Clinical trial NCT06183723: Optimizing Care for Challenging People Living With HIV
Official title: Feasible Program of Sustainable Medical Care for People Living With HIV Who Are Difficult to Treat or Marginalized in Taiwan
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Adherence, Medication
HIV Infections
Social Media
Keywords: HIV
Adherence
Social media platform
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2023-12-27
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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:

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.

Primary outcomes:
measure: Comparative Analysis of Baseline Versus 1st and 2nd Follow-Up Assessments on Viral Load in copies/mL
timeFrame: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
measure: Comparative Analysis of Baseline Versus 1st and 2nd Follow-Up Assessments on CD4 Count in cells/mm^3
timeFrame: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
measure: Comparative Analysis of Baseline Versus 1st and 2nd Follow-Up Assessments on WHOQOL-BREF Taiwan Version in score
timeFrame: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
measure: Comparative Analysis of Baseline Versus 1st and 2nd Follow-Up Assessments on HIV symptoms index (HIV-SI) in score
timeFrame: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
measure: Comparative Analysis of Baseline Versus 1st and 2nd Follow-Up Assessments on Self-Reported Medication Adherence in percentage
timeFrame: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
Secondary outcomes:
measure: Difference in Proportion of Days Covered (PDC) at the Second Follow-Up Compared to Baseline over the Past 180 Days
timeFrame: At baseline and 168th (+-14) day after enrollment
Other outcomes:
Locations:
city: Kaohsiung city
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Chun-Yuan Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: