BackgroundBackground

The National Institutes of Health has funded The National Institutes of Health has funded HPTN HPTN 058: A Phase III randomized controlled trial to 058: A Phase III randomized controlled trial to evaluate the efficacy of drug treatment in evaluate the efficacy of drug treatment in prevention of HIV infection among opiate prevention of HIV infection among opiate dependent injectors dependent injectors (“the 058 Trial”). The trial will (“the 058 Trial”). The trial will be conducted at Heng Chien, Guangxi Zhuang be conducted at Heng Chien, Guangxi Zhuang Autonomous Region, Urumqi, Xinjiang Uighur Autonomous Region, Urumqi, Xinjiang Uighur Autonomous Region of China and Chiang Mai, Autonomous Region of China and Chiang Mai, Thailand. Recognizing the potential for injection Thailand. Recognizing the potential for injection drug users (IDUs) to be exposed to excess risk of drug users (IDUs) to be exposed to excess risk of arrest or other negative legal consequences by arrest or other negative legal consequences by virtue of their participation in the research study, virtue of their participation in the research study, the HPTN 058 protocol requires the annual the HPTN 058 protocol requires the annual monitoring of law and its implementation related monitoring of law and its implementation related to IDUs participating in the trial. To assess the to IDUs participating in the trial. To assess the risks to IDUs of participating in the clinical trial, risks to IDUs of participating in the clinical trial, the HPTN 058 Protocol Team commissioned this the HPTN 058 Protocol Team commissioned this report. report.

Research ProceduresResearch Procedures

Laws related to possible research risk were Laws related to possible research risk were collected and analyzed by a qualified collected and analyzed by a qualified Chinese lawyer using standard legal Chinese lawyer using standard legal research methods. National and local laws research methods. National and local laws were collected in nine domains: drug use were collected in nine domains: drug use (including drug control laws, syringe laws, (including drug control laws, syringe laws, needle exchange programs and drug needle exchange programs and drug treatment); HIV-specific criminal exposure or treatment); HIV-specific criminal exposure or transmission; criminal justice/procedure; transmission; criminal justice/procedure; right to health care and right to HIV right to health care and right to HIV treatment; reportability of HIV, AIDS, and treatment; reportability of HIV, AIDS, and STDs; HIV testing laws; privacy of medical STDs; HIV testing laws; privacy of medical information; anti-discrimination provisions, information; anti-discrimination provisions, and any other laws that influence risk or and any other laws that influence risk or stigma among drug users in a significant stigma among drug users in a significant way. way.

Research ProceduresResearch Procedures The qualitative research team was trained on the The qualitative research team was trained on the

applicable law and research procedures prior to applicable law and research procedures prior to conducting interviews. The researchers identified conducting interviews. The researchers identified and recruited 44 key informants at each of the and recruited 44 key informants at each of the two study sites. The research protocol was two study sites. The research protocol was reviewed and approved by the applicable reviewed and approved by the applicable Institutional Review Boards at Temple University Institutional Review Boards at Temple University and the China Centers for Disease Control. and the China Centers for Disease Control.

The RPA identifies three types of key informants:The RPA identifies three types of key informants:1) 1) systems participantssystems participants who have a good overall view of who have a good overall view of

police/health/drug systems which may impact on the police/health/drug systems which may impact on the transmission of HIV among IDUs; transmission of HIV among IDUs;

2) 2) interactor participantsinteractor participants who interact with IDUs on a day who interact with IDUs on a day to day basis and are able to provide information about to day basis and are able to provide information about how each system works at a practical level; and how each system works at a practical level; and

3) 3) IDU participantsIDU participants who describe their daily interaction who describe their daily interaction with law enforcement, as well as the legal, public with law enforcement, as well as the legal, public health, and drug treatment systems with which they health, and drug treatment systems with which they interact. interact.

IDU Interview SubjectsIDU Interview Subjects(n=32)(n=32)

Heng Heng ChienChien

UrumqiUrumqi TotalTotal

GenderGender

MaleMale 1515 1212 2727

FemaleFemale 11 44 55

EthnicityEthnicity

HanHan 1515 22 1717

MinorityMinority 11 1414 1515

Living AreaLiving Area

RuralRural 1616 00 1616

UrbanUrban 00 1616 1616

Systems and Interactor Systems and Interactor Interview Subjects (n= 56Interview Subjects (n= 56

Legal SystemsLegal Systems

Prison officialPrison official 11

Judge Judge 11

ProsecutorProsecutor 11

Policy-maker or local authorities Policy-maker or local authorities 11

Legal InteractorsLegal Interactors

Police: Supervisory Police: Supervisory 22

Police: Street-level Police: Street-level 22

Prison guards Prison guards 22

Public Health Systems Public Health Systems

Public health authorities Public health authorities 11

Drug treatment facilities: officials Drug treatment facilities: officials 11

Director of NGO working with HIV Director of NGO working with HIV 11

Harm reduction director Harm reduction director 11

Public Health InteractorsPublic Health Interactors

Public health cliniciansPublic health clinicians 22

Emergency ward physicians Emergency ward physicians 22

Harm reduction workersHarm reduction workers 22

Drug treatment facilities: staff Drug treatment facilities: staff 22

NGO staff working in HIV NGO staff working in HIV 22

Research System and InteractorsResearch System and Interactors

People with > 6 months People with > 6 months experience staffing an IDU experience staffing an IDU research projectresearch project

33

Investigators operating an IDU Investigators operating an IDU research projectresearch project

11

TOTAL (per site)TOTAL (per site) 2828

Systems and Interactor Systems and Interactor Interview Subjects (n= 56)Interview Subjects (n= 56)

Specific AimsSpecific Aims1) To use RPA tools to document laws and law 1) To use RPA tools to document laws and law

enforcement practices in Heng Chien, enforcement practices in Heng Chien, Guangxi Autonomous Region and Urumqi, Guangxi Autonomous Region and Urumqi, Xinjiang Uighur Autonomous Region that may Xinjiang Uighur Autonomous Region that may increase risks faced by the injection drug user increase risks faced by the injection drug user participating in the 058 Trial; participating in the 058 Trial;

2) To compile and deliver to the 058 Trial 2) To compile and deliver to the 058 Trial protocol team and other stakeholders a protocol team and other stakeholders a comprehensive risk analysis based upon the comprehensive risk analysis based upon the findings of the RPA that clearly indicates any findings of the RPA that clearly indicates any evidence of elevated risk to participants that evidence of elevated risk to participants that may result from their screening and may result from their screening and enrollment in the study; enrollment in the study;

3) To recommend to the protocol team 3) To recommend to the protocol team strategies to reduce or eliminate possible law strategies to reduce or eliminate possible law and enforcement related risks posed by study and enforcement related risks posed by study

screening and enrollment proceduresscreening and enrollment procedures. .

Law on the BooksLaw on the Books Drug possession, distribution and production Drug possession, distribution and production

are subject to serious punishment including the are subject to serious punishment including the death penalty. death penalty.

As to drug users, As to drug users, the law prescribes detention the law prescribes detention for no more than 15 days a fine of less than for no more than 15 days a fine of less than 2000 RMB.2000 RMB. Besides these penalties, the drug user could be Besides these penalties, the drug user could be

sent to a detoxification center for 3 to 6 months’ sent to a detoxification center for 3 to 6 months’ treatment. If he/she is found to have relapsed after treatment. If he/she is found to have relapsed after detoxification, he/she could be sent to a detoxification, he/she could be sent to a reeducation camp for up to 3 years’ rehabilitation reeducation camp for up to 3 years’ rehabilitation labor. labor.

