Online Cohort of Sexual and Gender Minorities: Evaluating Digital Interventions to Improve HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment Uptake and Adherence

Oswaldo Cruz Foundation3,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

3,000

Conditions

HIV Infections

Interventions

Weekly WhatsApp Adherence MessagesBEHAVIORAL

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

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 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. Exclusion Criteria: incorrectly answering the attention-check questions; and incomplete responses, defined as not reaching the end of the screening questionnaire

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Months 3, 6, 9, and 12

Secondary Outcomes

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.