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App and coaching help men stick with HIV prevention pill

NCT ID NCT05072093

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a program to help men who have sex with men (MSM) stay on daily PrEP (a pill that prevents HIV) and reduce sexually transmitted infections (STIs). 240 men in Atlanta used a mobile app that flagged when they might stop PrEP, then a peer counselor and doctor stepped in to offer support. The study also offered on-demand PrEP (taking pills only around sex) and long-acting injectable PrEP as alternatives. Participants were followed for up to 2 years to see if they stayed on PrEP and how many got STIs.

What this could mean

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

Active substance
PrEP (Truvada) and on-demand PrEP
What this could lead to
If successful, this approach could help men at risk for HIV stay on PrEP longer and reduce sexually transmitted infections.
What could go wrong
This is a completed Phase 4 study with 240 participants in one city, so results may not apply to everyone. The intervention relies on app use and counseling, which may not work for all.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

240 people

The number who actually took part.

Started

Nov 2021

Finished

Mar 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 to 45 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Male at birth * Self-identify as Cisgender Male * Ages 18-45 years * ≥1 male anal sex partner in the 12 months before the baseline interview * Live in the Atlanta MSA * Owns cell phone with data service * Willing to download a health-related app to their cell phone as part of the research study * Able to provide ≥ 2 means of contact * Not currently enrolled in another HIV prevention clinical trial * Confirmed HIV-negative at baseline visit Exclusion Criteria: * Female at birth * Do not self-identify as Cisgender Male * Individuals \< 18 years of age or \> 45 years of age * HIV positive status * No male anal sex partner in the 12 months before the baseline interview * Does not own mobile phone with data service * Not willing to download a health-related app to their cell phone as part of the research study * Live outside the metro Atlanta MSA and/or planning to move from Atlanta area in the next 2 years * Currently enrolled in an HIV prevention or treatment clinical trial * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • PRISM Research Center

    Atlanta, Georgia, 30322, United States

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Other studies related to the condition(s) this trial covers.