Differentiated Service Delivery (DSD) for People Living with HIV (PLHIV) and Comorbidities
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Incompetent subjects who cannot give informed written consent.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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
Time frame
BaselineSecondary outcomes
1
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.
Time frame
At 12 months2
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
Time frame
12 months preceding the participation in this Programme3
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.
Time frame
At 12 months4
Changes in systolic and diastolic blood pressure
Changes in systolic and diastolic blood pressure during study.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov