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| Name | Class |
|---|---|
| Ministry of Health and Welfare, Taiwan | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People living with HIV with poor adherence to HAART | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of social-behavior model and eHealth | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HIV Viral Load from Baseline to 1st and 2nd Follow-Up | 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 | At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment |
| Change in CD4 Count from Baseline to 1st and 2nd Follow-Up | 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 | At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment |
| Change in Quality of Life Score (WHOQOL-BREF Taiwan Version) from Baseline to 1st and 2nd Follow-Up | 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 | At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment |
| Change in HIV symptoms index (HIV-SI) in score from Baseline to 1st and 2nd Follow-Up | 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 | At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment |
| Change in Self-Reported Antiretroviral Therapy (ART) Medication Adherence from Baseline to 1st and 2nd Follow-Up | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Proportion of Days Covered (PDC) over the Past 180 Days from Baseline to 1st and 2nd Follow-Up | 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 | At baseline and 168th (+-14) day after enrollment |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Chun-Yuan Lee, M.D. | Kaohsiung Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 814032 | Taiwan |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment |
| D001519 | Behavior |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |