Clinical trial NCT06500013: WhatsApp Intervention to Assess the Effect of Messages in Adherence to Antiretrovirals in Young People With HIV in Peru
Official title: Intervention With WhatsApp Messaging to Assess 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: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Keywords: HIV
mHealth
messages
adherence
ART
antiretroviral therapy
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel model with 1:1 assignment to one of two study arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in the Result of SMAQ Questionnaire Adjusted for the Effect of Covariables
timeFrame: Baseline, 16 weeks.
Secondary outcomes:
measure: ART adherence measured by SMAQ Questionnaire at 4, 8 and 12 weeks of intervention
timeFrame: 4, 8 and 12 weeks of intervention
measure: Loss to follow-up
timeFrame: From the start of delivery intervention until study completion
measure: Time of permanence in the study
timeFrame: Baseline until study completion (16 weeks).
measure: Metrics on the use of a bidirectional platform for intervention delivery
timeFrame: End of the intervention at 16 weeks.
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Hospital Cayetano Heredia
Study officials:
affiliation: Universidad Peruana Cayetano Heredia
name: Jeffrey Freidenson, M.D
role: PRINCIPAL_INVESTIGATOR
References: