1 IN 2 BLACK MSM 1 IN 4 LATINO MSM. and. will be diagnosed with HIV within their lifetime.

Transcription

1 MODULE 2

2 FACULTY

3 1 IN 2 BLACK MSM and 1 IN 4 LATINO MSM will be diagnosed with HIV within their lifetime.

4 Young Black MSM account for MORE THAN HALF of new infections among young MSM

5 more than any other subgroup by race/ethnicity, age and sex

6 WHEN NEW INFECTIONS AMONG YOUNG BLACK GAY MEN INCREASE BY NEARLY 50% IN 3 YEARS, WE NEED TO DO MORE TO SHOW THEM THAT THEIR LIVES MATTER PRESIDENT BARACK OBAMA

7 Patient: Michael CASE STUDY Demographics 24 years Black MSM Chief Complaint Anxious about risk for HIV Social History Lives in Washington, DC New job, health insurance benefits Identifies as gay Large social network Goes out to the clubs regularly Casual dating, but recently started seeing someone more seriously Medical History No primary care provider; experience with health care limited to urgent care when symptomatic Tested for HIV 3 months ago. Results: HIV-negative Tested for STI 5 months ago. Results: Positive for Gonorrhea; treated successfully Family History Raised by single mom Out about his sexual orientation to his mother Mental Health and Substance Use History Some anxiety and depression Alcohol use at clubs on weekends; binge drinks sometimes Marijuana use: regular Methamphetamines: admits to trying crystal meth No tobacco Sexual Health History Age at first sexual intercourse: 15 Has sex with men only Receptive partner in anal sex Inconsistent condom use Life time male partners = 19

8 CASE STUDY Michael Video Blog - Part 1 Damn! I am not looking forward to this. Gonorrhea was no joke, so next stop? The HIV testing van. And on date night no less! Jonathan calls it pay to play. I m no angel but I m careful most of the time. Shit, Derrick was pretty careful too and now him and three other guys came back positive. That s just crazy He s losin it, keeps talking about his uncle, a skeleton under a sheet, white crap in his mouth, sitting in his own shit cause nobody would touch him and talking about God s wrath. Thank God that was then, cause I can t help thinking my number s up sooner or later. Then onto the drugs I d have to live on for the rest of my life. Now that s something to look forward to (gets up to go out shakes it off). Gotta enjoy life while you can. Time to turn up!

9 The goal of His Health is to increase the capacity, quality and effectiveness of health care providers to screen, diagnose, link and retain Black MSM in HIV clinical care.

10 MODULE OVERVIEW The HIV Epidemic & Black MSM Preventing HIV Infection Pharmacological Interventions: Treatment as Prevention and Pre-Exposure Prophylaxis PrEP Treatment

11 LEARNER OBJECTIVES 1 Understand HIV prevention challenges and opportunities for Black men who have sex with men (MSM) 2 Adopt CDC recommended HIV testing strategies as part of patient care 3 Incorporate CDC recommended prevention strategies as part of patient care for both HIV-negative and HIVpositive Black MSMs 4 Explain PrEP treatment for HIV-negative Black MSM

12 DEFINITIONS PrEP (PRE-EXPOSURE PROPHYLAXIS): HIV medicine taken daily to prevent the acquisition of HIV TasP (TREATMENT AS PREVENTION): HIV transmission prevention method that uses antiretroviral treatment (ART) and viral suppression BLACK: Men of African descent, American and all others MSM: Men who are sexually active with other men

13 THE HIV EPIDEMIC IN BLACK MSM

14 Diagnoses, % TRANSMISSION AMONG MSM IS INCREASING Diagnoses of HIV Infection Among Adolescents and Young Adults Aged Years, by Transmission Category, : 46 States and 5 US-Dependent Areas 100% 80% 60% 40% 20% 0% Year of Diagnosis Male-to-male sexual contact Heterosexual contact Male-to-male sexual contact and IDU IDU Other

15 Diagnoses, No. YOUNG BLACK MSM IS THE FASTEST GROWING MSM POPULATION Diagnoses of HIV Infection Among MSM Aged Years by Race/Ethnicity in 46 States and 5 US-Dependent Areas, Year of Diagnosis Black Hispanic/Latino White Native Hawaiian/Other Pacific Islander Asian American Indian/Alaska Native

