App and coaching help men stick with HIV prevention pill
NCT ID NCT05072093
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
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Mar 2025
- Lead sponsor
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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
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18 to 45 years
- Sex
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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 Hide 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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