Pollution; ExposureNCT03351504
Solar Lighting to Reduce Indoor Air Pollution in Rural Uganda
A study testing Solar lighting system in people with Pollution; Exposure and Hypertension, run by Massachusetts General Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pollution; Exposure, Hypertension, Pollution Related Respiratory Disorder
- What is being tested?
- Solar lighting system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Feb 2018to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women living in Nyakabare Parish, Uganda with no prior history of chronic lung disease
Who cannot join
- Current active tuberculosis in any family member
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Solar Lighting Intervention Trial to Reduce Indoor Air Pollution and Improve Adult Respiratory Health in Rural Uganda
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.
Read the 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.
- Being tested
- Solar lighting system
- Keywords
- household air pollution, fine particulate matter, kerosene
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Solar lighting system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fine particulate matter (PM2.5) and Black Carbon
Sampling for PM2.5 and Black Carbon over 48 hours will be collected
Measured: 48 hour
Secondary outcomes (7)
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
Measured: baseline, 3 months, 6 months, 12 months after the intervention
Blood pressure
Resting blood pressure
Measured: baseline, 3 months, 6 months, 12 months after the intervention
Forced Expiratory Volume in one Second (FEV1)
Pre- and Post- bronchodilator spirometry
Measured: baseline, 3 months, 6 months, 12 months after the intervention
Heart rate variability
Resting 10 minute heart rate variability
Measured: baseline, 3 months, 6 months, 12 months after the intervention
Stool microbiome
Microbial sequencing of the stool will be performed
Measured: baseline, 3 months, 6 months, 12 months after the intervention
Qualitative interviews
1:1 qualitative interviews will be performed with participants
Measured: Post-intervention
Respiratory symptoms
Presence/absence of respiratory symptoms based on the American Thoracic Society Respiratory Disease questionnaire
Measured: baseline, 3 months, 6 months, 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start7 Feb 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pollution; ExposureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Peggy S Lai, Massachusetts General Hospital
- Investigators
- Peggy S Lai, MD MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351504
- Sponsor's protocol ID
- 2017P000306/PHS
- Status last verified
- Dec 2020
- First submitted
- 19 Nov 2017
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Apr 17;134(1):75-90. doi: 10.1021/EHP.6c00064. eCollection 2026 May 5.
PubMed 42148043Ponticiello 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.
PubMed 37052216Wallach 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.
PubMed 35225388
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solar Lighting Intervention Trial to Reduce Indoor Air Pollution and Improve Adult Respiratory Health in Rural Uganda
- ClinicalTrials.gov ID
- NCT03351504
- Acronym / sponsor ID
- 2017P000306/PHS
- Keywords
- household air pollution, fine particulate matter, kerosene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Harvard School of Public Health (HSPH)
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (usual lighting) | No intervention | –Participants will continue to use their usual lighting sources. |
| Intervention (solar lighting) | Experimental | Other: Solar lighting systemParticipants will receive an indoor solar lighting system |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women living in Nyakabare Parish, Uganda with no prior history of chronic lung disease
Key exclusion criteria (1 listed)
- Current active tuberculosis in any family member
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solar lighting systemconsisting 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. | Other | Intervention (solar lighting) |
Primary outcome
Fine particulate matter (PM2.5) and Black Carbon
Time frame: 48 hour
Sampling for PM2.5 and Black Carbon over 48 hours will be collected
7 secondary outcomes
Daily use of solar lighting system (hours per day)
Time frame: baseline, 3 months, 6 months, 12 months after the intervention
Blood pressure
Time frame: baseline, 3 months, 6 months, 12 months after the intervention
Forced Expiratory Volume in one Second (FEV1)
Time frame: baseline, 3 months, 6 months, 12 months after the intervention
Heart rate variability
Time frame: baseline, 3 months, 6 months, 12 months after the intervention
Stool microbiome
Time frame: baseline, 3 months, 6 months, 12 months after the intervention
Qualitative interviews
Time frame: Post-intervention
Respiratory symptoms
Time frame: baseline, 3 months, 6 months, 12 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 42148043Huang 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. 2026 Apr 17;134(1):75-90. doi: 10.1021/EHP.6c00064. eCollection 2026 May 5.
- Derived from this study: PubMed 37052216Ponticiello 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.
- Derived from this study: PubMed 35225388Wallach 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peggy S Lai, MD MPH principal investigator
Massachusetts General Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solar lighting system in people with Pollution; Exposure and Hypertension, run by Massachusetts General Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fine particulate matter (PM2.5) and Black Carbon (time frame: 48 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03351504, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.