tenofovir disoproxil and emtricitabine for RC-Prep

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
RC-Prep
tenofovir disoproxil and emtricitabine - Drug
Eligibility
18 - 65
Female
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 24 Weeks

24 Weeks
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 Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

PrEP with Truvada
1 of 1
Experimental Treatment

125 Total Participants · 1 Treatment Group

Primary Treatment: tenofovir disoproxil and emtricitabine · No Placebo Group · Phase 4

PrEP with Truvada
Drug
Experimental Group · 1 Intervention: tenofovir disoproxil and emtricitabine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir disoproxil
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
369 Previous Clinical Trials
60,576 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

Eligibility Criteria

Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
: People who report using needles that have been used by someone else in the past 6 months, people who are currently in a methadone, buprenorphine, or suboxone treatment program, or people who engage in high-risk sexual behaviors are considered to be at high risk for contracting HIV.
are at a higher risk for HIV People who engage in transactional sex are at a higher risk for HIV because they are more likely to have unprotected sex with multiple partners.
Has sex with someone who is known to be at a high risk for HIV without using a condom.
People who are 18 to 64 years old can vote in the United States.
In order to be able to give consent, one must be of legal age
have sex without a condom with one or more men in the past six months who you don't know the HIV status of.
I've had unprotected sex in the last six months with someone who is HIV-positive.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.