Effect of a Mobile Health Intervention on Treatment Adherence

Effect of an Mobile Health Intervention on Adherence to Antiretroviral Treatment in Adult Patients Living With HIV Compared to Standard Care

This is a randomized clinical trial across the whole of the patients who attend the HIV Unit of the Hospital Civil Viejo, a sample calculated in 43 patients for each group (intervention and control). Patients who have HIV infection and are starting antiretroviral treatment (ART), who are between 18 and 50 years old and have a mobile device, will be included in the study. The messages will consist of medical appointment reminders and adherence and motivational messages for a period of six months.

Study Overview

• Status: Completed
• Conditions: HIV I Infection
• Intervention / Treatment: Device: mobile health (mHealth)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Recently diagnosed with HIV infection

  . starting with antiretroviral therapy and haven't taken ART before

• Patients with the status of "lost to follow up" who return to re-initiate ART

Exclusion Criteria:

• Patients who are participating in other study
• patients above 18 years old
• Patients who does not have signal phone at their residency
• Those who refuses to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daily message group; This group would be receiving text messages intended to improve treatment adherence and text reminders for appointments to improve care retention.	Device: mobile health (mHealth); A message will be sent on Monday and Friday at 9:00 am for 3 months, the first day they will receive a message focused on adherence and the second day a message focused on motivation. Subsequently, a message will be sent on Mondays for 3 more months. Reminders for appointments with your treating physician will be sent during the entire intervention period (6 months).
No Intervention: Control group; This group would be just observed through the same period as the intervention group but the participants will only receive the standard care provide by the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
antiretroviral treatment adherence	The practice of patients where they take their medications as prescribed. To proceed with the calculation, the following formula should be applied: [(number of units dispensed - number of units remaining) / (prescribed number of units per day x number of days between the two visits)] x 100.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
care retention	Person living with HIV who enters and remains in comprehensive HIV care by health services, according to their needs. It is recorded at 6 months and 12 months of follow-up, with the patient's compliance with their medical appointments.	6 months
HIV viral loal	Amount of genetic material (RNA) of the virus in blood in the most recent determination.Measure by Reverse transcriptase polymerase chain reaction test reported as copies/ml	6 months
TCD4+ count in blood	Number of CD4 + T lymphocytes in the blood. Measure by flow cytometry and reported as cells/mm3	6 months

Collaborators and Investigators

• Sponsor: Hospital Civil de Guadalajara

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: December 24, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 27, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: adherence; electronic health
• Other Study ID Numbers: 138/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No