HIVNCT06500013
WhatsApp Intervention to Assess the Effect of Messages in Adherence to Antiretrovirals in Young People With HIV in Peru
A study testing Self-designed messages and Standardized messages in people with HIV, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- HIV
- What is being tested?
- Self-designed messages and Standardized messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 sitePeru
- Study dates
- 15 Mar 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)?
Read more
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
- Being tested
- Self-designed messages, Standardized messages
- Keywords
- HIV, mHealth, messages, adherence, ART, antiretroviral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-designed messagesBehavioural
Messages designed by participants
Standardized messagesBehavioural
Messages designed by researchers based on behavioral change theories
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standardized messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 16 weeks.
Secondary outcomes (4)
ART adherence measured by SMAQ Questionnaire at 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.
Measured: 4, 8 and 12 weeks of intervention
Loss to follow-up
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
Measured: From the start of delivery intervention until study completion
Time of permanence in the study
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.
Measured: Baseline until study completion (16 weeks).
Metrics on the use of a bidirectional platform for intervention delivery
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.
Measured: End of the intervention at 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start15 Mar 2024
- Primary completion18 Nov 2024
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel model with 1:1 assignment to one of two study arms.
- Masking
- None (open label)
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Freidenson, Universidad Peruana Cayetano Heredia
- Investigators
- Jeffrey Freidenson, M.D, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500013
- Sponsor's protocol ID
- 104475
- Status last verified
- Mar 2025
- First submitted
- 29 Jun 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the trial will be made available 6 months after study completion. Access will be provided after a formal request has been reviewed and approved by the Institutional Review Boards of the study sponsor and study center, and with a signed data sharing agreement. The study protocol, informed consent, and statistical analysis plan will be published in a peer-reviewed journal. Requested data and clinical study reports will be provided through a secure data-sharing platform.
Publications
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.
PubMed 40403302
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06500013
- Acronym / sponsor ID
- 104475
- Conditions
- HIV
- Keywords
- HIV, mHealth, messages, adherence, ART, antiretroviral therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel model with 1:1 assignment to one of two study arms.
| Arm | Type | Receives |
|---|---|---|
| Self-designed messages | Experimental | Behavioral: Self-designed messagesThis 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. |
| Standardized messages | Active comparator | Behavioral: Standardized messagesThis 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-designed messagesMessages designed by participants | Behavioural | Self-designed messages |
| Standardized messagesMessages designed by researchers based on behavioral change theories | Behavioural | Standardized messages |
Primary outcome
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.
4 secondary outcomes
ART adherence measured by SMAQ Questionnaire at 4, 8 and 12 weeks of intervention
Time frame: 4, 8 and 12 weeks of intervention
Loss to follow-up
Time frame: From the start of delivery intervention until study completion
Time of permanence in the study
Time frame: Baseline until study completion (16 weeks).
Metrics on the use of a bidirectional platform for intervention delivery
Time frame: End of the intervention at 16 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 40403302Freidenson-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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the trial will be made available 6 months after study completion. Access will be provided after a formal request has been reviewed and approved by the Institutional Review Boards of the study sponsor and study center, and with a signed data sharing agreement. The study protocol, informed consent, and statistical analysis plan will be published in a peer-reviewed journal. Requested data and clinical study reports will be provided through a secure data-sharing platform.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Freidenson, M.D principal investigator
Universidad Peruana Cayetano Heredia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-designed messages and Standardized messages in people with HIV, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Result of SMAQ Questionnaire Adjusted for the Effect of Covariables (time frame: Baseline, 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06500013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.