Stop Hep B @ Birth
Stop Hep B @ Birth: Community-Oriented Care Model for the Prevention of Mother-To-Child Transmission of Hepatitis B in Peri-Urban Yangon
연구 개요
상태
정황
상세 설명
An estimated 248 million people worldwide are chronically infected with hepatitis B virus (HBV); and 75% of them live in Asia. Mother-to-child transmission (MTCT) accounts for the majority of chronic hepatitis B infections in Southeast Asia. Elimination of MTCT of HBV is theoretically possible with a comprehensive suite of interventions that includes birth dose vaccination, hepatitis B immune globulin, and antenatal antiviral therapy (e.g., tenofovir). However, the ideal gestational age to initiate antenatal tenofovir remains undefined; and evidence is lacking for implementation strategies capable of providing cost-effective, equitable access to a comprehensive suite of interventions to prevent MTCT of HBV in low-resource settings.
Component I: Prevention of Vertical Transmission Pregnant women living in the study area will be identified and screened for hepatitis B by a network of antenatal care (ANC) providers and existing community outreach workers; HBsAg positive patients will be invited to participate in the study. Consenting participants will provide serum samples to assess eligibility for anti-viral therapy: creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelet count, HCV, HIV. Pregnant women eligible for antiviral therapy according to WHO criteria, or who have viral load (VL) >200,000 IU/mL, will be treated with tenofovir starting at 20 weeks gestation through 4 weeks postpartum. Hospital-based delivery will be encouraged. All newborns, including those delivered at home, will receive the HBV birth dose vaccine within 24 hours of delivery, and newborns of women on tenofovir treatment will also receive Hepatitis B Immunoglobulin within 24 hours after delivery. Children will be linked to routine immunization services in Myanmar to complete their HBV vaccination series (HBV is co-formulated in a pentavalent vaccine). Maternal VL will be measured at delivery; infants will be tested for hepatitis B infection at 24-28 weeks postpartum.
Component II -- Household Screening and Treatment The household members of HBsAg positive pregnant women who consent to participate in the study will be screened for HBV-related immune status and chronic HBV infection. Non-immune individuals (HBsAb/Ag negative) will be vaccinated; HBsAg positive household members will be assessed for treatment eligibility and initiated on anti-viral therapy according to World Helath Organization guidelines. Eligible household members will also be screened every six months for hepatocellular carcinoma (HCC) by liver ulatrasound and alpha-fetoprotein levels
Qualitative Study:
In-depth interviews with approximately 30 HBsAg-positive women, 30 HBVsAg-negative women, and 20 household members of study participants will be conducted to assess barriers and facilitators related to HBV testing and treatment. Approximately 15 key-informant interviews with healthcare providers and community leaders will also be conducted. Sample size will depend on data saturation and will be adjusted based on results of data analysis during the study.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Khin Pyone Kyi, MD
- 전화번호: +95 9 250 022 398
- 이메일: pmcthbv2018kpk@gmail.com
연구 연락처 백업
- 이름: Eindra Htoo, MD
- 전화번호: +95 9 975 477 478
- 이메일: eindrahtoo@cpintl.org
연구 장소
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Yangon, 미얀마
- 모병
- BK Kee Clinic
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연락하다:
- Hnin Nandar Htut
- 이메일: nandar@bkkeefoundation.org
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Pregnant women >= 18 years of age
- Gestational age =<34 weeks
- Test positive for HBsAg
- Live in study site area in South Dagon and Dagon Seikkan Townships, Yangon Region
- Give informed consent to participate in the study
- Newborns and household members of pregnant women enrolled in the study according to previous inclusion criteria
Exclusion Criteria:
- Alanine aminotransferase (ALT) levels >300 IU/L
For qualitative study:
Inclusion criteria
- Key informants (e.g., healthcare providers and community leaders in the study area) OR
- HBsAg+ women and their household members in the study area
- HBsAg- women and their household members in the stud area
- Give informed consent to participate in the study
- History of renal dysfunction
- CrCL < 50mL/min
- ALT>5 times the upper limit of normal (ULN)
- Evidence of decompensated cirrhosis (e.g., jaundice, ascites, history of upper gastrointestinal bleeding/esophageal varices, and hepatic encephalopathy)
- Any concomitant condition or treatment that, in view of the clinical site investigator, would contraindicate participation or satisfactory follow-up in the study HIV positive status unless 1) they are currently on additional ART therapy, or 2) their viral load is demonstrated to be <50 copies. Women who are newly diagnosed with HIV and referred to start a TDF-based regimen may be considered eligible once they have started the TDF-based regimen.
