Integrated Antenatal Screening for HIV, Syphilis, and Hepatitis B Virus (HBV) in Pregnant Women in Burkina Faso and The Gambia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,800
- 试验地点
- 2
- 主要终点
- Coverage of the strategy in the study maternities before its implementation
研究概览
简要总结
The TRI-MOM program aims to implement and evaluate a simplified (based on inexpensive rapid diagnostic tests), integrated (in governmental health facilities) and coordinated (between health care workers) strategy for the triple elimination of HIV, syphilis and HBV mother-to-child transmission (MTCT) in nine maternal and child health services, 5 in Burkina Faso and 5 in The Gambia.
The TRI-MOM program has two components:
- an "intervention" component consisting of a pilot study to reinforce the antenatal screening and prevention of MTCT (PMTCT) capacities for the 3 targeted infections through the implementation of a simplified, integrated and coordinated strategy of triple elimination of MTCT.
- an "evaluation" component which will assess the impact of the TRI-MOM strategy on PMTCT services, reduction of HBV MTCT and women empowerment.
详细描述
The TRI-MOM (TRIple elimination Model Of Mother-to-child transmission of HIV/Syphilis and HBV in Burkina Faso and The Gambia) program aims to implement and evaluate a simplified (based on inexpensive rapid diagnostic tests), integrated (in governmental health facilities) and coordinated (between health care workers) strategy for the triple elimination of HIV, syphilis and HBV MTCT in nine maternal and child health services, 5 in Burkina Faso and 5 in The Gambia. In The Gambia, the program will be conducted in collaboration with the national HIV, sexually transmitted infections (STI) and hepatitis programmes.
The TRI-MOM program has two components:
- an "intervention" component consisting of a pilot study to reinforce the antenatal screening and PMTCT capacities for the 3 targeted infections through the implementation of a simplified, integrated and coordinated strategy of triple elimination of MTCT. This pilot study will be conducted in 9 selected maternities.
- an "evaluation" component which will assess the impact of the TRI-MOM strategy on PMTCT services, reduction of HBV MTCT and women empowerment.
Intervention component :
The TRI-MOM strategy includes 4 main activities:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women attending a postnatal visit in one of the selected maternities (no maternal age limit)
排除标准
- •Refusal to participate in the study
- •Unable to provide consent
研究组 & 干预措施
TRI-MOM
Women attending their first postnatal visit in one of the selected maternities (no maternal age limit) will be eligible to participate in the study
干预措施: TRI-MOM intervention (Other)
结局指标
主要结局
Coverage of the strategy in the study maternities before its implementation
时间窗: Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
Proportion of women screened for HIV, Syphilis and HBV during pregnancy
Coverage of the strategy in the study maternities after its implementation
时间窗: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
Proportion of women screened for HIV, Syphilis and HBV during pregnancy
次要结局
- Sensitivity of the hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) (PROTECT-B ancillary study)(Data collected at cohort inclusion)
- Knowledge of the targeted infections before the strategy implementation(Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy))
- Acceptability of the implemented strategy and PMTCT and preferences : screening refusal after the strategy implementation(Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy))
- Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal before the strategy implementation(Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy))
- Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal after the strategy implementation(Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy))
- Knowledge of the targeted infections after the strategy implementation(Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy))
- Specificity of the HBcrAg-RDT (PROTECT-B ancillary study)(Data collected at cohort inclusion)
- Negative predictive value of the HBcrAg-RDT (PROTECT-B ancillary study)(Data collected at cohort inclusion)
- Acceptability of the implemented strategy and PMTCT and preferences : screening refusal before the strategy implementation(Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy))
- Positive predictive value of the HBcrAg-RDT (PROTECT-B ancillary study)(Data collected at cohort inclusion)