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Clinical Trials/NCT05187741
NCT05187741CompletedNot Applicable

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

Hospital Civil de Guadalajara1 site in 1 country80 target enrollmentStarted: April 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
antiretroviral treatment adherence

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: mobile health (mHealth) (Device)

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.

Outcomes

Primary Outcomes

antiretroviral treatment adherence

Time Frame: 6 months

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.

Secondary Outcomes

  • HIV viral loal(6 months)
  • TCD4+ count in blood(6 months)
  • care retention(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Luis Eduardo del Moral Trinidad

Public Health Master Student

Hospital Civil de Guadalajara

Study Sites (1)

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