- Concurrent participation in any other clinical trial without written agreement of the study team
- Does not intend to deliver within catchment area, and/or intends to migrate before newborn follow-up is complete
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 |
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실험적: Tenofovir Disoproxil Fumerate
Pregnant women (>=20 weeks of gestation) will be treated with TDF if clinically eligible; newborns will receive birth dose vaccine (and HBIG if eligible).
Non-eligible women will be treated according to normal practices; newborns will still receive birth dose vaccine.
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Antenatal screening for HBV, anti-viral treatment with tenofovir according to treatment eligibility criteria, and birth dose vaccination at delivery to prevent mother-to-child transmission of HBV
다른 이름들:
Treated according to normal Myanmar processes for HBV positive patients
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Vaccine within 24 hours
기간: Within 24 hours of birth
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Proportion of newborns of HBsAg positive mothers receiving HBV vaccine within 24 hours of birth
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Within 24 hours of birth
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Effective treatment of pregnant women
기간: During pregnancy (until delivery) of each woman, average of 9 months
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Proportions of pregnant women with chronic HBV (HBsAg positive) who are (a) linked to care (attend BK Kee Clinic for assessment of treatment eligibility); (b) complete TDF eligibility testing; (c) initiate tenofovir treatment (TDF, among those eligible); (d) adhere to TDF treatment until delivery and (e) continue treatment until 4 weeks post-partum o Low/medium/high high medication adherence are defined, respectively, as ≤6, 6-7 or 8 points on the Morisky Medication Adherence Scale (MMAS-8) |
During pregnancy (until delivery) of each woman, average of 9 months
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Household contact screening
기간: Upon identification of participating women, until the end of the project, average of 1 year
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Proportions of adult household contacts who (a) are screened for chronic HBV infection and immunity (HBsAg/Ab); (b) are linked to care (among HBsAg positive) or vaccinated (if HBsAb negative); (c) complete appropriate testing for hepatocellular carcinoma (HCC) screening, (d) eligible for TDF treatment; (e) initiate chronic HBV treatment with TDF
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Upon identification of participating women, until the end of the project, average of 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total screening of mothers
기간: During pregnancy (until delivery) of each woman, average of 9 months
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Proportion of pregnant women in the target population who are:
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During pregnancy (until delivery) of each woman, average of 9 months
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Antenatal care for HBV positive pregnant mothers
기간: During pregnancy (until delivery) of each woman, average of 9 months
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Proportions of pregnant women with chronic HBV who:
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During pregnancy (until delivery) of each woman, average of 9 months
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Vaccination of HBV negative pregnant mothers
기간: During pregnancy (until delivery) of each woman, average of 9 months
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Proportion of women who tested negative for HBsAg and HBsAb at baseline who complete the HBV vaccination schedule
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During pregnancy (until delivery) of each woman, average of 9 months
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Treatment of high viral load pregnant mothers
기간: At delivery; during antenatal care testing; at 4 months postpartum, throughout the project, average of 12 months
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Among women who had VL>200,000 IU/mL at baseline and were eligible for TDF treatment:
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At delivery; during antenatal care testing; at 4 months postpartum, throughout the project, average of 12 months
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Viral suppression
기간: At delivery, throughout the project (one off)
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Associations of maternal viral suppression (VL <200,000 at delivery and: baseline HBV VL, duration of exposure to TDF, and TDF adherence
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At delivery, throughout the project (one off)
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Mother-to-child transmission
기간: At 28 weeks postpartum, throughout the project (one off)
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Proportion of infants born to HBsAg positive mothers who
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At 28 weeks postpartum, throughout the project (one off)
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Household screening
기간: At household screening, throughout the project (one off)
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Among household members screened for HBsAg and HBsAb: o Prevalence of chronic infection (% HBsAg positive); and immune status (% HBsAb positive and HBsAg negative) |
At household screening, throughout the project (one off)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Completed vaccination courses
기간: Before age 1, average of 1 year
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Proportion of infants of HBsAg positive mothers who complete HBV vaccination prior to study termination, before and after coronavirus- and coup- related delays in public vaccination program
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Before age 1, average of 1 year
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Proportion of pregnant women with HBsAg identified by surveillance team members
기간: During pregnancy, average of 9 months
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Proportion of pregnant women with HBsAg identified by surveillance team members
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During pregnancy, average of 9 months
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Timeliness of pregnancy surveillance
기간: During pregnancy, average of 9 months
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Among pregnant women identified by surveillance team members:
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During pregnancy, average of 9 months
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Equity of intervention
기간: During pregnancy and in first year after delivery, average of 16 months
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Distributions of select outcomes according to age, sex and axes of social disadvantage: household wealth; educational attainment; occupation; and ethnic/religious affiliation
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During pregnancy and in first year after delivery, average of 16 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Khin Phone Kyi, MD, Myanmar Liver Foundation
- 수석 연구원: Adam K Richards, MD, University of California, Los Angeles
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HBV2020
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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