NCT03058835CompletedPhase 4
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 162 (actual)
- First submitted
- 8 Feb 2017
- Start date
- 1 Sept 2016
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Rutgers, The State University of New Jersey
- Diseases
- HIV
- NCT number
- NCT03058835
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 162
- From 1 Sept 2016 to the primary completion date, 30 Sept 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active alcohol or drug use or dependence which may interfere with adherence to study requirements
Other illness
- HIV-infected at screening or enrollment
- 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
Other
- Estimated CrCl \< 60 mL/min
- Pregnant or breast feeding
- Actively trying to achieve pregnancy
Who the study is looking for
- 18 - 64 years old
- Able to give consent
- "At risk" for HIV as defined by any of the following:
- unprotected sex (in past 6 months) with 1 or more men of unknown HIV status
- evaluated for an STI within 6 months prior to screening
- sex in last 6 months with an HIV-infected partner
- 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
- individuals engaging in transactional sex (i.e sex for money, drugs, or housing)
- 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
Age in the registry: 18 years to 64 years · Sex: Female · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| New Jersey Medical School Clinical Research Center Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.