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临床试验/NCT06225791
NCT06225791已完成不适用

Implementation Research to Accelerate Multiple Micronutrient Supplementation During Pregnancy in Indonesia

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 5,384 人开始时间: 2023年12月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5,384
试验地点
1
主要终点
MMS Adherence (frequency)

研究概览

简要总结

The objective of this research is to understand how antenatal multiple micronutrient supplements (MMS) can be effectively implemented and scaled within the Indonesian national health system context to support improved maternal nutrition and birth outcomes. Formative research has been conducted to design the implementation strategies that will be tested in this second phase of the study. The objectives are to:

  • Examine different MMS delivery strategies (i.e., packaging strategies and behavior change communication (BCC) strategies) in relation to MMS adherence.
  • Assess acceptability, feasibility, fidelity, and coverage of MMS program implementation within antenatal care services (ANC)

详细描述

The study will utilize qualitative and quantitative methods to:

  • Test different MMS delivery strategies (bottle count [90 vs. 180 tablets] and communication strategies [BCC vs. expanded BCC vs. MMS orientation only]) for enhancing supplementation consumption - measured as coverage and adherence.
  • Assess acceptability, feasibility, and fidelity of MMS program implementation within antenatal care services (ANC)

More specifically, the investigators will implement and evaluate different MMS packaging (90 count bottle vs 180-count bottle) strategies and behavior change communication (BCC) strategies. The 3 BCC approaches are further described below.

  • BCC, BCC without Interpersonal Communication (IPC) strategy is a briefer more basic approach that hopes to improve health care providers knowledge about MMS and the providers ability to communicate with pregnant women. This approach will be rolled out by training one district-level facilitator in each district to become a trainer who will be responsible for training health providers in the corresponding study sub-districts.
  • Expanded BCC ('BCC with Interpersonal Communication [IPC]') needs more intensive training of master trainers to train health care providers and focuses more on the counselling skills portion. The BCC without IPC is more feasible to implement within the existing system, the investigators anticipate that the BCC with IPC achieve better behavior change results.
  • MMS Orientation: Women in the control group will receive the existing standard of counselling care. The providers will not be given any sort of training on counselling. Due to the fact that MMS is a new product that the providers will be providing pregnant women, all health care providers will receive a standard MMS orientation so providers are comfortable with the new supplement.

The study will be conducted in 25 districts representing the western, central, and eastern regions of Indonesia, Indonesia's socio-cultural diversity, and varying capacity of ANC systems across districts. After selection, the 25 districts were divided to receive high-intensity (8 districts), moderate-intensity (5 districts), or low-intensity (12 districts) evaluation activities with those exposed to high-intensity evaluation efforts having comprehensive individual-level data collected by study employed data collectors while the low-and moderate-intensity district data collection efforts are being done within the context of the existing health system.

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
All
接受健康志愿者
是

入选标准

  • •for 3,360 pregnant women (PW) enrolled from 8 high-intensity evaluation districts (sample group 1)
  • •Enrolled in ANC 1 through government health facilities.
  • •Received MMS at ANC 1
  • •Gestational age at ANC 1 ≤ 20 weeks (verified by health professionals)
  • •Consent provided to participate in the study.

排除标准

  • •for 3,360 pregnant women (PW) enrolled from 8 high-intensity evaluation districts (sample group 1)
  • •PW with complicated pregnancy complications (e.g., thalassemia, hemochromatosis,)
  • •PW planning to move outside study district during study period.
  • •Inclusion Criteria for 72 PW / recently delivered women participating in in-depth interviews (IDI) only (sample group 2)
  • •Enrolled in ANC 1 through government health facilities.
  • •Received MMS at ANC 1
  • •Gestational age at ANC 1 ≤ 20 weeks (verified by health professionals)
  • •Consent provided to participate in qualitative component of study.
  • •Received MMS for at least 3 months.
  • •Attended > 2 ANC visits.
  • •< 4 weeks post-partum
  • •Exclusion Criteria for 72 PW / recently delivered women participating in in-depth interviews (IDI) only (sample group 2)
  • •Enrolled in Sample 1
  • •Women who are more than 4 weeks postpartum.
  • •Inclusion Criteria for 180 healthcare providers participating in focus group discussions (FGDs) (sample group 3)
  • •Government health workers who provide ANC services (e.g., midwives, general practitioners, and nutritionists)
  • •Government health facility management staff (e.g., Head of Puskesmas Community Health Clinic, Coordinating Midwife, Head of Pharmacy)
  • •Willing to give consent to participate in the FGD.
  • •Exclusion Criteria for 180 healthcare providers participating in FGDs (sample group 3) • Healthcare Providers who have already participated in a FGD will not be eligible to participate in another FGD
  • •Inclusion Criteria for 76 government decision-makers participating in FGD or IDI (sample group 4)
  • •District-, provincial-, or national-level decision-makers working in nutrition, maternal, newborn and child health, or pharmaceutical roles associated with the antenatal care system in Indonesia.
  • •Willing to give consent to participate in the FGD or IDI.
  • •Exclusion Criteria for 76 government decision-makers participating in FGD or IDI (sample group 4)

研究组 & 干预措施

Enhanced MMS delivery with one 180-count bottle

Active Comparator

Pregnant women are provided with one 180-count bottle of MMS along with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 with MMS orientation with expanded BCC). (1 sub-district with each of the 13 districts with high- or moderate-intensity evaluation).

干预措施: MMS (180x1) + BCC or expanded BCC (Behavioral)

Standard MMS delivery with two 90-count bottles

No Intervention

Pregnant women are provided with two 90-count bottles of MMS at two different time points during pregnancy, along with standard MMS delivery strategy (MMS orientation only). (1 sub-district within each of the 13 districts with high- or moderate-intensity evaluation).

Enhanced MMS delivery with two 90-count bottles

Active Comparator

Pregnant women are provided with two 90-count bottles of MMS at two different time points during pregnancy, along with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC). (1 sub-district within each of the 13 districts with high- or moderate-intensity evaluation).

干预措施: MMS (90x2) + BCC or expanded BCC (Behavioral)

结局指标

主要结局

MMS Adherence (frequency)

时间窗: Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks

The frequency of which MMS tablets are consumed by a pregnant woman. (sample group 1)

MMS Adherence (amount)

时间窗: Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks

The number of MMS tablets (from a total possible 180 tablets) a pregnant woman consumes (sample group 1).

次要结局

  • Fidelity of providing MMS among Health Providers as assessed by focus group discussions(6 months, 12 months)
  • MMS Acceptability among Pregnant Women(Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks)
  • MMS Acceptability among Health Providers assessed by focus group discussions(6 months, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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