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Solar Lighting to Reduce Indoor Air Pollution in Rural Uganda

Primary Purpose

Pollution; Exposure, Hypertension, Pollution Related Respiratory Disorder

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Solar lighting system

About this trial

This is an interventional treatment trial for Pollution; Exposure focused on measuring household air pollution, fine particulate matter, kerosene

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Massachusetts General Hospital
Mbarara University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control (usual lighting)

Intervention (solar lighting)

Arm Description

Participants will continue to use their usual lighting sources.

Participants will receive an indoor solar lighting system

Outcomes

Primary Outcome Measures

Fine particulate matter (PM2.5) and Black Carbon

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)

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

Resting blood pressure

Forced Expiratory Volume in one Second (FEV1)

Pre- and Post- bronchodilator spirometry

Heart rate variability

Resting 10 minute heart rate variability

Stool microbiome

Microbial sequencing of the stool will be performed

Qualitative interviews

1:1 qualitative interviews will be performed with participants

Full Information

NCT ID

NCT03351504

First Posted

November 19, 2017

Last Updated

December 5, 2020

Sponsor

Massachusetts General Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03351504

Brief Title

Solar Lighting to Reduce Indoor Air Pollution in Rural Uganda

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

February 7, 2018 (Actual)

Primary Completion Date

October 31, 2019 (Actual)

Study Completion Date

October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pollution; Exposure, Hypertension, Pollution Related Respiratory Disorder

Keywords

household air pollution, fine particulate matter, kerosene

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

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.

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control (usual lighting)

Arm Type

No Intervention

Arm Description

Participants will continue to use their usual lighting sources.

Arm Title

Intervention (solar lighting)

Arm Type

Experimental

Arm Description

Participants will receive an indoor solar lighting system

Intervention Type

Other

Intervention Name(s)

Solar lighting system

Intervention Description

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.

Primary Outcome Measure Information:

Title

Fine particulate matter (PM2.5) and Black Carbon

Description

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

Time Frame

48 hour

Secondary Outcome Measure Information:

Title

Daily use of solar lighting system (hours per day)

Description

A current monitory is installed as part of the solar lighting system that measures the hours per day each light switch is turned on

Time Frame