Optimizing Care for Challenging People Living With HIV

Not Applicable

• Conditions: Social Media; Adherence, Medication; HIV Infections
• Interventions: Other: Combination of social-behavior model and eHealth

• 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
• Status Verified: 2024-03
• Study Start: 2024-03-18
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20
• Primary Completion: 2025-06-30
• 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

Arm && Interventions

Group	Intervention	Description
People living with HIV with poor adherence to HAART	Combination of social-behavior model and eHealth	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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