NCT05668624

Brief Summary

Investigators will conduct a randomized controlled trial substituting traditional forms of household energy (biomass for cooking and kerosene for lighting) with liquified petroleum gas (LPG) stoves/fuel and solar power (in areas marker for solar grids by the Government of Rwanda) in rural Rwanda. Eligible households (n=650) using traditional forms of energy will be recruited from eastern Rwanda. In each household, investigators will recruit either one adult female and one adult male or just one adult, and one child (aged 8-15 years). Following baseline health and exposure assessment, a randomized treatment arm (n=250 homes) will receive a full subsidy for LPG fuel and solar power, a control arm (n=250 homes) will continue to use traditional energy, and a random-subsidy arm (n=150 homes) will be randomized to a discounted price (at baseline and every 6-months) for solar and LPG in a pay-as-you-go (PAYG) service model (i.e., pre-pay a desired amount through mobile money). The random subsidy arm will then decide whether or not to cook with the discounted LPG or their traditional stove. Participants will be followed for 3 years with repeated measures of household air pollution (HAP) exposure (48-hour fine particulate matter (PM2.5) and black carbon (BC)), energy use, health, and preferences. Primary health endpoints include blood pressure (BP) in adults and lung-function growth in children; secondary endpoints include BP in children and lung-function change in adults. To complement the trial, the random-subsidy arm will generate policy-relevant information on causal relationships between energy costs, solar and LPG usage, and HAP exposures. The investigators propose 3 aims: Aim 1. In an ITT framework, investigators will evaluate the effect of a household energy intervention on exposure to HAP and indicators of morbidity separately among Rwandan women, men, and children within n=500 households. Aim 2. Using exposure-response modeling, investigators will characterize associations between exposure to HAP and indicators of morbidity separately among Rwandan women, men, and children within n=650 households (500 trial households + 150 random subsidy households). Aim 3. Using a random-encouragement design, investigators will investigate causal relationships between randomized energy costs, measured energy usage, and estimated exposure to HAP among n=400 households (150 random subsidy households + 250 full subsidy treatment arm households).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,680

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 17, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

December 7, 2022

Last Update Submit

January 14, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in systolic blood pressure (adults)

    Blood pressure will be measured approx. every 6 months for the 3-year follow-up period

  • Spirometry (children): FEV1 trajectory

    Spirometry will be measured approx. every 6 months for the 3-year follow-up period

  • Spirometry (children): FVC trajectory

    Spirometry will be measured approx. every 6 months for the 3-year follow-up period

Secondary Outcomes (11)

  • Change in systolic blood pressure (children)

    Blood pressure will be measured approx. every 6 months for the 3-year follow-up period

  • Change in diastolic blood pressure (children)

    Blood pressure will be measured approx. every 6 months for the 3-year follow-up period

  • Spirometry (children): FEV1/FVC trajectory

    Spirometry will be measured approx. every 6 months for the 3-year follow-up period

  • Spirometry (children): FEF25-75 trajectory

    Spirometry will be measured approx. every 6 months for the 3-year follow-up period

  • Spirometry (children): PEF trajectory

    Spirometry will be measured approx. every 6 months for the 3-year follow-up period

  • +6 more secondary outcomes

Study Arms (3)

Full Subsidy Arm

EXPERIMENTAL

This arm receives free LPG and stove for cooking following the baseline measures, for the duration of the 3-year follow-up period. For those households in Government of Rwanda designated areas for solar microgrids, this arm will also be connected to and provided free access to solar electricity for lighting.

Other: Clean household energy

Control Arm

NO INTERVENTION

This arm will remain using traditional forms of energy for cooking and lighting.

Discount Subsidy Arm

EXPERIMENTAL

This arm will be randomized to a discounted price (at baseline and every 6-months during the 3-year study) for solar electricity (in areas marker for solar grids by the Government of Rwanda) and LPG gas in a pay-as-you-go (PAYG) service model (i.e., pre-pay an affordable amount through mobile money, a common form of currency transactions in Rwanda). For example, this arm will be asked to cook as normal and decide whether or not to cook with the discounted LPG or their traditional stove (i.e., they will not be required to pay for LPG).

Other: Clean household energy

Interventions

LPG stoves/fuel for cooking and solar electricity for lighting

Discount Subsidy ArmFull Subsidy Arm

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • This research will recruit and enroll 650 households (250 households in the full subsidy arm; 250 households in the control arm; 150 households in the discount subsidy arm).
  • Home resides in the study area of Isangano and Karambi
  • Uses biomass as primary cooking fuel
  • Either both an adult male (at least 18 years old) and female (at least 18 years old), or just one adult (at least 18 years old), head(s) of household willing to consent and at least one child between 8 and 15 years of age willing to assent; We will recruit the younger child in families with more than one child between 8-15 years of age. We will also confirm the child is living at home throughout the year and not attending boarding school elsewhere.
  • No commercial cooking
  • No smoking in the household
  • Not planning to move in 3-year timeframe
  • Not currently pregnant (females); Note: If the female becomes pregnant during the study she will not be able to participate in any visits that occur during her pregnancy but she will be able to participate after she has given birth. However, if there is another adult in the household then this will not preclude the other two people (i.e., the other adult and the child) from continuing to participate throughout that time.

You may not qualify if:

  • Home resides outside the study area
  • Uses clean fuel as primary cooking fuel
  • Participants outside the age ranges: Adult male (at least 18 years old) and female (at least 18 years old) heads of household willing to consent and at least one child between 8 and 15 years of age willing to assent
  • Conducts commercial cooking
  • Smoking members of the household
  • Planning to move in 3-year timeframe
  • Currently pregnant (females)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Field site in Rwanda (Isangano and Karambi)

Ndego, Eastern Province, 80521, Rwanda

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 30, 2022

Study Start

November 17, 2022

Primary Completion

August 22, 2025

Study Completion

August 22, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations