Effect of a Mobile Health Intervention on Treatment Adherence

Not Applicable

Completed

• Conditions: HIV I Infection
• Interventions: Device: mobile health (mHealth)

• Registration Number: NCT05187741
• Lead Sponsor: Hospital Civil de Guadalajara

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2021-12-24
• Study First Posted: 2022-01-12
• Study Start: 2022-04-01
• Status Verified: 2022-11
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Last Update Submitted: 2022-11-27
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily message group	mobile health (mHealth)	This group would be receiving text messages intended to improve treatment adherence and text reminders for appointments to improve care retention.

Primary Outcome Measures

Name	Time	Method
antiretroviral treatment adherence	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 Outcome Measures

Name	Time	Method
HIV viral loal	6 months	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
TCD4+ count in blood	6 months	Number of CD4 + T lymphocytes in the blood. Measure by flow cytometry and reported as cells/mm3
care retention	6 months	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.

Trial Locations

Locations (1)

Hospital Civil de Guadalajara "Fray Antonio Alcalde"; 🇲🇽 Guadalajara, Jalisco, Mexico