Individual drug use/ possession of small amounts is Individual drug use/ possession of small amounts is often handled under the Security Administrative often handled under the Security Administrative Punishment Regulations, a set of general powers Punishment Regulations, a set of general powers exercised by the public security organs to respond exercised by the public security organs to respond to breaches of public order deemed too minor for to breaches of public order deemed too minor for criminal punishment.criminal punishment.[[

Compulsory Registration Compulsory Registration and Treatmentand Treatment

Drug users who are identified by the police Drug users who are identified by the police are subject to registration, and may be are subject to registration, and may be entered into treatment or re-education entered into treatment or re-education through an administrative process. through an administrative process. The “treatment,” which in many if not most cases The “treatment,” which in many if not most cases

can include cold-turkey detoxification, lasts can include cold-turkey detoxification, lasts between three months and one year. People in between three months and one year. People in treatment facilities are expected to work. In theory treatment facilities are expected to work. In theory they are entitled to a wage but in practice their they are entitled to a wage but in practice their “earnings” typically go to paying the costs of their “earnings” typically go to paying the costs of their confinement. confinement.

Drug users who repeatedly relapse graduate to Drug users who repeatedly relapse graduate to another sort of administrative rehabilitation facility, another sort of administrative rehabilitation facility, the Education through Labor camp. Several the Education through Labor camp. Several hundred thousand Chinese are confined in these hundred thousand Chinese are confined in these facilities, about a third of whom are drug users.facilities, about a third of whom are drug users.

Findings: Findings: A public health A public health research project involving IDUs research project involving IDUs

cannot operate without the cannot operate without the cooperation of the police.cooperation of the police.

““We have a county-level AIDS We have a county-level AIDS Working Committee which involves Working Committee which involves Public Health, Public Security, Public Health, Public Security, Education, and many other Education, and many other departments. It is a multi-sectoral departments. It is a multi-sectoral coordinating committee on AIDS. In coordinating committee on AIDS. In the committee, only the Public the committee, only the Public Security Department is the one with Security Department is the one with which we keep very close touch. It which we keep very close touch. It is impossible for us to initiate a is impossible for us to initiate a program involving IDUs without program involving IDUs without sufficient communication with local sufficient communication with local police in advance.” police in advance.” (Public Health (Public Health Department Official in Heng ChienDepartment Official in Heng Chien))

Findings: Findings: A public health A public health research project involving IDUs research project involving IDUs

cannot operate without the cannot operate without the cooperation of the police.cooperation of the police.

““It would be too late for you to coordinate It would be too late for you to coordinate with local police after their law with local police after their law enforcement activities have had negative enforcement activities have had negative impacts on you program. Actually, we impacts on you program. Actually, we had been negotiating with the police had been negotiating with the police station long before the initiation of our station long before the initiation of our program.” program.” (Community-based syringe (Community-based syringe exchange program administrator)exchange program administrator)

““Whether or not we will go to program Whether or not we will go to program sites to arrest IDUs [for confinement in a sites to arrest IDUs [for confinement in a detoxification center] depends on our detoxification center] depends on our director’s attitude. If he tells us nothing director’s attitude. If he tells us nothing specifically about it, we will. ” specifically about it, we will. ” (Street (Street level police officer in Heng Chien)level police officer in Heng Chien)

Findings: if there is cooperation Findings: if there is cooperation with police, the chance of with police, the chance of

interference at the research site interference at the research site is lowis low

Clients were occasionally arrested Clients were occasionally arrested at methadone clinics and SEPs:at methadone clinics and SEPs: ““Someone reported to the police that Someone reported to the police that

there were drug dealers at the site. there were drug dealers at the site. Then the police went to the site and Then the police went to the site and arrested the peer educator. The arrested the peer educator. The epidemic prevention station officials epidemic prevention station officials negotiated with the police. After three negotiated with the police. After three days incarceration, the educator was days incarceration, the educator was released. From then on, police never released. From then on, police never arrest IDUs at the sites. ” arrest IDUs at the sites. ” (IDU-7, (IDU-7, Heng Chien)Heng Chien)

Findings: if there is cooperation Findings: if there is cooperation with police, the chance of with police, the chance of

interference at the research site interference at the research site is lowis low

In HPTN 033, there was no interference In HPTN 033, there was no interference at either site.at either site. ““At the very beginning, both the researchers At the very beginning, both the researchers

and the IDUs were afraid that the police and the IDUs were afraid that the police would come to the clinic to arrest IDUs. But would come to the clinic to arrest IDUs. But it did not happen.” it did not happen.” (Researcher at Urumqi)(Researcher at Urumqi)

““In the process of HPTN033 In the process of HPTN033 implementation, the health sector and implementation, the health sector and police developed very good relations. At police developed very good relations. At first the IDUs were afraid of being arrested first the IDUs were afraid of being arrested by the police at the program site, but it by the police at the program site, but it never happened. ” (never happened. ” (Treatment staff Treatment staff member, Heng Chien)member, Heng Chien)

Findings: street level police Findings: street level police generally do not arrest IDUs generally do not arrest IDUs

solely for drug use.solely for drug use.

