0.79 (0.31)	0.77 (0.28)
18-Month Follow Up	0.83 (0.25)	0.75 (0.31)

Life-Steps for PreP vs Standard of Care: Slope: 0.019 (95% CI 0.003 to 0.035), p = 0.024, Bayesian Mixed Effects Model

Population analysed: At each time-point, participants who completed this specific measure are included.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Life-Steps for PreP	1 of 151 (0.7%)	1 of 151 (0.7%)	0 of 151
Standard of Care	5 of 149 (3.4%)	1 of 149 (0.7%)	0 of 149

Limitations and caveats (from the sponsor): The number of participants at each visit fluctuates due to attendance.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven A Safren, Ph.D. principal investigator

University of Miami

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lifesteps for PrEP and Daily text message reminders in people with Adherence, Medication, run by University of Miami at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With TFV-DP Concentrations Consistent With Adherence (≥4 Doses/Week) (time frame: 3, 6, 9, 12, 15, and 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04316715.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.