Clinical trial NCT04327843: Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)
Official title: Reducing the Burden of Chronic Psychotic Disorders in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Medication Nonadherence
Schizo Affective Disorder
Keywords: nonadherence
Schizophrenia
Africa
Schizoaffective
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-03-31
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed, three phase project will refine and test a first-ever care approach in SSA that combines LAI with a behavioral program specifically intended to promote medication adherence in chronic psychotic disorders (CPDs). In addition to the novel focus, innovative elements include: 1.) a manualized curriculum that targets specific barriers and facilitators to medication adherence in Tanzanians with CPD, 2.) targeting known, high-risk individuals with CPD (those who miss ≥20% of prescribed antipsychotic medication, and 3.) using existing injection clinic health workers to deliver the adherence promotion program. Strengths include the highly generalizable methods and use of LAIs that are available in low-resource settings.

Detailed description: In this Phase 3 portion, the study team will select appropriate measures, train staff and build capacity in measure implementation, and finalize the intervention for delivery by healthcare workers. Finally, in a training/proof-of-concept exercise, the healthcare workers will implement the adapted CAE-L in a high-risk sample of Tanzanians with CPD (individuals with schizophrenia or schizoaffective disorder who have had recent medication adherence problems). Taken together, the proposed project has substantial public health importance. It will provide the prerequisite materials, training and infrastructure needed for a prospective trial in reducing CPD burden and improving brain health in Tanzania and other countries in Sub-Saharan Africa.

The focus of this project is on feasibility, patient acceptability, and research capacity-building. Therefore a specific hypothesis is not being tested. The investigators will assess descriptive statistics and change from baseline in the primary and secondary measures using standard pre-post techniques.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Diagnosis of schizophrenia or schizoaffective disorder
* Known to have medication treatment adherence problems as identified by the TRQ (20% or more missed medications in past week or past month)
* Ability to be rated on psychiatric rating scales
* Willingness to take long-acting injectable medication
* Able to provide written, informed consent to study participation

Exclusion Criteria:

* History of allergy or intolerance to haloperidol or haloperidol decanoate
* Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment
* Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
* Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist
* Immediate risk of harm to self or others
* Female who is currently pregnant or breastfeeding

Primary outcomes:
measure: Tablets Routine Questionnaire (TRQ)
timeFrame: Change from Baseline to 6 month visit
measure: Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections:
timeFrame: Baseline to 6 month visit
Secondary outcomes:
measure: Drug Attitude Inventory (DAI)
timeFrame: Baseline to 6 month visit
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline to 6 month visit
measure: Clinical Global Impressions (CGI)
timeFrame: Baseline to 6 month visit
measure: Social and Occupational Functioning Scale (SOFAS)
timeFrame: Baseline to 6 month visit
measure: Body Mass Index
timeFrame: Baseline to Month 6(week 25)
measure: ESRS-A Parkinsonism
timeFrame: Baseline to 6 months(25 weeks)
measure: ESRS-A Dystonia
timeFrame: Baseline to 6 months(25 weeks)
measure: ESRS-A Dyskinesia
timeFrame: Baseline to 6 months(25 weeks)
measure: ESRS-A Akathisia
timeFrame: Baseline to 6 months(25 weeks)
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: MUHAS
Study officials:
affiliation: Case Western Reserve University
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mbwambo J, Kaaya S, Lema I, Burant CJ, Magwiza C, Madundo K, Njiro G, Blixen CE, Cassidy KA, Levin JB, Sajatovic M. 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. BMC Psychiatry. 2022 Jan 27;22(1):62. doi: 10.1186/s12888-022-03695-8.