16 PREVENTING HIV INFECTION

17 CASE STUDY Michael Video Blog - Part 2 (Holds up tests results - non-reactive is circled) Phew! I can breathe again. Shit, that was close. Never been so scared yet so relieved at the same time in all my life. God I NEVER want to go through that again, NEVER, EVER. That was my come to Jesus moment. Man. I may be getting way more than most but I use condoms EVERY time well, except with Jonathan after 5 cocktails (I love you baby) or Frank or that one Tina night at Club Liberty So tonight: two drink limit, focus on Jonathan and oral only for now. Derrick coming up positive made it real. There s no going back for him. Meds or no meds, his life is changed forever. The hell with that!

18 Pop-up Question WHAT STEPS WOULD YOU TAKE TO ADDRESS MICHAEL S CONCERNS ABOUT ACQUIRING HIV? A. OFFER HIM AN HIV TEST B. SUGGEST HE TEST EVERY 3 MONTHS C. TELL HIM HE SHOULD REDUCE HIS NUMBER OF SEX PARTNERS D. REFRAIN FROM CONDOMLESS ANAL SEX E. REFER HIM TO A CONDOM DISTRIBUTION PROGRAM F. TALK TO HIM ABOUT PRE-EXPOSURE PROPHYLAXIS G. ALL OF THE ABOVE

19 COMBINATION HIV PREVENTION

20 Testing Structural Behavioral Biomedical COMBINATION HIV PREVENTION

21 FOURTH GENERATION HIV TESTS TO BETTER ID EARLY CASES Screen for antibodies as well as HIV-1 p-24 antigen Detect infection ~3 weeks following exposure Reduce window period during which false negatives are likely Identifying acute HIV is crucial for prevention as viral loads are typically very high during that period of infection, making someone much more likely to pass on the virus.

22 HPTN 052 STUDY

23 HPTN 052 (FINAL RESULTS) STABLE HETEROSEXUAL COUPLES Phase 3 Study Americas, African, Asian Sites N=1763 Serodiscordant Couples CD cells/mm3 RANDOMIZATION 1:1 DELAYED ART CD4 250 cells/mm3 STATUS OF PARTICIPANTS Enrolled (n=1763) Remained in trial (n=1642) (n=1535) EARLY ART CD cells/mm3 PRIMARY ENDPOINTS 1. Transmission - Virologically linked transmission events 2. Clinical Events - WHO stage 4 clinical events - Pulmonary TB - Severe bacterial infection and/or death

24 Cumulative Probability EARLY ART LED TO A 96% REDUCTION OF SEXUAL TRANSMISSION OF HIV Delayed ART Linked HIV Transmission Early ART.25 HR: 0.04 (95% CI ) (P<0.001) Years

25 Linked Partner Infections (number) NO HIV TRANSMISSION AMONG PEOPLE WHO WERE VIRALLY SUPPRESSED Linked HIV Transmission 36 Delayed ART Early ART Overall

26 PARTNER STUDY

27 PARTNER Study HIV TRANSMISSION RISK THROUGH CONDOMLESS SEX IN SERODISCORDANT COUPLES Upon Entry MSM (n=282) MALE (n=245) FEMALE (n=240) HIV-negative: condomless sex (years) Follow Up HIV(+): HIV-negative: on ART years (years) in study Diagnosed with STI (%) HIV-negative HIV-positive HIV-negative: condomless sex Number of acts/year Total number 43 16, , ,000

28 RATE OF COUPLE TRANSMISSION

29 PARTNER Study RATE OF COUPLE TRANSMISSION Per 100 Couple-Years Follow Up Heterosexual (Male) Vaginal sex with ejaculation (192 CYFU) Heterosexual (Female) Vaginal sex (272 CYFU) MSM Receptive anal sex With ejaculation (93 CYFU) Without ejaculation (157 CYFU) Insertive anal sex (262 CYFU) Rate (95% CI)

30 MOUNTING EVIDENCE FOR PREP AMONG MSMS U.S. MSM safety trial iprex trial PROUD study HPTN 067/ADAPT ATN 110 US PrEP Demo Project Ipergay trial

31 MOUNTING EVIDENCE FOR PREP AMONG MSMS U.S. MSM safety trial iprex trial PROUD study HPTN 067/ADAPT ATN 110 US PrEP Demo Project Ipergay trial

32 iprex Study MSM & TRANSGENDER WOMEN Multinational Double-Blind Study Screened N=4905 RANDOMIZATION 1:1 Similar baseline demographic characteristics (except mean age), sexual risk factors, STIs and HBV status Follow-up person-years (median 1.2 years) EMTRICITABINE/TENOFOVIR DF N= 1251 PLACEBO N= 1248 Follow-up: Median 1.2 years STUDY OUTCOMES HIV seroconversion Adverse events Metabolic effects HBV exacerbations Risk behavior and STIs (including HSV) Adherence

33 Cumulative Probability of HIV Infection iprex Study CUMULATIVE PROBABILITY OF HIV INFECTION 100% 44% reduction of acquisition of HIV compared to those on placebo 92% for those who took their meds 50% Placebo Emtricitabine/Tenofovir DF Detectable Drug Levels 0% Weeks

34 iprex Study ADVERSE EVENTS Nausea more frequent in the emtricitabine/tenofovir DF arm during weeks 1 to 4

35 iprex Study RENAL SAFETY Elevation in serum creatinine >1.1xULN - FTC/TDF versus placebo: 2% versus 1% - Normalized after treatment discontinuation 4 out of 5 participants who restarted FTC/TDF did not experience a new elevation Similar safety findings in other PrEP trials

36 iprex Study BONE SAFETY HIV uninfected MSMs - Even distribution by race - <30 years of age (~66%) - Similar baseline body composition, risk factors and bone density Emtricitabine/tenofovir DF (n=247) - Small (0.7% to 1.0%) decrease in spine and total hip BMD relative to placebo at week 24 - No differences in bone fractures between groups

37 PrEP TREATMENT AND MONITORING

38 CASE STUDY Michael Video Blog - Part 3 Got me a new job. Got me some insurance and I m finally going to see a doctor. Maybe even get regular about it. I ve been hearing about PrEP but don t think it s easy to get. Man, if I could take something that would keep me from thinking I m going to die every time I have sex, count me in! I m tired of feeling one slip up away from ruining my life. On the other hand, it s getting a mixed rap on Jack d. It s bad enough having people judge me for using an app to get laid. I sure as hell don t want anyone calling me a PrEP or Truvada whore. I ve even seen people posting that they won t see anyone who is negative on PrEP or PrEPped as they say! Not sure how my friends will see it. But they know me. You d think they would think it s a good thing. We ll see. Anyway, I m just happy I m finally getting to talk to someone who can break it down. Later.

39 Pop-up Question WHAT MAKES MICHAEL A CANDIDATE FOR PREP? (MARK ALL THAT APPLY) A. HE S YOUNG B. HE S HIV-NEGATIVE C. HE S A SEXUALLY ACTIVE ADULT D. HE S A MAN WHO HAS SEX WITH MEN E. HE S BEEN DIAGNOSED WITH AN STI IN THE LAST 6 MONTHS F. HE S NOT IN A MONOGAMOUS RELATIONSHIP WITH AN HIV-NEGATIVE PARTNER

40

41 WHO IS ELIGIBLE FOR PrEP? Adult men - Without acute or established HIV infection - Any male sex partners in the past 6 months - Not in a monogamous partnership with someone who has recently tested HIV-negative AND at least one of the following: Any anal sex without condoms (receptive or insertive) in the past 6 months Any STI diagnosed or reported in the past 6 months Is in an ongoing sexual relationship with an HIV-positive male partner

42 HIV-negative status must be confirmed prior to initiating PrEP and every 3 months thereafter If symptoms of acute infection are present and recent exposures (<1 month) are suspected, delay initiating PrEP for at least 1 month until negative HIV status is reconfirmed Negative HIV status should be confirmed with a test approved by the FDA to aid diagnosis of acute or primary HIV infection

43 RISK BEHAVIOR ASSESSMENT FOR MSM In the past 6 months Have you had sex with men, women or both? - If men or both sexes, how many men have you had sex with? How many times did you have receptive anal sex (you were the bottom) with a man who was not wearing a condom? How many of your male sex partners were HIV-positive? - With these HIV-positive male partners, how many times did you have insertive anal sex (you were the top) without you wearing a condom? Have you used methamphetamines (such as crystal or speed)?

