AdultNCT05996081
Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia
A study testing Adherence toolkit in people with Adult and HIV Infections, run by University of Groningen at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult, HIV Infections
- What is being tested?
- Adherence toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- People who have severe mental or physical constraints, drop-out or withdraw after the commencement of the trial
Trial locations and contacts
1 site in 1 country.
Tri Pudy Asmarawati, MD contact
About this study
Official title: A Practical Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia: Protocol for a Usability Study and Cluster Randomised Controlled Trial
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.
Read the 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
- Being tested
- Adherence toolkit
- Keywords
- Adherence, Antiretroviral therapy, HIV, Medication beliefs, Quality of life, Treatment knowledge
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence toolkitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Adherence toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 3, 6, and 12 months
Secondary outcomes (7)
Viral load
The viral load test will measure the number of HIV copies in a milliliter of plasma (in copies/ml).
Measured: 0 and 12 months
CD4 cell count
The CD4 cell count will measure the number of CD4 cells in plasma (in cells/mm^3).
Measured: 0 and 12 months
HIV treatment knowledge
HIV treatment knowledge will be assessed using a validated Bahasa Indonesia version of 8-item brief estimate of health knowledge and action-HIV questionnaire. The questionnaire comprises eight statements, three items assessing HIV knowledge and five items evaluating treatment action. Each response is assigned a score of 0, indicating an incorrect, unsure, or disagree answer, or score 1, indicating a correct or agree answer. The total scores range from 0 to 8, and higher scores correspond with adequate HIV treatment knowledge.
Measured: 0, 3, 6, and 12 months
Medication beliefs
Medication beliefs will be examined by a validated Bahasa Indonesia version of the 18-item beliefs about medicines questionnaire. The questionnaire consists of two sections with 18 statements. The general section contains two four-item scales asking about medication beliefs in general, relating to medication harm (General-Harm) and overuse (General-Overuse). The specific section comprises two five-item scales asking about the necessity of prescribed medication (Specific-Necessity) and concerns about its negative effects (Specific-Concerns). The response for each statement is given on a 5-point Likert scale, where 1 means "Strongly disagree" and 5 means "Strongly agree". The total scores for the harm and overuse scales range from 5 to 20, while for necessity and concerns range from 5 to 25. Higher scores denote stronger medication beliefs.
Measured: 0, 3, 6, and 12 months
Health-related quality of life
Health-related quality of life will be determined by a validated Bahasa Indonesia version of the 31-item World Health Organization (WHO) quality of life-HIV brief questionnaire. The questionnaire contains 31 questions that examine general quality of life (questions 1 and 2) and six domains of health-related quality of life including physical health (questions 3, 4, 14, and 21), psychological health (questions 6, 11, 15, 24, and 31), level of independence (questions 5, 20, 22, and 23), social relationships (questions 17, 25, 26, and 27), environmental health (questions 12, 13, 16, 18, 19, 28, 29, and 30), and spirituality/personal beliefs (questions 7, 8, 9, and 10). Individual items are rated on a 5-point Likert scale where 1 indicates a negative perception and 5 indicates a positive perception. Scoring and coding of each domain follows the instructions provided by WHO, so that each domain scores range between 4 and 20 with higher scores reflect better quality of life.
Measured: 0, 3, 6, and 12 months
Usability
A Bahasa Indonesia version of validated system usability scale questionnaire will be used to measure the usability of the adherence toolkit. The questionnaire consists of ten statements with answers given on a 5-point Likert scale, ranging from "Strongly disagree" (1) to "Strongly agree" (5). The total scores range from 0 to 100, with a higher score indicating higher perceived usability and a score of 68 is considered the average.
Measured: 1 month
Acceptability
A one-on-one interview will be performed to explore the perception of HIV care providers on acceptance, experience, and room for improvement of the adherence toolkit.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start2 Jan 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Airlangga
- Responsible party
- Principal investigator, Zamrotul Izzah, University of Groningen
- Investigators
- Zamrotul Izzah, MSc, Principal investigator, Universitas Airlangga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996081
- Sponsor's protocol ID
- V1-072023
- Status last verified
- Aug 2023
- First submitted
- 21 Jul 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be available only to authorised persons for analysis and reporting purposes.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Practical Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia: Protocol for a Usability Study and Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05996081
- Acronym / sponsor ID
- V1-072023
- Conditions
- Adult, HIV Infections
- Keywords
- Adherence, Antiretroviral therapy, HIV, Medication beliefs, Quality of life, Treatment knowledge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Collaborators
- Universitas Airlangga
- Study start
- 2 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Adherence toolkitIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- People who have severe mental or physical constraints, drop-out or withdraw after the commencement of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence toolkitThe 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. | Behavioural | Intervention |
Primary outcome
Adherence to antiretroviral therapy (ART)
Time frame: 0, 3, 6, and 12 months
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.
7 secondary outcomes
Viral load
Time frame: 0 and 12 months
CD4 cell count
Time frame: 0 and 12 months
HIV treatment knowledge
Time frame: 0, 3, 6, and 12 months
Medication beliefs
Time frame: 0, 3, 6, and 12 months
Health-related quality of life
Time frame: 0, 3, 6, and 12 months
Usability
Time frame: 1 month
Acceptability
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No. De-identified data will be available only to authorised persons for analysis and reporting purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tri Pudy Asmarawati, MD contact
Zamrotul Izzah, MSc principal investigator
Universitas Airlangga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence toolkit in people with Adult and HIV Infections, run by University of Groningen at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zamrotul Izzah, MSc (6285655191257, zamrotulizzah@ff.unair.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to antiretroviral therapy (ART) (time frame: 0, 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.