Using time-resolved monitor wearing data to study the effect of clean cooking interventions on personal air pollution exposures.

BACKGROUND: Personal monitoring can estimate individuals' exposures to environmental pollutants; however, accuracy depends on consistent monitor wearing, which is under evaluated. OBJECTIVE: To study the association between device wearing and personal air pollution exposure. METHODS: Using personal device accelerometry data collected in the context of a randomized cooking intervention in Ghana with three study arms (control, improved biomass, and liquified petroleum gas (LPG) arms; N = 1414), we account for device wearing to infer parameters of PM2.5 and CO exposure. RESULTS: Device wearing was positively associated with exposure in the control and improved biomass arms, but weakly in the LPG arm. Inferred community-level air pollution was similar across study arms (~45 µg/m3). The estimated direct contribution of individuals' cooking to PM2.5 exposure was 64 µg/m3 for the control arm, 74 µg/m3 for improved biomass, and 6 µg/m3 for LPG. Arm-specific average PM2.5 exposure at near-maximum wearing was significantly lower in the LPG arm as compared to the improved biomass and control arms. Analysis of personal CO exposure mirrored PM2.5 results. CONCLUSIONS: Personal monitor wearing was positively associated with average air pollution exposure, emphasizing the importance of high device wearing during monitoring periods and directly assessing device wearing for each deployment. SIGNIFICANCE: We demonstrate that personal monitor wearing data can be used to refine exposure estimates and infer unobserved parameters related to the timing and source of environmental exposures. IMPACT STATEMENTS: In a cookstove trial among pregnant women, time-resolved personal air pollution device wearing data were used to refine exposure estimates and infer unobserved exposure parameters, including community-level air pollution, the direct contribution of cooking to personal exposure, and the effect of clean cooking interventions on personal exposure. For example, in the control arm, while average 48 h personal PM2.5 exposure was 77 µg/m3, average predicted exposure at near-maximum daytime device wearing was 108 µg/m3 and 48 µg/m3 at zero daytime device wearing. Wearing-corrected average 48 h personal PM2.5 exposures were 50% lower in the LPG arm than the control and improved biomass and inferred direct cooking contributions to personal PM2.5 from LPG were 90% lower than the other arms. Our recommendation is that studies assessing personal exposures should examine the direct association between device wearing and estimated mean personal exposure.

Immunogenicity and safety of the RTS,S/AS01 malaria vaccine co-administered with measles, rubella and yellow fever vaccines in Ghanaian children: A phase IIIb, multi-center, non-inferiority, randomized, open, controlled trial.

BACKGROUND: To optimize vaccine implementation visits for young children, it could be efficient to administer the first RTS,S/AS01 malaria vaccine dose during the Expanded Programme on Immunization (EPI) visit at 6 months of age together with Vitamin A supplementation and the third RTS,S/AS01 dose on the same day as yellow fever (YF), measles and rubella vaccines at 9 months of age. We evaluated the safety and immunogenicity of RTS,S/AS01 when co-administered with YF and combined measles-rubella (MR) vaccines. METHODS: In this phase 3b, open-label, controlled study (NCT02699099), 709 Ghanaian children were randomized (1:1:1) to receive RTS,S/AS01 at 6, 7.5 and 9 months of age, and YF and MR vaccines at 9 or 10.5 months of age (RTS,S coad and RTS,S alone groups, respectively). The third group received YF and MR vaccines at 9 months of age and will receive RTS,S/AS01 at 10.5, 11.5 and 12.5 months of age (Control group). All children received Vitamin A at 6 months of age. Non-inferiority of immune responses to the vaccine antigens was evaluated 1 month following co-administration versus RTS,S/AS01 or EPI vaccines (YF and MR vaccines) alone using pre-defined non-inferiority criteria. Safety was assessed until Study month 4.5. RESULTS: Non-inferiority of antibody responses to the anti-circumsporozoite and anti-hepatitis B virus surface antigens when RTS,S/AS01 was co-administered with YF and MR vaccines versus RTS,S/AS01 alone was demonstrated. Non-inferiority of antibody responses to the measles, rubella, and YF antigens when RTS,S/AS01 was co-administered with YF and MR vaccines versus YF and MR vaccines alone was demonstrated. The safety profile of all vaccines was clinically acceptable in all groups. CONCLUSIONS: RTS,S/AS01 can be co-administered with Vitamin A at 6 months and with YF and MR vaccines at 9 months of age during EPI visits, without immune response impairment to any vaccine antigen or negative safety effect.

Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial.

BACKGROUND: Household air pollution exposure is a major health risk, but validated interventions remain elusive. METHODS/DESIGN: The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life. A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus, if she is the primary cook, and if she does not smoke. We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life. Additionally, an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses, which we will present alongside intention-to-treat analyses. Major funding was provided by the National Institute of Environmental Health Sciences, The Thrasher Research Fund, and the Global Alliance for Clean Cookstoves. DISCUSSION: Household air pollution exposure is a major health risk that requires well-tested interventions. GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG, and will thus help inform health and energy policies in developing countries. TRIAL REGISTRATION: The trial was registered with clinicaltrials.gov on 13 April 2011 with the identifier NCT01335490 .