- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06183723
Optimizing Care for Challenging People Living With HIV
Feasible Program of Sustainable Medical Care for People Living With HIV Who Are Difficult to Treat or Marginalized in Taiwan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chun-Yuan Lee, M.D.
- Phone Number: 5682 88673121101
- Email: leechunyuan@kmu.edu.tw
Study Locations
-
-
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Kaohsiung city, Taiwan, 814032
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional 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
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).
|
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. |
What is the study measuring?
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
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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
|
At baseline and 168th (+-14) day after enrollment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chun-Yuan Lee, M.D., Kaohsiung Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- KMUHIRB-SV(I)-20230081
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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