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NCT Number: NCT06500013

WhatsApp Intervention to Assess the Effect of Messages in Adherence to Antiretrovirals in Young People With HIV in Peru

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Cayetano Heredia

Lima, Lima Province, 15102, Peru

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Self-designed messages

Behavioral

Messages designed by participants

Standardized messages

Behavioral

Messages designed by researchers based on behavioral change theories

Primary outcomes

  1. Change from Baseline in the Result of SMAQ Questionnaire Adjusted for the Effect of Covariables

    Time frame: 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 outcomes

  1. ART adherence measured by SMAQ Questionnaire at 4, 8 and 12 weeks of intervention

    Time frame: 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.

  2. Loss to follow-up

    Time frame: 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

  3. Time of permanence in the study

    Time frame: 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.

  4. Metrics on the use of a bidirectional platform for intervention delivery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Peruana Cayetano Heredia

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 15, 2024
Registry last updated
Mar 26, 2025

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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