A pill a day: testing a new shield against HIV for women
NCT ID NCT03058835
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This study looks at whether US women at risk for HIV can and will take Truvada, a daily pill that prevents HIV infection. Researchers will measure how well women stick to the pill regimen over 24 weeks and explore their attitudes toward this prevention method. The goal is to see if this approach is practical and acceptable for women in real-world settings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Truvada (tenofovir disoproxil and emtricitabine) tablets taken daily as pre-exposure prophylaxis
- What this could lead to
- If successful, this could show that daily PrEP is a practical and acceptable way to reduce HIV risk in US women, potentially expanding its use.
- What could go wrong
- This is a demonstration project, not a large efficacy trial, so results may not apply broadly. Adherence may be lower than hoped, and side effects or access barriers could limit real-world use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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162 people
The number who actually took part.
- Started
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Sep 2016
- Finished
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Sep 2024
- 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 64 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * 18 - 64 years old * Able to give consent * "At risk" for HIV as defined by any of the following: 1. unprotected sex (in past 6 months) with 1 or more men of unknown HIV status 2. evaluated for an STI within 6 months prior to screening 3. sex in last 6 months with an HIV-infected partner 4. IDU with report of using previously used or shared needles in past 6 months or has been in a methadone, buprenorphine, or suboxone treatment program in past 6 months or engaging in high-risk sexual behaviors 5. individuals engaging in transactional sex (i.e sex for money, drugs, or housing) 6. Infrequently uses condoms during sex with 1 or more partners of unknown HIV status who are known to be at substantial risk of HIV infection (IDU or bisexual male partner) * CrCl ≥ 60 ml/min * HIV- uninfected women desiring PrEP Exclusion Criteria: * Active alcohol or drug use or dependence which may interfere with adherence to study requirements * HIV-infected at screening or enrollment * Estimated CrCl \< 60 mL/min * Past participation in an HIV vaccine study * Positive Hepatitis B surface antigen test * Underlying medical condition with survival unlikely during follow-up period * Any condition that in the opinion of study staff would make participation in the study unsafe or interfere with achieving study objectives * Pregnant or breast feeding * Actively trying to achieve pregnancy
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Genom att skicka in godkänner du våra Användarvillkor
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
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Emory University
Atlanta, Georgia, 30322, United States
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New Jersey Medical School Clinical Research Center
Newark, New Jersey, 07103, United States
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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West Virginia University
Morgantown, West Virginia, 26505, United States
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