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Enrolling by invitation NCT06183723

Optimizing Care for Challenging People Living With HIV

No phase Interventional Adherence, Medication HIV Infections Social Media

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combination of social-behavior model and eHealth.
Who it may be relevant to
Registry conditions: Adherence, Medication, HIV Infections, Social Media. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • Change in HIV Viral Load from Baseline to 1st and 2nd Follow-Up [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment]
Secondary outcome measures (1)
  • Change in Proportion of Days Covered (PDC) over the Past 180 Days from Baseline to 1st and 2nd Follow-Up [Time frame: At baseline and 168th (+-14) day after enrollment]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Taiwan · 1 center
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City

Identifiers

NCT: NCT06183723 · KMUHIRB-SV(I)-20230081

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