Most of the time, the IDUs being Most of the time, the IDUs being detained can trade freedom or detained can trade freedom or short-term detoxification for short-term detoxification for information.information. ““When we arrest an IDU, we will ask When we arrest an IDU, we will ask

him from whom he buys drugs; who him from whom he buys drugs; who else uses drugs, and so on. To avoid else uses drugs, and so on. To avoid being put in detoxification for a long being put in detoxification for a long time or penalized, the IDU will tell us time or penalized, the IDU will tell us what we want to know. This way, we what we want to know. This way, we identify drug dealers.” identify drug dealers.” (Street level (Street level police officer, Heng Chien)police officer, Heng Chien)

Findings: street level police Findings: street level police generally do not arrest IDUs generally do not arrest IDUs

solely for drug use.solely for drug use.

““Once you are arrested, the police Once you are arrested, the police will ask who sells drugs to you, will ask who sells drugs to you, where you get the money, and who where you get the money, and who uses drugs with you. If you tell them uses drugs with you. If you tell them nothing, the police will use physical nothing, the police will use physical violence. Nearly all the IDUs being violence. Nearly all the IDUs being detained will be cooperative.” detained will be cooperative.” (IDU-9, (IDU-9, Urumqi)Urumqi)

““We seldom just arrest IDUs and put We seldom just arrest IDUs and put them into the detoxification center. them into the detoxification center. The most important reason for us to The most important reason for us to arrest them is to find out the drug arrest them is to find out the drug dealers behind them.” dealers behind them.” (Street level (Street level police officer, Urumqi)police officer, Urumqi)

Findings: street level police Findings: street level police generally do not arrest IDUs generally do not arrest IDUs

solely for drug use.solely for drug use.

Unofficial “fines” are a way for local Unofficial “fines” are a way for local police officers to augment their low police officers to augment their low incomes.incomes. ““We have a very low wage and need to We have a very low wage and need to

arrest IDUs and penalize them to make arrest IDUs and penalize them to make money sometimes.” money sometimes.” (Street level police (Street level police officer, Heng Chien)officer, Heng Chien)

““The police called my parents and asked for The police called my parents and asked for 2000 RMB in exchange for my release. My 2000 RMB in exchange for my release. My parents paid the money to them and I was parents paid the money to them and I was released. ” released. ” (IDU-13, Heng Chien)(IDU-13, Heng Chien)

““On average, we need to hand over 3,150 On average, we need to hand over 3,150 RMB in exchange for release or to avoid RMB in exchange for release or to avoid arrest. Sometimes, we can bargain with the arrest. Sometimes, we can bargain with the police.” police.” (IDU-9, Urumqi)(IDU-9, Urumqi)

Findings: street level police Findings: street level police generally do not arrest IDUs generally do not arrest IDUs

solely for drug use.solely for drug use. In recent years there has been some In recent years there has been some

effort by the security authorities to effort by the security authorities to reduce the occurrence of informal reduce the occurrence of informal payments.payments. ““Formerly, the police would take money Formerly, the police would take money

from IDUs in exchange for release or to from IDUs in exchange for release or to avoid arrest. But now, they would not. They avoid arrest. But now, they would not. They sent all the IDUs being arrested to sent all the IDUs being arrested to detoxification.” (IDU-8, Urumqi)detoxification.” (IDU-8, Urumqi)

““Before 2002, the police would take money Before 2002, the police would take money from me in exchange for release. But once I from me in exchange for release. But once I am arrested nowadays, I will be sent to am arrested nowadays, I will be sent to detoxification center. (IDU-15, Heng Chien)detoxification center. (IDU-15, Heng Chien)

