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Household Air Pollution and Health: A Multi-country LPG Intervention Trial

Study acronym: HAPIN
StatusCompleted
PhaseNot applicable
Started2018-05-07
View on ClinicalTrials.gov ↗

Amendment history

2026-09-29
notable
Results posted: 2026-09-28
2026-05-07
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures v27
Secondary endpoints25 to 27 entries
ChangeGestational in MaternalSystolic Blood Pressure ChangeGestational Diastolic Blood Pressure Systolic Blood Pressure in New Mothers Diastolic bloodBlood pressure ChangePressure in New Mothers Diastolic Blood Pressure Among Older Adult Women Brachial artery reactivity testing (BART) Change in Carotid intima-media thickness (CIMT) Among Older Adult Women Change in St. George Respiratory Questionnaire (SGRQ) Score Change in Short Form 36 Survey (SF-36) Score Among Older Adult Women Change in Weight Change in Body Mass Index (BMI) Change in Height Change in Urinary Biomarkers Change in DriedChi [...] [...]
Primary endpoints7 entries, revised
Change in Caregiver Reported Early Childhood Development Instrument (CREDI) Score During Extended Follow-up Change in Child Linear Growth During Extended Follow-up Change in Malawi Developmental Assessment Tool (MDAT) Score Change in Systolic Blood Pressure Among Older Adult Women
Study description-3 characters
[...] interventions have provided cleaner biomass-based cookstoves, but have failed to reduce exposure to levels that produce m [...] 0 pregnant women (aged 18-34 years, 9 - <20 weeks gestation), and will randomly assign half their households to receive L [...] pated to continue to cook primarily with solid biomass fuels, and will receive compensation based on a uniform set of tri [...]
2025-12-04
notable
Active, Not Recruiting→Completed Study Status, Study Description, Outcome Measures, Contacts/Locations, References, Document Section v26
Trial statusActive, Not Recruiting→Completed
Primary completion dateestimated 2026-06-30→confirmed 2025-06-30
Completion dateestimated 2026-06-30→confirmed 2025-06-30
Secondary endpointsdetails revised at 1 of 25 entries
Study description-243 characters
[...] severe pneumonia incidence, and stunting of the child, and systolic blood pressure in the older adult woman. Secondary outcomes include preterm birth and development in the child, maternal blood pressure during pregnancy, and endothelial function, respiratory impairment, atherosclerosis, carcinogenic metabolites, and quality of life in the older adult woman. This study will address the following specific aims: (1) usi [...]
Study sites4 entries, revised
Rwanda Research Site, London School of Hygiene and Tropical Medicine, University of Liverpool
Publications51 to 49 entries
Iribagiza C, Sharpe T, Coyle J, Nkubito P, Piedrahita R, Johnson M, Thomas EA. Evaluating the Effects of Access to Air Quality Data on Household Air Pollution and Exposure-An Interrupted Time Series Experimental Study in Rwanda. Sustainability 2021; 13 (20): 11523. doi:10.3390/su132011523. Iribagiza [...]
2024-11-20
minor
Study Status, Sponsor/Collaborators, Outcome Measures v25
Secondary endpointsdetails revised at 12 of 25 entries
Collaborators18 to 19 entries
University of Liverpool
2024-11-04
minor
Study Status, Document Section v24
Re-verified, no change to tracked fields
Show 23 earlier versions
2024-03-22
minor
Study Status, References v23
Publications23 to 51 entries
Kearns KA, Naeher LP, McCracken JP, Boyd Barr D, Saikawa E, Hengstermann M, Mollinedo E, Panuwet P, Yakimavets V, Lee GE, Thompson LM. Estimating personal exposures to household air pollution and plastic garbage burning among adolescent girls in Jalapa, Guatemala. Chemosphere. 2024 Jan;348:140705. d [...]
2024-03-13
minor
Study Status, Document Section v22
Re-verified, no change to tracked fields
2024-02-13
minor
Study Status, Study Description, Outcome Measures v21
Secondary endpointsdetails revised at 2 of 25 entries
Study description+4 characters
[...] ining HAP interventions globally. The intervention delivery occursoccurred whenuntil the child iswas one year of age. The researchers will continue to follow pa [...]
