Clinical trial NCT06129916: Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Opioid Dependence
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: UNITAID
name: World Health Organization
name: Médecins du Monde
name: Frontline AIDS
name: London School of Hygiene and Tropical Medicine
name: International Network of People who Use Drugs
name: Monash University
name: Population Services International
name: Burnet Institute
name: University of Bristol
name: Alliance for the Public's Health
name: Coact Technical Support Limited
First posted: 2023-11-13
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will collect data from participants with opioid use disorder across seven diverse LMIC: Egypt, India, Kyrgyzstan, South Africa, Tanzania, Ukraine, and Vietnam.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: 48 weeks
measure: Retention in Care
timeFrame: 48 weeks
measure: Nonmedical opioid use
timeFrame: 48 weeks
Secondary outcomes:
measure: % 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
timeFrame: 48 weeks
measure: % of participants with self reported symptoms of depression at 48 weeks.
timeFrame: 48 weeks
measure: % of participants with self-reported symptoms of anxiety at 48 weeks.
timeFrame: 48 weeks
measure: % of participants reporting recent thoughts of or attempts at suicide at 48 weeks.
timeFrame: 48 weeks
measure: Patient-reported outcomes using the EuroQol measures of health status
timeFrame: 48 weeks
measure: Patient-reported outcomes using the EuroQol visual analogue scale (EQVAS)
timeFrame: 48 weeks
measure: % of participants reporting a non-fatal overdose in the last 6 months
timeFrame: 48 weeks
measure: % of participants reporting risky levels of alcohol use (range 0-12, higher score indicates higher risk alcohol use).
timeFrame: 48 weeks
measure: % 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)
timeFrame: 48 weeks
measure: % of participants reporting being arrested by the police in the last 6 months measured at 48 weeks.
timeFrame: 48 weeks
measure: % of participants who have been in prison in the last 6 months measured at 48 weeks
timeFrame: 48 weeks
Other outcomes:
Locations:
Study officials:
affiliation: PATH
name: Kimberly Green
role: PRINCIPAL_INVESTIGATOR
References: