Delivery of Health CareNCT06738134
Differentiated Service Delivery (DSD) for People Living with HIV (PLHIV) and Comorbidities
An observational study of Delivery of Health Care and HIV Infections, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is an implementation study evaluating differentiated service delivery model for the care of comorbidities for people living with HIV (PLWH). The Hybrid Type 3 study design is adopted, with the primary goal of evaluating implementation outcomes, and secondary goals of evaluating service and client outcomes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delivery of Health Care, HIV Infections
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: PLWH eligible to participate in this study are PLWH aged 18 years or above followed up at the HIV Clinic, and with one or more cardiometabolic comorbidities, including hypertension, diabetes, hyperlipidaemia, metabolic-associated fatty liver disease, cardiovascular diseases, and cerebrovascular diseases.
Who may be able to join
- PLWH eligible to participate in this study are PLWH aged 18 years or above
- followed up at the HIV Clinic, and with one or more cardiometabolic comorbidities, including hypertension, diabetes, hyperlipidaemia, metabolic-associated fatty liver disease, cardiovascular diseases, and cerebrovascular diseases. They will be eligible if HIV physicians consider them having sub-optimal control of their comorbidities, suspected of having complications, or would benefit from screening of complications resulting from their comorbidities. These indications are selected as they involve specialist care, including investigations and treatment, which are not available at the HIV Clinic.
Who cannot join
- Incompetent subjects who cannot give informed written consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Catherine Cheung, 85235053376, catherinecheung@cuhk.edu.hk
Grace LUI, MBChB
About this study
Official title: Implementation of Differentiated Service Delivery Model of Care for People Living with HIV with Comorbidities
This is an implementation study evaluating differentiated service delivery model for the care of comorbidities for people living with HIV (PLWH). The Hybrid Type 3 study design is adopted, with the primary goal of evaluating implementation outcomes, and secondary goals of evaluating service and client outcomes according to the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, including Proctor's Conceptual Framework for Implementation Outcomes, using mixed methods for data collection and analyses. PLWH will be identified from the Integrated Treatment Centre, an HIV clinic in Hong Kong, which provides care to around 3500 PLWH, with services including out-patient care of patients with human immunodeficiency virus (HIV) infection, antiviral therapy for HIV and hepatitis co-infection, and treatment of sexually transmitted diseases. PLWH with comorbidities will be asked to participate in a survey for willingness to participate. Those interested will be co-managed at the HIV Comorbidities Clinic at the Prince of Wales Hospital, where the DSD model of care is conducted. Evaluation of implementation outcomes will be performed at the end of the programme.
Read the detailed description
PLWH who are receiving effective and durable anti-retroviral therapy (ART) have similar life expectancy as the general population, but the patients do suffer from two-fold higher burden of disability associated with chronic comorbidities as compared with people without HIV infection. The screening and management of these chronic comorbidities are gaining attention in both high-income and low- and middle-income settings.
There are at present different models of care to deliver healthcare for the screening and management of comorbidities for PLWH. Fully integrated care of both HIV and comorbidities in a one-stop clinic brings numerous benefits, including optimal utilization of resources, provision of holistic care, and de-stigmatization; but also encounters various challenges, such as placing burden on human and spatial resources in HIV clinics, and the limited availability of co-medications in HIV clinics. In high-income settings, traditional models of care are often physician-centred, thus more innovative models have been explored, involving integrated care in the primary care setting, or consultations by multiple specialists in an integrated clinic, but these require a high magnitude of coordination and have resource implications, limiting feasibility universally. On the other hand, a "differentiated service delivery (DSD)" model is an adaptive model of care that aims to tailor healthcare delivery services according to patients' individual clinical needs and preferences, while taking into consideration resource availability in the local context. This model of care is successful in the delivery of HIV care and management of ART, and is patient-centred, offering patients a mode of care most optimal for their lifestyle and needs without imposing unmanageable burden on the healthcare system. DSD is advocated to be developed for the aging population of PLWH to provide patient-centred healthcare service for management of their comorbidities and other age-related issues, but has not been well studied.
The rising use of telemedicine since the Coronavirus disease 2019 (COVID-19) pandemic in the management of HIV and other chronic diseases would facilitate the incorporation of more patient-centred options in healthcare service delivery according to patients' needs and preferences. Telemedicine interventions improve access to care, control of disease, and quality of life in people with chronic non-communicable diseases. In particular, telemonitoring interventions and synchronous video teleconsultations are found to be beneficial in disease control and enhancing patient-physician interaction.
