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

NCT03058835 | Unknown Phase 4 FDA Drug

• 2 other identifiers: Pro20150001562IN-US-276-1340
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

PrEP Adherence Monitoring

Keywords

HIV; Truvada

Outcome Measures

Primary Outcomes (3)

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

  Attitudes towards PrEP will be assessed with questionnaires at weeks 12 and 24.

  24 Weeks

• Assess feasibility of Truvada procurement through the established Gilead access program

  Logistic regression comparing the proportion of participants with tenofovir plasma levels greater than 0.3 will be analyzed

  24 Weeks

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

  Adherence to Truvada PrEP will be assessed at week 12 and week 24 using dried blood spots and questionnaire responses concerning adherence to PrEP

  24 Weeks

Study Arms (1)

PrEP with Truvada

EXPERIMENTAL

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

Drug: tenofovir disoproxil and emtricitabine

Interventions

tenofovir disoproxil and emtricitabine DRUG

Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.

Also known as: Truvada tablets

PrEP with Truvada

Eligibility Criteria

• Age: 18 Years - 64 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (4)

Emory University

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

New Jersey Medical School Clinical Research Center

Newark, New Jersey, 07103, United States

Location

West Virginia University

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Shobha Swaminathan, MD

  New Jersey Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 23, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)