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The goal of this clinical trial is to learn which type of messages is more efficacious to improve adherence to medication in young people living with HIV. The main question is aims to answer is:
-Are messages designed by participants (self-designed) more efficacious than messages designed by health providers to improve adherence to antiretroviral treatment (HIV medications)?
Researchers will compare both types of messages to see if one is better than the other in helping participants take their medications.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-designed messages | Experimental | This group of participants will design their own messages, and receive them via mobile messaging up to 3 times a week in the day and time of their choosing, for 16 weeks. |
|
| Standardized messages | Active Comparator | This group of participants will receive messages designed by researchers based on behavioral change theories, up to 3 times a week in the day and time of their choosing, for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-designed messages | Behavioral | Messages designed by participants |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Result of SMAQ Questionnaire Adjusted for the Effect of Covariables | The SMAQ questionnaire evaluates medication adherence. It provides a dichotomic result of adherence (yes/no), and a semiquantitative estimate of adherence. Greater than 95% adherence is considered as adherent, and less than 95% as non-adherent. | Baseline, 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| ART adherence measured by SMAQ Questionnaire at 4, 8 and 12 weeks of intervention | SMAQ provides a dichotomic result of adherence (yes/no): we will report percentage of participants adherent to ART per study group during the intervention. | 4, 8 and 12 weeks of intervention |
| Loss to follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Freidenson, M.D | Universidad Peruana Cayetano Heredia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Cayetano Heredia | Lima | Lima Province | 15102 | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40403302 | Derived | Freidenson-Bejar J, Espinoza D, Calderon-Flores R, Mejia F, Gonzalez-Lagos E. Intervention With WhatsApp Messaging to Compare the Effect of Self-Designed Messages and Standardized Messages in Adherence to Antiretroviral Treatment in Young People Living With HIV in a Hospital in Lima, Peru: Protocol for a Nonblinded Randomized Controlled Trial. JMIR Res Protoc. 2025 May 22;14:e66941. doi: 10.2196/66941. |
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De-identified individual participant data collected during the trial will be made available 6 months after study completion. Access will be provided after a formal request has been reviewed and approved by the Institutional Review Boards of the study sponsor and study center, and with a signed data sharing agreement. The study protocol, informed consent, and statistical analysis plan will be published in a peer-reviewed journal. Requested data and clinical study reports will be provided through a secure data-sharing platform.
Beginning 6 months after the trial ends, until 5 years after the trial end date.
IPD may be shared to qualified researchers for scientific purposes. This will require the review and approval of a formal petition including the research proposal and statistical analysis plan, and a data sharing agreement.
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Parallel model with 1:1 assignment to one of two study arms.
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| Standardized messages |
| Behavioral |
Messages designed by researchers based on behavioral change theories |
|
Loss to follow-up is defined as either (i) participants not responding to messages for ≥ 30 continuous days since receiving the intervention and not responding to messages or questionnaires at the end of their intervention period (t=16), or (ii) particip |
| From the start of delivery intervention until study completion |
| Time of permanence in the study | Time of permanence in the study, indicated from the first date of intervention delivery until loss to-follow up or study completion. We will describe the median and interquartile range of this result in both study arms. | Baseline until study completion (16 weeks). |
| Metrics on the use of a bidirectional platform for intervention delivery | Frequencies, percentages, and means with a standard deviation of messages and questionnaires programmed for sending, sent, received, read, and answered by participants. Frequencies and percentages of different process indicators self-reported by participants. | End of the intervention at 16 weeks. |