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Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia

NCT05996081 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-08-16

No results posted yet for this study

Summary

The goal of this usability study and a cluster randomised controlled trial is to investigate the effectiveness of an adherence toolkit as a decision support tool to improve adherence to antiretroviral therapy. The main questions it aims to answer are: 1) is the adherence toolkit useable and acceptable among HIV care providers in Indonesian clinical practice? and 2) is the adherence toolkit superior than the usual care in improving adherence to antiretroviral therapy among people living with HIV in Indonesia? HIV clinics in Surabaya, Indonesia, will be recruited to participate in the study. HIV care providers will be included in the usability study, whereas people living with HIV will be enrolled in the cluster randomised controlled trial. People living with HIV will be randomly assigned in a 1:1 ratio to the control group receiving usual HIV care and the intervention group receiving an intervention using the adherence toolkit in addition to usual HIV care.

Conditions

  • Adult
  • HIV Infections

Interventions

BEHAVIORAL

Adherence toolkit

The adherence toolkit consists of a flowchart of adherence intervention, a self-reported adherence questionnaire, and an intervention wheel as a decision support tool for a healthcare provider. The toolkit can guide HIV care providers to identify problems causing nonadherence and to tailor the effective interventions based on the individual problems. It is available in a Bahasa Indonesia version, accompanied by a user guide on the practical application of the intervention, and can be used digitally or printed on paper. The intervention wheel is an integrated HIV medication adherence influencing factors and effective adherence-promoting interventions derived from systematic reviews and meta analyses, including previous studies conducted in Indonesia.

Sponsors & Collaborators

  • Universitas Airlangga

    collaborator OTHER

  • University of Groningen

    lead OTHER

Principal Investigators

  • Zamrotul Izzah, MSc · Universitas Airlangga

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05996081 on ClinicalTrials.gov