Background: We assessed whether the Preventative Intervention for Cholera for 7 Days (PICHA7) WASHmobile program reduced diarrhea and cholera serological responses and improved child growth in the Democratic Republic of the Congo (DRC). Methods: The PICHA7 WASHmobile cluster-randomized controlled trial enrolled diarrhea patient households in urban Bukavu, DRC. Households were randomized into 2 arms: single in-person visit for the DRC government's diarrhea patient standard message on oral rehydration solution use and a basic water, sanitation, and hygiene (WASH) message (standard arm); or this standard message and the PICHA7 program with weekly voice and text mobile health (mHealth) messages and quarterly in-person visits (PICHA7 arm). The primary outcome was diarrhea in the past 2 weeks assessed monthly for 12 months. Secondary outcomes were healthcare facility visits for diarrhea, Vibrio cholerae serological response, stunting, underweight, wasting, and diarrhea with rice water stool over 12 months. A Vibrio cholerae serological response was defined by a rise in serum V. cholerae O1 O-specific polysaccharide (OSP) immunoglobulin A (IgA) or immunoglobulin G (IgG) from baseline to the 1-month follow-up. Generalized estimating equations were used for regression models to account for clustering at the individual and household level. Results: Between December 2021 and December 2022, 2334 participants were randomly allocated to 2 arms: 1138 standard arm and 1196 PICHA7 arm. Diarrhea prevalence during the 12-month surveillance period was significantly lower among PICHA7 arm participants compared to standard arm participants (prevalence ratio, 0.39 [95% confidence interval {CI}: .32–.48]). PICHA7 arm participants had lower odds of visiting a healthcare facility for diarrhea during the 12-month surveillance period (OR: 0.44 [95% CI: .25–.77]) and lower odds of diarrhea with rice water stool (OR: 0.48 [95% CI: .27–.86]). Significantly lower V. cholerae IgA serological responses were observed in the PICHA7 arm compared to the standard arm, defined by a change in serum IgA to V. cholerae O1 OSP from baseline to the 1-month follow-up (coefficient of between-arm difference from baseline to 1 month: −0.85 [95% CI: −1.60 to −.09]). PICHA7 arm children aged <5 years were significantly less likely to be stunted (52% vs 63% standard arm) (OR: 0.65 [95% CI: .43–.99]) at the 12-month follow-up. All WASH components had high adherence. Conclusions: The PICHA7 WASHmobile program, which combines mHealth with quarterly in-person visits, lowered healthcare facility visits for diarrhea, cholera serological responses, and stunting in the DRC. Clinical Trials Registration: NCT05166850.

Healthcare-acquired infections are a major problem in healthcare facility settings around the world. The Democratic Republic of the Congo (DRC) has over 2 million diarrhea patients hospitalized each year. These healthcare settings become high-risk environments for spreading diarrheal illnesses such as cholera. The objective of the Preventative Intervention for Cholera for 7 Days (PICHA7) program is to develop evidence-based water, sanitation, and hygiene (WASH) interventions to reduce cholera and other severe diarrheal diseases in the DRC. The study objective was to evaluate the effectiveness of PICHA7 program delivery in increasing handwashing with a cleansing agent at stool/vomit- and food-related events in a healthcare facility setting among diarrhea patients and patient attendants. A pilot of the PICHA7 program was conducted among 284 participants in 27 healthcare facilities from March 2020 to November 2021 in urban Bukavu in the South Kivu Province of the DRC. The standard arm received the standard message provided in the DRC to diarrhea patients on the use of oral rehydration solution and a basic WASH message at healthcare facility discharge. The PICHA7 arm received the PICHA7 WASH pictorial module delivered by a health promoter focused on handwashing with a cleansing agent at the bedside of the diarrhea patient in the healthcare facility and provision of a soapy water bottle (water and detergent powder). Within 24 h of intervention delivery, a three-hour structured observation of handwashing practices at stool/vomit- and food-related events (key events) was conducted in healthcare facilities of diarrhea patients and their attendants. Compared to the standard arm, there was significantly more handwashing with a cleansing agent at key events in the PICHA7 arm (40% vs. 15%) (odds ratio: 5.04; (95% confidence interval (CI): 2.01, 12.7)). These findings demonstrate that delivery of the PICHA7 WASH pictorial module and provision of a soapy water bottle to diarrhea patients and their attendants presents a promising approach to increase handwashing with a cleansing agent among this high-risk population in healthcare facilities in the eastern DRC.

Background We assessed whether the Preventative-Intervention-for-Cholera-for-7-Days (PICHA7) program reduced diarrhea and improved child growth in the Democratic Republic of the Congo (DRC). Methods The PICHA7 cluster-randomized controlled trial enrolled diarrhea patient households in urban Bukavu, DRC. Households were randomized into two arms: single in-person visit for the DRC government’s diarrhea patient standard message on oral rehydration solution use and a basic WASH message (standard arm); or this standard message and the PICHA7 program with quarterly in-person visits and weekly voice and text mobile health messages (mHealth) (PICHA7 arm). The primary outcome was diarrhea in the past two weeks assessed monthly for 12 months. Secondary outcomes were diarrhea with rice water stool, healthcare facility visits for diarrhea, stunting, underweight, and wasting over 12 months. Generalized estimating equations were used for regression models to account for clustering at the individual and household level. Results Between December 2021 and December 2022, 2334 participants in 359 households were randomly allocated to two arms: 1138 standard arm and 1196 PICHA7 arm. Diarrhea prevalence during the 12 month surveillance period was significantly lower among PICHA7 arm participants (Prevalence Ratio: 0.39 (95% Confidence Interval (CI): 0.32, 0.48). PICHA7 arm participants had lower odds of diarrhea with rice water stool (Odds Ratio (OR): 0.48 (95% CI: 0.27, 0.86)), and lower odds of visiting a healthcare facility for diarrhea during the 12 month surveillance period (OR: 0.44 (95% CI: 0.25, 0.77)). PICHA7 arm children 0-4 were significantly less likely to be stunted (52% vs. 63% standard arm) (OR: 0.65 (95% CI: 0.43, 0.98)) at the 12 month follow-up. All WASH components had high adherence. Conclusion The PICHA7 program which combines mHealth with quarterly in-person visits lowered diarrhea prevalence and stunting in the DRC. Clinical Trials Registration NCT05166850. Key Points The PICHA7 program combines mHealth with in-person visits and was assessed with a randomized controlled trial. Compared to the standard arm, the PICHA7 program lowered diarrhea prevalence for all ages and reduced stunting in children 0-4 years in the DRC.