Increasing Retention-in-care of HIV Positive Women in PMTCT Services Through Continuous Quality Improvement -Break Through Series in Primary & Secondary Health Care Facilities in Nigeria: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 491
- 试验地点
- 2
- 主要终点
- Proportion of HIV+ pregnant women in care 6 months postpartum
研究概览
简要总结
This study aims to address the research question: Will continuous quality improvement, using a Break Through Series approach, increase uptake of PMTCT services and retention-in-care of HIV-infected pregnant women and mothers at six and 12 months postpartum?
Continuous Quality Improvement (CQI) is a health systems intervention to assist programs to systematically improve services and health outcomes. The Break Through Series (BTS) is a specific CQI approach is a short-term (6- to 15-month) learning system that brings together teams from several hospitals or clinics ("collaboratives") to seek improvement in a focused topic area through a common process of data sharing and review Primary Objective To assess whether retention-in-care of HIV-infected women at six (6) months postpartum is higher at health facilities implementing CQI-BTS approaches than at health facilities not implementing CQI-BTS approaches.
Secondary Objectives
To assess whether implementation of CQI-BTS initiatives at health facilities increases:
- Uptake of PMTCT services by HIV-infected pregnant women;
- Retention-in-care of HIV-infected women at twelve (12) months postpartum;
- Retention-in-care of HIV-exposed babies at six (6) and twelve (12) months of age;
- Uptake of a pre-defined, minimum set of integrated RH/PMTCT services by HIV-infected women in health facilities.
详细描述
Methods/ Study design/ Population/ Interventions Study Design: A cluster randomized controlled trial in which 32 public primary and secondary health care facilities are randomized into 16 intervention and 16 control sites. The control sites will receive routine CIHP support, while the intervention sites will receive structured CQI-BTS interventions.
Study sites Based on pre-set site selection criteria, 32 sites were selected from a total of 241 eligible sites supported by the Centre for Integrated Healthcare Programs (CIHP), to provide comprehensive HIV care and treatment programs. These sites are at higher levels of standardized care compared to Government of Nigeria sites where there is minimal standardization of care. The following criteria were used to select health facilities for the study;
- Facility supports ANC/PMTCT services and has capacity to provide ART until 12-18 months post-partum
- Onsite delivery of HIV+ women by the facility
- Provision of postpartum care follow-up for HIV+ women
- ANC attendance with at least 2 HIV+ women per month for general hospitals and at least 1 per month for primary health care (PHCs)
- Availability of, at least, two trained community health extension workers
- Facilities providing PMTCT services for more than six months prior to onset of study
Study Participants:
Participants are HIV-infected pregnant women presenting at study sites for 1st booking at antenatal clinics with gestational age of 34 weeks or less, ART naive, accept ARV and agree to remain in care for at least six months post-partum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •They must be pregnant women newly diagnosed for HIV during ANC
- •Clients must present with gestational age of 34weeks or less at ANC enrollment
- •They must accept in principle to take ARVs and remain in care.
- •They must be willing to participate until at least six months postpartum
- •Must be domiciled in the facility coverage area.
- •Previously diagnosed HIV positive pregnant women yet to start ART
排除标准
- •Clients requesting fee/remuneration for participation
- •Positive women already on ART.
- •Unbooked HIV positive pregnant woman coming in labour.
- •Positive pregnant women with gestational age more than 34 weeks.
结局指标
主要结局
Proportion of HIV+ pregnant women in care 6 months postpartum
时间窗: Six months post partum
Denominator= Total number of HIV + pregnant women enrolled to participate in the study Numerator= Total number of HIV + pregnant women retained at six months postpartum
次要结局
- Proportion of HIV exposed infants with Dry Blood Spot (DBS) samples taken at 6-8 months of life(2 months post delivery of exposed infant)
研究者
DR BOLA OYELEDUN
Chief Executive Officer
Centre for Integrated Health Programs, Nigeria