Optimizing Care for Challenging People Living With HIV

Feasible Program of Sustainable Medical Care for People Living With HIV Who Are Difficult to Treat or Marginalized in Taiwan

Conduct an intervention combining social and behavioral health models with digital health technologies to improve their adherence to their medication schedules. The success of the intervention is assessed by comparing adherence rates before and after its implementation to see if there's a notable enhancement in how well patients follow their antiretroviral therapy.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV Infections; Adherence, Medication; Social Media
• Intervention / Treatment: Other: Combination of social-behavior model and eHealth

Detailed Description

This is an intervention strategy for HIV-infected individuals based on their viral load measurements and medication adherence rates, measured by the proportion of days covered (PDC) for the past 365 days. A specific PDC threshold identifies individuals with less than 90% viral suppression at under 200 copies/mL. An intervention approach integrating social and behavioral models with electronic health (eHealth) technology is implemented for cases with a PDC below this threshold. The intervention aims to enhance the patient's adherence to their medication regimen. The effectiveness of this intervention is evaluated by comparing indicators before and after its application to determine if there are significant improvements in the participants' compliance with their antiretroviral therapy.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 814032
    • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. PLWH with adherence below the specific proportion of days covered (PDC), which is defined as the specific level that corresponds to 90% at viral suppression (< 200 copies/mL).

Exclusion Criteria:

1. Under 18 years of age.
2. Illiterate.
3. Non-consenting individuals.
4. Less than 365 days from the initial use of antiretroviral drugs to the assessment for inclusion in the study.
5. Inability to obtain complete medication records for the 365 days prior to inclusion.
6. Lack of a smart phone.
7. No willingness to return for follow-up at the participating hospital.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: People living with HIV with poor adherence to HAART; People living with HIV (PLWH) with adherence below the specific proportion of days covered (PDC), which is defined as the specific level that corresponds to 90% at viral suppression (< 200 copies/mL).

Other: Combination of social-behavior model and eHealth; The study examines how an intervention combining the social-behavior model and eHealth can improve medication adherence among individuals who struggle to follow their medical regimens. The platform offers multiple features including health education, medication reminders, online consultations, chat rooms, news, and Q&A services. The intervention and follow-up are based on a 28-day month. The first intervention period runs from the first to the third month post-enrollment, with the introduction of the main features and sharing of health education videos and monthly short films. A follow-up assessment and questionnaire are completed after the third month. The second intervention period is between the fourth and sixth months and includes similar features, and face-to-face counseling. New health education videos and monthly short films are shared as well. After the sixth month, another assessment is conducted to evaluate the post-intervention effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HIV Viral Load from Baseline to 1st and 2nd Follow-Up	Comparison of HIV viral load (copies/mL) at baseline, 1st follow-up, and 2nd follow-up. The data will be reported as the mean change in viral load from baseline at each time point	At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
Change in CD4 Count from Baseline to 1st and 2nd Follow-Up	Comparison of CD4 cell count (cells/μL) at baseline, 1st follow-up, and 2nd follow-up. The data will be reported as the mean change in CD4 count from baseline at each time point	At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
Change in Quality of Life Score (WHOQOL-BREF Taiwan Version) from Baseline to 1st and 2nd Follow-Up	Assessment of participants' quality of life using the WHOQOL-BREF (Taiwan Version) questionnaire at baseline, 1st follow-up, and 2nd follow-up. The results will be reported as the mean score change from baseline at each time point	At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
Change in HIV symptoms index (HIV-SI) in score from Baseline to 1st and 2nd Follow-Up	Assessment of symptoms using the HIV symptoms index (HIV-SI) at baseline, 1st follow-up, and 2nd follow-up. The results will be reported as the mean score change from baseline at each time point	At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
Change in Self-Reported Antiretroviral Therapy (ART) Medication Adherence from Baseline to 1st and 2nd Follow-Up	Assessment of self-reported ART medication adherence at baseline, 1st follow-up, and 2nd follow-up. The results will be reported as the proportion of participants who were adherent at each time point, as well as the mean adherence score change from baseline	At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Proportion of Days Covered (PDC) over the Past 180 Days from Baseline to 1st and 2nd Follow-Up	Assessment of Proportion of Days Covered (PDC) over the Past 180 Days at baseline and 2nd follow-up. The results will be reported as the percentage at each time point, as well as the mean percentage change from baseline	At baseline and 168th (+-14) day after enrollment

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Collaborators: Ministry of Health and Welfare, Taiwan
• Investigators: Principal Investigator: Chun-Yuan Lee, M.D., Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 31, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Adherence; HIV; Social media platform
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; HIV Infections; Medication Adherence; Health Services Administration; Delivery of Health Care; Patient Care Management; Telemedicine
• Other Study ID Numbers: KMUHIRB-SV(I)-20230081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No