Optimizing Care for Challenging People Living With HIV

Not Applicable

• Conditions: Social Media; Adherence, Medication; HIV Infections

• Registration Number: NCT06183723
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-27
• Study Start: 2024-03-18
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-31
• Last Update Posted: 2025-09-08
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in HIV Viral Load from Baseline to 1st and 2nd Follow-Up	At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment	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
Change in Quality of Life Score (WHOQOL-BREF Taiwan Version) from Baseline to 1st and 2nd Follow-Up	At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment	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
Change in HIV symptoms index (HIV-SI) in score from Baseline to 1st and 2nd Follow-Up	At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment	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
Change in CD4 Count from Baseline to 1st and 2nd Follow-Up	At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment	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
Change in Self-Reported Antiretroviral Therapy (ART) Medication Adherence from Baseline to 1st and 2nd Follow-Up	At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment	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

Secondary Outcome Measures

Name	Time	Method
Change in Proportion of Days Covered (PDC) over the Past 180 Days from Baseline to 1st and 2nd Follow-Up	At baseline and 168th (+-14) day after enrollment	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

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan