Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of Long-acting Depot Buprenorphine (LADB) for the Treatment of Opioid Dependence in Low- and Middle-income Countries (LMIC): a Multicentre International Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 760
- 主要终点
- Treatment Satisfaction Questionnaire for Medication 1.4 assessed through patient reported outcomes on effectiveness, side-effects, convenience and global satisfaction in relation to the medication
研究概览
简要总结
The goal of the proposed study is to generate evidence on the acceptability, feasibility, effectiveness, and cost-effectiveness of introducing long-acting depot buprenorphine (LADB) as an additional option for the treatment of opioid dependence in low- and middle-income countries (LMIC) among people who inject drugs (PWID) with opioid dependence. The study results will be used to inform global and local policies and guidelines to introduce LADB as a treatment option and to advocate for access to a sustainable supply of LADB in LMIC.
详细描述
Despite the proven effectiveness of opioid agonist maintenance treatment (OAMT), its coverage and use remain low globally and, particularly, in low- and middle-income countries (LMIC), in part due to challenges related to limited choice of OAMT medication and dosing options. The long-acting depot buprenorphine (LADB) formulation of OAMT, with either weekly or monthly administration, could provide a more discreet, convenient, and less stigmatizing form of treatment and the potential to improve client retention in care, as well as economic stability. It therefore may address unmet need among individuals who could benefit from OAMT and are not already taking it or who would prefer a long-acting option over current OAMT options. Studies have demonstrated the effectiveness and acceptability of LADB among those with opioid dependence in high-income settings. However, there are no known such studies conducted in LMIC.
The aim of the study is to determine the acceptability, feasibility, effectiveness, public health impact, and cost-effectiveness of introducing LADB in a range of LMIC.
The study will collect data from participants with opioid use disorder, service providers, and health policymakers/decision-makers across seven diverse LMIC: Egypt, India, Kyrgyzstan, South Africa, Tanzania, Ukraine, and Vietnam.
This is a multicenter, mixed-method study designed with community engagement and co-production. The study consists of four interlinked modules: Module 1 (feasibility) includes a process evaluation to monitor implementation and assess barriers, drawing on program data and interviews with service providers and other key stakeholders; Module 2 (effectiveness) involves a prospective cohort choice study among people with opioid dependence, initiating LADB and following up over 48 weeks; Module 3 (values and preferences, plus acceptability) includes key informant interviews and focus group discussions with people with opioid dependence to understand overall acceptability, values, preferences, experiences, and concerns relating to LADB; Module 4 (public health impact and cost-effectiveness) involves modeling based on collected data to estimate impact and cost-effectiveness of LADB in LMIC settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are 18 years old or older.
- •Are verified (by certified clinician) opioid dependents according to the International Classification of Diseases 11th Revision.
- •Are not pregnant (verified by screening).
- •Are eligible to receive OAMT at a participating site.
- •Consent to attend the clinic and adhere to clinical protocols
- •Have the capacity to consent to participating in research.
- •Provide written informed consent.
排除标准
- •Have a history or presence of an allergic or adverse response (including rash or anaphylaxis) to BUP or the Atrigel® delivery system (a registered trademark of Tolmar Therapeutics Inc.) if Sublocade is chosen.
- •Have any contraindication to BUP or methadone.
- •Show signs of clinically significant medical conditions which would compromise compliance with the protocol and/or client safety in line with clinical guidelines for the administration of injectable BUP for OAMT.
- •Are currently taking oral or depot naltrexone therapy or are enrolled in any form of naltrexone therapy within 30 or 90 days prior to study screening, respectively.
- •Are in thepost partum period (defined as 6 weeks) or confirmed as pregnant.
- •Have an inability or unwillingness to provide informed consent or abide by the requirements of the study.
研究组 & 干预措施
PWID who opt for LADB
People with opioid dependence who opt to initiate LADB across a range of LMIC settings over a 48-week period
干预措施: long-acting depot buprenorphine (LADB) (Drug)
结局指标
主要结局
Treatment Satisfaction Questionnaire for Medication 1.4 assessed through patient reported outcomes on effectiveness, side-effects, convenience and global satisfaction in relation to the medication
时间窗: 48 weeks
The primary measure for treatment satisfaction will be collected through the Treatment Satisfaction Questionnaire for Medication 1.4 at 48 weeks. This is a generic measure of treatment satisfaction with medication. It has 14 questions divided into subscales (effectiveness; side effects, convenience and global satisfaction). Response are on a Likert-scale of 5 or 7 points except for 1 yes/no question on the presence of side effects. The scores are calculated for each of the subscales, which range from 0 to100 with higher scores indicating higher patient satisfaction with medication.
Retention in Care
时间窗: 48 weeks
The primary measure for retention in care will be estimated as the proportion of people on LADB at 48 weeks
Nonmedical opioid use
时间窗: 48 weeks
Assess degree of non-medical opioid use in the last month measured at week 48, in terms of number of days that non-medical opioids were not used in the last 4 weeks.
次要结局
- Patient-reported outcomes using the EuroQol measures of health status(48 weeks)
- % of participants who have received testing for HIV and Hepatitis C (HCV) at 48 weeks, frequency of testing, % testing positive for antibodies to HIV or HCV and % linked to treatment and % retained into treatment(48 weeks)
- % of participants with self reported symptoms of depression at 48 weeks.(48 weeks)
- % of participants with self-reported symptoms of anxiety at 48 weeks.(48 weeks)
- % of participants reporting recent thoughts of or attempts at suicide at 48 weeks.(48 weeks)
- Patient-reported outcomes using the EuroQol visual analogue scale (EQVAS)(48 weeks)
- % of participants reporting a non-fatal overdose in the last 6 months(48 weeks)
- % of participants reporting risky levels of alcohol use (range 0-12, higher score indicates higher risk alcohol use).(48 weeks)
- % of participants reporting experience of Stigma and discrimination is measured through the substance use stigma mechanism scale (SU-SMS) (range 1-5, higher scores denote greater stigma and discrimination)(48 weeks)
- % of participants reporting being arrested by the police in the last 6 months measured at 48 weeks.(48 weeks)
- % of participants who have been in prison in the last 6 months measured at 48 weeks(48 weeks)