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Behavioral, biomedical and structural  Behavioral biomedical and structural interventions to prevent HIV infection  in MSM and TG Nittaya Phanuphak, MD Thai Red Cross AIDS Research Centre Thai Red Cross AIDS Research Centre Open Day and Seminar for World AIDS Day O D dS i f W ld AIDS D Silom Community Clinic 1 December 2011


HIV prevention HIV prevention Behavioral  interventions

Biomedical interventions

Structural interventions


Behavioral interventions  for HIV prevention in MSM and TG • Interventions to promote various risk reduction  g g behaviors using different methods/settings to  delivery the messages – at an individual‐level,  small group‐level small group level, or community or community‐level level – Reducing unprotected anal sex – Having oral sex instead of anal sex l d f l – Reducing number of partners – Avoiding serodiscordant partners and strategic  p positioning g – Reducing anal sex even with condom use


Behavioral interventions  for HIV prevention in MSM and TG • Review of 44 studies evaluating 58 interventions,  with a total of 18,585 participants – – – –

Individual‐level behavior change (21 studies) Small group‐level approaches (26 studies) Community‐level interventions (11 studies) 16 (27.6%) were targeted at HIV‐infected individuals  ( ) g

• Overall, – 27% (95%CI 15‐37%) decrease in reporting of  unprotected anal intercourse, compared to little/no  intervention Johnson WD, et al. Cochrane Database System Rev 2008; 3:CD001230.


Behavioral interventions  for HIV prevention in MSM and TG • Major challenges – Most behavioral intervention trials were conducted in developed  world ld – Which behavioral strategies are most effective in MSM and TG? – Which messages are most effective in promoting these behaviors? Which messages are most effective in promoting these behaviors? – What methods and settings are most effective to deliver the  messages?  g

• It is closely linked to “structural interventions”  and it is  part of the comprehensive HIV prevention package part of the comprehensive HIV prevention package  which also includes “biomedical interventions” Johnson WD, et al. Cochrane Database System Rev 2008; 3:CD001230.


Biomedical interventions  for HIV prevention in MSM and TG • Oral PrEP • ART for prevention: treatment of  serodiscordant couples, test‐and‐treat p , • nPEP, STI diagnosis and treatment • Vaccine V i • Male circumcision • Rectal microbicides


Efficacy of HIV Prevention Strategies  From Randomized Clinical Trials Study

Effect Size, % (95% CI)

ART for prevention; HPTN 052, Africa, Asia Americas Asia, PrEP for discordant couples; Partners PrEP, Uganda, Kenya PrEP for heterosexual men and women; TDF2, TDF2 Botswana Medical male circumcision; Orange Farm, Rakai, Kisumu PrEP for MSMs; iPrEX, Americas, Thailand South Africa Thailand, Sexually transmitted diseases treatment; Mwanza, Tanzania Microbicide; CAPRISA 004, 004 South Africa HIV vaccine; RV144, Thailand

0

20

40 60 Efficacy (%)

96 ((73-99)) 73 (49-85) 63 ((21-84)) 54 (38-66) 44 ((15-63)) 42 (21-58) 39 ((6-60)) 31 (1-51)

80

100

Karim SS, Karim QA. Lancet 2011 Jul 17. Slide from Clinical Care Options HIV


iPrEx: PrEP Efficacy in HIV‐Negative,  At‐Risk MSM and TG • N = 2499 subjects randomized to oral TDF/FTC or placebo / – 44% reduction in HIV acquisition through 136 wks previously  reported t d[1] • Update: 42% risk reduction through 144 wks[2] • AEs of PrEP mild, time limited[2] – Headache (4%), nausea (2%), weight loss (2%) – No difference in rate of kidney toxicity • Only Only 9% of seroconverters had detectable drug levels vs 51% of  9% of seroconverters had detectable drug levels vs 51% of nonseroconverters[2] • No No evidence of resistance in seroconverters evidence of resistance in seroconverters[[2]] 1. Grant RM, et al. N Engl J Med. 2010;363:2587-2599. 2. Grant R, et al. CROI 2011. Abstract 92. Slide from Clinical Care Options HIV


iPrEx: PrEP Adherence and Efficacy iPrEx: PrEP Adherence and Efficacy • Detectable drug level,  adherence correlated with  protective efficacy[1] Recorded Adherence (Pill Use) and Efficacy

I Incidence/ /100 PYs

7

Placebo FTC/TDF

6 5 4

• Blood levels suggest 38% to  50% of patients took less than  specified daily dosing[2]

– Differences seen for US  (97%) (97%) vs non‐US (50%)  US (50%) participants

3 2 1 0

Efficacy 95% CI

< 50%

16%

-54% 54% to 54%

50% to 90%

> 90%

20% to -20% 64%

36% to 84%

34%

68%

1. Grant R, et al. CROI 2011. Abstract 92. Graphic used with permission. 2. Anderson P, et al. CROI 2011. Abstract 96LB. Slide from Clinical Care Options HIV


iPrEx Substudy: Effects of PrEP on  Bone Mineral Density[1]

Partticipants (% %)

Significantly greater proportion of  f l f subjects with > 5% loss of spine  BMD in PrEP group (P = .047) – Clinical implications unclear Proportion p of Participants p With > 5% BMD Loss From Baseline (Any Time Point) 1 P = .047 2 1 FTC/TDF C/ 0 8 Placebo

– PrEP: 15/1251 (1.2%) – Placebo: 11/1248 (0.8%)

6 4

P = .720 720

2 0

Spine

Total Hip

Baseline spine, hip Z‐scores  l h significantly lower than expected  based on general population norms No significant difference in  proportion of patients with spine or  hip Z‐scores hip Z scores ≤  ≤ ‐2 2.0  0 No significant difference in rate of  fractures in entire iPrEx study group  (P = .41) 41)[2]

Preliminary results with many  caveats, including need to account  for drug exposure in substudy, and for drug exposure in substudy, and  relatively poor adherence

1. Mulligan K, et al. CROI 2011. Abstract 94LB. Graphic used with permission. 2. Grant RM, et al. N Engl J Med. 2010;363:2587-2599. Slide from Clinical Care Options HIV


Challenges of PrEP g • Adherence – adherence – adherence – Intermittent PrEP   HPTN 067 – Need for peer support system and use of technology?

• Drug resistance in real‐life situation – Poor adherence to drugs and to HIV testing schedule Poor adherence to drugs and to HIV testing schedule – Use of TDF vs TDF/FTC

• Use in special groups of MSM/TG – Hepatitis B infection – Methamphetamine users – Prone to have kidney toxicity y y

• Acceptability and feasibility


HPTN 052: Immediate vs Delayed  ART in Serodiscordant Couples HIV-infected, sexually active serodiscordant couples; l CD4 CD4+ cell ll count of the infected partner: 350-550 350 550 cells/mm3 (N = 1763 couples)

Immediate ART Initiate ART at CD4+ cell count 350-550 cells/mm3 ( = 886 couples) (n l ) Delayed ART 3* I iti t ART att CD4+ cell Initiate ll countt ≤ 250 cells/mm ll / (n = 877 couples) *Based on 2 consecutive values ≤ 250 cells/mm3.

Primary efficacy endpoint: virologically linked HIV transmission

Primary clinical endpoints: WHO stage 4 events, pulmonary TB, severe bacterial  infection and/or death

Couples received intensive counseling on risk reduction and use of condoms DSMB recommended release of results as soon as possible following April 28, 2011, review; follow up continues but all HIV follow-up HIV-infected infected partners offered ART after release of results

Cohen MS, et al. N Engl J Med. 2011;365: 493-505. Slide from Clinical Care Options HIV


HPTN 052: HIV Transmission Reduced  by 96% in Serodiscordant Couples Total HIV‐1 Transmission Events: 39 (4 in immediate arm and  35 in delayed arm; P < .0001)

Linked Transmissions:  28

Delayed Arm:  27

P < .001

Immediate Arm: 1 Arm: 1

Unlinked or TBD  Transmissions: 11

Single transmission in patient in  immediate ART arm believed  to have occurred close to time  therapy began and prior to HIV‐1 RNA  suppression

Cohen MS, et al. N Engl J Med. 2011;365: 493-505. Slide from Clinical Care Options HIV


HPTN 052: Primary Clinical Events  During Follow‐up • 41% reduction in HIV‐related clinical events in HIV‐infected  p patients randomized to immediate vs delayed therapy y py

