NCT03351504

Brief Summary

This study evaluates the impact of a solar lighting system on kerosene lamp use, levels of indoor air pollution, and health in women living in rural Uganda. Half of the participants will receive the lighting systems immediately, while the other half will receive them after an 18 month delay.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

November 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 7, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

February 7, 2025

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

November 19, 2017

Last Update Submit

February 4, 2025

Conditions

Pollution; ExposureHypertensionPollution Related Respiratory Disorder

Keywords

household air pollutionfine particulate matterkerosene

Outcome Measures

Primary Outcomes (1)

  • Fine particulate matter (PM2.5) and Black Carbon

    Sampling for PM2.5 and Black Carbon over 48 hours will be collected

    48 hour

Secondary Outcomes (7)

  • Daily use of solar lighting system (hours per day)

    baseline, 3 months, 6 months, 12 months after the intervention

  • Blood pressure

    baseline, 3 months, 6 months, 12 months after the intervention

  • Forced Expiratory Volume in one Second (FEV1)

    baseline, 3 months, 6 months, 12 months after the intervention

  • Heart rate variability

    baseline, 3 months, 6 months, 12 months after the intervention

  • Stool microbiome

    baseline, 3 months, 6 months, 12 months after the intervention

  • +2 more secondary outcomes

Study Arms (2)

Control (usual lighting)

NO INTERVENTION

Participants will continue to use their usual lighting sources.

Intervention (solar lighting)

EXPERIMENTAL

Participants will receive an indoor solar lighting system

Other: Solar lighting system

Interventions

Solar lighting systemOTHER

consisting of a solar panel, rechargeable lead acid battery, charge controller, wiring and switches to 4 lighting points fitted with LED bulbs. This system will include a two-year service warranty.

Intervention (solar lighting)

Eligibility Criteria

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

You may qualify if:

  • Women living in Nyakabare Parish, Uganda with no prior history of chronic lung disease

You may not qualify if:

  • Current active tuberculosis in any family member

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mbarara University of Science and Technology

Mbarara, Uganda

Location

Related Publications (3)

  • Huang CY, Nuwagira E, Tisza M, Kim M, Tayebwa M, Vieira J, Lam N, Wallach E, Wiens M, Tsai AC, Valeri L, Vallarino J, Allen JG, Lai PS. Effect of household air pollution on the gut microbiome and virome of adult women living in Uganda. Environ Health Perspect. 2025 May 21. doi: 10.1289/EHP16002. Online ahead of print.

    PMID: 40397799DERIVED

  • Ponticiello M, Nuwagira E, Tayebwa M, Mugerwa J, Nahabwe H, Nakasita C, Tumuhimbise JB, Lam NL, Wiens MO, Vallarino J, Allen JG, Muyanja D, Tsai AC, Sundararajan R, Lai PS. "If you have light, your heart will be at peace": A qualitative study of household lighting and social integration in southwestern Uganda. J Glob Health. 2023 Apr 14;13:04026. doi: 10.7189/jogh.13.04026.

    PMID: 37052216DERIVED

  • Wallach ES, Lam NL, Nuwagira E, Muyanja D, Tayebwa M, Valeri L, Tsai AC, Vallarino J, Allen JG, Lai PS. Effect of a solar lighting intervention on fuel-based lighting use and exposure to household air pollution in rural Uganda: A randomized controlled trial. Indoor Air. 2022 Feb;32(2):e12986. doi: 10.1111/ina.12986.

    PMID: 35225388DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Peggy S Lai, MD MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Randomization will be performed using dummy codes to represent intervention and control groups by an independent statistician; blinding of the intervention to the participants and field team is not possible, but data analysis will take place prior to unblinding.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 19, 2017

First Posted

November 22, 2017

Study Start

February 7, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2020

Last Updated

February 7, 2025

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)UG(1)