Optimizing Care for Challenging People Living With HIV

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adherence, Medication, HIV Infections, Social Media

Intervention / Treatment
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* Other: Combination of social-behavior model and eHealth


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: People living with HIV with poor adherence to HAART<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative Analysis of Baseline Versus 1st and 2nd Follow-Up Assessments on Viral Load in copies/mL | Compare the data on Viral Load in copies/mL between Baseline Versus 1st and 2nd Follow-Up | At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment | 
| Comparative Analysis of Baseline Versus 1st and 2nd Follow-Up Assessments on CD4 Count in cells/mm^3 | Compare the data on cluster of differentiation 4 (CD4) Count in cells/mm^3 between Baseline Versus 1st and 2nd Follow-Up | At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment | 
| Comparative Analysis of Baseline Versus 1st and 2nd Follow-Up Assessments on WHOQOL-BREF Taiwan Version in score | Compare the data on WHOQOL-BREF Taiwan Version in score between Baseline Versus 1st and 2nd Follow-Up | At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment | 
| Comparative Analysis of Baseline Versus 1st and 2nd Follow-Up Assessments on HIV symptoms index (HIV-SI) in score | Compare the data on HIV symptoms index (HIV-SI) in score between Baseline Versus 1st and 2nd Follow-Up | At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment | 
| Comparative Analysis of Baseline Versus 1st and 2nd Follow-Up Assessments on Self-Reported Medication Adherence in percentage | Compare the data on Self-Reported Medication Adherence in percentage between Baseline Versus 1st and 2nd Follow-Up | At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Proportion of Days Covered (PDC) at the Second Follow-Up Compared to Baseline over the Past 180 Days | To compare the data on PDC over the past 180 days between Baseline Versus 2nd Follow-Up | At baseline and 168th (+-14) day after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Adherence, Social media platform