Optimizing Care for Challenging People Living With HIV

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06183723
• Other study ID #: KMUHIRB-SV(I)-20230081
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: March 2024
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Adherence, Medication
• HIV Infections
• Social Media

Intervention

Other:
• Combination of social-behavior model and eHealth
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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung city

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Ministry of Health and Welfare, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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