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MINISTRY OF EDUCATION AND TRAINING MISTRY OF HEALTH HANOI MEDICAL UNIVERSITY DINH THI THANH THUY OUTCOMES OF INTEGRATED SUBOXONE TREATMENT AT HIV OUTPATIENT CLINIC ON HIV-INFECTED OPIOID DEPENDENT PATIENT IN HANOI Specialization Code : Public Health : 9720701 THE MEDICAL DOCTORAL DISSERTATION SUMMARY HA NOI – 2022 THE RESEARCH WAS COMPLETED IN HANOI MEDICAL UNIVERSITY Supervisors: Assoc.Prof Le Minh Giang, Ph.D Assoc.Prof Tran Huu Binh, Ph.D Reviewer 1: Assoc.Prof Ho Thi Hien, Ph.D Reviewer 2: Assoc.Prof Do Thi Nhan, Ph.D Reveiwer 3: Assoc.Prof Le Anh Tuan, Ph.D The dissertation will be defended at the PhD Dissertation Judging Committee taken place at Hanoi Medical University At hour , date month year 2022 The dissertation can be found at: - National Library - Library of Hanoi Medical University LIST OF PUBLICATIONS Dinh Thị Thanh Thuy, Le Minh Giang, Todd Korthuis, Pham Phuong Mai, Lynn Kunkel, Nguyen Thu Hang (2020), Integrated model of opioid substitution treatment with suboxone at HIV outpatient clinic in Hanoi: perspective from providers and patients, Journal of Medical Research, Volume 125, No4 – 6/2020 Dinh Thi Thanh Thuy, Vu Minh Anh, Tran Huu Binh, Tong Thi Khuyen, Pham Quang Loc, Todd Korthuis, Le Minh Giang (2020), Effectiveness of buprenorphine/naloxone treatment on HIVinfected opioid dependent patient at HIV outpatient clinic in Hanoi, Journal of Medical Research, volume 132, No8, 11/2020 Dinh Thi Thanh Thuy, Vu Minh Anh, Tran Huu Binh, Todd Korthuis, Pham Phuong Mai, Le Minh Giang (2021) ARV adherence among HIV patients receiving buprenorphine/naloxone treatment in Hanoi, Vietnam Medical Journal, Volume 498, No2, 1/202 INTRODUCTION Opioid substance abuse is a global public health problem The total number of heroin and opium users is 30.4 million, equivalent to 1.2% of the global population aged 15-64 In Vietnam, the number of drug users is 246 000 (2019), of which about 40% are heroin users and mainly injecting behavior Global use and injection of opiates are responsible for an increased burden of diseases such as HIV, Hepatitis C (HCV), and Hepatitis B (HCV) The current approach method to dealing with opioid substance abuse is that addiction is a chronic disease and needs to be treated The main medications for opioid use disorder are naltrexone, methadone and buprenorphine, but methadone and buprenorphine are the most commonly used medications The most common model of organization for the treatment of opiate addiction is to organize specialized substance addiction treatment facilities in the community with the most common drug being methadone The trend of integrating opioid addiction treatment is increasingly popular with the goal of putting the patient at the center, increasing access, and maintaining treatment Buprenorphine with its advantages such as safe, ceiling level, no interaction with ARV medication, long hafl-life is organized to integrate treatment in different medical facilities The integrated model of opioid addiction treatment with buprenorphine in HIV treatment facilities is the most popular International evidence shows that integrating opioid addiction treatment in HIV treatment facilities increases service access rates and improves outcomes for addiction and HIV treatment However, in the context of Vietnam, whether the this model can help patients improve the outcomes of opioid use disorder treatment and HIV treatment, and increase adherence and retention in care or not? Therefore, we carried out an study “Outcomes of integrated Suboxone treatment at HIV outpatient clinic on HIV-infected opioid dependent patient in Hanoi” with two objectives: Objective 1: Evaluate outcomes of integrated Suboxone treatment at HIV outpatient facilities on HIV-infected opioid dependent in Hanoi from 2016 to 2019 Objective 2: Analyze associated factors with treatment outcomes in this group of patients New contributions of the dissertation: This is one of the first research projects on the outcomes of integrated Suboxone treatment at HIV outpatient clinics in Hanoi, Vietnam The study used a new drug called Suboxone (buprenorphine/naloxone) to treat opioid use disorder and organized integrated treatment at the outpatient HIV clinics in Hanoi The study provided the first evidence of opioid substituion treatment with Suboxone among HIV-infected opioid dependence patients in Hanoi, Vietnam The study contributed some valuable lessons on integrating opioid substitution at outpatient HIV facilities in Hanoi, The layout of dissertation: The dissertation consists of 128 pages (excluding references, appendices), including chapters: Introduction 03 pages Chapter Literature review 26 pages Chapter Methodology 23 pages Chapter 3: Result 44 pages Chapter 4: Conclusion 28 pages Conclusion 04 pages Recommendation 01 pages The dissertation includes: 33 tables, figures, images 130 references THEORETICAL FRAMEWORK Individual factors: Age Gender Carrier Substance abuse status Social Support Mental Health Adherence Treatment status Motivation to treatment Program level Clinic level factors Individual level factors OUTCOMES Program level factors: Changing in ARV treatment modal The policies on ARV treatment and addiction treatment Stigma Clinic level factors: Facility factor Personel Training Addiction treatment experience CHAPTER 1: LITERATURE REVIEW 1.1 Current status of opioid addiction in the world and Vietnam Opioid substance use was recorded in 192 countries out of a total of 229 countries studied These countries account for more than 99% of the world's population aged 15-64, which shows just how widespread opioids are globally compared to other drugs Out of a total of 57.8 million opiate users, 30.4 million use opiatesbased substances (opium, heroin), most concentrated in some parts of Asia (accounting for 60%) According to statistics, the number of drug users in Vietnam in 2019 was 235,314 people Until mid-2015, heroin use accounted for the majority of drug users, however, the use of synthetic drugs has been increasing in recent years, the number of drug users synthesis of methamphetamine and some other drugs increased to 70% in 2019 1.2.2 The association of opioid addiction with HIV infection and response measures in the world and Vietnam Opioid use disorder and injecting drug use (IDUs) have led to negative health consequences, especially HIV HIV prevalence among IDUs is 17,8%, equivalent to 2,8 million people In Vietnam, HIV prevalence among IDUs currently is at 12,7% (2019) Opioid substitution treatment is one of the effective methods to reduce injecting drug behavior and HIV transmission It is a common treatment with 81 countries providing methadone treatment and 56 countries providing buprenorphine treatment In Vietnam, opioid substitution treatment has been implemented since 2008, currently, there are 335 treatment facilities with 52,200 patients in 63 provinces and cities Besides, the pilot buprenorphine has been started since 2019 in provinces and cities with 578 patients 1.3 Model of opioid substitution treatment 1.3.1 Model of opioid substitution treatment in the world The most common form of treatment for opioid use disorder is outpatient treatment in the community The outpatient treatment model is organized in two forms: 1) organized into a specialized substance addiction treatment facility such as a methadone treatment facility and 2) integrated into primary health care facilities, private clinics, HIV and TB treatment facilities Buprenorphine with its advantages such as low overdose risk, long half-life, and milder withdrawal symptoms than methadone if discontinued, becomes a pharmacological therapy that fits the different integrative treatment model The studies around the world have provided evidence of the effectiveness all kinds of treatment settings, but there is no strong evidence that which treatment model lead to better treatment outcomes However, some studies suggest that sucessful opioid substitution treatment with a high retention rate and good quality of care focus on intergrated mult-service or integrated with other services 1.3.2 Model of opioid substitution treatment in Vietnam The most popular model of opioid substitution treatment organization in Vietnam is methadone clinic, organized into two levels: treatment facilities and drug dispensing facilities Integrating opioid substitution treatment and ARV treatment has been implemented with some integrated step and forms In summary, a research review on the treatment of opiate addiction with methadone is the most common form of treatment in the world However, the model of integrating treatment of CTDP addiction with buprenorphine into primary care, private clinics or HIV treatment facilities is being deployed strongly around the world The integrated treatment model aims to increase access to treatment for patients, especially for HIV-infected patients Therefore, we integrate the treatment of opiate addiction with Subxone at an HIV treatment facility in Vietnam CHAPTER 2: METHODOLOGY 2.1 Subject 2.1.1 Subjects for quantitative study component Study subjects are HIV-infected opioid dependent people 2.1.2 Subjects for qualitative study component The participants include groups: healthcare providers and patients participating in the study 2.2 Study site and time The study was conducted at HIV outpatient clinics in Hanoi from September 2016 to July 2020 2.3 Study method Using quasi-experimental (without control group) design and qualitative design 2.4 Sample 2.4.1 Sample for quantitative design Applied the calculating sample size formula: [ √ ( ) ( In which:  √ ( ) ) ( )] p1 = 35,2% is an estimated proportion of test negative morphine of patients at the gate of treatment  p2 = 53% is an estimated proportion of test negative morphine of patients after participating in the treatment  ; α = 0.05; Z1-α/2 = 1.96; β = 0.20; Z1-β = 0.84 Minimum sample size is 121 plus 10% loss during the study so the estimated sample is 135 The study recruited 136 participants 2.4.2 Sample size for qualitative study Each clinic invites medical staff and patients to participate The study invited 26 health workers and 23 patients 2.4.3 Sample selection Convenience sampling method was used in this study The study team approached and screened all potential patients from voluntary HIV testing facilities, HIV outpatient facilities, methadone clinics, and peer networks during the period from 2016 to 2018 2.5 Study and intervention process 2.5.1 Study process The research process went through phases: screening, baseline, months, months, months and 12 months follow up time points 2.5.2 Intervention process HIV treatment interventions: Participants will be supported to access and maintain ARV treatment according to current treatment guidelines of the Ministry of Health when participating in the study Intervention to treat opioid addiction with Suboxone: implemented according to the Guidelines for opioid substitution treatment with buprenorphine, issued under Decision 444/QD-BYT dated February 5, 2015 of the Ministry of Health 2.6 Research variables and indicators Gereral information: demographic and social characteristics, some health problems, social support and stigma Indicators for the outcomes of opiois substitution treatment with Subxone: substance use behavior in the past 30 days and urine test results for morphine; adherence and retention in treatment Indicator for the outcomes of ARV treatment: CD4 cell count, HIV viral load results (under 200 copies/ml and over 200 copies/ml), adherence to ART medication; status of receiving ARV medication Topics from indepth-interviews with subjects: Experiences of integrated treatment models, changes in the treatment process, challenges and benefits from patients treated in the hair graft model Topics from indepth-interviews with health workers: clinic characteristics, integrated activities, advantages and disadvantages in the process of implementing integration, plans to expand service integration 2.7 Tools and techniques for collecting information Information collection tools: Quantitative questionnaire, medical record extract, urine test for drugs, CD4 test, HIV viral load test and indepth interviews guides 2.8 Bias and control bias Bias: bias due to loss of subjects and bias of recall information before and after the intervention Bias control: regular contact and tracking of research subjects and ensure that all necessary information is collected according to the research time points; training investigators on research ethics and skills in working with vulnerable groups; clearly explain to the research subjects about the research purpose and use of the test results to ensure the accuracy of research information 2.9 Data analysis Analyzing quanlitative data Data were analyzed by using Stata 14.0/MP software Descriptive statistics to analyze socio-demographic characteristics (mean, median and percentage) Wilcoxone trend analysis method to analyze substance use behavior, CD4 cell count results and HIV viral load testing results over time Mixed-effect model to analyze factors related to positive urine morphine test results and adherence to ART The Kaplan-Meier method was used to construct a curve describing the retention rate in the treatment of opioid addiction with Suboxone and to estimate the discontinuation rate during the follow-up periods Cox regression model was used to determine the patient's risk of stopping treatment after 12 months of follow-up in the study Analyzing qualitative data In-depth interviews will be recorded and taped, cleaned of personal data and analyzed using Atlas.ti qualitative data management and analysis software Using thematic analysis method, the qualitative content will be coded according to the coding table built based on the interview guide and the research theoretical framework 2.10 Research ethics The study was approved by the Biomedical Research Review Board of Hanoi Medical University under the approval certificate No 134 dated October 29, 2013 CHAPTER 3: RESULTS 3.1 Characteristics of demographic, socioeconomic, health status and substance use history of participants at baseline 3.1.1 Characteristics of demographic and socioeconomic of participants at baseline - The average age of the subjects was 38 ± 5,8 years old, in which the age group ranging from 31 to 40 years old accounted for the majority (63,2%), most of whom are men (96,3%) About 52,9% of the subjects have not finished high school; 44,1% of the subjects have never been married; 43,4% of the subjects have jobs and 52,2% of the subjects have an income of million VND or more - The mean score of the stigma related to substance use is 1,6±0,8 The average score of HIV-related stigma is 2,0±0,7, in which the highest score of the status of being discriminated is 2,5±0,9 and 10 100% 100% 80% 6.9% 6.4% 6.0% 6.5% 2.4% 1.8% 2.0% 1.8% 1.9% 1.5% 1.0% p-trend value