Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479109
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
Evaluation of a Behavioral Intervention to Optimize Supplement Adherence in Ethiopia
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Evaluation of Prototype Solutions for Optimizing IFA or MMS Adherence Among Pregnant Women and Adolescent Girls in Ethiopia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial aims to learn if a set of behavioral materials designed to be used by providers and pregnant women increases supplement adherence among pregnant women in Ethiopia The main questions the study aims to answer are
Do the behavioral materials increase adherence to iron and folic acid supplements IFAS or multiple micronutrient supplements MMS among women attending antenatal care visits
Are the materials relevant easy to use acceptable and scalable During the analysis researchers will compare supplement adherence between women exposed to the behavioral materials and women not exposed to the behavioral materials Researchers will also compare supplement adherence before and after the behavioral intervention ensuring a comprehensive evaluation
Participants will include providers in intervention clinics and pregnant women attending intervention and control clinics for antenatal care ANC
A total of 28 clinics will receive the behavioral intervention and another 28 will serve as controls providing the standard antenatal care counseling
Pregnant women attending intervention clinics for ANC will receive behavioral materials to use at home as a reminder to take ther supplements IFAS or MMS
Pregnant women attending control clinics will receive the standard ANC counseling
Do the behavioral materials increase adherence to iron and folic acid supplements IFAS or multiple micronutrient supplements MMS among women attending antenatal care visits
Are the materials relevant easy to use acceptable and scalable During the analysis researchers will compare supplement adherence between women exposed to the behavioral materials and women not exposed to the behavioral materials Researchers will also compare supplement adherence before and after the behavioral intervention ensuring a comprehensive evaluation
Participants will include providers in intervention clinics and pregnant women attending intervention and control clinics for antenatal care ANC
A total of 28 clinics will receive the behavioral intervention and another 28 will serve as controls providing the standard antenatal care counseling
Pregnant women attending intervention clinics for ANC will receive behavioral materials to use at home as a reminder to take ther supplements IFAS or MMS
Pregnant women attending control clinics will receive the standard ANC counseling
Detailed Description:
The design to meet the study objectives is as follows
1 A cross-section baseline and endline design with a nonequivalent control group will be used to assess the effect of the behavioral intervention materials for pregnant women and ANC providers Pregnant women in intervention and control sites will be interviewed using a structured questionnaire to assess adherence to IFAS or MMS These women will be interviewed before the start of the intervention at the selected clinics baseline Four to six months 4-6mo after the intervention another sample of women who attended ANC visits and received IFAS or MMS will be invited for an interview endline
2 Key informant interviews KIIs with service providers will be used to explore the relevance usability acceptability scalability and other factors related to the intervention Interviews will be conducted with the woredadistrict-level maternal newborn and child healthMaternal Child Health MCH coordinator the Primary Health Care Unit PHCU director midwivesnurses from health clinics and Health Extension Workers HEWs and Health Development Army volunteers from health posts
3 In-depth interviews IDIs with pregnant women who received the intervention will be conducted to learn about the experiences with the materials
The study will be implemented in sixteen districts woredas within four regions of Ethiopia - South Ethiopia Central Ethiopia South-West Ethiopia and Sidama four woredasdistricts in each region Per the direction of the Ministry of Health two regions South-West and Sidama will continue to receive the standard of care IFAS and the other two will receive MMS
1 A cross-section baseline and endline design with a nonequivalent control group will be used to assess the effect of the behavioral intervention materials for pregnant women and ANC providers Pregnant women in intervention and control sites will be interviewed using a structured questionnaire to assess adherence to IFAS or MMS These women will be interviewed before the start of the intervention at the selected clinics baseline Four to six months 4-6mo after the intervention another sample of women who attended ANC visits and received IFAS or MMS will be invited for an interview endline
2 Key informant interviews KIIs with service providers will be used to explore the relevance usability acceptability scalability and other factors related to the intervention Interviews will be conducted with the woredadistrict-level maternal newborn and child healthMaternal Child Health MCH coordinator the Primary Health Care Unit PHCU director midwivesnurses from health clinics and Health Extension Workers HEWs and Health Development Army volunteers from health posts
3 In-depth interviews IDIs with pregnant women who received the intervention will be conducted to learn about the experiences with the materials
The study will be implemented in sixteen districts woredas within four regions of Ethiopia - South Ethiopia Central Ethiopia South-West Ethiopia and Sidama four woredasdistricts in each region Per the direction of the Ministry of Health two regions South-West and Sidama will continue to receive the standard of care IFAS and the other two will receive MMS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None