Effect of a Mobile Health Intervention on Treatment Adherence

NCT05187741 | Completed DMC

• 1 other identifier: 138/21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV I Infection

Keywords

electronic health; adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• care retention

  6 months

• HIV viral loal

  6 months

• TCD4+ count in blood

  6 months

Study Arms (2)

Daily message group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

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.

Interventions

mobile health (mHealth) DEVICE

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).

Daily message group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44280, Mexico

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Health Master Student

Model Details: Randomized control trial

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 12, 2022
• Study Start: April 1, 2022
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)