Antenatal Multiple Micronutrient Supplementation (MMS) in Indonesia

Not Applicable

Recruiting

• Conditions: Nutrient Deficiency
• Interventions: Behavioral: MMS (180x1) + BCC or expanded BCC; Behavioral: MMS (90x2) + BCC or expanded BCC

• Registration Number: NCT06225791
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

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)

Detailed Description

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.

1. High intensity evaluation areas (8 districts) Evaluation of MMS acceptability, coverage, adherence, feasibility, and fidelity will include data collection from health professionals and pregnant women by study data collectors, and by ANC monitoring activities.

2. Moderate intensity evaluation areas (5 districts) Evaluation of ANC records with aggregate coverage and adherence numbers will be shared with investigators. In addition, data collectors will collect MMS acceptability, feasibility, and fidelity data within 2 of those 5 districts.

3. Low intensity evaluation area (12 districts) Evaluation of ANC records with aggregate coverage and adherence numbers will be shared with investigators. In addition, a household coverage survey will be administered in a subset of districts (n=6) post-intervention to examine MMS acceptability, adherence, coverage, and implementation feasibility and fidelity. The coverage survey will be designed after 6 months of implementation and will be submitted as a separate application to the Johns Hopkins Bloomberg School of Public Health Institutional Review Board, and a separate entry into Clinicaltrials.gov.

Within the 8 high-intensity districts and 5 moderate-intensity districts that are the subject of this Clinicaltrials.gov submission, the study will utilize a three-arm cluster randomized design (with sub-district health center as the unit of randomization).

Study Timeline

• Study First Submitted: 2023-12-19
• Study Start: 2023-12-25
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-17
• Last Update Submitted: 2024-01-17
• Study First Posted: 2024-01-26
• Last Update Posted: 2024-01-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3688

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced MMS delivery with one 180-count bottle	MMS (180x1) + BCC or expanded BCC	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).
Enhanced MMS delivery with two 90-count bottles	MMS (90x2) + BCC or expanded BCC	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).

Primary Outcome Measures

Name	Time	Method
MMS Adherence (frequency)	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)	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).

Secondary Outcome Measures

Name	Time	Method
Fidelity of providing MMS among Health Providers as assessed by focus group discussions	6 months, 12 months	Administration of an observation checklist (sample group 3),measured via focus group discussions at two time points during the study (middle and end)
MMS Acceptability among Pregnant Women	Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks	The proportion of pregnant women (sample group 1 and 2) who agree with domain-specific statements which reflect different aspects of MMS acceptability (MMS packaging, MMS physical properties, MMS side effects, and MMS counseling using The Theoretical Framework of Acceptability uses a 5-point Likert scale where 5 is "strongly agree" and 1 is "strongly disagree". Score range 5-35, a higher score reflects higher acceptability.
MMS Acceptability among Health Providers assessed by focus group discussions	6 months, 12 months	Healthcare provider acceptability of MMS across multiple domains (e.g., feasibility of delivering counseling and packaging, time burden) (sample group 3). Measured via focus group discussions at two time points during the study (middle and end).

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta, Indonesia