PrEP Adherence MonitoringPhase 4NCT03058835
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
A Phase 4 study testing tenofovir disoproxil and emtricitabine in people with PrEP Adherence Monitoring, run by Rutgers, The State University of New Jersey at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PrEP Adherence Monitoring
- What is being tested?
- tenofovir disoproxil and emtricitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2016to Sep 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30322
Rush University Medical Center
Chicago, Illinois, 60612
West Virginia University
Morgantown, West Virginia, 26505
New Jersey Medical School Clinical Research Center
Newark, New Jersey, 07103
About this study
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.
Read the detailed description
Study Design:
This is a 24 week prospective pilot study assessing attitudes toward and feasibility of using Truvada PrEP in a population of women at risk for HIV acquisition.At this site 31 HIV- uninfected women desiring PrEP will be enrolled at each site (confirm number). We will have to consent about 50 women which includes screen failures.The study will assess attitudes towards and adherence to PrEP with questionnaires at weeks 12 and 24. Tenofovir levels procured at week 12 and 24 week of PrEP will be used to assess adherence to PrEP.
Primary objectives:
- Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas.
- Assess feasibility of Truvada procurement through the established Gilead access program
- Evaluate adherence at week 12 and week 24 using dried blood spots
Secondary objective:
- Describe HIV incidence
- Describe associations of positive and negative attitudes toward PrEP with acceptance of PrEP and subsequent adherence
- Assess adherence at weeks 12 and 24
- Evaluate the relationship between PrEP adherence and sexual activity
- Compare geographic areas with respect to PrEP attitudes
- Mentor junior investigators at each site.
- Conditions
- PrEP Adherence Monitoring
- Being tested
- tenofovir disoproxil and emtricitabine
- Keywords
- HIV, Truvada
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir disoproxil and emtricitabineDrug
Also called Truvada tablets
Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.
| Study group | Role | What they receive |
|---|---|---|
| PrEP with Truvada | Experimental | All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP Receives: Drug: tenofovir disoproxil and emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots
Dried blood spot tenofovir-diphosphate levels were summarized using prespecified adherence threshold categories at week 12 and week 24.
Measured: 24 Weeks
PrEP Awareness and Interest Questionnaire Responses at Week 24
Assessment of participants' attitudes toward pre-exposure prophylaxis using questionnaires
Measured: 24 weeks
Secondary outcomes (1)
Feasibility of Obtaining Truvada Via the Gilead Access Program
Evaluation of feasibility using logistic regression comparing the proportion of participants with tenofovir plasma levels >0.3
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startSep 2016
- Primary completionSep 2024
- Study completionSep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PrEP Adherence MonitoringStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shobha Swaminathan, Rutgers, The State University of New Jersey
- Investigators
- Shobha Swaminathan, MD, Principal investigator, New Jersey Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058835
- Sponsor's protocol ID
- Pro20150001562
- Other IDs
- IN-US-276-1340
- Status last verified
- Aug 2026
- First submitted
- 8 Feb 2017
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
- ClinicalTrials.gov ID
- NCT03058835
- Acronym / sponsor ID
- Pro20150001562
- Conditions
- PrEP Adherence Monitoring
- Keywords
- HIV, Truvada
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2024 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design:
This is a 24 week prospective pilot study assessing attitudes toward and feasibility of using Truvada PrEP in a population of women at risk for HIV acquisition.At this site 31 HIV- uninfected women desiring PrEP will be enrolled at each site (confirm number). We will have to consent about 50 women which includes screen failures.The study will assess attitudes towards and adherence to PrEP with questionnaires at weeks 12 and 24. Tenofovir levels procured at week 12 and 24 week of PrEP will be used to assess adherence to PrEP.
Primary objectives:
- Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas.
- Assess feasibility of Truvada procurement through the established Gilead access program
- Evaluate adherence at week 12 and week 24 using dried blood spots
Secondary objective:
- Describe HIV incidence
- Describe associations of positive and negative attitudes toward PrEP with acceptance of PrEP and subsequent adherence
- Assess adherence at weeks 12 and 24
- Evaluate the relationship between PrEP adherence and sexual activity
- Compare geographic areas with respect to PrEP attitudes
- Mentor junior investigators at each site.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrEP with Truvada | Experimental | Drug: tenofovir disoproxil and emtricitabineAll study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 18 - 64 years old
- Able to give consent
- "At risk" for HIV as defined by any of the following:
- CrCl ≥ 60 ml/min
- HIV- uninfected women desiring PrEP
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tenofovir disoproxil and emtricitabineAlso: Truvada tabletsPre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP. | Drug | PrEP with Truvada |
Primary outcome
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots
Time frame: 24 Weeks
Dried blood spot tenofovir-diphosphate levels were summarized using prespecified adherence threshold categories at week 12 and week 24.
PrEP Awareness and Interest Questionnaire Responses at Week 24
Time frame: 24 weeks
Assessment of participants' attitudes toward pre-exposure prophylaxis using questionnaires
1 secondary outcome
Feasibility of Obtaining Truvada Via the Gilead Access Program
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shobha Swaminathan, MD principal investigator
New Jersey Medical School
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tenofovir disoproxil and emtricitabine in people with PrEP Adherence Monitoring, run by Rutgers, The State University of New Jersey at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots (time frame: 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.