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NCT Number: NCT07772791

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, 21040-360, Brazil

Location status: Recruiting

Location contact

Thiago S Torres, PhD

CONTACT

[email protected]

+55 2138659128

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weekly WhatsApp Adherence Messages

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Medication Adherence to PrEP

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Thiago S Torres, PhD

CONTACT

[email protected]

+55 2138659128

Sponsors and collaborators

Lead sponsor

Oswaldo Cruz Foundation

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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