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

NCT06500013 | Active Not Recruiting

• 1 other identifier: 104475
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; mHealth; messages; adherence; ART; antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

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

  4, 8 and 12 weeks of intervention

• Loss to follow-up

  From the start of delivery intervention until study completion

• Time of permanence in the study

  Baseline until study completion (16 weeks).

• Metrics on the use of a bidirectional platform for intervention delivery

  End of the intervention at 16 weeks.

Study Arms (2)

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.

Behavioral: Self-designed messages

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.

Behavioral: Standardized messages

Interventions

Self-designed messages BEHAVIORAL

Messages designed by participants

Self-designed messages

Standardized messages BEHAVIORAL

Messages designed by researchers based on behavioral change theories

Standardized messages

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: * Male * Female * Transgender * Other
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead

Study Sites (1)

Hospital Cayetano Heredia

Lima, Lima Province, 15102, Peru

Location

Related Publications (1)

• 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.

  PMID: 40403302 DERIVED

Study Officials

• Jeffrey Freidenson, M.D

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel model with 1:1 assignment to one of two study arms.

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 15, 2024
• Study Start: March 15, 2024
• Primary Completion: November 18, 2024
• Study Completion: July 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months after the trial ends, until 5 years after the trial end date.
• Access Criteria: 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.

Locations

PE (1)