Optimizing Care for Challenging People Living With HIV

NCT06183723 | Enrolling By Invitation

• 1 other identifier: KMUHIRB-SV(I)-20230081
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adherence, Medication; HIV Infections; Social Media

Keywords

HIV; Adherence; Social media platform

Outcome Measures

Primary Outcomes (5)

• 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

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

Secondary Outcomes (1)

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

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

Study Arms (1)

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).

Other: Combination of social-behavior model and eHealth

Interventions

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.

People living with HIV with poor adherence to HAART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).

You may not qualify if:

• Under 18 years of age.
• Illiterate.
• Non-consenting individuals.
• Lack of a smart phone.
• No willingness to return for follow-up at the participating hospital.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead
• Ministry of Health and Welfare, Taiwan: collaborator

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 814032, Taiwan

Location

MeSH Terms

Conditions

Medication Adherence; HIV Infections

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Chun-Yuan Lee, M.D.

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 27, 2023
• Study Start: March 18, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

TW (1)