NCT07313631

Brief Summary

The objective of this study is to examine the impact of a free health insurance offer on healthcare use, spending, self-reported health, and economic participation of women in Taraba state of Nigeria.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Oct 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Oct 2023Dec 2027

Study Start

First participant enrolled

October 1, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

January 2, 2026

Status Verified

October 1, 2025

Enrollment Period

3.9 years

First QC Date

December 17, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

Health insuranceCare-seeking behaviorHealthcare utilizationNigeria

Outcome Measures

Primary Outcomes (15)

  • Respondent has health insurance

    Zero if not no health insurance, 1 if has health insurance.

    6 months, 9 months, 11 months post treatment.

  • Has health insurance card

    Zero if respondent has no health insurance card, 1 if they have a health insurance card.

    6 months, 9 months, 11 months post treatment

  • Respondent has successfully used health insurance for consultations, diagnoses, medications, or tests.

    Zero if respondent has not successfully used health insurance for consultations, diagnoses, medications, or tests. 1 if the respondent has successfully used health insurance for consultations, diagnoses, medications, or tests.

    6 months, 9 months, 11 months.

  • Sought treatment for most recent illness

    Zero if respondent did not seek care for most recent illness. 1 if respondent did seek care for most recent illness

    6 months, 9 months, 11 months.

  • Number of health facility visits in last 3 months.

    Reported number of health facility visits outside the home in the last 3 months.

    6 months, 9 months, 11 months.

  • Most recent health facility visit was to a public sector facility

    Zero if last care event was in a private facility, 1 if last care seeking event was in a public facility

    6 months, 9 months, 11 months.

  • Money for health care is a key barrier

    Zero if "getting money needed for advice or treatment" is not listed as a barrier. 1 if "getting money needed for advice or treatment" listed as a barrier.

    6 months, 9 months, 11 months.

  • Most recent birth was in a health facility

    Zero if most recent birth was not in a government or private health facility. 1if most recent birth was in a government or private health facility. Limited to births in last 3 months.

    6 months, 9 months, 11 months.

  • Child has received any vaccinations

    Zero if children aged under 12 months has not received any vaccinations. 1 if child has received at least one vaccination.

    6 months, 9 months, 11 months.

  • Total cost of most recent healthcare

    Total cost of most recent healthcare visit, winsorized at the 1% and 99% levels.

    6 months, 9 months, 11 months.

  • Most recent care episode reflects catastrophic health expenditure

    1 if most recent healthcare visit expenditure represents represents greater than 10% of household consumption

    6 months, 9 months, 11 months.

  • Total indebtedness from healthcare or illness-related expenses

    Total amount of money owed for medical expenses, winsorized at the 1% and 99% levels.

    6 months, 9 months, 11 months.

  • Respondent is depressed

    Score equal to or greater than 10 on Center for Epidemiologic Studies Depression Scale.

    6 month, 9 month, 11 month.

  • Perceived health status

    Response to the following question: Think about your health over the last 3 months, including any long-term illnesses, hospital or clinic visits, or other ailments, how would you rate your health on a scale of 1-10 where 1 is very low health and 10 is very healthy with no ailments?

    6 months, 9 months, 11 months.

  • Number of productive days lost to severe illness in the past 3 months

    Reported number of productive days lost to severe illness in the past 3 months

    6 months, 9 months, 11 months

Secondary Outcomes (17)

  • Has ever tried to use health insurance

    6 months, 9 months, 11 months post treatment

  • Number of antenatal care visits

    6 months, 9 months, 11 months.

  • Most recent health facility care event visit was to a secondary/tertiary care facility (hospital)

    6 months, 9 months, 11 months.

  • Received lab test as part of antenatal care in most recent pregnancy

    6 months, 9 months, 11 months.

  • Child has received OPV

    6 months, 9 months, 11 months.

  • +12 more secondary outcomes

Study Arms (2)

Treatment (Health insurance offer)

EXPERIMENTAL

Randomly-selected members of selected Women Affinity Groups (WAGs) randomized to the treatment arm receive an offer for a free, 12-month health insurance policy under the Taraba State Health Insurance Agency's Basic Minimum Package of Health Services (BMPHS), covering essential primary and secondary care (including consultations, preventive services, maternal and child health, emergency care, mental health, and laboratory services).

Other: No-Cost Health Insurance

Control (No insurance offer)

NO INTERVENTION

Members of WAGs randomized to the control arm do not receive the insurance coverage offer during the study period and continued with usual access to care without project-provided coverage.

Interventions

Provision of a free, 12-month insurance policy from the Taraba State Health Insurance Agency that covers the Basic Minimum Package of Health Services (BMPHS), including outpatient and inpatient consultations, preventive and reproductive health services, maternal and child health care, mental health care, emergency services, and laboratory testing.

Treatment (Health insurance offer)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Members of one of 1,000 randomly selected women's groups operating in Bali local government area in Taraba State, Nigeria.

You may not qualify if:

  • At least 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bali LGA

Beli, Taraba State, Nigeria

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The survey enumerators will not blinded to the treatment status.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster-randomized controlled trial at the Women Affinity Group (WAG) level; 1,000 WAGs randomly assigned (stratified by ward and age strata) into treatment or control (500 each), with four women sampled per group (4,000 total participants).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 2, 2026

Study Start

October 1, 2023

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

January 2, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

We will share a de-identified dataset with all collected IPD.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
We will release data two years after each data collection: Round 1: November 2027 Round 2: February 2028 Round 3: April 2028
Access Criteria
The data will be publicly available on the World Bank's microdata website. Use of the dataset must be acknowledged using a citation which would include: 1. the identification of the Principal Investigators, 2. the title of the survey (including country, acronym and year of implementation) 3. the survey reference number 4. the source and date of download

Locations