WhatsApp Intervention to Assess the Effect of Messages in Adherence to Antiretrovirals in Young People With HIV in Peru
NCT Number: NCT06500013
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV
Interventions: BEHAVIORAL: Self-designed messages|BEHAVIORAL: Standardized messages
Sponsor: Universidad Peruana Cayetano Heredia
Sex: ALL
Age: ADULT
Enrollment: 131
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-03-15
Completion Date: 2024-12
Locations: Hospital Cayetano Heredia, Lima, 15102, Peru

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.

Primary Outcome Measures: 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. \>95% adherence is considered as "yes", and \<95% as "no"., Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks.
Secondary Outcome Measures: Description of the message creation process in both arms of the study., Description of number of messages for each study arm. In the standardized messages arm, description of main suggestions by participants to refine the messages. In the self-designed messages arm, reporting of mean quantity of messages created per participant, and main reasons for addition, modification or elimination of messages., Baseline and end of intervention at 16 weeks.|Description of main themes in self-designed messages, Description of main themes identified in self-designed messages via thematic analysis., End of the intervention at 16 weeks.|Description of the use of Behavioral Change Techniques in standardized messages., Reporting of percentages of each Behavioral Change Technique used in the design of standardized messages., End of the intervention at 16 weeks.|Description of main themes identified in semi-structured interviews with healthcare workers, research assistants and members of the research team regarding barriers and facilitators for implementation of the intervention at the study center, Description of main themes identified using thematic analysis of semi-structured interviews with healthcare workers from the National HIV Program involved in some research processes, research assistants, and members of the research team regarding factors serving as perceived barriers and facilitators to implementing the intervention at the study center., End of the intervention at 16 weeks.|Risk of participant permanence in the study in both study arms, Survival analysis to evaluate permanence in the study and loss to follow-up in both study arms. This will consider the number of participants that remain in the intervention in each arm at each measurement in time (baseline, 1 week, 2 weeks and so on), and then calculate the risk of staying in the study at each point in time, and at the end of the study. Then, comparing both risks as a hazard ratio (proportion)., Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 16 weeks.|Evaluate the use of a bidirectional platform for multiple aspects of HIV care at the study center, Reporting metrics regarding delivery of the intervention: frequencies, percentages and means with standard deviation of messages and questionnaires programmed for sending, sent, received, read and answered by participants. Using a thematic analysis, the main themes identified in the content of conversations with participants in the chat will be reported. Frequencies and percentages of different process indicators self-reported by participants., End of the intervention at 16 weeks.