- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07772791
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Thiago S Torres, PhD
- 전화번호: +55 2138659128
- 이메일: ttorres79@gmail.com
연구 장소
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, 브라질, 21040-360
- 모병
- Instituto Nacional de Infectologia Evandro Chagas
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연락하다:
- Thiago S Torres, PhD
- 전화번호: +55 2138659128
- 이메일: ttorres79@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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간섭 없음: No Weekly Messages
Participants will receive the standard study follow-up procedures without the weekly WhatsApp adherence messages.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Medication Adherence to PrEP or ART
기간: Baseline and Months 3, 6, 9, and 12
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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.
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Baseline and Months 3, 6, 9, and 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Medication Adherence to PrEP
기간: Baseline and Months 3, 6, 9, and 12
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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.
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Baseline and Months 3, 6, 9, and 12
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .