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Antiretroviral

PrEP Adherence Strategies for HIV Prevention in Women

Q: What type of participants is this trial targeting?

<p>This trial is accepting 125 participants who are rc-<a href="https://www.withpower.com/clinical-trials/prep">prep</a> and between 18 to 64 years old. To qualify, they must meet the following criteria: IDU with a documented history of using shared needles or partaking in methadone, buprenorphine, or <a href="https://www.withpower.com/clinical-trials/suboxone">suboxone</a> treatment within 6 months; engaging in high risk sexual activities; transactional sex (for money, drugs or housing); infrequent condom use during intercourse with one partner of unknown <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a> status known for substantial risk of HIV infection ; desiring PrEP as an uninfected woman; capable of providing consent and evidence of unprotected sexual activity with one man infected by HIV</p>

Phase 4

Waitlist Available

Led By Shobha Swaminathan, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 - 64 years old

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial will assess women's attitudes toward taking PrEP, their ability to obtain it through existing channels, and how well they stick to the regimen.

Who is the study for?

This trial is for US women aged 18-64 who are at risk of HIV, which includes those with unprotected sex, evaluated for STIs recently, used shared needles, engaged in transactional sex or have partners at substantial risk. They must be able to consent and desire PrEP. Excluded are those with Hepatitis B, poor kidney function, drug dependence affecting adherence to the study requirements, pregnant or breastfeeding women.Check my eligibility

What is being tested?

The study tests attitudes towards and feasibility of obtaining Truvada PrEP (tenofovir disoproxil and emtricitabine), as well as how well US women adhere to this medication regimen designed to prevent HIV before exposure.See study design

What are the potential side effects?

Possible side effects of Truvada PrEP include nausea, headache, stomach pain and weight loss. Some may experience changes in kidney function or bone density.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Truvada

Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas

Evaluate adherence to Truvada PrEP at week 12 and week 24 using dried blood spots

Trial Design

1Treatment groups

Experimental Treatment

Group I: PrEP with TruvadaExperimental Treatment1 Intervention

All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tenofovir disoproxil

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,107 Total Patients Enrolled

Shobha Swaminathan, MDPrincipal Investigator - New Jersey Medical School

Rutgers, The State University of New Jersey

1 Previous Clinical Trials

136 Total Patients Enrolled

Media Library

Tenofovir Disoproxil and Emtricitabine (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT03058835 — Phase 4

PrEP Adherence Monitoring Research Study Groups: PrEP with Truvada

PrEP Adherence Monitoring Clinical Trial 2023: Tenofovir Disoproxil and Emtricitabine Highlights & Side Effects. Trial Name: NCT03058835 — Phase 4

Tenofovir Disoproxil and Emtricitabine (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03058835 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research permit elderly individuals to participate?

"Eligibility for this trial necessitates that participants be between 18 and 64 years of age."

Answered by AI

What have other researchers discovered about the combined use of tenofovir disoproxil and emtricitabine?

"Currently, there are 93 active experiments investigating the effects of tenofovir disoproxil and emtricitabine with 29 trials in their concluding stage. Though a majority of these tests occur in Boylston, Massachusetts, 1,559 locations worldwide have launched clinical trials for this drug combination."

Answered by AI

What type of participants is this trial targeting?

"This trial is accepting 125 participants who are rc-prep and between 18 to 64 years old. To qualify, they must meet the following criteria: IDU with a documented history of using shared needles or partaking in methadone, buprenorphine, or suboxone treatment within 6 months; engaging in high risk sexual activities; transactional sex (for money, drugs or housing); infrequent condom use during intercourse with one partner of unknown HIV status known for substantial risk of HIV infection ; desiring PrEP as an uninfected woman; capable of providing consent and evidence of unprotected sexual activity with one man infected by HIV"

Answered by AI

Has the FDA sanctioned tenofovir disoproxil and emtricitabine?

"After a thorough assessment, our team at Power concluded that the safety of tenofovir disoproxil and emtricitabine merits a score of 3 - this is because it has been approved by phase 4 trials."

Answered by AI

What conditions are tenofovir disoproxil and emtricitabine typically employed to address?

"Tenofovir disoproxil and emtricitabine is a regular treatment for human immunodeficiency virus type 1 (HIV-1). In addition, it has been prescribed to address HIV infections, the spread of HIV, as well as other forms of HIV-1 infection."

Answered by AI

Is there any available capacity for patients to join this experiment?

"This particular research project is no longer seeking enrolment. It was initially posted on September 1st 2016 and had its last update on October 25th 2022. As an alternative, there are currently 94 medical trials that require participants - with one trial specifically targeting rc-prep patients, and 93 additional studies recruiting for tenofovir disoproxil and emtricitabine treatments."

Answered by AI

What is the magnitude of participants in this clinical investigation?

"The recruitment period for this trial has recently concluded. It was initially posted on September 1st 2016, with the last update taking place on October 25th 2022. There are presently one study recruiting participants that involve rc-prep and 93 studies involving tenofovir disoproxil plus emtricitabine seeking enrolment of patients into their research program."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project

Shobha Swaminathan 2016. "IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03058835.

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