Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Smartphone app and digital pill aim to boost HIV prevention in substance users

NCT ID NCT03512418

Disease control Sponsor: Brigham and Women's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a digital pill and smartphone app to help people with substance use disorders take their HIV prevention medication (PrEP) consistently. Thirty HIV-negative men who have sex with men and have moderate to severe substance use disorder participated. They used a digital pill that sends a signal when swallowed, and some also received a smartphone-based intervention to encourage adherence. The goal was to see if this approach is feasible and acceptable.

What this could mean

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

Active substance
Truvada (emtricitabine/tenofovir disoproxil fumarate) overencapsulated in a digital pill
What this could lead to
If successful, this approach could help people with substance use disorders take their HIV prevention medication more consistently, reducing HIV infections.
What could go wrong
This is a small, early feasibility study with only 30 participants, so results may not apply to larger populations. The digital pill system may be inconvenient or not acceptable to all users.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

30 people

The number who actually took part.

Started

Jun 2019

Finished

Apr 2024

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

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: * Cisgender MSM * Moderate to severe non-alcohol substance use disorder * Self-reported missed PrEP doses (\> or equal to 2 doses in 1 week over past 3 months) * HIV negative * On PrEP or initiating PrEP * Has qualifying laboratory testing: Cr clearance, HBV, liver function tests * Owns a smartphone with Android or iOS * Age 18 or older Exclusion Criteria: * Non-English speaker * HIV positive * History of Crohn's disease or ulcerative colitis * History of gastric bypass, bowel stricture * History of GI malignancy or radiation to abdomen * Unable/unwilling to ingest a digital pill * Allergy to gelatin, silver or zinc (components of the digital pill) * Does not qualify for PrEP (abnormal liver function, or Cr Clearance \<60)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HIV infections are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

substance-related disorder HIV infectious disease prevention target

As listed by the trial registrant

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

HIV infections Substance use disorders

Contacts and locations

Locations

  • Fenway Health

    Boylston, Massachusetts, 02215, United States

More trials for these conditions

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