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CompletedNCT05187741Updated Nov 29, 2022

Effect of a Mobile Health Intervention on Treatment Adherence

An interventional study of mobile health (mHealth) in HIV I Infection, sponsored by Hospital Civil de Guadalajara. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-29.

Sponsored by Hospital Civil de Guadalajara · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV I Infection

Keywords

  • electronic health
  • adherence
03

In context

Lead sponsor

Hospital Civil de Guadalajara is the lead sponsor of 39 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • 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)

  • 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.

Interventions

  • Devicemobile 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).

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. TCD4+ count in blood

    Number of CD4 + T lymphocytes in the blood. Measure by flow cytometry and reported as cells/mm3

    Time frame: 6 months

07

Study locations

1 site
  • Hospital Civil de Guadalajara "Fray Antonio Alcalde"
    Guadalajara, Jalisco 44280, Mexico
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05187741
Lead sponsor
Hospital Civil de Guadalajara
Responsible party
Luis Eduardo del Moral Trinidad (Public Health Master Student, Hospital Civil de Guadalajara) — Principal investigator
First posted
Jan 12, 2022
Start date
Apr 1, 2022
Primary completion
Nov 15, 2022
Completion
Nov 15, 2022
Last update
Nov 29, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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