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Can nurse counseling and daily texts keep HIV prevention pills on track?

NCT ID NCT04316715

Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers at the University of Miami are testing two ways to help men who have sex with men take their HIV prevention medication, known as PrEP, more consistently. One group receives four weekly counseling sessions with a nurse, using techniques from cognitive behavioral therapy and motivational interviewing, plus optional booster sessions. Another group gets daily text message reminders to take their pill. The study measures medication levels in dried blood spots and self-reported adherence over 18 months to see which approach works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A behavioral program of four weekly nurse-led counseling sessions plus daily text message reminders
What this could lead to
If the counseling and text reminders help, this approach could become a practical way to support people in taking HIV prevention medication consistently.
What could go wrong
Behavioral support does not work for everyone, and text reminders can be easy to ignore. The study measures pill levels in blood over 18 months, so real-world adherence may still fall short of the target.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

300 people

The number who actually took part.

Started

Sep 2020

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Medication Adherence HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adherence, medication

Contacts and locations

Locations

  • Fenway Health

    Boston, Massachusetts, 02215, United States

  • University of Miami

    Miami, Florida, 33136, United States

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