Differentiated Service Delivery (DSD) for People Living with HIV (PLHIV) and Comorbidities

NCT06738134 | Recruiting

• 1 other identifier: DSD_v1_dated 13Mar2024
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Delivery of Health Care; HIV Infections

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Baseline

Secondary Outcomes (21)

• Impact on clinical outcomes

  At 12 months

• Unscheduled clinic visits

  12 months preceding the participation in this Programme

• Satisfaction with the Programme among PLWH

  At 12 months

• Changes in systolic and diastolic blood pressure

  Through study completion, an average of 1 year

• Changes in body weight

  Through study completion, an average of 1 year

Eligibility Criteria

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

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.

You may qualify if:

• 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.

You may not qualify if:

• Incompetent subjects who cannot give informed written consent.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

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

• Grace LUI

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace LUI

CONTACT

35051716; gracelui@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor (Honorary)

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: December 17, 2024
• Study Start: May 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)