Clinical trial NCT03058835: IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
Official title: IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: PrEP Adherence Monitoring
Keywords: HIV
Truvada
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas
timeFrame: 24 Weeks
measure: Assess feasibility of Truvada procurement through the established Gilead access program
timeFrame: 24 Weeks
measure: Evaluate adherence to Truvada PrEP at week 12 and week 24 using dried blood spots
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Newark
country: United States
facility: New Jersey Medical School Clinical Research Center
state: New Jersey
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: New Jersey Medical School
name: Shobha Swaminathan, MD
role: PRINCIPAL_INVESTIGATOR
References: