Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)

Case Western Reserve University

Status and phase: Completed; Phase 3

Conditions: Medication Nonadherence; Schizophrenia; Schizo Affective Disorder

Treatments: Behavioral: Customized Adherence Enhancement; Drug: Haloperidol Decanoate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04327843

1-17-19

R21MH114700 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

CAE + LAI

Experimental group

Description:

Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI)

Treatment:

Drug: Haloperidol Decanoate

Behavioral: Customized Adherence Enhancement