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

NCT ID: NCT03058835

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PrEP with Truvada

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

Group Type: EXPERIMENTAL

tenofovir disoproxil and emtricitabine

Intervention Type: DRUG

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

Interventions

tenofovir disoproxil and emtricitabine

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

Intervention Type: DRUG

Other Intervention Names

Truvada tablets

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Shobha Swaminathan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shobha Swaminathan, MD

Role: PRINCIPAL_INVESTIGATOR

New Jersey Medical School

Locations

Emory University

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

New Jersey Medical School Clinical Research Center

Newark, New Jersey, United States

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IN-US-276-1340

Identifier Type: OTHER

Identifier Source: secondary_id

Pro20150001562

Identifier Type: -

Identifier Source: org_study_id