SW To reduce the risk of sexually-acquired HIV infection in high risk adults, as part of a comprehensive HIV prevention plan that includes consistent and correct condom use, risk reduction counseling, regular HIV testing, and treatment of any other sexually-transmitted infections.” (FDA Consumer Health Information, July 2012)
So why do we need PrEP? Why can’t everyone just use condoms?
SW Young MSM were underrepresented in prior PrEP trials. Youth ages 13-29 years accounted for 39% of new HIV infections in 2009 in the U.S. Over two-thirds of all new youth infections occurred in MSM MSM aged 13–24 had the greatest percentage increase (44%) in diagnoses of HIV infection from 2007 through 2010 and exceeded the number of diagnoses among those aged 35–44 by 2010.
SWIn the U.S., youth ages 13-29 years accounted for 39% of new HIV infections in 2009. Over two-thirds (69%) of all new youth infections occurred in MSM and among young black MSM, and new HIV infections increased 48% from 2006 - 2009. Among all MSM, Hispanic/Latino MSM accounted for 6,000 (20%) new HIV infections in 2009. The largest percentage of new infections (45%) occurred in those aged 13–29
SW Truvada works by blocking reverse transcriptase—the protein that lets HIV make copies of itself. If the virus can’t copy itself, it dies and the “host” never gets infected.
SW Partners PrEP: TDF vs Truvada vs placebo iPrEx Study: 2,499 MSM got Truvada or placebo PrEP arm reduced their risk of HIV infection by 44%. Those that took PrEP consistently enough that the medicine could be measured in their blood, reduced their risk of HIV infection by 92%. Partners PrEP: 4,700 serodiscordant couples in Africa Truvada group reduced their risk for HIV infection by 75% Those that took PrEP consistently enough that the medicine could be measured in their blood, reduced their risk of HIV infection by 90%. CDC TDF2 Study: 1200 young men and women in Botswana Truvada reduced their risk for HIV infection by 63% There was a 78% risk reduction when excluding participants who had not refilled their medication for >30 days
SW 44 vs 92% is a Big Difference
SW The CDC recommends visits at least every 2-3 months to assess for side effects, test for HIV and STI’s and monitor adherence. In prior PrEP studies, changes in kidney blood test results were very rare, and resolved when participants stopped taking the drugs. Researchers also measured participants’ bone density while on Truvada and found that these medications did cause a slight reduction in bone thickness, but not an increase in fractures.
KD 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
SW Clin trials help us learn more about HIV and how to stop the epidemic January, 2011: CDC issued guidelines for PrEP use in high-risk MSMs PrEP to be used as part of comprehensive set of prevention services, including condoms, risk-reduction, adherence counseling, STI diagnosis and treatment Should be part of a plan of care with regular HIV testing, adherence counseling and monitoring of side effects (every 2-3 months). August 2012: Similar guidelines published for high risk heterosexual adults.
SW Project PrEPare is an innovative HIV prevention study designed to explore the safety, acceptability and feasibility of PrEP among young men who have sex with men (YMSM) who are at risk for HIV infection in the United States. This study will take place at 14 clinical sites across the U.S. with about 200 HIV-uninfected YMSM, ages 18-22. What is Project PrEPare? Project PrEPare is a comprehensive HIV prevention study designed to obtain additional data on the safety and efficacy of FTC/TDF and to evaluate patterns of use, rates of adherence, and patterns of sexual risk behavior among YMSM who are provided with FTC/TDF help to determine if PrEP could become a part of a comprehensive HIV prevention package for YMSM in the real world. All participants will complete one of two proven behavioral HIV-prevention interventions offered at their local sites, be provided ongoing counseling, regular HIV/STI testing, and medical follow-up along with a daily dose of PrEP (FTC/TDF).
KD Where will Project PrEPare take place? Project PrEPare will take place at 14 clinical sites across the United States. Study sites can be found in Tampa, Los Angeles, Washington DC, Philadelphia, Chicago, Bronx, New Orleans, Miami, Memphis, Houston, Detroit, Baltimore, Boston and Denver. Site specific contact information can be found on the Project PrEPare website – www.projectprepare.net No history of significant bone or kidney disease Planning to stay in the area for at least 1 year When will Project PrEPare begin, and how long will it last? Project PrEPare is expected begin enrollment in the fall of 2012 and every participant will be followed for at least 48 weeks but could be followed up to 120 weeks. Participants will visit the study clinics at four, eight and 12 weeks, and every 12 weeks thereafter. t risk” criteria
KD HIV testing at each visit, counseling at each visit
KD All participants receive intensive risk-reduction intervention to reduce HIV-related risk behavior In a randomized controlled trial of PCC, Dilley and colleagues found that men receiving the PCC intervention had a significant decrease in percent (p < 0.002 and p = 0.001, respectively) and in mean number of episodes (p < 0.008 and p < 0.001, respectively) of unprotected anal sex, compared to those receiving standard HIV counseling, at both the 6 and 12-month follow-up points (Dilley, et al., 2002).
KD $dexa weeks is $75, other weeks are $50. If eligible and refuse but do PrEP survey: get gift card. Tokens provided for all visits
KD PCC, condoms, STD screening and treatment, referrals for hepatitis B vaccination as needed, and periodic HIV testing and counseling)
Project PrEPare - presented by Dr. Sarah Wood and Kimberley Desir
CHOP Project PrEPare TeamStudy Coordinator: Alison Lin MPH,email@example.comPhysician: Sarah Wood MD,firstname.lastname@example.orgResearch Nurse: Courtney RooneyRN, email@example.comResearch Assistant: Kimberley DesirBA, 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) isantiretroviral medicine taken dailyby HIV-negative people to reducetheir risk of infection
Truvada-based PrEP Truvada is a combination of 2 drugs: tenofovir andemtricitabine Used as HIV treatment since 2004 Approved for PrEP in 2012 as part of acomprehensive HIV prevention plan
What Is PrEP?•Another tool in the preventiontoolbox•A prevention bridge
What PrEP Isn’tA “morning after” pillA guarantee against HIVA prevention method for STIsother than HIV
How well does it work?TRIAL Pop n= Intervention OverallefficacyEfficacywithmaximaladherenceiPrEx MSM 2499 Truvada v placebo 42% 92%PartnersPrEPSerodisc.Couples~4700couplesTruvada v TDFalone vs placebo75% 90%TDF2 HeterosexM & F1219 Truvada v placebo 63% 78%Fem PrEP Women 18-351951 Truvada v placebo Stoppedby DSMBVOICE Women 5028 Oral TDF vs vaginalgel vs Truvada vsplaceboNoteffectiveToo low todetermine
For PrEP to work you have totake it every dayAll of the PrEP studies haveshown the greatest HIV riskreduction among the mostadherent participantsAdherence 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 concernedthat people who use PrEP willhave a false sense ofprotection and may engage inrisky sexual behaviors becauseof itWhat are Risks of PrEP?
But, doing more risky thingshasn’t been the case for:•youth when condoms were madewidely available in schools;• youth when birth control has beenprovided; or•adults in any of the previous PrEPtrials•In prior PrEP trials, risk behaviorsactually 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 youtaking PrEP?Do you have a health care provider you can talk toabout PrEP?
Where is PrEP available?Your primary doctorInfectious diseases specialistsClinical trials
Current PrEP StudiesThere are over 21,000 people world wide who are helpingus end the HIV epidemic by enrolling in PrEP studies
Project PrEPare Study ObjectivesAdolescent Trials Network Protocol 110Study Goals• To get more information about safety of Truvada®• To evaluate how well YMSM take PrEP and if there riskbehavior changes• To explore how well risk reduction interventions work aspart of PrEP programs
Project PrEPare: Study PopulationApproximately 200HIV-uninfectedYMSM ages 18-22 athigh risk of acquiringHIV infectionTrans womenincludedPhiladelphia willrecruit 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. Theremaining visits will be every 3 monthsAll participants get daily TruvadaEach study visit involves comprehensive HIVprevention care: physical exam, blood and urine tests,risk reduction counselingHIV testing every monthDEXA (bone density) scanning throughoutthe study.
What is involved for participants?Behavioral InterventionsPersonalized Cognitive Counseling (PCC)Integrated Next Step Counseling (iNSC):Text messaging daily reminders for adherence
Participant CompensationParticipants will be compensated for all study visitsTokens will be provided for all visitsCondoms provided at all visits
Risks of InvolvementMinor side effectsBone changesKidney changesChanges in risk behavior
What are the benefits ofenrollment?Studies have shown that PrEP reduces the risk of HIVinfection in MSM especially in those most adherent tothe medicationsParticipants may benefit from receiving the behavioralrisk reduction counseling
Why Join a PrEP Clinical Trial?Access to extra support for adherence and riskreductionClose monitoringHelp the community learn more about ways to stopthe HIV epidemicMake sure that youth are represented in what weknow 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.pdfwww.prepfacts.orgPrEP watch: http://www.prepwatch.org/#guidance