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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: PrEP Adherence Monitoring
• Intervention / Treatment: Drug: tenofovir disoproxil and emtricitabine

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:

1. Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas.
2. Assess feasibility of Truvada procurement through the established Gilead access program
3. Evaluate adherence at week 12 and week 24 using dried blood spots

Secondary objective:

1. Describe HIV incidence
2. Describe associations of positive and negative attitudes toward PrEP with acceptance of PrEP and subsequent adherence
3. Assess adherence at weeks 12 and 24
4. Evaluate the relationship between PrEP adherence and sexual activity
5. Compare geographic areas with respect to PrEP attitudes
6. Mentor junior investigators at each site.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical School Clinical Research Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 - 64 years old
• Able to give consent

• "At risk" for HIV as defined by any of the following:

  1. unprotected sex (in past 6 months) with 1 or more men of unknown HIV status
  2. evaluated for an STI within 6 months prior to screening
  3. sex in last 6 months with an HIV-infected partner
  4. 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
  5. individuals engaging in transactional sex (i.e sex for money, drugs, or housing)
  6. 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PrEP with Truvada; 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; Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.; Other Names: Truvada tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Shobha Swaminathan, MD, New Jersey Medical School

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Truvada
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine
• Other Study ID Numbers: Pro20150001562; IN-US-276-1340 (Other Identifier: Gilead Sciences Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes