An interventional pilot of customized adherence enhancement combined with long-acting injectable antipsychotic medication (CAE-L) for poorly adherent patients with chronic psychotic disorder in Tanzania

Jessie Mbwambo, Sylvia Kaaya, Isaac Lema, Christopher J Burant, Catherine Magwiza, Kim Madundo, Godwin Njiro, Carol E Blixen, Kristin A Cassidy, Jennifer B Levin, Martha Sajatovic, Jessie Mbwambo, Sylvia Kaaya, Isaac Lema, Christopher J Burant, Catherine Magwiza, Kim Madundo, Godwin Njiro, Carol E Blixen, Kristin A Cassidy, Jennifer B Levin, Martha Sajatovic

Abstract

Background: Chronic psychotic disorders (CPD) impose a particularly significant burden in resource-limited settings. Combining long-acting antipsychotic medication (LAI) with a customized adherence enhancement intervention (CAE-L) has potential to advance care.

Methods: Nineteen adults ≥ age 18 with CPD who self-reported missing ≥20% of antipsychotic medication within the last month were stabilized on oral haloperidol prior to transitioning to monthly haloperidol decanote for 25 weeks. Outcome evaluations were conducted at baseline and Week 25. Primary outcomes were oral medication adherence assessed via the Tablet Routines Questionnaire (TRQ) and LAI injection frequency. Secondary outcomes included CPD symptoms measured by the Brief Psychiatric Rating Scale and Clinical Global Impressions, functioning evaluated using the Social and Occupational Functioning Scale, and medication attitudes assessed with the Drug Attitudes Inventory.

Results: Mean sample age was 38.79 (SD = 9.31) with 18 individuals completing the study. There was one serious adverse event, a relapse into substance use, not deemed study-related. Mean endpoint LAI dosage was 65.79 mg (SD = 22.38). TRQ mean scores were 21.84 (SD =13.83) and 12.94 (SD = 11.93) at screen and baseline respectively. For only two individuals who were on concomitant oral medication at 25 weeks, TRQ change was not calculated. LAI injection frequency was 100%. Medication attitudes scores significantly improved from 7.89 (SD = 2.72) to 9.83 (SD = 0.52) (p = .001.) Changes in CPD symptoms and functioning were non-significant.

Conclusions: CAE-L appears to be preliminarily feasible and acceptable in Tanzanians with CPD.

Trial registration: The study was registered on ClinicalTrials.gov (NCT04327843) on March 31, 2020.

Keywords: Antipsychotic; Psychosis; Schizophrenia; Treatment adherence.

Conflict of interest statement

In the last 3 years, MS has received research grants from Nuromate, Otsuka, Alkermes, International Society for Bipolar Disorders (ISBD), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Patient-Centered Outcomes Research Institute (PCORI). MS has been a consultant to Alkermes, Otsuka, Janssen, Myriad, Health Analytics, Frontline Medical Communications. MS has received royalties from Springer Press, Johns Hopkins University Press, Oxford Press, UpToDate. MS has also received compensation for the preparation of continuing medical education (CME) Activities form Physician’s Institute, MCM Education, CMEology, Potomac Center for Medical Education, Global Medical Education, Creative Educational Concepts. The remaining authors declare no conflict of interest.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study flow and enrollment

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