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OpenTrials
Enrolling by Invitation

NCT Number: NCT06183723

Optimizing Care for Challenging People Living With HIV

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in HIV Viral Load from Baseline to 1st and 2nd Follow-Up

    Time frame: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment

    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

  2. Change in CD4 Count from Baseline to 1st and 2nd Follow-Up

    Time frame: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment

    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

  3. Change in Quality of Life Score (WHOQOL-BREF Taiwan Version) from Baseline to 1st and 2nd Follow-Up

    Time frame: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment

    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

  4. Change in HIV symptoms index (HIV-SI) in score from Baseline to 1st and 2nd Follow-Up

    Time frame: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment

    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

  5. Change in Self-Reported Antiretroviral Therapy (ART) Medication Adherence from Baseline to 1st and 2nd Follow-Up

    Time frame: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment

    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

Secondary outcomes

  1. Change in Proportion of Days Covered (PDC) over the Past 180 Days from Baseline to 1st and 2nd Follow-Up

    Time frame: At baseline and 168th (+-14) day after enrollment

    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

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Collaborators

  • Ministry of Health and Welfare, Taiwan

Registry information

Official study title

Feasible Program of Sustainable Medical Care for People Living With HIV Who Are Difficult to Treat or Marginalized in Taiwan

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Dec 27, 2023
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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