HIV I InfectionNCT05187741
Effect of a Mobile Health Intervention on Treatment Adherence
A study testing mobile health (mHealth) in people with HIV I Infection, run by Hospital Civil de Guadalajara at 1 site in Mexico.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV I Infection
- What is being tested?
- mobile health (mHealth)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2022to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44280
About this study
Official title: Effect of an Mobile Health Intervention on Adherence to Antiretroviral Treatment in Adult Patients Living With HIV Compared to Standard Care
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.
- Conditions
- HIV I Infection
- Being tested
- mobile health (mHealth)
- Keywords
- electronic health, adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: mobile health (mHealth) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
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
Measured: 6 months
TCD4+ count in blood
Number of CD4 + T lymphocytes in the blood. Measure by flow cytometry and reported as cells/mm3
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Apr 2022
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV I InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Eduardo del Moral Trinidad, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187741
- Sponsor's protocol ID
- 138/21
- Status last verified
- Nov 2022
- First submitted
- 13 Dec 2021
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Del Moral Trinidad LE, Andrade Villanueva JF, Martinez Ayala P, Cabrera Silva RI, Herrera Godina MG, Gonzalez-Hernandez LA. Effectiveness of an mHealth Intervention With Short Text Messages to Promote Treatment Adherence Among HIV-Positive Mexican Adults: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Jan 28;13:e57540. doi: 10.2196/57540.
PubMed 39881127
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Mobile Health Intervention on Adherence to Antiretroviral Treatment in Adult Patients Living With HIV Compared to Standard Care
- ClinicalTrials.gov ID
- NCT05187741
- Acronym / sponsor ID
- 138/21
- Conditions
- HIV I Infection
- Keywords
- electronic health, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Daily message group | Experimental | Device: mobile health (mHealth)This group would be receiving text messages intended to improve treatment adherence and text reminders for appointments to improve care retention. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Daily message group |
Primary outcome
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.
3 secondary outcomes
care retention
Time frame: 6 months
HIV viral loal
Time frame: 6 months
TCD4+ count in blood
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Derived from this study: PubMed 39881127Del Moral Trinidad LE, Andrade Villanueva JF, Martinez Ayala P, Cabrera Silva RI, Herrera Godina MG, Gonzalez-Hernandez LA. Effectiveness of an mHealth Intervention With Short Text Messages to Promote Treatment Adherence Among HIV-Positive Mexican Adults: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Jan 28;13:e57540. doi: 10.2196/57540.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile health (mHealth) in people with HIV I Infection, run by Hospital Civil de Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antiretroviral treatment adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05187741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.