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| Name | Class |
|---|---|
| Indonesia University | OTHER |
| Hasanuddin University | OTHER |
| Universitas Airlangga | OTHER |
| Vitamin Angels |
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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:
The study will utilize qualitative and quantitative methods to:
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.
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMS (90x2) + BCC or expanded BCC | Behavioral | Provision of 90-count bottles x 2, with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC) |
| Measure | Description | Time Frame |
|---|---|---|
| MMS Adherence (amount) | The number of MMS tablets (from a total possible 180 tablets) a pregnant woman consumes (sample group 1). | Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks |
| MMS Adherence (frequency) | The frequency of which MMS tablets are consumed by a pregnant woman. (sample group 1) | Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MMS Acceptability among Pregnant Women | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of pregnant women being given 180 tablets of MMS | MMS coverage as assessed by the number of pregnant women being given 180 tablets of MMS as compared to the estimated number of pregnant women in the population (e.g., within the 24 study sub-districts) via routine data collection from facility to district health office (aggregate data). | Monthly up to 18 months |
Inclusion Criteria for 3,360 pregnant women (PW) enrolled from 8 high-intensity evaluation districts (sample group 1)
Exclusion Criteria for 3,360 pregnant women (PW) enrolled from 8 high-intensity evaluation districts (sample group 1)
Inclusion Criteria for 72 PW / recently delivered women participating in in-depth interviews (IDI) only (sample group 2)
Exclusion Criteria for 72 PW / recently delivered women participating in in-depth interviews (IDI) only (sample group 2)
Inclusion Criteria for 180 healthcare providers participating in focus group discussions (FGDs) (sample group 3)
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)
Exclusion Criteria for 76 government decision-makers participating in FGD or IDI (sample group 4)
• None
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| Name | Affiliation | Role |
|---|---|---|
| Endang Achadi, PhD | Indonesia University | Principal Investigator |
| Kristin Hurley, PhD, MPH | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Jakarta | Indonesia |
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| UNKNOWN |
MMS will be implemented across 13 districts in Indonesia. In each of the 8 high-intensity evaluation districts and 5 moderate-intensity evaluation districts, 3 study arms/sub-districts have been purposively selected (total n = 24 sub-districts).
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| MMS (180x1) + BCC or expanded BCC | Behavioral | Provision of 180-count bottles x 1, with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC) |
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| Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks |
| MMS Acceptability among Health Providers assessed by focus group discussions | 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). | 6 months, 12 months |
| Fidelity of providing MMS among Health Providers as assessed by focus group discussions | Administration of an observation checklist (sample group 3),measured via focus group discussions at two time points during the study (middle and end) | 6 months, 12 months |
| Number of MMS tablets consumed | MMS adherence as assessed by the number of MMS tablets (from a total of 180 tablets) women who receive MMS are consuming. Routine Data Collection (aggregate data) from facility to district health office. | Monthly up to 18 months |