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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2022

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.

Interventions

  • Drug: tenofovir disoproxil and emtricitabine
    • Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas
    • Time Frame: 24 Weeks
    • Attitudes towards PrEP will be assessed with questionnaires at weeks 12 and 24.
  • Assess feasibility of Truvada procurement through the established Gilead access program
    • Time Frame: 24 Weeks
    • Logistic regression comparing the proportion of participants with tenofovir plasma levels greater than 0.3 will be analyzed
  • Evaluate adherence to Truvada PrEP at week 12 and week 24 using dried blood spots
    • Time Frame: 24 Weeks
    • Adherence to Truvada PrEP will be assessed at week 12 and week 24 using dried blood spots and questionnaire responses concerning adherence to PrEP

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rutgers, The State University of New Jersey
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shobha Swaminathan, Associate Professor – Rutgers, The State University of New Jersey
  • Overall Official(s)
    • Shobha Swaminathan, MD, Principal Investigator, New Jersey Medical School
  • Overall Contact(s)
    • Marta Paez-Quinde, 973-972-3810, paezqumv@njms.rutgers.edu

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