The currently proposed DSD model of care has the following benefits: (1) patient-centred care with individualized care delivery options according to patients' preference, such as offering teleconsultation as an alternative, options of different drug delivery modes, and personalized management plans according to individual clinical needs; (2) shared care between HIV care providers and internal medicine specialists, with close communication regarding clinical data and treatment plans, while avoiding duplication of resources; (3) draws on the availability of telemedicine tools in public healthcare services in Hong Kong; (4) patient empowerment by educating patients on treatment goals, performing selfmonitoring of disease, and scheduling appointments according to clinical indications; and (5) optimizing care of complex comorbidities by providing specialist care, and screening and management of comorbidities according to evidencebased guidelines.
- Conditions
- Delivery of Health Care, HIV Infections
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of PLWH
Acceptability of PLWH, as defined by the proportion of PLWH who perform the survey who indicate "willingness to participate" in the DSD programme.
Measured: Baseline
Participation willingness
Similarities and differences between PLWH who are willing and not willing to participate in the DSD programme, by comparing their demographic and clinical data, and the factors assessed in the survey that are associated with perceived benefits and barriers to participation in this programme
Measured: Baseline
Secondary outcomes (21)
Impact on clinical outcomes
Number of new diagnoses made and changes in ART regimen per 100 patient-year follow-up during participation of the Programme, compared with the same parameters in the 12 months preceding the participation in this Programme.
Measured: At 12 months
Unscheduled clinic visits
Safety is measured by the number of unscheduled clinic visits at general out-patient clinics, ad hoc HIV clinic telephone enquiry and consultations, Accidents and Emergency Department attendance, and hospital admission per 100 patient-year follow-up during participation of the Programme, compared with the same parameters in the 12 months preceding the participation in this Programme
Measured: 12 months preceding the participation in this Programme
Satisfaction with the Programme among PLWH
Satisfaction is defined by the level of satisfaction with the Programme among PLWH. This is measured by a survey to be administered at the end of 12 months follow-up, to determine level of satisfaction with each of the components of the Programme and overall satisfaction.
Measured: At 12 months
Changes in systolic and diastolic blood pressure
Changes in systolic and diastolic blood pressure during study.
Measured: Through study completion, an average of 1 year
Changes in body weight
Changes in body weight during the study.
Measured: Through study completion, an average of 1 year
Changes in body mass index
Changes in body mass index during the study
Measured: Through study completion, an average of 1 year
Changes in fasting glucose
Changes in fasting glucose during the study
Measured: Through study completion, an average of 1 year
Changes in HbA1C
Changes in HbA1c during the study
Measured: Through study completion, an average of 1 year
Changes in lipid profiles
Changes in lipid profiles such as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride during the study
Measured: Through the study completion, an average of 1 year
Changes in creatinine
Changes in creatinine during the study
Measured: Through study completion, an average of 1 year
Changes in alanine transaminase
Changes in alanine transaminase during the study
Measured: Through study completion, an average of 1 year
Self-reported adherence to non-ART medications
Adherence to prescribed non-ART medications is measured by self-reported adherence to prescribed non-ART medications in the preceding 7 days of the consultations.
Measured: Through the study completion, an average of 1 year
Change in health-related quality of life (HrQoL) measured by SF12
Change in health-related quality of life (HrQoL) measured by SF12 during the study
Measured: Through study completion, an average of 1 year
Change in health-related quality of life (HrQoL) measured by WHOQOLHIV BREF
Change in health-related quality of life (HrQoL) is measured by WHOQOLHIV BREF during the study
Measured: Through study completion, an average of 1 year
Preception by healthcare workers at HIV clinic
Perception of this programme as a whole, and its key components, as agreeable or not. Healthcare workers at the HIV clinic will be asked to complete a survey for assessment of their perception of the programme and intention to refer eligible patients to the Programme. This survey will be performed after the Briefing session at HIV clinic, and after completion of all participant recruitment.
Factors which healthcare workers anticipate or have encountered that are facilitators and barriers to refer eligible patients to the Programme will be evaluated from the survey.
Measured: This survey will be performed at baseline and after all patients completed all follow-ups.
Feasibilty 1- Rate of recruitment
Recruitment rate is defined as the proportion of PLWH attending the first consultation at the Comorbidities Clinic among all PLWH who have participated in the Acceptability Survey.
