HIV Infections Clinical Trial
Official title:
Feasible Program of Sustainable Medical Care for People Living With HIV Who Are Difficult to Treat or Marginalized in Taiwan
Verified date | March 2024 |
Source | Kaohsiung Medical University Chung-Ho Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 210 |
Est. completion date | December 31, 2030 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung city |
Lead Sponsor | Collaborator |
---|---|
Kaohsiung Medical University Chung-Ho Memorial Hospital | Ministry of Health and Welfare, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 |
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