An Evaluation of the Effectiveness of a Maternal, Neonatal and Child Health Component for Matasa Matan Arewa and Smart Start Targeting Married Adolescent Girls in Nigeria and Ethiopia

NCT06680765 | Active Not Recruiting

• 1 other identifier: 1735-2023
• Study Type: interventional
• Target: 2,338
• Locations: 1 country
• Sites: 1

Brief Summary

Evidence on the effectiveness of interventions aimed at creating demand and access to pre-conceptual and antenatal care (ANC) among adolescent girls and young women (AGYW) from sub-Saharan Africa is scarce. A program called Adolescents 360 (A360) led by Population Services International in Nigeria, Ethiopia, Kenya and Tanzania supports adolescent girls to identify contraceptives as a relevant tool for enabling them to pursue their self-defined life aspirations. Avoiding or delaying childbirth is crucial for AGYW to pursue their life goals, but motherhood remains a vital aspiration for many. A360 respects these aspirations and supports AGYW to pursue motherhood when the time comes, safely and aligning with their unique preferences. In 2022, A360 set out to design a maternal, neonatal and child health (MNCH) component that would be layered to the existing sexual and reproductive health interventions in Ethiopia and Nigeria. A360 employed human-centered design (HCD) to design these components. The implementation of these components in real-world settings began in 2023. A360 has designed an evaluation to determine the effectiveness of the MNCH components in improving the AGYW's comprehensive knowledge of what is needed to pursue healthy pregnancies, increase their self-efficacy to access ANC and garner support from their key influencers in the process of pursuing healthy pregnancies. The evaluation's primary objective is to determine the effectiveness of the MNCH components at increasing comprehensive knowledge, self-efficacy and key influencer support to pursue healthy pregnancies among married AGYW in Nigeria and Ethiopia. The secondary objectives are: (a) to evaluate the component's effectiveness at increasing comprehensive knowledge of what care is required to attain healthy pregnancies, (b) to evaluate the component's effectiveness at increasing self-efficacy to attend ANC, (c) to determine the component's efficacy at eliciting support from AGYW's key influencers when they are pursuing healthy pregnancies, and (d) to surface the system-level barriers, facilitators, and opportunities for program improvement during the implementation of the MNCH components. The MNCH components are implemented in Kaduna and Jigawa states in Nigeria and in Oromia, Sidama, Amhara, South and Central regions in Ethiopia. The evaluation is based in the same geographies where the components are implemented. The evaluation uses an implementation-effectiveness hybrid design, blending an outcome evaluation and an implementation science component. The outcome evaluation constitutes of a quantitative survey using a longitudinal approach with two study arms, an intervention, and a comparison arm. It has three assessments: a recruitment phase, and two follow-ups (3 months after recruitment and 8 weeks post-partum (only for pregnant AGYW). Participant recruitment is conducted using recruitment scripts after obtaining oral consent and the administration of a set of screening questions to assess eligibility. Full consenting procedures are executed and written consent obtained prior to involvement in any of the evaluation components. A structured questionnaire is used to gather quantitative data from the survey using a Computer Assisted Personal Interview (CAPI) approach. Furthermore, FGD, IDI and KII facilitation guides are used to gather qualitative data. During this process, all sessions are audio-recorded. Audio records are transcribed verbatim and translated. Data is collected by trained enumerators and qualitative researchers who are certified to conduct human subjects' research. Analysis of quantitative data will follow a repeated measures approach employing generalized estimating equations. The repeated measurements of each subject will be made at two times. Between group t-tests and chi-square tests of comparison will be conducted to identify secondary outcomes which show statistically significant differences between participants in the intervention and comparison arms. The qualitative data transcripts will be rigorously analyzed using NVivo or Dedoose. Open-coding and closed-coding will be utilized to identify themes in the qualitative data. Claim statements attributing change to key intervention drivers will be drawn from narrative stories of program beneficiaries guided by the intervention's theory of change. The evaluation received ethical approvals from Ethiopian Midwives Association (EMwA) Institutional Review Commitee (IRC) and the PSI Research Ethics Board (REB) prior to the enumerators training and field data collection. Subsequently, the ethical approval letters were submitted to the sub-national health departments for their reference and support in the management of the field work.

Conditions

Pre-conceptual Care; Antenatal Care; Postpartum Family Planning; Adolescent Maternal Health

Keywords

Health pregnancies; Antenatal care; Pre-conceptual care; Maternal, neonatal and child health; Post-partum family planning

Outcome Measures

Primary Outcomes (1)

• Comprehensive knowledge of what is needed to pursue a healthy pregnancy

  The proportion of AGYW who have 'comprehensive' knowledge of what is needed at conception to attain a healthy pregnancy. It is estimated as a composite measure derived from a combination of questions assessing AGYW's knowledge about pre-conceptual behaviors (proper nutrition, screening tests and treatment for HIV and sexually transmitted infections, use of prenatal vitamins, and avoidance of harmful substances).

  3 months

Secondary Outcomes (2)

• Pre-conceptual self-efficacy

  3 months

• Satisfaction of the support received from husband during pregnancy

  3 months

Study Arms (2)

Comparison group

ACTIVE COMPARATOR

Smart Smart and MMA are implemented in primary health centres and health posts by community health nurses, health extension workers or midwives. AGYW undergo counselling as individuals or as a group (for Nigeria through life, family and health classes- four sessions with 15-20 girls). Sessions focus on creating relevance of contraceptives as a tool for pursuing life aspirations and as a means to contribute to the household financial security through birth spacing. Girls who opt to voluntarily adopt modern contraceptive methods receive them on spot or at a later date based on their preferences and needs. For Nigeria, sessions are moderated by trained female mentors, while for Ethiopia health extension workers moderate sessions guided by a goal card.

Behavioral: Comparison group

Intervention group

EXPERIMENTAL

Smart Pathways and MMA plus are the MNCH components which are implemented alongside the respective sexual and reproductive health interventions. These interventions target AGYW (15-19 in Nigeria and 15-24 in Ethiopia). These interventions are implemented at primary health centres and health posts. Eligible women are recruited using a targeted mobilization approach by trained mobilisers. In both locations, AGYW go through sessions covering preconceptual care and nutrition, ANC education and services and referral. Intervention components are delivered by trained health providers at the health centres and posts.

Behavioral: Intervention group

Interventions

Intervention group BEHAVIORAL

These are behavioural interventions delivered by trained HEWs or Health providers at primary care facilities (PHCs in Nigeria and Health posts in Ethiopia).

Also known as: Smart Pathways and MMA plus

Intervention group

Comparison group BEHAVIORAL

These are behavioural interventions delivered by trained HEWs or Health providers at primary care facilities (PHCs in Nigeria and Health posts in Ethiopia).

Also known as: Smart Start and MMA

Comparison group

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 15 to 19 (Nigeria) and 15-24 (Ethiopia)
• Married
• Resident in a study geography
• For pregnant AGYW she should be at most 24 weeks gestation
• If not pregnant, AGYW should be at risk of pregnancy (not using a contraceptive method at the time of the survey with or without intend to conceive)

You may not qualify if:

• Married AGYW, aged 15-19 (Nigeria) or 15-24 (Ethiopia) who decline to give consent
• If pregnant, has an advanced pregnancy (≥ 25 weeks' gestation)
• If not pregnant, currently using a contraceptive method

Sponsors & Collaborators

• Population Services International: lead

Study Sites (1)

Population Services International

Nairobi, Kenya

Location

MeSH Terms

Interventions

Methylmalonic Acid

Intervention Hierarchy (Ancestors)

Malonates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research and Learning Lead - A360

Model Details: The study constitutes of an intervention and a comparison group. In Nigeria, the intervention group participants are drawn from the specific LGAs where the MMA program enhanced with the MNCH component is implemented. The comparison group is drawn from LGAs implementing MMA without the MNCH component. The study is conducted in specific PHCs purposely selected to host the evaluation and the catchment areas that are served by the PHCs. In Ethiopia, the study will be implemented in four out of the five regions that implement the Smart Start interventions. The intervention group is drawn from eight (8) woredas in the four regions where Smart Start with Smart pathways is implemented. The comparison group is based in 8 woredas geographically distant from those offering Smart Pathways.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 8, 2024
• Study Start: November 17, 2023
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

KE (1)