Clinical trial NCT06479109: Evaluation of a Behavioral Intervention to Optimize Supplement Adherence in Ethiopia
Official title: Evaluation of Prototype Solutions for Optimizing IFA or MMS Adherence Among Pregnant Women and Adolescent Girls in Ethiopia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Adherence, Patient
Keywords: IFAS adherence
MMS adherence
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2024-06-27
Enrollment: 5096
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 woreda/district-level maternal, newborn, and child health/Maternal Child Health (MCH) coordinator, the Primary Health Care Unit (PHCU) director, midwives/nurses 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 woredas/districts 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women:

  * Between 15 and 49 years of age.
  * Have had at least one ANC visit and received IFAS or MMS in the prior four months.
  * For unmarried 15-18 years of age: agree for her parent/guardian to be contacted.
  * Women in Intervention sites: Have received and used the intervention materials for at least one month.
* Health providers in intervention sites:

  * Provide antenatal care and/or coordinate IFAS/MMS service provision at the clinic or post level.
  * Health volunteers working in health extension services are 19 years or older and actively engaged in the implementation of the intervention

Exclusion Criteria:

* Pregnant women

  * Receiving IFAS supplementation for the treatment of anemia.
  * For unmarried 15-18 years of age: her parent/guardian lives outside the study woreda/district.
  * For Intervention sites: Has not attended ANC visits in the prior 4-6 months and did not receive the intervention materials.
* Health providers in intervention sites:

  * Have worked for less than six months in the health center or the health post at the intervention sites.
  * Health volunteers working in health extension services are younger than 19 years old and not involved in house visits.

Primary outcomes:
measure: Percentage of pregnant women who report consuming five or more [ 80 percent] IFA/MMS tablets in the past week
timeFrame: Baseline, 8 months, 9 months
measure: Percentage of pregnant women who report consuming 24 or more [80 percent] IFA/MMS tablets in the last 30 days [past month]
timeFrame: Baseline, 8 months, 9 months
measure: Percentage of pregnant women who report consuming 90 or more IFA/MMS tablets during the entire pregnancy
timeFrame: Baseline, 8 months, 9 months
measure: Total number of pills provided based on the count of IFAS blister/strips or MMS pills in bottles
timeFrame: Baseline, 8 months, 9 months
measure: Total number of pills consumed based on the count of IFAS blister/strips or MMS pills in bottles
timeFrame: Baseline, 8 months, 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hawassa
country: Ethiopia
facility: Four regions in Ethiopia: South Ethiopia, Central Ethiopia, South-West Ethiopia, Sidama
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Maria-Elena Figueroa, PhD
role: PRINCIPAL_INVESTIGATOR
References: