NCT05996081

Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia

A Practical Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia: Protocol for a Usability Study and Cluster Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University of Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Consistent adherence to antiretroviral therapy (ART) is important to maintain viral suppression and good quality of life among people living with HIV. However, maintaining a high level of ART adherence is challenging because adherence is a complex behaviour and many factors contribute to nonadherence. Therefore, a decision support tool is proposed to help HIV care providers in addressing the barriers and providing the adherence-promoting interventions tailored to the individual needs. The present study comprises a usability assessment followed by a cluster randomised controlled trial to investigate the effectiveness of the adherence toolkit as a decision support tool on improving adherence to ART. Twelve HIV clinics in Surabaya, Indonesia, will be randomised 1:1 to the control (usual care) and intervention (adherence toolkit and usual care) group. The intervention period will last for 12 months, with outcome measures will be collected at initiation, 3-, 6-, and 12-month post-initiation. The primary outcome is adherence to ART measured using a self-reported adherence questionnaire and pharmacy refill records. The secondary outcomes include clinical outcomes (viral load, CD4), HIV treatment knowledge, medication beliefs, and health-related quality of life. The findings will enable HIV care providers, people living with HIV, and policy makers to make informed decision about the value of the adherence toolkit for being used in daily clinical practice.

Conditions

• Adult
• HIV Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-02
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2023-08-16
• Last updated: 2023-08-16

Locations

1 site across 1 country: Indonesia