NCT03058835

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• PrEP Adherence Monitoring

Interventions

Type	Name	Description
DRUG	tenofovir disoproxil and emtricitabine	Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.

Timeline

• Start date: 2016-09-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2017-02-23
• Last updated: 2023-09-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study