Failure Prrobability

– Excess events in delayed arm driven mainly by TB (33 vs 17 cases), particularly  extrapulmonary TB (17 vs 3 cases) HR: 0.6 (95% CI: 0.4-0.9; P = .01) Delayed (n = 65)

0 25 0.25 0.20 0.15

Immediate (n = 40)

0.10 0.05 0

877 886 0

701 700

317 333

86 85

32 36

1 2 3 4 Yrs Since Randomization

25Number at risk 29 5

Cohen MS, et al. N Engl J Med. 2011;365: 493-505. Slide from Clinical Care Options HIV


Challenges of Treatment as  Prevention (TasP) • HIV HIV prevention efficacy in groups other than  ti ffi i th th heterosexual couples – MSM/TG, people who use drugs – How to define a “couple”?  Concurrent partners?

• Where and how to identify HIV+ individuals to offer  them the treatment? them the treatment? – Innovative way to get more people into HIV testing

• Autonomy, toxicity, adherence, resistance • A Acceptability and feasibility  t bilit d f ibilit  Thai MSM Test and  Th i MSM T t d Treat Pilot Study


Comprehensive HIV prevention  package for MSM and TG • HIV counseling and testing, provision of  condoms and lubricants nPEP STI diagnosis condoms and lubricants, nPEP, STI diagnosis  and treatment, PrEP, ART for HIV+ individuals  when eligible/with serodiscordant  h li ibl / i h di d partner(s)/all HIV+… • How to best get more MSM and TG to access  the package and retain in the services? h k d i i h i ?


Structural interventions  for HIV prevention in MSM and TG • Ways to attract more MSM and TG into HIV  p prevention services – Provider‐initiated testing and counseling (PITC)  model in clinic‐based model in clinic based VCT VCT – Targeted mobile VCT clinic with on‐site HIV testing – Internet and other social networks I t t d th i l t k

• Ways to retain MSM and TG in HIV prevention  services 


PITC for HIV at the TRC‐AC Cervical and  C i l d anal Pap  smear The Thai Red Cross Anonymous Clinic

Health check‐ Health check up package

STI diagnosis  and  treatment

HIV HIV Testing nPEP

Nutrition service,       special event campaign,  outreach activities


Success of PICT using STI and anal Pap Smear  at the Thai Red Cross Men’s Health Clinic at the Thai Red Cross Men’s Health Clinic • MSM‐friendly clinic, among  1,429 MSM clients in 2009 – 52% known HIV+ve – 35% known HIV‐ve and 13%  unknown HIV status Previous HIV status

Ms. Wasana Sathianthammawit

STI MSM clients

Anal Pap MSM clients

HIV-ve Unknown HIV-ve

Unknown

Acceptance of HIV testing 34%

98%

77%

85%

% tested +ve for HIV

13%

13%

33%

8%

Mr. Charnwit Pakam


High prevalence of anal HPV infection and  high‐grade anal dysplasia  in Thai MSM • Anal HPV infection was seen in  85% of HIV+ MSM and 59% of  HIV MSM HIV‐ • High‐risk, oncogenic HPV types  was identified in 58% of HIV+ was identified in 58% of HIV+  MSM and 37% of HIV‐ MSM D Ni Dr. Nipatt Teeratakulpisarn T t k l i

HIV+ (n=123)

HIV- (n=122) Total (n=245)

P-value

Abnormal HRA

66 7% 66.7%

44 7% 44.7%

55 7% 55.7%

0 001 0.001

AIN I

39.8%

26.0%

32.9%

0.02

AIN II-III II III

18.7%

8.9%

13.8%

0.04

All AIN

58.5%

35.0%

46.8%

<0.001

Funded in part by the MSM Initiative Community Awards #107051-43-IAMM and 107388-44-IAMM


Majority of newly diagnosed HIV+ clients  in clinic‐based VCT already need ART • During 2006‐2009, among 19,525 VCT clients of the  During 2006 2009 among 19 525 VCT clients of the TRC Anonymous Clinic – HIV prevalence 13.2% (MSM 29%, women HIV prevalence 13.2% (MSM 29%, women 13.2%, MSW 8%) 13.2%, MSW 8%) – 73% had CD4 count measured (91% of these occurred  within 1 month of HIV diagnosis, median 3 days)

Phanuphak N, et al. JAIDS 2011;56:244-252.


Youth‐Targeted Mobile Health Clinic • Youth in educational institution: University and school • Youth‐friendly service  HIV testing (30‐min rapid test) •

Games to win prizes and  p shows

Body fat and muscle mass  measurement using BIA scale Sexual health education Other blood tests: hepatitis B,  blood group, syphilis

• •

• 112 MSM attended, 96% accepted HIV testing, 3 found  to be HIV+ (2.7%), none of the women and MSW were  tested positive  Funded by the Thai Red Cross AIDS Research Centre and the Commission of Higher Education


MSM‐Targeted Mobile Health Clinic  i S in Saunas  • BIA scale with brief advice on exercise tips • Rapid HIV testing and rapid syphilis testing • 90 tested for HIV  90 tested for HIV  18 HIV+ (21.1%) and 1 had acute  18 HIV+ (21 1%) and 1 had acute HIV infection

Photos used with permission Funded by the Thai Red Cross AIDS Research Centre and USAID


www.adamslove.org


Bus Stop and BTS Station Banner


Visitors of Adam’s Love website  (Aug ‐ Nov 17, 2011) • 39,905 39 905 new visitors i it (49 056 visits): (49,056 i it ) male l 72%, 72% ffemale l 28% • 1,460 members from Thailand, US, Indonesia, Japan, K Korea, M Malaysia, l i Si Singapore, and d Chi China • More than 10 million hits; among the top 5: – – – – –

Thailand – nearly 9 million hits United States – 320,000 hits Japan – 187,000 187 000 hits Singapore – 73,000 hits Indonesia – Nearly 64,000 hits

• Partnering with amfAR to explore the possibility to initiate similar website in Indonesia


Ways to retain MSM and TG in  HIV prevention services • Low rate of HIV re‐testing among Thai MSM – Silom Clinic: 60.5% of HIV Silom Clinic: 60.5% of HIV‐negative negative MSM had repeated  MSM had repeated

HIV testing, with a mean of 3 visits during 2005‐2010  (median 2 visits) – SEARCH 008: 65.1% had repeated HIV testing over 1 yr,  mean 2.2 visits

• Can we use other services to get MSM and TG clients 

to come back to our clinics again and again….?

Data from SEARCH 008 study and information shared by Dr. Frits van Griensven


Ways to retain HIV‐negative MSM and TG  in HIV prevention services (MSM youths) • What are the reasons to come or not to come back for  Wh t th t tt b kf

regular HIV testing?  – Reasons not to come: pain (25%), waste of money (21%), and  ( ) ( )

waste of time (20%) – Reasons to come: free HIV testing (36%), HIV treatment  R t f HIV t ti (36%) HIV t t t availability to them immediately if tested positive (32%), and  provision of HIV information (16%) provision of HIV information (16%)

• What other services would they like to have in a clinic 

where they will come for regular HIV testing? – Majority requested to have STD service (45%) and body 

shape and weight management (32%) in HIV testing clinic h d h ( ) l Data from Youth Mobile Health Clinic study, not yet published.


MSM VCT study MSM VCT study • Using MSM‐targeted  services in BKK, Bali, Jakarta – BIA scale and health check‐up – nPEP PEP and d STI service STI i – Anal Pap smear – MSM peer supporter team MSM peer supporter team

• To retain 350 MSM in the  MSM peer supporter team program • Regular “peer‐way” communication– Regular HIV testing for HIV‐ve • Use of social networking tools     MSM (BlackBerry Messenger, WhatsApp, – Retention in HIV care for HIV+ve MSM Facebook) in addition to phone    calls/emails calls/emails   Funded by the NIH/PEPFAR grant


Summary • Effective HIV prevention strategies for MSM and  TG, both new and old ones, are available  plan  fast and plan wisely how to use them now • All of us, good‐hearted people, do have our  ll f dh d l d h roles in various aspects, in various organizations,  trying to curb down HIV epidemic among MSM  and TG in our country and the region y g


THANK YOU THANK YOU

Behavioral, bio-medical and structural interventions to prevent HIV infection in MSM and TG  

The presentation of " Behavioral, bio-medical and structural interventions to prevent HIV infection in MSM and TG."by Dr Nittiya Phanuphak –...

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