Design, Development, and Testing of BEST4Baby, an mHealth Technology to Support Exclusive Breastfeeding in India: Pilot Study.

BACKGROUND: Exclusive breastfeeding (EBF) at 6 months of age in most low- and middle-income countries, including India, is surprisingly low. There is a relative lack of mobile health apps that specifically focus on leveraging the use of peer counselors (PCs) to support mothers as a means of increasing EBF practices in low- and middle-income countries. OBJECTIVE: This study aimed to design, develop, and test the usability of Breastfeeding Education Support Tool for Baby (BEST4Baby), a mobile health app specifically designed to support PCs in providing in-home breastfeeding counseling support to mothers in rural India on optimal breastfeeding practices. METHODS: A user-centered design process with an agile development methodology was used. The approach involved stakeholders and mothers who were trained to serve as PCs to guide BEST4Baby's design and development, including the app's content and features. PCs were engaged through focus groups with interactive wireframes. During the 24-month pilot study period, we conducted a feasibility test of the BEST4Baby app with 22 PCs who supported home visits with mothers residing in rural India. The intervention protocol required PCs to provide education and follow mothers using the BEST4Baby app, with 9 scheduled home visits from the late prenatal stage to 6 months post partum. BEST4Baby's usability from the PCs' perspective was assessed using the translated System Usability Scale (SUS). RESULTS: The findings of this study align with best practices in user-centered design (ie, understanding user experience, including context with iterative design with stakeholders) to address EBF barriers. This led to the cultural tailoring and contextual alignment of an evidence-based World Health Organization breastfeeding program with an iterative design and agile development of the BEST4Baby app. A total of 22 PCs tested and rated the BEST4Baby app as highly usable, with a mean SUS score of 85.3 (SD 9.1), placing it over the 95th percentile for SUS scores. The approach translated into a highly usable BEST4Baby app for use by PCs in breastfeeding counseling, which also statistically increased EBF practices. CONCLUSIONS: The findings suggest that BEST4Baby was highly usable and accepted by mothers serving as PCs to support other mothers in their EBF practices and led to positive outcomes in the intervention group's EBF rates. The pilot study demonstrated that using the specially designed BEST4Baby app was an important support tool for mothers to serve as PCs during the 9 home visits. TRIAL REGISTRATION: Clinicaltrials.gov NCT03533725; https://clinicaltrials.gov/ct2/show/NCT03533725.

Immunogenicity of Fractional Dose Inactivated Poliovirus Vaccine in India.

INTRODUCTION: Following the withdrawal of Sabin type 2 from trivalent oral poliovirus vaccine (tOPV) in 2016, the introduction of ≥1 dose of inactivated poliovirus vaccine (IPV) in routine immunization was recommended, either as 1 full dose (0.5mL, intramuscular) or 2 fractional doses of IPV (fIPV-0.1mL, intradermal). India opted for fIPV. We conducted a comparative assessment of IPV and fIPV. METHODS: This was a 4-arm, open-label, multicenter, randomized controlled trial. Infants were enrolled and vaccines administered according to the study design, and the blood was drawn at age 6, 14, and 18 weeks for neutralization testing against all 3 poliovirus types. RESULTS: Study enrolled 799 infants. The seroconversion against type 2 poliovirus with 2 fIPV doses was 85.8% (95% confidence interval [CI]: 80.1%-90.0%) when administered at age 6 and 14 weeks, 77.0% (95% CI: 70.5-82.5) when given at age 10 and 14 weeks, compared to 67.9% (95% CI: 60.4-74.6) following 1 full-dose IPV at age 14 weeks. CONCLUSION: The study demonstrated the superiority of 2 fIPV doses over 1 full-dose IPV in India. Doses of fIPV given at 6 and 14 weeks were more immunogenic than those given at 10 and 14 weeks. Clinical Trial Registry of India (CTRI). Clinical trial registration number was CTRI/2017/02/007793.

Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants.

Multivalent combination vaccines have reduced the number of injections and therefore improved vaccine acceptance, timeliness of administration and global coverage. The hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib; Infanrix hexa™) vaccine, administered according to various schedules, is widely used for the primary vaccination of infants worldwide. In the current publication, we are presenting the immunogenicity and safety of 3 doses of DTPa-HBV-IPV/Hib vaccine when administered to Indian infants. 224 healthy infants (mean age 6.8 weeks) were vaccinated at 6-10-14 weeks (W) of age (n = 112) or 2-4-6 months (M) of age (n = 112). One month after the third vaccine dose, the seroprotection/seropositivity status against diphtheria, pertussis, tetanus, polio, hepatitis B and Hib antigens ranged from 98.6% to 100% in both groups. The vaccine response rate to the pertussis antigens ranged from 97% to 100%. Pain (6-10-14W group: 25.2%; 2-4-6M group: 13.4%) and fever (15.3% and; 15.2%, respectively) were the most frequently reported solicited local and general symptoms. Unsolicited adverse events were reported for 35.7% (6-10-14W group) and 22.3% (2-4-6M group) of subjects. No vaccine related serious adverse events were reported. In conclusion, the hexavalent DTPa-HBV-IPV/Hib vaccine was immunogenic and well tolerated, irrespective of the dosing schedule.