project prepare - presented by dr. sarah wood and kimberley desir

CHOP Project PrEPare TeamStudy Coordinator: Alison Lin MPH, lina1@email.chop.edu

Physician: Sarah Wood MD, woodsa@email.chop.edu

Research Nurse: Courtney Rooney RN, rooneyc@email.chop.edu

Research Assistant: Kimberley Desir BA, DesirK@email.chop.edu

OverviewWhat is PrEP ?Why PrEP MattersThe Science of PrEPMaking Prevention ChoicesHow To Get PrEParedProject PrEPare at CHOPRisks and Benefits

What Is PrEP?

Pre-exposure prophylaxis (PrEP) is antiretroviral medicine taken daily by HIV-negative people to reduce their risk of infection

Truvada-based PrEP Truvada is a combination of 2 drugs:

tenofovir and emtricitabine

Used as HIV treatment since 2004

Approved for PrEP in 2012 as part of a comprehensive HIV prevention plan

What Is PrEP?•Another tool in the prevention toolbox

•A prevention bridge

What PrEP Isn’t A “morning after” pillA guarantee against HIV A prevention method for STIs other than HIV

Why PrEP Matters

The Science of PrEP

How well does it work? TRIAL Pop n= Intervention Overall

efficacy

Efficacy with maximal adherence

iPrEx MSM 2499 Truvada v placebo

42% 92%

Partners PrEP

Serodisc. Couples

~4700 couples

Truvada v TDF alone vs placebo

75% 90%

TDF2 Heterosex M & F

1219 Truvada v placebo

63% 78%

Fem PrEP Women 18-35

1951 Truvada v placebo

Stopped by DSMB

VOICE Women 5028 Oral TDF vs vaginal gel vs Truvada vs placebo

Not effective

Too low to determine

For PrEP to work you have to take it every day

All of the PrEP studies have shown the greatest HIV risk reduction among the most adherent participants

Adherence Matters

What are the Risks of PrEP? •Truvada is generally safe and well tolerated •Minor side effects can occur including nausea, vomiting, diarrhea, and dizziness.•Most side effects get better within 1-2 months•No evidence of resistance to Truvada in trials•Serious side effects

•Changes in bone mineral density •Kidney disease

Some people are concerned that people who use PrEP will have a false sense of protection and may engage in risky sexual behaviors because of it

What are Risks of PrEP?

But, doing more risky things hasn’t been the case for:•youth when condoms were made

widely available in schools;

• youth when birth control has been provided; or

•adults in any of the previous PrEP trials

•In prior PrEP trials, risk behaviors actually decreased

•.

Making Prevention ChoicesThings to consider in making the decisionCan you remember to take a pill every day? Do you have any history of bone or kidney

problems? Do you have people in your life who will

support you taking PrEP? Do you have a health care provider you can

talk to about PrEP?

Where is PrEP available? Your primary doctor Infectious diseases specialists Clinical trials

Current PrEP StudiesThere are over 21,000 people world wide who are helping

us end the HIV epidemic by enrolling in PrEP studies

Project PrEPare Study Objectives

Adolescent Trials Network Protocol 110Study Goals

• To get more information about safety of Truvada®

• To evaluate how well YMSM take PrEP and if there risk behavior changes

• To explore how well risk reduction interventions work as part of PrEP programs

Project PrEPare: Study PopulationApproximately

200 HIV-uninfected YMSM ages 18-22 at high risk of acquiring HIV infection

Trans women included

Philadelphia will recruit 25 youth

What is involved for participants? The trial is 1-2 years longPrescreening is in person or onlineMonthly study visits for the first 4 months.

The remaining visits will be every 3 monthsAll participants get daily Truvada Each study visit involves comprehensive HIV

prevention care: physical exam, blood and urine tests, risk reduction counseling

HIV testing every month DEXA (bone density) scanning throughout

the study.

What is involved for participants? Behavioral Interventions

Personalized Cognitive Counseling (PCC)Integrated Next Step Counseling (iNSC): Text messaging daily reminders for adherence

Participant Compensation

Participants will be compensated for all study visitsTokens will be provided for all visits Condoms provided at all visits

Risks of Involvement Minor side effectsBone changesKidney changes Changes in risk behavior

What are the benefits of enrollment?Studies have shown that PrEP reduces the risk

of HIV infection in MSM especially in those most adherent to the medications

Participants may benefit from receiving the behavioral risk reduction counseling

Why Join a PrEP Clinical Trial?Access to extra support for adherence and

risk reduction Close monitoringHelp the community learn more about ways

to stop the HIV epidemic Make sure that youth are represented in

what we know about PrEP

To Learn More About PrEP: Project PrEPare Website:

www.projectprepare.netCenters for Disease Control and Prevention:www.cdc.gov/msm/prepProject inform:

http://www.projectinform.org/pdf/prep_msm.pdf

www.prepfacts.orgPrEP watch:

http://www.prepwatch.org/#guidance

Discussion