44 SUMMARY GUIDANCE CONSIDER IF HIV-positive sexual partner Recent bacterial STI High number of sex partners Inconsistent or no condom use Commercial sex work High-prevalence area or network ELIGIBLE IF Documented negative HIV test result before prescribing PrEP No signs/symptoms of acute HIV infection Creatinine clearance >60 ml/min; no contraindicated medications HBV status known and, if appropriate, vaccination given COURSE OF ACTION Specific tests: oral/rectal gonorrhea and chlamydia NAAT, and syphilis serology tests Other services (every three months): HIV test, medication adherence counseling, behavioral risk reduction support, side effect assessment, STI symptom assessment At 3 months and every 6 months thereafter: assess renal function Every 6 months: test for bacterial STIs

45 ONE FDA-APPROVED DRUG FOR PrEP AS OF JAN 2016 TRUVADA Emtricitabine/tenofovir DF (200/300 mg) qd Daily, continuing, oral dose, 90-day supply

46 TIME TO ACHIEVE PROTECTION Preliminary pharmacokinetic data on lead-time to achieve maximal intracellular concentrations tenofovir diphosphate with daily dosing of tenofovir DF: Blood: ~20 days Rectal tissue: ~7 days Cervicovaginal tissues: 20 days Penile tissues: no data

47 DISCONTINUING PrEP Upon discontinuation of PrEP, clinicians should document: HIV status at time of discontinuation. Reason for PrEP discontinuation. Recent medication adherence and reported sexual behavior.

48 TAKE AWAYS PrEP is part of a comprehensive prevention strategy Educate Refer Support Monitor

49 REFERENCES Grant, R. M., Lama, J. R., Anderson, P. L., McMahan, V., Liu, A. Y., Vargas, L., & Montoya- Herrera, O. (2010). Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. New England Journal of Medicine, 363(27), Krakower, D. S., & Mayer, K. H. (2016). The role of healthcare providers in the roll out of preexposure prophylaxis. Current Opinion in HIV and AIDS, 11(1), Grant, R. M., & Koester, K. A. (2016). What people want from sex and preexposure prophylaxis. Current Opinion in HIV and AIDS, 11(1), 3-9. Golub, S.A. (2012.) Impact of PrEP Messaging Factors on Comprehension, Adherence Motivation, and Risk Compensation Intentions [PowerPoint Slides]. Retrieved from conference/impact-of-prep-messaging-factors /Calabrese, S., St. George, D., Callis, B., Buchelli, M. (2015.) Impact of PrEP Messaging Factors on Comprehension, Adherence Motivation, and Risk Compensation Intentions [PowerPoint Slides]. Retrieved from Prevention_Final.pdf Calabrese, S., St. George, D., Callis, B., Buchelli, M. (2015.) Impact of PrEP Messaging Factors on Comprehension, Adherence Motivation, and Risk Compensation Intentions [PowerPoint Slides]. Retrieved from

50 REFERENCES Malebranche, D. (2015.) Beyond PrEP: Intersectionality, Resilience, & the Health of Black MSM [PowerPoint Slides]. Retrieved from Ard, K.L. (2015). PrEP in the Real World: Clinical Case Studies [PowerPoint Slides]. Retrieved from Smith, D.K., Flash, C., Thrun, M. (2014). NCSD Webinar: PrEP 101 for STD Directors [PowerPoint Slides]. Retrieved from Black AIDS Institute. (2016). Black Lives Matter: What s PrEP got to do with it? Los Angeles, CA. Retrieved from Chicago Department of Health. (2015). Get the Facts: Invasive Meningococcal Disease [factsheet]. Retrieved from 015MeningitisFactSheet6_3_15.pdf

51 REFERENCES Rodger A, et al. (2014). 21st CROI. Boston. Abstract 153LB. YBGLI. (2014). PrEP for Black Gay and Bi-sexual Men in the US: What You Need to Know. Retrieved from AIDS United. (2015). PrEP Kit: A Resource Guide about Pre-Exposure Prophylaxis, National and Local Resources. Retrieved from United Nations Programme on HIV/AIDS (UNAIDS). (2015). Oral Pre-Exposure Prophylaxis: Questions and Answers. Retrieved from

52 RESOURCES CDC.gov Clinician Consultation Center NCCC.ucsf.edu HIVGuidelines.org