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

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.

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