Online Cohort of Sexual and Gender Minorities: Evaluating Digital Interventions to Improve HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment Uptake and Adherence
1 other identifier
interventional
3,000
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2026
CompletedFirst Submitted
Initial submission to the registry
August 14, 2026
CompletedFirst Posted
Study publicly available on registry
August 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
August 19, 2026
August 1, 2026
2.5 years
August 14, 2026
August 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline and Months 3, 6, 9, and 12
Secondary Outcomes (1)
Medication Adherence to PrEP
Baseline and Months 3, 6, 9, and 12
Study Arms (2)
Weekly WhatsApp Messages
EXPERIMENTALParticipants 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 INTERVENTIONParticipants will receive the standard study follow-up procedures without the weekly WhatsApp adherence messages.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- incorrectly answering the attention-check questions; and incomplete responses, defined as not reaching the end of the screening questionnaire
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2026
First Posted
August 19, 2026
Study Start
May 25, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
August 19, 2026
Record last verified: 2026-08