Question 1

I-PrEP Program

Answer

The Immediate-PrEP (I-PrEP) program is designed to reduce the testing and prescription delays typically found in traditional clinics by prescribing PrEP within 1 to 7 days after HIV testing. This feature is possible through the innovation of the Total Test, which combines the immediate result turnaround of rapid HIV testing, with a nucleic acid test (NAT) that detects exposures in the prior 7 days. If you're eligible for the I-PrEP program, you will receive up to a month’s worth of medication at no cost. We will also help connect you to a community provider/clinic so that you can continue PrEP after the study.

Question 2

Eligibility Criteria

Age 18 or older,
Negative HIV rapid test results from Total Test within the prior 7 days *,
Within the past 3 months, must meet at least one of the following criteria:
- Condomless anal sex with an HIV-infected person or person of unknown HIV status who was not taking antiretroviral therapy (ART) or PrEP; or
- Shared injection needles with an HIV-infected person or person of unknown HIV status who was not taking ART or PrEP; or
- Exchanged sex for money, drugs or other item

* If negative HIV rapid test is greater than 7 days ago, eligible participants may rescreen for I-PrEP in three months Exclusion Criteria for I-PrEP

Positive HIV rapid test results by Early Test or Total Test
Biologically assigned female sex at birth
Enrolled on I-PrEP less than 6 months ago, or enrolled on I-PrEP two previous times (ever)

Answer

Men who have sex with men and transgender females who test negative by HIV rapid test will be offered the opportunity to initiate immediate-PrEP (I-PrEP) on the day of their HIV screening at no cost if they meet certain criteria.
Inclusion Criteria for I-PrEP

Question 3

Program in Detail

Answer

After consenting to receive I-PrEP, your blood will be drawn to measure kidney function and test for hepatitis B, since both abnormal kidney function and hepatitis B are potential safety issues for those who take PrEP. You will then be referred to the AVRC HQ to pick up the medication as early as the same day or within 7 days of HIV testing.

At the AVRC HQ, a pharmacist will provide medication counseling and dispense a two-week supply of PrEP with tenofovir disoproxil fumarate (TDF) 300mg + emtricitabine (FTC) 200mg as a fixed dose combination tablet (Truvada®) to be taken once daily. A case manager will help connect you to a PrEP provider in the community so that you can continue on PrEP after the study. Baseline labs will be reviewed by a clinical provider within the first week of study enrollment. In the event that your HIV NAT result is positive, you will immediately be contacted to discontinue PrEP, and be referred to the Primary Infection Resource Consortium (PIRC) study for initiation of appropriate HIV treatment. If your HIV NAT result is negative, you may return for a second clinic visit or have a phone follow-up for assessment of PrEP adherence and tolerability. A second two-week supply of PrEP will be available as needed. PrEP will be stopped if: 1) the kidney function is abnormal, 2) you have an intolerance to the medication, or 3) you are HIV-NAT-positive. No more than four weeks of medication will be dispensed.

All individuals will be offered referrals to other community HIV prevention care and services organizations. High risk, HIV-uninfected persons who do not qualify for I-PrEP or refuse I-PrEP will be given education and referrals for community PrEP resources.