2023-04-13
minor
Study Status, Study Description, Outcome Measures v20
Primary completion date2023-06-30→2026-06-30
Completion date2023-06-30→2026-06-30
Secondary endpoints16 to 25 entries
Change in Maternal Blood Pressure Change in Diastolic blood pressure DifferencesFetal inGrowth WHO fetalNon-severe growthPneumonia WHO outcomesSevere betweenPneumonia WHO interventionPocket andBook controlNon-severe Pneumonia WHO Pocket Book Severe Pneumonia Hypoxemic Pneumonia Ultrasound or Radiograph Pneumonia Change in child development Brachial artery reactivity testing (BART) Change in Carotid intima-media thickness (CIMT) AdultChange respiratoryin healthSt. andGeorge well-beingRespiratory Questionnaire (SGRQ) Score AdultChange Quality of Life:in Short Form 36 surveySurvey and(SF-36) Euro [...] [...]
Primary endpoints4 to 7 entries
Change in Caregiver Reported Early Childhood Development Instrument (CREDI) Score Change in Child Linear Growth Change in Malawi Developmental Assessment Tool (MDAT) Score Change in Systolic Blood Pressure Incidence of HAPIN Defined Severe Pneumonia Systolic blood pressure
Study description+974 characters
[...] ts for initiating and sustaining HAP interventions globally. The intervention delivery occurs when the child is one year of age. The researchers will continue to follow participants in India, Guatemala and Rwanda until the child is 5 years old to assess the longer-term effects of the intervention. Previous evidence suggests that the benefits of reduced expos [...]
2022-10-28
minor
Study Status v19
Start date2018-04-16→2017-09-01
2022-09-26
minor
Study Status, Document Section v18
Re-verified, no change to tracked fields
2022-08-31
minor
Study Status, Sponsor/Collaborators, Outcome Measures, Document Section v17
Primary completion date2021-10-01→2023-06-30
Completion date2022-08-31→2023-06-30
Secondary endpoints15 to 16 entries
Change in neuro-development
Collaborators19 to 18 entries
Global Alliance for Clean Cookstoves
2022-06-23
minor
Study Status, Document Section v16
Re-verified, no change to tracked fields
2022-05-22
minor
Study Status, Outcome Measures, Document Section v15
Completion date2022-06-30→2022-08-31
Secondary endpoints10 to 15 entries
ChangeDifferences in fetal growth outcomes between intervention and control Adult Quality of Life: Short Form 36 survey and EuroQOL-5D survey SevereWHO severe pneumonia WHO non-severe pneumonia Hospitalization for respiratory illness Diastolic blood pressure Mean arterial pressure Pulse pressure
Primary endpoints4 entries, revised
Blood pressure Length-for-age z-score 2 standard deviations below the standard Systolic blood pressure
2022-03-31
minor
Study Status, Document Section v14
Re-verified, no change to tracked fields
2021-11-01
minor
Study Status, Outcome Measures, IPDSharing, Document Section v13
Primary completion dateestimated 2021-09→confirmed 2021-10-01
Completion date2021-09→2022-06-30
Secondary endpoints9 to 10 entries
WHOGestational severeage at birth Severe pneumonia
2021-07-20
minor
Study Status, Outcome Measures v12
Primary completion date2021-08→2021-09
Completion date2021-08→2021-09
2020-04-27
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Outcome Measures, Contacts/Locations v11
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 7200→confirmed 3640
Secondary endpoints9 entries, revised
WHO Severesevere Pneumoniapneumonia
Primary endpoints4 entries, revised
Incidence of HAPIN Severe Pneumonia
Study sitesdetails revised at 4 of 4 sites
2020-01-30
minor
Study Status, Outcome Measures, Contacts/Locations v10
Secondary endpointsdetails revised at 1 of 9 entries
Study sites4 entries, revised
Sri Ramachandra UniversityInstitute of Higher Education and Research
2019-05-02
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility v9
Eligibility criteria+73 characters
Inclusion Criteria for Pregnant Women: Confirmed pregnancy (hCG positive blood or urine test) Aged 18 to 34<35 years old (via self-report) Uses biomass stove predominantly Lives in study area 9 - <20 weeks gestation confirmed by ultrasound Singleton pr [...] (one fetus) Viable fetus with normal fetal heart rate (120- 160180 beats per minute) at time of ultrasound LivesContinued inpregnancy studyat areathe time of randomization confirmed by self-report Uses biomass stove predominantly Agrees to participate with informed consent Exclusion Criter [...] riteria for Older Adult Woman in the Same Household: Aged [...]
Secondary endpoints8 to 9 entries
Change in gross motorchild development QualityWHO ofSevere lifePneumonia Short Form 36 survey
Study description+150 characters
[...] eholds to receive LPG stoves and an 18-month supply of LPG. ControlsControl households are anticipated to continue to cook primarily with solid biomass fuels, and will receive thecompensation samebased cookstoveson anda LPGuniform supply at the endset of thetrial-wide studyprinciples, customized to each site based on formative research. The mother will be followed along with her child until the [...] holds with a second, non-pregnant older adult woman (aged 40-79 to <80 years) the researchers will also enroll and follow her duri [...] ple time points. The primary outcomes are low birth weight, severe pneumo [...] [...]
