HIV
Conditions
Keywords
HIV, mHealth, messages, adherence, ART, antiretroviral therapy
Brief summary
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: * Receive either messages designed by themselves or by health providers for 4 months. * Be able to chat with health providers at any time, with special focus regarding questions about their condition, medications and health services. * Complete questionnaires via WhatsApp describing how they are taking their medications, and how often they forget to take them. * Complete questionnaires via WhatsApp describing their opinion about receiving the messages and being able to chat with health providers.
Interventions
BEHAVIORALSelf-designed messages
Messages designed by participants
BEHAVIORALStandardized messages
Messages designed by researchers based on behavioral change theories
Sponsors
Universidad Peruana Cayetano Heredia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Parallel model with 1:1 assignment to one of two study arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* People living with HIV of age 18-29 at the moment of signing informed consent. * Being a patient of the study center's Infectious Diseases clinic or National HIV Program, between March 2024 and July 2024. * Ownership of a mobile phone that supports WhatsApp.
Exclusion criteria
* Being pregnant at the moment of signing informed consent. * Being illiterate at the moment of signing informed consent. * Being blind at the moment of signing informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Result of SMAQ Questionnaire Adjusted for the Effect of Covariables | Baseline, 16 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ART adherence measured by SMAQ Questionnaire at 4, 8 and 12 weeks of intervention | 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. |
| Loss to follow-up | From the start of delivery intervention until study completion | 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 |
| Time of permanence in the study | Baseline until study completion (16 weeks). | 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. |
| Metrics on the use of a bidirectional platform for intervention delivery | End of the intervention at 16 weeks. | 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. |
Countries
Peru
Outcome results
None listed