Effect of a Mobile Health Intervention on Treatment Adherence

HIV I Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05187741
• Other study ID #: 138/21
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2022
• Source: Hospital Civil de Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV I Infection

Intervention

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).

Locations

Country	Name	City	State
Mexico	Hospital Civil de Guadalajara "Fray Antonio Alcalde"	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	TCD4+ count in blood	Number of CD4 + T lymphocytes in the blood. Measure by flow cytometry and reported as cells/mm3	6 months