Online Cohort of Sexual and Gender Minorities: Evaluating Digital Interventions to Improve HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment Uptake and Adherence
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Thiago S Torres, PhD
- Telefonnummer: +55 2138659128
- E-post: ttorres79@gmail.com
Studieorter
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-
Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Brasilien, 21040-360
- Rekrytering
- Instituto Nacional de Infectologia Evandro Chagas
-
Kontakt:
- Thiago S Torres, PhD
- Telefonnummer: +55 2138659128
- E-post: ttorres79@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Weekly WhatsApp Messages
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.
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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.
|
|
Inget ingripande: No Weekly Messages
Participants will receive the standard study follow-up procedures without the weekly WhatsApp adherence messages.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Medication Adherence to PrEP or ART
Tidsram: 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.
|
Baseline and Months 3, 6, 9, and 12
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Medication Adherence to PrEP
Tidsram: 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.
|
Baseline and Months 3, 6, 9, and 12
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Blodburna infektioner
- Urogenitala sjukdomar
- Genitala sjukdomar
- Immunsystemets sjukdomar
- Infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Smittsamma sjukdomar
- Sexuellt överförbara sjukdomar, virala
- Sexuellt överförbara sjukdomar
- Lentivirusinfektioner
- Retroviridae-infektioner
- Immunologiska bristsyndrom
- HIV-infektioner
Andra studie-ID-nummer
- 89404825.2.0000.5262
Läkemedels- och apparatinformation, studiedokument
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