Measured: At 12 months
Feasibilty 2- Retention rate of the Programme
Retention rate of the Programme is defined as the proportion of PLWH completed 12-month follow up among those agreed to join the Programme.
Measured: At 12 months
Fidelity 1
Fidelity is defined as the extent to which the Programme is conducted as planned in our original protocol, including adherence to the protocol and quality of programme delivery. Adherence to each core component of the Programme is assessed, and is defined as the proportion of PLWH completing all complication screening procedures
Measured: At 12 months
Fidelity 2
Fidelity is defined as the extent to which the Programme is conducted as planned in our original protocol, including adherence to the protocol and quality of programme delivery. Adherence to each core component of the Programme is assessed, and is defined as the proportion of scheduled teleconsultations attended by PLWH
Measured: At 12 months
Fidelity 3
Fidelity is defined as the extent to which the Programme is conducted as planned in our original protocol, including adherence to the protocol and quality of programme delivery. Adherence to each core component of the Programme is assessed, and is defined as the proportion of teleconsultations with prior submission of report from eHealth Management module
Measured: At 12 months
Fidelity 4
Fidelity is defined as the extent to which the Programme is conducted as planned in our original protocol, including adherence to the protocol and quality of programme delivery. Adherence to each core component of the Programme is assessed, and is defined as the proportion of PLWH who have co-medications delivered according to opted mode of delivery
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 May 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery of Health CareStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Lui, Chinese University of Hong Kong
- Investigators
- Grace LUI, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738134
- Sponsor's protocol ID
- DSD_v1_dated 13Mar2024
- Status last verified
- Nov 2024
- First submitted
- 20 Mar 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Differentiated Service Delivery Model of Care for People Living with HIV with Comorbidities
- ClinicalTrials.gov ID
- NCT06738134
- Acronym / sponsor ID
- DSD_v1_dated 13Mar2024
- Conditions
- Delivery of Health Care, HIV Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 17 Dec 2024 (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.
This is an implementation study evaluating differentiated service delivery model for the care of comorbidities for people living with HIV (PLWH). The Hybrid Type 3 study design is adopted, with the primary goal of evaluating implementation outcomes, and secondary goals of evaluating service and client outcomes according to the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, including Proctor's Conceptual Framework for Implementation Outcomes, using mixed methods for data collection and analyses. PLWH will be identified from the Integrated Treatment Centre, an HIV clinic in Hong Kong, which provides care to around 3500 PLWH, with services including out-patient care of patients with human immunodeficiency virus (HIV) infection, antiviral therapy for HIV and hepatitis co-infection, and treatment of sexually transmitted diseases. PLWH with comorbidities will be asked to participate in a survey for willingness to participate. Those interested will be co-managed at the HIV Comorbidities Clinic at the Prince of Wales Hospital, where the DSD model of care is conducted. Evaluation of implementation outcomes will be performed at the end of the programme.
Detailed description
PLWH who are receiving effective and durable anti-retroviral therapy (ART) have similar life expectancy as the general population, but the patients do suffer from two-fold higher burden of disability associated with chronic comorbidities as compared with people without HIV infection. The screening and management of these chronic comorbidities are gaining attention in both high-income and low- and middle-income settings.
There are at present different models of care to deliver healthcare for the screening and management of comorbidities for PLWH. Fully integrated care of both HIV and comorbidities in a one-stop clinic brings numerous benefits, including optimal utilization of resources, provision of holistic care, and de-stigmatization; but also encounters various challenges, such as placing burden on human and spatial resources in HIV clinics, and the limited availability of co-medications in HIV clinics. In high-income settings, traditional models of care are often physician-centred, thus more innovative models have been explored, involving integrated care in the primary care setting, or consultations by multiple specialists in an integrated clinic, but these require a high magnitude of coordination and have resource implications, limiting feasibility universally. On the other hand, a "differentiated service delivery (DSD)" model is an adaptive model of care that aims to tailor healthcare delivery services according to patients' individual clinical needs and preferences, while taking into consideration resource availability in the local context. This model of care is successful in the delivery of HIV care and management of ART, and is patient-centred, offering patients a mode of care most optimal for their lifestyle and needs without imposing unmanageable burden on the healthcare system. DSD is advocated to be developed for the aging population of PLWH to provide patient-centred healthcare service for management of their comorbidities and other age-related issues, but has not been well studied.
