Solar Lighting to Reduce Indoor Air Pollution in Rural Uganda

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03351504

Collaborator

Mbarara University of Science and Technology (Other), Harvard School of Public Health (HSPH) (Other)

Enrollment

Locations

Arms

32.8

Actual Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pollution; Exposure Hypertension Pollution Related Respiratory Disorder	Other: Solar lighting system	N/A

Detailed Description

One fifth of the global population relies on kerosene lamps for lighting, yet few studies have focused on kerosene lighting as a source of indoor air pollution. In our preliminary studies performed in Uganda, we show that homes using solar lighting have much lower levels of indoor air pollution compared to homes using kerosene lighting. The primary goal of this study is to determine the extent to which solar lighting will reduce kerosene use and indoor air pollution in rural Uganda, whether this intervention improves lung health, and to identify the role bacteria in our gut have on determining whether or not people will get sick from indoor air pollution.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Solar Lighting Intervention Trial to Reduce Indoor Air Pollution and Improve Adult Respiratory Health in Rural Uganda

Actual Study Start Date :

Feb 7, 2018

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Oct 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control (usual lighting) Participants will continue to use their usual lighting sources.
Experimental: Intervention (solar lighting) Participants will receive an indoor solar lighting system	Other: Solar lighting system 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.

Arm

Intervention/Treatment

No Intervention: Control (usual lighting)

Participants will continue to use their usual lighting sources.

Experimental: Intervention (solar lighting)

Participants will receive an indoor solar lighting system

Other: Solar lighting system

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.

Outcome Measures

Primary Outcome Measures

Fine particulate matter (PM2.5) and Black Carbon [48 hour]
Sampling for PM2.5 and Black Carbon over 48 hours will be collected

Secondary Outcome Measures

Daily use of solar lighting system (hours per day) [baseline, 3 months, 6 months, 12 months after the intervention]
A current monitory is installed as part of the solar lighting system that measures the hours per day each light switch is turned on
Blood pressure [baseline, 3 months, 6 months, 12 months after the intervention]
Resting blood pressure
Forced Expiratory Volume in one Second (FEV1) [baseline, 3 months, 6 months, 12 months after the intervention]
Pre- and Post- bronchodilator spirometry
Heart rate variability [baseline, 3 months, 6 months, 12 months after the intervention]
Resting 10 minute heart rate variability
Stool microbiome [baseline, 3 months, 6 months, 12 months after the intervention]
Microbial sequencing of the stool will be performed
Qualitative interviews [Post-intervention]
1:1 qualitative interviews will be performed with participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Current active tuberculosis in any family member

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Mbarara University of Science and Technology	Mbarara		Uganda

Sponsors and Collaborators

Massachusetts General Hospital
Mbarara University of Science and Technology
Harvard School of Public Health (HSPH)

Investigators

Principal Investigator: Peggy S Lai, MD MPH, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peggy S Lai, Assistant Professor, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT03351504

Other Study ID Numbers:

2017P000306/PHS

First Posted:

Nov 22, 2017

Last Update Posted:

Dec 9, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peggy S Lai, Assistant Professor, Massachusetts General Hospital

household air pollution

fine particulate matter

kerosene

Additional relevant MeSH terms:

Respiration Disorders

Respiratory Tract Diseases

Study Results

No Results Posted as of Dec 9, 2020