Acceptability and Feasibility of IPTp With Dihydroartemisinin-piperaquine With or Without Azithromycin to Prevent Malaria, Sexually Transmitted and Reproductive Tract Infections in HIV-uninfected Pregnant Women (IMPROVE) in Kenya.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Adherence in pregnant women
研究概览
简要总结
This multi-centre study will compare the acceptability, feasibility, cost and incremental cost-effectiveness of intermittent preventive treatment (IPTp) with dihydroartemisinin-piperaquine (DP) with or without azithromycin to the current strategy of IPTp with sulphadoxine-pyrimethamine (SP) to prevent malaria, sexually transmitted and reproductive tract infections in HIV-uninfected pregnant women (IMPROVE).
详细描述
Primary objectives:
- To assess the acceptability, costs and incremental cost-effectiveness of IPTp-DP, with or without AZ, compared to current policy of IPTp-SP in HIV-uninfected pregnant women.
- To assess the feasibility of delivering IPTp-DP with or without a targeted information transfer intervention among HIV-uninfected pregnant women attending ANC in the routine health system i.e. non-trial settings.
Acceptability, costs and incremental cost-effectiveness will be assessed in the context of the IMPROVE clinical trial in Kenya, Malawi and Tanzania (see NCT02909712).
We will also conduct an 'implementation feasibility' study in the routine setting in adjacent sites to the IMPROVE trial site in Kenya (only), using a 3-arm cluster randomized design to assess systems effectiveness, implementation strength, scalability, and identify potential operational hurdles for scale up. Ministry of health nurses providing routine ANC services will be trained to provide IPTp-DP or given refresher training for current policy (IPTp-SP). The interventions will be implemented for a period of 10 months. Approximately 5-6 months after the start of implementation, delivery effectiveness will be assessed through exit interviews with pregnant women leaving ANC clinics. Women who receive the correct doses of the interventions will be followed up at home 4-5 days after their clinic visit (i.e. no more than 2 days after their 3-day regimen finished) and interviewed about adherence, including pill counts. The quantitative study will be supplemented by a qualitative study to explain the quantitative outcomes and to assess perceptions of scalability of the interventions tested.
Feasibility study Interventions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
The feasibility study in the routine setting was not masked, this was a 3-arm study where interventions were delivered by ministry of health staff.
The acceptability study was nested in the clinical trial which was a 3-arm placebo controlled multicentre trial (see NCT02909712) .
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Kenya Government owned health facilities, Level 3 or 4 health facilities
- •Pregnant women attending ANC through non-trial health facilities for a scheduled antenatal care visit in the second or third trimester who receive one of the three study interventions depending on which arm is allocated to that health facility
排除标准
- •Mission or private health facilities, Kenya government owned Level 2 or level 5 health facilities, health facilities included in the trial
- •Pregnant women accessing private health facilities
- •Health facilities, or pregnant women, involved in other malaria or HIV in pregnancy intervention trials or studies.
- •Pregnant women in the first trimester, or pregnant women for who their last visit was less than one month ago
研究组 & 干预措施
IPTp-SP
Arm 1. Standard single-day stat course of quality-assured SP (Fansidar ®) of 3 tablets (500 mg of sulphadoxine and 25 mg of pyrimethamine). SP given monthly
干预措施: Monthly intermittent preventive treatment with sulfadoxine-pyrimethamine (Drug)
IPTp-DP
Arm 2. Standard 3-day course of 3 to 5 tablets (40/320mg) of DP per day based on bodyweight (Eurartesim®, AlfaSigma, Italy). DP given monthly
干预措施: Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine (Drug)
IPTp-DP Plus
Arm 3. Standard 3-day course of 3 to 5 tablets (40/320mg) of DP per day based on bodyweight (Eurartesim®, AlfaSigma, Italy) plus targeted information for health providers.
干预措施: Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transfer (Drug)
结局指标
主要结局
Adherence in pregnant women
时间窗: Assessed 6-10 months after implementation commences
Proportion of pregnant women attending ANC who receive the drug course correctly and who have verified they completed the treatment at home during a home visit.
次要结局
- Effectiveness of service delivery(Assessed 6-10 months after implementation commences)