Clinical trial NCT05996081: Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia
Official title: A Practical Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia: Protocol for a Usability Study and Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adult
HIV Infections
Keywords: Adherence
Antiretroviral therapy
HIV
Medication beliefs
Quality of life
Treatment knowledge
Lead sponsor: University of Groningen
Sponsor class: OTHER
Collaborators: name: Universitas Airlangga
First posted: 2023-08-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Doctors, nurses, and pharmacists who have been trained to provide HIV care and treatment by the Indonesian Ministry of Health
* People living with HIV who have been receiving any ART regimens for at least six months, aged 18 years and older, with any coinfection or comorbidity, suspected to be nonadherent to HIV medications (e.g., having sustained treatment interruptions, inconsistent prescription refill, increased viral load \>1,000 copies/ml, decreased CD4 count \<200 cells/mm3, or developed opportunistic infections), and provided informed consent

Exclusion Criteria:

* People who have severe mental or physical constraints, drop-out or withdraw after the commencement of the trial

Primary outcomes:
measure: Adherence to antiretroviral therapy (ART)
timeFrame: 0, 3, 6, and 12 months
Secondary outcomes:
measure: Viral load
timeFrame: 0 and 12 months
measure: CD4 cell count
timeFrame: 0 and 12 months
measure: HIV treatment knowledge
timeFrame: 0, 3, 6, and 12 months
measure: Medication beliefs
timeFrame: 0, 3, 6, and 12 months
measure: Health-related quality of life
timeFrame: 0, 3, 6, and 12 months
measure: Usability
timeFrame: 1 month
measure: Acceptability
timeFrame: 12 months
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: HIV clinics
Study officials:
affiliation: Universitas Airlangga
name: Zamrotul Izzah, MSc
role: PRINCIPAL_INVESTIGATOR
References: