The first cases of HIV infection associated with injecting drug users (IDU) in China were reported in 1989 among a group of 146 drug users in a detoxification centre in Yunnan province . The disease spread rapidly through this population and by 2002 had reached IDU in all 31 provinces [2–4]. By 2005, HIV was thought to have infected 288 000 drug users, accounting for 44.3% of all HIV infections . The number of registered drug users in 2005 was 1.16 million , but the actual number, including those unregistered, is likely to be considerably higher .
Most of China's registered drug users are unmarried men, aged between 15 and 29 years, heroin users that prefer injection over other forms of use [4,8]. Needle sharing among IDU is common, with reports ranging from around 50% [9,10] to over 70% [11–13]. Chinese drug users are more likely to engage in pre- and extra-marital sex than those not using drugs , and many female drug users may exchange sex for drugs or money. These women are also those most likely to share needles [9,14]. Consistent condom use is generally poor [11,12,14], as is knowledge about HIV/AIDS, sexually transmitted diseases and blood borne viruses such as hepatitis C virus (HCV) [9,12,13]. As such IDU represent a significant bridge for the transmission of HIV into the general population, as already seen in Yunnan , and, in those provinces with a severe drug-use problem, such as Yunnan, Guangxi and Xinjiang, there is already evidence of a generalized epidemic .
International experiences have demonstrated that harm reduction programmes, either needle exchange or methadone maintenance programmes combined with health education and promotion activities, are effective in reducing HIV transmission among IDU populations [17–19]. Until recently, harm reduction strategies were viewed as assisting drug users and promoting the use of prohibited drugs, and were thus regarded as illegal. Given these legal barriers, the only HIV prevention program targeting IDU was health education, but this single strategy had proven to be hopelessly ineffective in reducing HIV transmission among and from IDU.
In 1998, however, the Ministry of Health changed tack and began promoting “needle social marketing” , a term which refers to a harm reduction strategy that promotes the use of new needles and syringes for each injection and discourages the sharing of injection equipment . It involves increasing the commercial availability and accessibility of needles and syringes to IDU without affecting profits from existing local needle and syringe sources as well as using peer influence among IDU social networks to discourage the practice of sharing used needles and syringes. After lengthy negotiations, this strategy became acceptable to both health and police officials. As it was still unclear how effective this strategy would be for reducing HIV transmission among IDU in China, a community intervention trial was conducted to evaluate the effectiveness of needle social marketing programmes. In this paper, we report the results of that first trial.
Subjects and methods
The study was conducted in Guangdong province and Guangxi Zhuang Autonomous Region (Guangxi ZAR) both of which had an HIV epidemic among IDU, and whose governments were willing to participate in the study. Four counties/townships were selected to act as intervention and control communities, as described below and outlined in Fig. 1.
First, the Guangdong and Guangxi Centres for Disease Control were requested to recommend five project sites (counties or townships) that had a similar number of registered drug users, proportion of drug injection, and cumulative number of reported HIV cases, and provide background information on these sites.
Second, qualitative methods—in-depth interviews, group discussions and observations—were used to collect information about the target population, including drug use information, purchasing and sharing of needles, sexual behaviour, and awareness of AIDS-related knowledge . After the qualitative study, three sites from each province were recommended for baseline survey.
Third, a baseline survey was conducted to evaluate AIDS-related knowledge, sexual and drug use behaviours and the HIV and HCV infection rates. This information was used to identify two comparable counties or townships in each province for the intervention, one of which was assigned to the intervention arm, the other to the control arm.
Needle social marketing strategies
The intervention began in 2002 in September in Dagou and in November in Luzhai, and was conducted in both detoxification centres as well as the wider community. The target population were all IDU in the intervention sites. Activities utilized local resources such as, pharmacies, hospitals and clinics to reach IDU.
In detoxification centres, the intervention mainly consisted of health education by health workers, which involved handing out educational pamphlets, displaying educational posters, delivering lessons about drug abuse and HIV/AIDS by health workers, viewing a photo exhibition and educational videos.
In the community, intervention activities included handing out educational pamphlets, displaying educational posters, face to face health education sessions between health workers and drug users, peer education and dispensing and recall of needles. Health workers visited drug users' homes or places where they gathered. Drug users could also collect materials/needles from the local hospital or Center for Disease Control (CDC) and from peer educators. Needle/syringe distribution was mainly conducted by peer educators who visited drug users' homes or places where they gathered, and who usually distributed between three and ten needles at a time. The maximum number of needle and syringes a drug user was allowed to collect at one time was 20 for a week.
The effectiveness of the intervention was evaluated by two surveys (baseline and final survey), as well as laboratory testing for HCV and HIV. The final assessment was conducted in June 2003 in Guangdong and in July 2003 in Guangxi, giving a total trial period of nine and ten months, respectively, in the two provinces. IDU who had injected in the past three months were invited to participate. In detoxification centres, all IDU who were admitted to the facility for less than one month were surveyed. In the community, IDU were recruited through key informants and peer educators, through mail outs, using contact information obtained from the local detoxification centre, and by health workers who recruited them in their home. Participants were given a card which promised them 30 Chinese Yuan (about US$4) if they returned for a follow-up interview in one year's time.
The questionnaire included questions about AIDS-related knowledge (transmission and prevention), drug use risk behaviours in the last thirty days (rate of sharing various injection equipment and number of partners), the number of times needles were shared in ten injections over the last three months, and information about sexual practices (number and types of partners in the last three-six months, condom use, etc.).
Five millilitre blood samples were collected from all participants at the baseline and final surveys for HIV and HCV antibody testing. The specimen was first tested by ELISA (Organon Teknika, The Netherlands). Positive specimens were double checked using a different test kit (Jinhao Kinghawk Pharmaceutical, Beijing, China). For discordant test results, Western Blot (Genelabs Technologies, Inc., Singapore) testing was used to confirm the result. HCV was tested by ELISA (Organon Technika, The Netherlands).
Data analysis was undertaken using SAS Version 8.12 (SAS Institute, Cary, NC, USA). Categorical variables were compared between the intervention and control groups at baseline and follow-up using Chi-squared tests, and continuous variables were compared by t-test. The incidences of HIV and HCV were calculated based on a subset of retrospective cohort of drug injectors who initiated the injection after the intervention was launched.
The study was reviewed and approved by the Ethical Review Committee (i.e. Institutional Review Board) in the Chinese Academy of Preventive Medicine (the institute was re-organized as Chinese Center for Disease Control and Prevention in 2002).
A total of 823 IDU took part in the baseline survey. At follow-up, one hundred and two participants (12.4%) were successfully followed; however records could only be linked for 42 of these people because 60 had lost their ID cards. Because of the poor follow-up rate, the study design was modified to a cross-sectional design and a further 750 drug users were surveyed bringing the total at second survey to 852.
Demographic characteristics of drug users
Demographic information about the participants is given in Table 1. Intervention and control arms within each province were statistically dissimilar in terms of the distribution of several characteristics, in particular sex, age, occupation, ethnicity (Guangxi only) and education (Guangdong only). Participants in the baseline and final survey in all of the four programme sites were predominantly male (>85%) and most were aged between 20 and 39 years (>85%). In Guangxi ZAR more participants were unmarried than married, while in Guangdong there was a balanced proportion of unmarried and married/cohabitating participants. Han were the dominant ethnic group for the sites in Guangdong province (>99%). In Guangxi ZAR, Zhuang was the main ethnic group in Yongning (>75%) and composed around a third of the population for Luzhai county (28–30%). In Guangdong and in Luzhai county in Guangxi ZAR, most people had finished secondary school (50–62%). In Yongning county most people had only finished primary school (48–49%). Unemployment was higher in Yu'nan and Luzhai counties (47–66%). Farming was the main occupations in Yongning and Dagou, and a large number were also unemployed. Businessmen were more prominent in Yu'nan county (13–18%).
Needle distribution and collection
In Dagou 47 000 disposable syringes were dispensed and 24 780 of them were returned (return rate = 53%). Approximately 170 disposable syringes were dispensed every day and 120–160 drug users received them. Roughly 2000 educational pamphlets were distributed and 300 posters were displayed.
In Luzhai, more than 5000 items of educational materials were distributed. A total of 57 209 disposable syringes were dispensed to around 400 drug users and 52 930 of these were returned (92% return rate).
Exposure to intervention
Exposure rates varied from component to component. The proportion of drug users who reported receiving needles from the intervention program was 69.5% (4% from clinics, and 65.5% from out-reach peer educators) in Guangdong and 46.8% (11.8% from clinics, and 35% from out-reach peer educators) in Guangxi. Educational pamphlets were received by 60.8 and 59.4% of participants respectively, and 70.9 and 69.6% had seen educational posters, respectively. More than half of the participants in Guangxi had participated in a face-to-face counselling session with a health worker (52.7%) or a peer educator (55.2%), and in Guangdong these figures were 61.7 and 66.0%, respectively.
Change in high-risk drug use and sexual behaviours
At baseline, the number of IDU who had shared needles in the previous month was no different between intervention and control communities in both provinces, but at follow-up was significantly lower in the intervention arm compared with the control arm (Table 2).
The number of needle-sharing partners was not different between intervention and control at final survey. Sharing water was also not different between intervention and control at baseline or final survey.
Few drug users reported any sexual activity in the month before the survey, so the numbers for analysing condom use were small. Consistent condom use during sex was low and there was no difference between intervention and control groups at baseline in both provinces. The number of those who always used a condom was higher in interventions than in controls in final evaluation survey in both provinces but only statistically significant in Guangdong (P = 0.015), not in Guangxi (P = 0.17).
Change in HIV and HCV prevalence and incidence
The HIV infection rate at the baseline survey was significantly higher in the intervention group compared with the control at both the baseline and follow up surveys in both provinces (Table 2). However, although not statistically significant, the rates did change between baseline and follow-up: decreasing in the intervention communities by 6.4% in Dagou (P = 0.16) and 3% in Luzhai (P = 0.54); while in control communities it either increased (Yongning; +1.7%; P = 0.68) or remained the same (Yu'nan, P = 0.99).
The HCV infection rate was also higher in the intervention group compared with the control at the baseline survey in both provinces, but there was no significant difference at follow-up (Table 2). If the baseline and follow-up rates are compared, Guangxi saw a non significant reduction in the intervention group (−4.2%, P = 0.22) and a non-significant increase in the control group (+6.6%, P = 0.07). In Guangdong, the rates were significantly reduced at follow-up for both the intervention (−10.2%, P < 0.01) and control (−29.6%, P < 0.01) groups.
To investigate this further, the incidence of HIV and HCV was also compared between the intervention and control arms at final survey among only those who had started drug injection since the intervention started. The incidence of HIV infection was 18.1% (17/94) in the intervention arm compared with 23.6% (26/110) among controls (P = 0.391). Taken separately, the HIV incidence rates were significantly lower among intervention participants in Guangdong (12.9 vs. 33.3%, P = 0.011), but not in Guangxi (28.1 vs. 16.9%, P = 0.285). The HCV incidence rate was 51% (48/94) in the intervention arm and 83.6% (92/110) in the control arm (P < 0.001). The lower incidence in the intervention arm was significant in both Guangdong (48.8 vs. 86.7%, P = 0.001) and Guangxi (56.2 vs. 81.5%, P < 0.014).
There were several limitations to the design of this study. The trial was initially planned as a longitudinal study; however few of the baseline participants were successfully recruited for the follow-up survey. There were several reasons for this, including inadequate staff, time and money to be able to locate and recruit participants. Furthermore, half of those who participated in both surveys had lost their cards, which suggests that reimbursement was not an effective strategy for retention. Other participants were lost through death, incarceration, fear of arrest and emigration for work. These factors had a serious impact on the plan to evaluate this group as a cohort study.
Another limitation was the dissimilarity between intervention and control arms at baseline. Ideally, the two study sites should have been comparable with regards to demographic variables and key outcome measures, but out of six communities included in the baseline survey, none were perfectly comparable and other factors limited selection. For example, there were problems with finding enough IDU willing to participate in Tianyang, Guangxi, so this site could not be used. At the time this study was carried out, the notion of trialling needle exchange was extremely controversial, and so it was both important and quite difficult to find communities that were willing to allow the trial to proceed. Given that the rates of key risk factors, such as the rate of needle sharing and the number of needle-sharing partners, were higher in the intervention group at baseline, the drop seen in these rates is greater than could have been seen in the control group. Thus this dissimilarity is likely to overestimate the intervention effect. However, the intervention did result in reduced risk behaviours and incidence of HIV and HCV, which was the overall goal.
Despite its limitations, this study was able to demonstrate that needle social marketing could reduce some risk behaviours among IDU and thus reduce HIV and HCV infections; for those IDU who started injecting during the trial, HIV and HCV infections rates were markedly reduced, although the numbers were perhaps too small to see statistically significant differences for HIV. Importantly the rate of injecting reduced, lending further support to the position that needle exchange programmes do not increase drug use [22,23]. In addition, the participants in this study reported a low rate of sexual activity. This is in contrast to other reports from China [24–26] which have reported higher rates of unprotected sex. In our study, underreporting may be associated with social desirability bias, but could also be an artefact of the gender ratio – the proportion of females in these other studies has been higher than in this study and women are more likely than men to sell sex to support their drug habit .
The main success of the trial was that it demonstrated the feasibility of introducing needle social marketing as an HIV control strategy in China. These results were thus endorsed by the Ministry of Health and were used to inform the development of national guidelines on needle exchange. They were also used to support the successful application to the Global Fund against AIDS, Tuberculosis and Malaria Round 4. The needle exchange has been included among harm reduction strategies in the Regulations for the Prevention and Treatment of AIDS, issued in March 2006, and in the China's Action Plan for Reducing and Preventing the Spread of HIV/AIDS (2006 – 2010), which is the technical document to guide implementation of the new law. Since this document's issuance in March 2006, needle programmes around China have been massively scaled up – from 93 to 729 by the end of 2006 . Scale-up will continue and this intervention will hopefully prove to be an effective measure in the control and prevention of HIV in China.
The authors gratefully acknowledge the assistance of the World AIDS Foundation for funding for this trial. The results of this study were first presented at the 15th International AIDS Conference in Bangkok, Thailand in July 15, 2004.
Sponsorship: This study was supported by the World AIDS Foundation grant number WAF 217 (00-009). Preparation of the manuscript was partly supported the China Multidisciplinary AIDS Prevention Training Program with NIH Research Grant # U2R TW06918 funded by the Fogarty International Center, National Institute on Drug Abuse, and the National Institute of Mental Health.
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