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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

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