HIV InfectionsNCT07772791
Online Cohort of Sexual and Gender Minorities: Evaluating Digital Interventions to Improve HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment Uptake and Adherence
A study testing Weekly WhatsApp Adherence Messages in people with HIV Infections, run by Oswaldo Cruz Foundation at 1 site in Brazil.
Trial summary
This study will create and follow an online cohort of sexual and gender minorities in Brazil to better understand the use of HIV prevention and treatment strategies, particularly pre-exposure prophylaxis (PrEP) and antiretroviral treatment (ART). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Weekly WhatsApp Adherence Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteBrazil
- Study dates
- 25 May 2026to Dec 2028
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male sex assigned at birth and identifying as a man, travesti, transgender person, or non-binary person; age ≥18 years; residing in Brazil; access to the internet; and self-reporting sex with a man in the past 12 months.
Who cannot join
- incorrectly answering the attention-check questions; and incomplete responses, defined as not reaching the end of the screening questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, Rio de Janeiro, 21040-360
Thiago S Torres, PhD, +55 2138659128, ttorres79@gmail.com
About this study
Official title: Online Cohort of Sexual and Gender Minorities: Evaluating the Effect of Digital Interventions on the Uptake and Adherence to HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment
This study will create and follow an online cohort of sexual and gender minorities in Brazil to better understand the use of HIV prevention and treatment strategies, particularly pre-exposure prophylaxis (PrEP) and antiretroviral treatment (ART). Participants will complete online questionnaires at the beginning of the study and every three months for one year to provide information about medication use and adherence, sexual behaviors, HIV prevention and testing, sexually transmitted infections, mental health, and experiences of discrimination in health services.
Participants who are using PrEP or ART and agree to take part in the intervention will be randomly assigned to receive either a digital intervention or no digital intervention. The digital intervention will consist of weekly WhatsApp messages for six months, including reminders and information intended to support adherence to PrEP or ART.
The main question of the study is whether weekly WhatsApp messages can improve adherence to PrEP or ART among sexual and gender minorities in Brazil. The study hypothesis is that participants who receive the digital intervention will have higher adherence to PrEP or ART than participants who do not receive the intervention.
- Conditions
- HIV Infections
- Being tested
- Weekly WhatsApp Adherence Messages
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly WhatsApp Adherence MessagesBehavioural
Participants randomized to the intervention arm will receive weekly WhatsApp messages for 6 months designed to support adherence to pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART). Messages will include medication reminders and brief, standardized information related to HIV prevention and treatment. Messages will be delivered through a scheduled automated system.
| Study group | Role | What they receive |
|---|---|---|
| Weekly WhatsApp Messages | Experimental | Participants receiving weekly WhatsApp messages for 6 months to support adherence to PrEP or ART, including medication reminders and brief standardized HIV prevention and treatment information. Receives: Behavioral: Weekly WhatsApp Adherence Messages |
| No Weekly Messages | No intervention | Participants will receive the standard study follow-up procedures without the weekly WhatsApp adherence messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence to PrEP or ART
Medication adherence will be assessed using a visual analog scale in which participants report the percentage of prescribed PrEP or ART doses taken during the previous 30 days, from 0% to 100%. Participants reporting adherence greater than 95% will be classified as adherent. The primary analysis will compare the proportion of participants classified as adherent between the weekly WhatsApp intervention and control groups over follow-up.
Measured: Baseline and Months 3, 6, 9, and 12
Secondary outcomes (1)
Medication Adherence to PrEP
Self-reported adherence to PrEP during the previous 30 days, measured using a 0% to 100% visual analog scale. Participants reporting adherence greater than 95% will be classified as adherent. Adherence will be evaluated over follow-up and compared between intervention and control groups among participants using PrEP.
Measured: Baseline and Months 3, 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start25 May 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oswaldo Cruz Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772791
- Sponsor's protocol ID
- 89404825.2.0000.5262
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cohort of Sexual and Gender Minorities: Evaluating the Effect of Digital Interventions on the Uptake and Adherence to HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment
- ClinicalTrials.gov ID
- NCT07772791
- Acronym / sponsor ID
- 89404825.2.0000.5262
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Oswaldo Cruz FoundationUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Aug 2026 (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.
This study will create and follow an online cohort of sexual and gender minorities in Brazil to better understand the use of HIV prevention and treatment strategies, particularly pre-exposure prophylaxis (PrEP) and antiretroviral treatment (ART). Participants will complete online questionnaires at the beginning of the study and every three months for one year to provide information about medication use and adherence, sexual behaviors, HIV prevention and testing, sexually transmitted infections, mental health, and experiences of discrimination in health services.
Participants who are using PrEP or ART and agree to take part in the intervention will be randomly assigned to receive either a digital intervention or no digital intervention. The digital intervention will consist of weekly WhatsApp messages for six months, including reminders and information intended to support adherence to PrEP or ART.
The main question of the study is whether weekly WhatsApp messages can improve adherence to PrEP or ART among sexual and gender minorities in Brazil. The study hypothesis is that participants who receive the digital intervention will have higher adherence to PrEP or ART than participants who do not receive the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly WhatsApp Messages | Experimental | Behavioral: Weekly WhatsApp Adherence MessagesParticipants receiving weekly WhatsApp messages for 6 months to support adherence to PrEP or ART, including medication reminders and brief standardized HIV prevention and treatment information. |
| No Weekly Messages | No intervention | –Participants will receive the standard study follow-up procedures without the weekly WhatsApp adherence messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male sex assigned at birth and identifying as a man, travesti, transgender person, or non-binary person; age ≥18 years; residing in Brazil; access to the internet; and self-reporting sex with a man in the past 12 months.
Key exclusion criteria (1 listed)
- incorrectly answering the attention-check questions; and incomplete responses, defined as not reaching the end of the screening questionnaire
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 |
|---|---|---|
| Weekly WhatsApp Adherence MessagesParticipants randomized to the intervention arm will receive weekly WhatsApp messages for 6 months designed to support adherence to pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART). Messages will include medication reminders and brief, standardized information related to HIV prevention and treatment. Messages will be delivered through a scheduled automated system. | Behavioural | Weekly WhatsApp Messages |
Primary outcome
Medication Adherence to PrEP or ART
Time frame: Baseline and Months 3, 6, 9, and 12
Medication adherence will be assessed using a visual analog scale in which participants report the percentage of prescribed PrEP or ART doses taken during the previous 30 days, from 0% to 100%. Participants reporting adherence greater than 95% will be classified as adherent. The primary analysis will compare the proportion of participants classified as adherent between the weekly WhatsApp intervention and control groups over follow-up.
1 secondary outcome
Medication Adherence to PrEP
Time frame: Baseline and Months 3, 6, 9, and 12
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 19 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly WhatsApp Adherence Messages in people with HIV Infections, run by Oswaldo Cruz Foundation at 1 site in Brazil.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. 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 Brazil. 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?
Contact Thiago S Torres, PhD (+55 2138659128, ttorres79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence to PrEP or ART (time frame: Baseline and Months 3, 6, 9, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.