Findings: some report research Findings: some report research participation is protective against participation is protective against

police actionpolice action

““A few IDU participants were even A few IDU participants were even released after being detained because released after being detained because of injecting or buying drugs.” (of injecting or buying drugs.” (Public Public health clinician, Urumqi)health clinician, Urumqi)

““In October 2005, Heng Chien CDC In October 2005, Heng Chien CDC began syringe exchange programs in began syringe exchange programs in two villages. The peer educators were two villages. The peer educators were designated by both the police and the designated by both the police and the health department. The police officials health department. The police officials promised that they would not arrest promised that they would not arrest IDUs at the site.” IDUs at the site.” (Researcher, Heng (Researcher, Heng Chien)Chien)

ConclusionsConclusionsPolice vigorously enforce criminal laws and detain Police vigorously enforce criminal laws and detain

hundreds of thousands of drug users for hundreds of thousands of drug users for involuntary treatment and reeducation each year. involuntary treatment and reeducation each year. No NGOs operate to support the health or social No NGOs operate to support the health or social status of IDUs. Nonetheless, in the sites we status of IDUs. Nonetheless, in the sites we investigated, research studies, syringe exchanges investigated, research studies, syringe exchanges and methadone programs were able to operate and methadone programs were able to operate with some degree of freedom from police intrusion with some degree of freedom from police intrusion or harassment of participants. Our policy analysis or harassment of participants. Our policy analysis identifies two key institutional factors: identifies two key institutional factors:

1) Public health programs for drug users have been 1) Public health programs for drug users have been introduced in China as a top-down measure, with introduced in China as a top-down measure, with strong support from the China CDC and Ministry strong support from the China CDC and Ministry of Health; of Health;

2) At the local level, there were health-oriented 2) At the local level, there were health-oriented organizations that had sufficient strength and will organizations that had sufficient strength and will to negotiate with police on the implementation of to negotiate with police on the implementation of punitive drug control laws.punitive drug control laws.

Current versions of Current versions of the RPAR tools and the RPAR tools and training materials training materials

are available on the are available on the world wide web at world wide web at

http://www.rpar.org.http://www.rpar.org.

Copies of the full China Copies of the full China report and other report and other

materials are available at materials are available at the RPAR Booththe RPAR Booth

Acknowledgments Acknowledgments

Legal and qualitative data were collected using tools Legal and qualitative data were collected using tools adapted by Scott Burris and Corey Davis from the Rapid adapted by Scott Burris and Corey Davis from the Rapid Policy Assessment and Response toolkit. Policy Assessment and Response toolkit.

The Rapid Policy Assessment and Response Tools were The Rapid Policy Assessment and Response Tools were initially developed by Scott Burris, Patrica Case and Zita initially developed by Scott Burris, Patrica Case and Zita Lazzarini with the support of the International Harm Lazzarini with the support of the International Harm Reduction Development Program of the Open Society Reduction Development Program of the Open Society Institute, and further refined under NIDA Grant # 5 R01 Institute, and further refined under NIDA Grant # 5 R01 DA17002-02, Zita Lazzarini, Principal Investigator. DA17002-02, Zita Lazzarini, Principal Investigator.

Wang Zhengzhi of Globe Law Firm, Beijing, collected Wang Zhengzhi of Globe Law Firm, Beijing, collected relevant laws and regulations. relevant laws and regulations.

Qualitative research was conducted and the resulting Qualitative research was conducted and the resulting data analyzed by Zhang Youchun, Fu Xiaoxing and local data analyzed by Zhang Youchun, Fu Xiaoxing and local interviewers in the site cities. Zhang and Fu drafted the interviewers in the site cities. Zhang and Fu drafted the final report, which was edited by Burris and Davis. final report, which was edited by Burris and Davis.

The team thanks Wang Ruotao and David Metzger for The team thanks Wang Ruotao and David Metzger for their assistance in organizing and conducting the their assistance in organizing and conducting the research. research.

Funding was provided by the HPTN through by the Funding was provided by the HPTN through by the University of Pennsylvania. University of Pennsylvania.