Collaborators17 to 19 entries
Eagle Research Center University of Oxford
2018-04-19
minor
Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility v8
Eligibility criteria+290 characters
Inclusion Criteria for Pregnant Women: AgeConfirmed ofpregnancy (hCG positive blood or urine test) Aged 18 to 34 years old (via self-report) 9 - <20 weeks gestation confirmed by ultrasound Singleton pregnancy (one fetus) NoViable fetus with normal fetal anomaliesheart identifiedrate during(120 first- 160 beats per minute) at time of ultrasound UseLives in study area Uses biomass stove predominantly Not currently a smoker No plans to move out of her current household in next 30 months Agrees to participate with informed consent Exclusion Criteria for Pregnant Women: LivesCurrently smokes cigare [...] [...]
Secondary endpointsdetails revised at 5 of 8 entries
Study description+4 characters
[...] tion site will recruit 800 pregnant women (aged 18-34 years, 9 - <20 weeks gestation), and will randomly assign half their households to receive LPG stoves and aan 3018-month supply of LPG. Controls will receive the same cooksto [...] er will be followed along with her child until the child is 21 yearsyear old. In households with a second, non-pregnant older adult woman (aged 3540-6479 years) the researchers will also enroll and follow her during the 3018-month follow-up period in order to assess cardiopulmonary, [...]
Collaborators17 entries, revised
PartnersUniversity inof HealthRwanda
2018-04-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-03→confirmed 2018-04-16
Study sitesdetails revised at 4 of 4 sites
2018-03-05
minor
Study Status v6
Start date2018-01→2018-03
2017-10-09
minor
Study Status v5
Start date2017-09→2018-01
2017-06-14
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v4
Study sites4 entries, revised
JohnsPuno HopkinsGlobal Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University Rwanda Research Site, London School of Hygiene and Tropical Medicine
Collaborators2 to 17 entries
Bill and Melinda Gates Foundation Berkeley Air Monitoring Group Colorado State University Global Alliance for Clean Cookstoves Global LPG Partnership Harvard University Johns Hopkins University London School of Hygiene and Tropical Medicine Partners in Health Asociacion Benefica Prisma Sri Ramachand [...]
2017-04-28
minor
Study Status, Oversight, Study Design, Contacts/Locations, IPDSharing v3
Study sitesdetails revised at 1 of 4 sites
2016-11-30
minor
2 amendments v1-v2
2 re-verifications since 2016-10-27, no change to tracked fields
2016-10-24
minor
Original filing
This study is a randomized controlled trial of liquefied petroleum gas (LPG) stove and fuel distribution in 3,200 households in four countries (India, Guatemala, Peru, and Rwanda). Following a common protocol, each intervention site will recruit 800 pregnant women (aged 18-34 years, 9 - \<20 weeks gestation) and will randomly assign half their households to receive LPG stoves and an 18-month supply of LPG. Control households are anticipated to continue to cook primarily with solid biomass fuels and will receive compensation based on a uniform set of trial-wide principles, customized to each site based on formative research. The mother will be followed along with her child until the child is 1 year old. The researchers estimate that 15% of households will have a second, non-pregnant older adult woman (aged 40 to \<80 years) who will also be enrolled at baseline and followed during the 18-month follow-up period. To optimize intervention use, the researchers will implement behavior change strategies informed by previous experiences and formative research in Year 1. This study will assess cookstove use, conduct repeated personal exposure assessments of household air pollution, and collect dried blood spots and urinary samples for biomarker analysis and biospecimen storage. The primary outcomes are low birth weight, severe pneumonia incidence, and stunting of the child, and systolic blood pressure in the older adult woman. Participants in India, Guatemala and Rwanda will be followed until the child is 5 years old to assess the longer-term effects of the intervention.
Trial Details
NCT Number NCT02944682
Lead Sponsor Emory University
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Bill and Melinda Gates Foundation, Berkeley Air Monitoring Group, Colorado State University, Global LPG Partnership, Harvard University, Johns Hopkins University, London School of Hygiene and Tropical Medicine, Asociacion Benefica Prisma, Sri Ramachandra University, Universidad del Valle, Guatemala, Universidad Peruana Cayetano Heredia, University of Georgia, Washington University School of Medicine, University of Rwanda, Eagle Research Center, University of Oxford, University of Liverpool
Conditions Infant, Low Birth Weight
Enrollment 6,704 participants
Start Date 2018-05-07
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-28