The rising use of telemedicine since the Coronavirus disease 2019 (COVID-19) pandemic in the management of HIV and other chronic diseases would facilitate the incorporation of more patient-centred options in healthcare service delivery according to patients' needs and preferences. Telemedicine interventions improve access to care, control of disease, and quality of life in people with chronic non-communicable diseases. In particular, telemonitoring interventions and synchronous video teleconsultations are found to be beneficial in disease control and enhancing patient-physician interaction.
The currently proposed DSD model of care has the following benefits: (1) patient-centred care with individualized care delivery options according to patients' preference, such as offering teleconsultation as an alternative, options of different drug delivery modes, and personalized management plans according to individual clinical needs; (2) shared care between HIV care providers and internal medicine specialists, with close communication regarding clinical data and treatment plans, while avoiding duplication of resources; (3) draws on the availability of telemedicine tools in public healthcare services in Hong Kong; (4) patient empowerment by educating patients on treatment goals, performing selfmonitoring of disease, and scheduling appointments according to clinical indications; and (5) optimizing care of complex comorbidities by providing specialist care, and screening and management of comorbidities according to evidencebased guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PLWH eligible to participate in this study are PLWH aged 18 years or above followed up at the HIV Clinic, and with one or more cardiometabolic comorbidities, including hypertension, diabetes, hyperlipidaemia, metabolic-associated fatty liver disease, cardiovascular diseases, and cerebrovascular diseases.
Key inclusion criteria (2 listed)
- PLWH eligible to participate in this study are PLWH aged 18 years or above
- followed up at the HIV Clinic, and with one or more cardiometabolic comorbidities, including hypertension, diabetes, hyperlipidaemia, metabolic-associated fatty liver disease, cardiovascular diseases, and cerebrovascular diseases. They will be eligible if HIV physicians consider them having sub-optimal control of their comorbidities, suspected of having complications, or would benefit from screening of complications resulting from their comorbidities. These indications are selected as they involve specialist care, including investigations and treatment, which are not available at the HIV Clinic.
Key exclusion criteria (1 listed)
- Incompetent subjects who cannot give informed written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptability of PLWH
Time frame: Baseline
Acceptability of PLWH, as defined by the proportion of PLWH who perform the survey who indicate "willingness to participate" in the DSD programme.
Participation willingness
Time frame: Baseline
Similarities and differences between PLWH who are willing and not willing to participate in the DSD programme, by comparing their demographic and clinical data, and the factors assessed in the survey that are associated with perceived benefits and barriers to participation in this programme
21 secondary outcomes
Impact on clinical outcomes
Time frame: At 12 months
Unscheduled clinic visits
Time frame: 12 months preceding the participation in this Programme
Satisfaction with the Programme among PLWH
Time frame: At 12 months
Changes in systolic and diastolic blood pressure
Time frame: Through study completion, an average of 1 year
Changes in body weight
Time frame: Through study completion, an average of 1 year
Changes in body mass index
Time frame: Through study completion, an average of 1 year
Changes in fasting glucose
Time frame: Through study completion, an average of 1 year
Changes in HbA1C
Time frame: Through study completion, an average of 1 year
Changes in lipid profiles
Time frame: Through the study completion, an average of 1 year
Changes in creatinine
Time frame: Through study completion, an average of 1 year
Changes in alanine transaminase
Time frame: Through study completion, an average of 1 year
Self-reported adherence to non-ART medications
Time frame: Through the study completion, an average of 1 year
Change in health-related quality of life (HrQoL) measured by SF12
Time frame: Through study completion, an average of 1 year
Change in health-related quality of life (HrQoL) measured by WHOQOLHIV BREF
Time frame: Through study completion, an average of 1 year
Preception by healthcare workers at HIV clinic
Time frame: This survey will be performed at baseline and after all patients completed all follow-ups.
Feasibilty 1- Rate of recruitment
Time frame: At 12 months
Feasibilty 2- Retention rate of the Programme
Time frame: At 12 months
Fidelity 1
Time frame: At 12 months
Fidelity 2
Time frame: At 12 months
Fidelity 3
Time frame: At 12 months
Fidelity 4
Time frame: At 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Grace LUI principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delivery of Health Care and HIV Infections, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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: looking for participants now, as of the sponsor's last update on 17 Dec 2024. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grace LUI (35051716, gracelui@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of PLWH (time frame: Baseline). The study lists 2 primary outcomes in all. 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 17 Dec 2024.