Marc Bulterys, MD PhD Director, Global AIDS Program, China U.S. Centers for Disease Control and Prevention International AIDS Conference (TUSA14) Washington, DC July 24, 2012 Center for Global Health Division of Global HIV/AIDS Using Implementation Science to Improve Community-based Methadone Maintenance in China

What is Implementation Science?  The study of the process of implementing evidence- based programs and practices  Effective implementation bridges the gap between science and practice (in order to produce similar outcomes in the “real world”)  Transferring and maintaining programs in real world settings is a long and complex process 2

“The aim of science is not infinite wisdom, but to set a limit to infinite error.” Bertolt Brecht 3

HIV-1 Subtype Epidemiology in East Asia 4

HIV Infection among IDU in China  High variation in HIV prevalence and incidence among IDU in different geographic areas of China  Regional differences appear to reflect different stages of the epidemic rather than differences in risk behaviors*  In certain areas of 7 provinces (Yunnan, Xinjiang, Sichuan, Guizhou, Guangxi, Guangdong, and Hunan) provinces, HIV prevalence among IDU reached >50% * BMC Infectious Diseases 2008; 8:

China’s National Methadone Maintenance Treatment (MMT) Program  Started with 8 clinics in 5 provinces serving approximately 1,000 clients in 2004  Expanded rapidly to 748 clinics nationwide in 2012 and over 361,000 cumulative clients  Benefited thousands of drug users with decreased drug use and criminality, improved quality of life, and higher rates of employment  Created enormous demand for trained MMT providers 6

 In 2007, Global AIDS Program (GAP) supported 1 st mobile MMT clinic in China  Served 50 rural villages near border with Burma at Ruili, Yunnan  Nearly all clients ethnic minority (Dai, Jingpo)  Retention rate 76%  Replicated by Government of China with 28 mobile clinics in 11 provinces 7 Example of Innovation: Mobile MMT Clinics

Challenges in the MMT Roll-Out in China  One of the main challenges has been high drop-out rate among clients  Relatively low methadone dosing may be a key reason behind this (average dose was only 48 mg in 2007)  Low training coverage and high turnover among providers appeared to be an important factor  In 2008, the national training program for MMT providers was redeveloped and greatly expanded  Program performance metrics indicate significantly increased mean daily methadone dose and mean duration in treatment by end of

Increase in mean daily methadone dose and mean duration in treatment (p<0.0001) 9

Further Operations Research Needed  Although it has been shown previously that higher methadone dosing leads to higher retention and other favorable MMT outcomes, why is it often not practiced in the field?  How to educate MMT providers in order to achieve higher retention and other favorable treatment outcomes? 10

MMT Public Health Evaluation (PHE) in Three Provinces in China  “A Methadone Maintenance Treatment Outcome Study in Three Provinces in China: Comparative Evaluation of the Impact of an Intensive Health Care Provider Training Program Combined with Expanded Services on Treatment Retention, Heroin Use, Methadone Dosing, and HIV Risk Practices”  Jointly conducted by the National Center for AIDS/STD Control and Prevention (NCAIDS), 3 Provincial CDC and Health Bureaus, and GAP-China (with partial funding from PEPFAR) 11

Specific Aims  To determine reasons why MMT providers prescribe lower methadone doses, on average, than Chinese national MMT clinical management guidelines (recommended dose mg daily)  To determine the effectiveness of educating MMT providers on prescribing individualized methadone doses consistent with international best practices 12

Study Design  This study consists of a qualitative, formative study followed by a 3-arm cluster-randomized controlled trial.  The qualitative study using key informant interviews has been conducted on a sample of MMT clinic staff, current clients, former clients, and family members.  The randomized controlled trial is currently being conducted in 54 MMT clinics, which have been randomized into one of three study arms:  Arm 1: Control group (standard of care)  Arm 2: Intensive health care provider training  Arm 3: Intensive health care provider training plus psychosocial counseling and other services 13

Study Population  Study sites: Guangdong, Guangxi, and Guizhou provinces  Study population and sample size:  Qualitative study: Key informant interviews were conducted in 2011 among MMT clinic staff, current clients, former clients, and family members of clients.  Randomized controlled trial: All opiate-dependent drug users newly enrolled in MMT or within one month of initiation are enrolled in the study. Planned enrollment of injecting drug users (IDU) will be at least 5,400 persons. It is estimated that about 2,300 non-IDU will also be enrolled. 14

Randomized Controlled Trial 15

Progress: Qualitative Study  Finished study training and key informant interviews in 3 provinces between July and August 2011:  Conducted in 10 MMT clinics  In-depth interviews of 55 participants  Recordings have been transcribed and analyzed.  “A Qualitative Study on Reasons for Relatively Low Methadone Dosing among Persons who Inject Drugs in Three Provinces in China” was presented yesterday at the 19th Int. AIDS Conf. by Dr. Lifeng Han [MOAD04] 16 ParticipantsNo. Former MMT clients13 Current MMT clients18 MMT clients' family members6 MMT service providers18

Progress: Randomized Controlled Trial  Participant enrollment began in March 2012  By May 30, 2012, recruitment of participants was as follows: 17 ProvinceNo. Screened No. Enrolled No. IDU No. Non-IDU Guangdong Guangxi Guizhou Total

Conclusions  Critical importance of implementation science in program quality improvement  Training programs play a crucial role in MMT clinic service quality and improved client outcomes  The challenges described here are not unique to China’s MMT program – lessons learnt may offer valuable guidance to harm reduction programs being developed in many other countries 18

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Thank you! 谢谢 !  Special thanks to all staff at NCAIDS and at Guangdong, Guangxi, and Guizhou CDC!  We are particularly grateful for the leadership of Zunyou Wu and Keming Rou at NCAIDS.  Zhijun Li, Lifeng Han, Guodong Mi, Chin-yih Ou, Serena Fuller, and Xiaoyu Wei (GAP China).  Thanks to collaborators/consultants: Abu Abdul-Quader (DGHA); Richard Needle (OGAC); Sten Vermund (Vanderbilt); Roger Detels (UCLA); Rich Garfein (UCSD); Billy Pick (USAID); and others. 20