NCT05777473

Brief Summary

This study will assess the nature and impact of social norms and networks to promote FP (Family Planning) intervention effects among low parity, married adolescent and young women in the Maradi region of Niger. Research activities will be layered on top of the USAID-funded Kulawa FP program that seeks to change FP-related behaviors among young, low parity women at scale in Niger in a subset of implementing villages. Kulawa, implemented by Save the Children U.S. (SCUS) and funded by USAID (2020-2025), will include small-group discussion for young, low parity girls coupled with community dialogues to address individual, social, and health system constraints to FP use and influence social norms that govern FP use. UCSD will not provide any services or implement any interventions as part of this study.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,825

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

4 years

First QC Date

February 22, 2023

Last Update Submit

May 21, 2024

Conditions

Keywords

Contraception BehaviorFemale AdolescentMarriedWest AfricaFamily PlanningContraceptive UseBirth Spacing

Outcome Measures

Primary Outcomes (2)

  • Contraception Use Questionnaire (individual items, not a scale)

    Change in use of effective methods of contraception

    Baseline, 12-month Midline, and 24-month Endline

  • Intentions To Use Contraception Questionnaire (individual items, not a scale)

    Change in behavioral intentions regarding effective contraceptive use

    Baseline, 12-month Midline, and 24-month Endline

Secondary Outcomes (3)

  • Social Norms regarding gender equity Questionnaire (individual items, not a scale)

    Baseline, 12-month Midline, and 24-month Endline

  • Female Empowerment Questionnaire (individual items, not a scale)

    Baseline, 12-month Midline, and 24-month Endline

  • Acceptance of effective contraceptive methods Questionnaire (individual items, not a scale)

    Baseline, 12-month Midline, and 24-month Endline

Study Arms (3)

Kulawa

EXPERIMENTAL

This arm will receive the standard Kulawa intervention. Kulawa is a USAID-funded program that seeks to change FP-related behaviors among young, low parity women at scale in Niger. Kulawa, implemented by Save the Children U.S. aims to increase use of quality FP services of all WRA, including young women ages 15-24 years, in 15 districts of Niger across 3 regions (Tillaberi, Maradi, and Zinder), covering a population of 12.5 million. Kulawa will address individual, social, and health system constraints to FP use through interventions to change behavior and influence social norms that govern FP use and related gender outcomes as well as interventions to improve FP service availability and quality. Kulawa SBC programming at the community-level will include small groups for young, low parity women and girls (ages 15-24) and community dialogues.

Behavioral: Household VisitsBehavioral: Small Groups

Kulawa SN (Tipping Point)

EXPERIMENTAL

This arm will receive the Kulawa intervention, with a social network-informed intervention (KulawaSN) layered on top. In this arm 50% of eligible women will be paired with an alter to receive the adapted intervention. The social network intervention will involve pairing up young married adolescents and women with someone identified as influential in their social networks and enrolling them in the Kulawa FP programming together.

Behavioral: Household VisitsBehavioral: Small GroupsBehavioral: Adopt-a-Friend

Control

NO INTERVENTION

This arm will serve as the control condition. Individuals in these villages will receive neither intervention (including any other FP-relevant SBC program)

Interventions

Household visits will be conducted to build trust in the health system, educate regarding different forms of modern contraception, (how administered, how they work, availability), dispel related myths (i.e., those regarding infertility), promote the health advantages of birth spacing, and create related dialogue among adolescent wives and other household members present during these visits. The community health worker will provide and resupply oral contraceptive pills and condoms to interested participants and will accompany the married adolescent to the nearest health facility for other forms of contraception, if requested to do so. To complement the household visits to married female adolescents, male community health workers will conduct home visits to discuss healthy timing and spacing of pregnancy with husbands of adolescent females, provide education on different forms of contraception, and discuss concerns husbands may have regarding use of contraception.

KulawaKulawa SN (Tipping Point)
Small GroupsBEHAVIORAL

In the wife-only groups, adolescent wives will be convened by trained adult female community members to learn and discuss a broad range of gender and health-related topics, with a focus on modern contraception, and cultivate self-efficacy, social support and life skills. The small groups will be led by trained female small group mentors who are trained peers and will follow a designated curriculum consisting of different topics each week. The husband groups will focus on fostering reflection and dialogue to contribute to more equitable gender norms, support for contraception use for HTSP, positive health seeking behavior for them and their families, and increased couples communication and joint SRH decision-making.

KulawaKulawa SN (Tipping Point)
Adopt-a-FriendBEHAVIORAL

The "Adopt a Friend" approach aims to promote the dissemination and discussion of new information and ideas among peers who are not directly involved in program activities. This involves asking each participant to choose a friend with whom she will share what she learns in home visits and her reflections. Adolescent girls will support each other in seeking sexual and reproductive health information or services if needed.

Kulawa SN (Tipping Point)

Eligibility Criteria

Age15 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For Women:
  • Married
  • years old; or mother-in-law of married adolescent (or replacement MIL)
  • Residing in the village where recruitment is taking place
  • Providing informed consent
  • For Men:
  • Must be the husband to an eligible adolescent participating in the study
  • Providing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center on Gender Equity and Health, University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Three-arm cluster randomized controlled trial (cRCT)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 21, 2023

Study Start

December 1, 2020

Primary Completion

December 1, 2024

Study Completion

May 1, 2025

Last Updated

May 23, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations