Project PrEPare - presented by Dr. Sarah Wood and Kimberley Desir
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Dr. Sarah Wood and Kimberley Desir's presentation to the RWPC's Positive Committee on Children's Hospital of Philadelphia's PrEP program, Project PrEPare, from April 2013.
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Project PrEPare - presented by Dr. Sarah Wood and Kimberley Desir
- 2. CHOP Project PrEPare Team Study 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
- 3. Overview What is PrEP ? Why PrEP Matters The Science of PrEP Making Prevention Choices How To Get PrEPared Project PrEPare at CHOP Risks and Benefits
- 4. What Is PrEP? Pre-exposure prophylaxis (PrEP) is antiretroviral medicine taken daily by HIV-negative people to reduce their risk of infection
- 5. 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
- 6. What Is PrEP? •Another tool in the prevention toolbox •A prevention bridge
- 7. What PrEP Isn’t A “morning after” pill A guarantee against HIV A prevention method for STIs other than HIV
- 13. The Science of PrEP
- 14. 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
- 15. 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
- 16. 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
- 17. 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?
- 18. 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
- 19. Making Prevention Choices Things to consider in making the decision Can 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?
- 20. Where is PrEP available? Your primary doctor Infectious diseases specialists Clinical trials
- 21. Current PrEP Studies There are over 21,000 people world wide who are helping us end the HIV epidemic by enrolling in PrEP studies
- 22. Project PrEPare Study Objectives Adolescent Trials Network Protocol 110 Study 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
- 23. 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
- 24. What is involved for participants? The trial is 1-2 years long Prescreening is in person or online Monthly study visits for the first 4 months. The remaining visits will be every 3 months All 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.
- 25. What is involved for participants? Behavioral Interventions Personalized Cognitive Counseling (PCC) Integrated Next Step Counseling (iNSC): Text messaging daily reminders for adherence
- 26. Participant Compensation Participants will be compensated for all study visits Tokens will be provided for all visits Condoms provided at all visits
- 27. Risks of Involvement Minor side effects Bone changes Kidney changes Changes in risk behavior
- 28. 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
- 29. Why Join a PrEP Clinical Trial? Access to extra support for adherence and risk reduction Close monitoring Help the community learn more about ways to stop the HIV epidemic Make sure that youth are represented in what we know about PrEP
- 30. To Learn More About PrEP: Project PrEPare Website: www.projectprepare.net Centers for Disease Control and Prevention: www.cdc.gov/msm/prep Project inform: http://www.projectinform.org/pdf/prep_msm.pdf www.prepfacts.org PrEP watch: http://www.prepwatch.org/#guidance
- 31. Discussion
Editor's Notes
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- 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)
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- 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
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- 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
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- 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.
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- 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
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- KD PCC, condoms, STD screening and treatment, referrals for hepatitis B vaccination as needed, and periodic HIV testing and counseling)
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