Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Adult HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A cluster randomised controlled trial consists of two parallel groups: group 1 gets a usual care (control), and group 2 receives a usual care and an adherence toolkit (intervention). The unit of randomisation is HIV clinic. Each HIV clinic will be randomly allocated to the intervention or control group. People living with HIV who are attending the clinic and receiving ART will be screened for their adherence prior to trial initiation. Those who are suspected to be nonadherent to HIV medications will be recruited to participate in the trial. The intervention period will last for 12 months for each participant in the intervention group, with equivalent follow-up period for participants in the control group. Outcome measures will be collected at 0, 3, 6, and 12 months.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

Individuals in the HIV clinics randomised to the control or intervention group will attend a consultation session as a usual HIV care based on the Indonesian guideline for HIV care and treatment (Ministry of Health Regulation No. 23/2022). Although it may slightly vary by clinic, for every visit they will collect their medications and receive general information from the HIV care provider on the prescribed ART regimens, including the dose, time of administration, potential side effects and how to deal with them, and the importance of adherence. They will be followed-up at the same time points as those in the intervention group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Individuals attending the HIV clinics that are randomised to the intervention group will receive an intervention over 12 months in addition to usual care. The intervention using an adherence toolkit will be delivered during regular clinic visits when they collect their medications.

Group Type EXPERIMENTAL

Adherence toolkit

Intervention Type BEHAVIORAL

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.

Interventions

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