Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB

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.

• % 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 [Срок оценки: 48 weeks]
• % of participants with self reported symptoms of depression at 48 weeks. [Срок оценки: 48 weeks]
• % of participants with self-reported symptoms of anxiety at 48 weeks. [Срок оценки: 48 weeks]
• % of participants reporting recent thoughts of or attempts at suicide at 48 weeks. [Срок оценки: 48 weeks]
• Patient-reported outcomes using the EuroQol measures of health status [Срок оценки: 48 weeks]
• Patient-reported outcomes using the EuroQol visual analogue scale (EQVAS) [Срок оценки: 48 weeks]
• % of participants reporting a non-fatal overdose in the last 6 months [Срок оценки: 48 weeks]
• % of participants reporting risky levels of alcohol use (range 0-12, higher score indicates higher risk alcohol use). [Срок оценки: 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) [Срок оценки: 48 weeks]
• % of participants reporting being arrested by the police in the last 6 months measured at 48 weeks. [Срок оценки: 48 weeks]
• % of participants who have been in prison in the last 6 months measured at 48 weeks [Срок оценки: 48 weeks]