There is good evidence for the effectiveness of opioid substitution therapy (OST) for injecting drug users (IDUs) in middle and high-income countries but little evidence regarding the provision of OST by non-government organisations (NGOs) in resource-poor settings. This paper reports on outcomes of an NGO-based OST program providing sub-lingual buprenorphine to opiate dependent IDUs in two north-east Indian states (Manipur and Nagaland), a region where conflict, under-development and injecting of heroin and Spasmoproxyvon (SP) are ongoing problems. The objectives of the study were: 1) to calculate OST treatment retention, 2) to assess the impact on HIV risk behaviours and quality of life, and 3) to identify client characteristics associated with cessation of treatment due to relapse.
This study involves analysis of data that were routinely and prospectively collected from all clients enrolled in an OST program in Manipur and Nagaland between May 2006 and December 2007 (n = 2569, 1853 in Manipur and 716 in Nagaland) using standardised questionnaires, and is best classified as operational research. The data were recorded at intake into the program, after three months, and at cessation. Outcome measures included HIV risk behaviours and quality of life indicators. Predictors of relapse were modelled using binary logistic regression.
The findings from this operational research indicate that the provision of OST by NGOs in the severely constrained context of Manipur and Nagaland achieved outcomes that are internationally comparable, and highlights strategies for strengthening similar programs in this and other resource-poor settings.
This paper reports on outcomes of an OST program providing buprenorphine to opiate dependent IDUs, delivered by non-government organisations (NGOs) in the north-east Indian states of Manipur and Nagaland. These states make up a region geographically isolated from the rest of India, and characterised by multiple sources of conflict including a longstanding civil insurgent struggle, poverty and unemployment. Approximately 2% of the population in Manipur and Nagaland inject drugs,[11] most commonly heroin and Spasmoproxyvon (SP, a synthetic opioid analgesic that contains dextropropoxyphene, dicyclomine hydrochloride and paracetamol). As a consequence, Manipur and Nagaland are the two states with the highest HIV prevalence in the country[11]. Both the epidemic and the response to it are more mature in Manipur, where sentinel surveillance data indicates that during the late 1990s HIV prevalence among IDUs approached 80%[12]. By 2007, HIV prevalence among IDUs was much reduced being 18% in Manipur and 1.9% in Nagaland[13]. The response to HIV and injecting drug use in this geo-politically complex environment was punitive and coercive, but harm reduction interventions such as needle and syringe exchange programs and condom distribution have been government policy since the mid 1990s[14].
Project ORCHID (Organised Response for Comprehensive HIV Interventions in the Districts of Nagaland and Manipur) is a Bill & Melinda Gates Foundation-funded HIV prevention project that has been working in selected districts of Manipur and Nagaland since 2004. It supports local partner NGOs to deliver a range of harm reduction interventions in rural and urban settings. In 2006, Project ORCHID initiated a buprenorphine-based OST program delivered by 11 local partner NGOs, initially with funding from the United Kingdom government's Department for International Developing (DFID), and subsequently from the National AIDS Control Organisation (NACO) and Emmanuel Hospital Association (EHA). The OST program is based in the community, operated out of drop-in centres. Sub-lingual buprenorphine is provided for registered IDUs seven days per week, and is administered by trained health care workers (mostly nurses) under the supervision of medical doctors, following a standardised protocol. The program was initially rapidly over-subscribed and waiting lists were created. The program is more fully described elsewhere[15].
During the DFID-funded period of the program (May 2006 - December 2007) more detailed information regarding characteristics of the clients and outcomes of the program were systematically collected as part of routine program monitoring. Analysis of these data were undertaken in order to address the following objectives: 1) to calculate OST treatment retention at 3, 6, 9 and 12 months, 2) to assess the impact of OST on HIV risk behaviours and quality of life, and 3) to identify client characteristics associated with reason for cessation of OST treatment.
This study involves analysis of data collected routinely during the implementation of an OST program, and is best classified as operational research, which can be defined as "The search for knowledge on interventions, strategies, or tools that can enhance the quality, effectiveness or coverage of programmes in which the research is being done" (p.711)[16]. There is a strong connection between program monitoring and evaluation and operational research. Study designs such as randomised controlled trials generate new knowledge about the efficacy of interventions in a controlled environment with strict inclusion and exclusion criteria, whereas operational research assesses effectiveness in routine settings that are far less controlled. The findings from operational research have direct and practical implications for health care delivery[16].
Data were prospectively collected from all clients enrolled in the OST program in Manipur and Nagaland between May 2006 and December 2007 (n = 2569, 1853 in Manipur and 716 in Nagaland) at intake, three months after entry into the program, and at cessation of treatment (regardless of the reason) using standardised questionnaires developed by the program. The questionnaires were interviewer-administered by the NGO nurse or outreach worker, and took approximately thirty minutes to complete. It was not always possible to conduct a face-to-face interview with clients at cessation of treatment, especially if cessation was due to relapse, so where necessary and possible, relevant information was drawn from the client file.
The intake and three month follow-up questionnaires captured self-reported information on socio-demographic characteristics, drug use, HIV risk behaviours, and quality of life. At cessation of treatment additional information was recorded regarding reason for cessation, family involvement during treatment, and adherence to treatment. Reasons for ceasing OST were categorised as: completed the program (meaning that the clients had withdrawn from buprenorphine and had not returned to their past pattern of drug use at the time of discharge); relapsed or involuntarily discharged (hereafter referred to as relapsed); and unknown reason for cessation.
Data were entered by the Project ORCHID monitoring and evaluation team using EpiInfo, and analysed using SPSS version 18. The statistical tests used were Chi-square, t-test, and McNemar's test, and statistical significance was calculated using two-tailed tests at the 95% confidence level. Clients who had ceased OST with an unknown reason (n = 281) were excluded from the analysis, except when calculating OST treatment retention and describing the client characteristics. In order to calculate OST treatment retention at 3, 6, 9 and 12 months, all clients commencing OST during May 2006 (n = 713) were tracked over the subsequent 12 months.
The impact of OST on HIV risk behaviours and quality of life was assessed by comparing changes between baseline and three month follow-up measures. Results were differentiated by the programmatic status of clients at the end of the data collection period i.e. completed the program, relapsed, or still on OST.
To determine factors associated with reason for cessation we identified all clients who had ceased treatment with a known reason for cessation (n = 895) i.e. those who had either completed the program or had relapsed. A binary logistic regression model was used to predict the likelihood of relapse at cessation of treatment rather than completion of the program. Unadjusted odds ratios with p-values less than 0.1 were considered eligible for the multivariate model, and gender and age were also included. The forced entry procedure was used to enter variables in the model.
Table 1 presents socio-demographic data for all clients at entry to OST disaggregated by state. In both Manipur and Nagaland, clients were predominantly male and the majority had at least a high school level of education. Almost half reported being unemployed and the most common source of referral to OST was friends/peers. A small proportion of the OST clients in Nagaland (13.2%) were female sex workers. Ages ranged from 16 to 61 years in Manipur with a mean age of 30.9 years. In Nagaland ages ranged from 18 to 55, with a mean age of 30.0 years.
Substantial improvements in self-reported HIV risk behaviours were observed among clients retained on OST between intake and 3 months (Table 3). There were significant reductions in needle sharing and unsafe sex. At intake one-quarter of clients reported sharing needles in the past month compared to 2% or less after three months on OST. There was a significant decrease in the proportion of clients being jailed/detained. Reductions in HIV risk behaviours were observed amongst all clients on treatment, even those clients who went on to cease OST due to relapse.
There was a consistent and marked improvement observed in the quality of life measures when intake is compared with three months after enrolment (Table 4). Of the clients successfully followed-up at 3 months, the proportion reporting a good quality of life had risen by approximately 40-50%. Other statistically significant improvements in quality of life were also evident including increased attendance at social events, reduced frequency of family conflict, and a reduction in work-related absenteeism amongst those with a job. The improvements in quality of life were observed amongst all clients on treatment, even those clients who went on to cease OST due to relapse. Notably, no statistically significant changes were observed with respect to the proportion of clients who were employed.
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