- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02149888
PRe-Exposure Prophylaxis Acceptability & Readiness Assessments for Toronto gaY, Bisexual and Other Men Who Have Sex With Men-5 (PREP-5)
A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM:The PREPARATORY-5 Study
Canada continues to see an unrelenting stream of new HIV diagnoses, with a disproportionate burden among gay, bisexual, and other MSM in major centers such as Toronto. Pre-exposure prophylaxis (PrEP) with oral, daily tenofovir/emtricitabine (TDF/FTC, Truvada®) is a novel biomedical approach to HIV prevention shown in the iPrEx trial to be safe and efficacious in reducing HIV acquisition by 44% among MSM, when provided in a comprehensive package of HIV prevention interventions including counseling, testing/treatment of sexually transmitted infections (STIs), and condoms. There is now widespread mobilization to assess the feasibility of PrEP roll-out worldwide, with urgent calls for 'demonstration projects' addressing real-world PrEP implementation issues.
PREPARATORY-5 is Canada's first PrEP demonstration project, and will examine real-world PrEP implementation issues including acceptability, effectiveness, impact on sexually transmitted infections, and strategies for supporting adherence outside the clinical trial setting. The investigators have also established a comprehensive community-based research program investigating the role of community-based organizations in PrEP implementation and delivery.
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
-
-
Ontario
-
Toronto, Ontario, 캐나다, M5B 1W8
- St. Michael's Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Self-identified man who has sex with men
- Age 18 years or older
- Able to communicate in both written and oral english
- HIRI-MSM score greater than or equal to 10
- At least one self-reported unprotected receptive anal sex act over the preceding 6 months
- Creatinine clearance greater than or equal to 60mL/min by Modified Diet in Renal Disease (MDRD) formula
- HIV un-infected at screening using standard ELISA and Western Blot testing
Exclusion Criteria:
- Clinical signs or symptoms suggestive of an HIV seroconversion illness within the last 3 months in the opinion of the investigator
- Use of pre- or post-exposure prophylaxis within the last 3 months
- Use of concomitant nephrotoxic drugs
- Use of concomitant immune modulatory drugs
- Hepatitis B surface antigen positivity
- Any condition or concomitant medication portending an increased risk of osteoporosis
- Enrollment in any other HIV prevention program or trial
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Tenofovir/emtricitabine
MSM receiving once daily TDF/FTC-based (Truvada®) pre-exposure prophylaxis
|
Once daily Tenofovir/emtricitabine (Truvada®)
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Participants' self-reported overall acceptability of PrEP
기간: 12 months
|
Participants' self-reported overall acceptability of PrEP over the full one-year follow-up period (including the use of the medication, clinic visits, and their impact on the participant's life) will be quantified using a Likert scale.
|
12 months
|
The level of community interest in PrEP
기간: 12 months
|
The level of community interest in PrEP will be measured by quantifying the volume, rate and HIV risk levels of patient referrals to the PrEP clinic from each key referral source
|
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Adherence to daily TDF/FTC-based PrEP
기간: 12 months
|
Adherence will be measured by self-report, pill count, and intra-RBC tenofovir diphosphate levels.
|
12 months
|
Time required by the patient, physician and research coordinator for each type of study visit.
기간: 12 months
|
The time required by the patient, physician and research coordinator will be measured for each type of study visit.
|
12 months
|
HIV infection
기간: 12 months
|
HIV infection will be detected using point-of-care tests, standard serology and HIV RNA testing.
|
12 months
|
Sexually transmitted infections
기간: 12 months
|
Testing will be performed at each study visit to screen for gonorrhea, chlamydia and syphilis infection, including pharyngeal swab cultures, rectal swab cultures and urine NAAT tests.
|
12 months
|
Burden of syndemic health problems
기간: 12 months
|
The burden of specific syndemic health problems (depression, social anxiety, substance abuse, sexual addiction, childhood sexual abuse, partner violence) will be quantified using standardized, validated psychometric tools.
|
12 months
|
Change in estimated glomerular filtration rate
기간: 12 months
|
Estimated by the Modified Diet in Renal Disease (MDRD) formula
|
12 months
|
Percentage change in bone mineral density at the lumbar spine and total hip
기간: 12 months
|
12 months
|
|
Adverse events
기간: 12 months
|
Adverse events will be assessed at each visit via clinical assessment and laboratory monitoring (CBC, phosphate, urinalysis).
|
12 months
|
Pilot testing study instruments
기간: 12 months
|
Outcomes related to pilot testing study instruments will include numbers of minutes required and participant-reported acceptability for each procedure
|
12 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Tan DHS, Schnubb A, Lawless J, Szadkowski L, Grennan T, Wilton J, Fowler S, Hart TA, Maxwell J, Raboud JM. Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study. CMAJ Open. 2018 Dec 10;6(4):E611-E617. doi: 10.9778/cmajo.20180068. Print 2018 Oct-Dec.
- Wilton J, Noor SW, Schnubb A, Lawless J, Hart TA, Grennan T, Fowler S, Maxwell J, Tan DHS. High HIV risk and syndemic burden regardless of referral source among MSM screening for a PrEP demonstration project in Toronto, Canada. BMC Public Health. 2018 Feb 27;18(1):292. doi: 10.1186/s12889-018-5180-8.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- PREPARATORY-5
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. .
에이즈에 대한 임상 시험
-
Hospital Clinic of Barcelona완전한
-
CDC FoundationGilead Sciences알려지지 않은
-
University of WashingtonNational Institute of Mental Health (NIMH)모병
-
University of Minnesota빼는HIV 감염 | HIV/에이즈 | 에이즈 | 보조기구 | 에이즈/HIV 문제 | 에이즈와 감염미국
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation완전한파트너 HIV 테스트 | 부부 에이즈 상담 | 커플커뮤니케이션 | HIV 발병률카메룬, 도미니카 공화국, 그루지야, 인도
-
Michael HoelscherClinton Health Access Initiative Inc.; Instituto Nacional de Saúde (INS), Ministério da... 그리고 다른 협력자들모집하지 않고 적극적으로HIV, 신생아 HIV 조기 진단(EID), 현장 진료 검사(PoC)모잠비크, 탄자니아
-
Allegheny Singer Research Institute (also known...모집하지 않고 적극적으로
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
-
Erasmus Medical Center모병
-
Erasmus Medical Center모집하지 않고 적극적으로
Tenofovir/emtricitabine에 대한 임상 시험
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Gilead Sciences 그리고 다른 협력자들아직 모집하지 않음
-
Instituto de Investigación Hospital Universitario...완전한
-
University of WashingtonGilead Sciences; CONRAD완전한
-
The First Affiliated Hospital of Zhengzhou UniversityNational Natural Science Foundation of China; The Affiliated Nanjing Drum Tower Hospital... 그리고 다른 협력자들아직 모집하지 않음만성 B형 간염 | 효능 | 안전 | B형 간염 바이러스 | 모자 감염 | 테노포비르 알라페나미드 푸마레이트
-
Southeast University, China알려지지 않은
-
Makerere UniversityMassachusetts General Hospital완전한
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Microbicide Trials Network완전한