CHOP Project PrEPare TeamStudy Coordinator: Alison Lin MPH, [email protected]
Physician: Sarah Wood MD, [email protected]
Research Nurse: Courtney Rooney RN, [email protected]
Research Assistant: Kimberley Desir BA, [email protected]
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