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OpenTrials
Completed

NCT Number: NCT05187741

Effect of a Mobile Health Intervention on Treatment Adherence

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.

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Key information

Conditions

HIV I Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44280, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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

  1. care retention

    Time frame: 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.

  2. HIV viral loal

    Time frame: 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

  3. TCD4+ count in blood

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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