Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia

NCT05996081 | Unknown DMC

• 1 other identifier: V1-072023
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult; HIV Infections

Keywords

Adherence; Antiretroviral therapy; HIV; Medication beliefs; Quality of life; Treatment knowledge

Outcome Measures

Primary Outcomes (1)

• Adherence to antiretroviral therapy (ART)

  The primary outcome of the trial is the difference in the changes of adherence rates between the intervention and the control group. The outcome will be repeatedly measured as proportion of people who adhere to ART in the intervention and control groups at study initiation and during the follow-up periods using a previously validated self-reported adherence questionnaire and pharmacy refill data.

  0, 3, 6, and 12 months

Secondary Outcomes (7)

• Viral load

  0 and 12 months

• CD4 cell count

  0 and 12 months

• HIV treatment knowledge

  0, 3, 6, and 12 months

• Medication beliefs

  0, 3, 6, and 12 months

• Health-related quality of life

  0, 3, 6, and 12 months

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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.

Behavioral: Adherence toolkit

Interventions

Adherence toolkit 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Groningen: lead
• Universitas Airlangga: collaborator

Study Sites (1)

HIV clinics

Surabaya, Indonesia

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Zamrotul Izzah, MSc

  Universitas Airlangga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zamrotul Izzah, MSc

CONTACT

6285655191257; zamrotulizzah@ff.unair.ac.id

Tri Pudy Asmarawati, MD

CONTACT

tpasmarawati@fk.unair.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 16, 2023
• Study Start: January 2, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)