Clinical Trials Logo

Clinical Trial Summary

The objective of this research is to use a localized mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI


Clinical Trial Description

Based on our prior work with CLSI women, mHealth strategies are an excellent way to keep in touch and push just-in-time content. During the pandemic, we were forced to close field sites and stop any in-person follow-up visits. Even prior to the pandemic, telephone follow-up surveys were conducted with 60% of participants. Post-pandemic, we conducted 95% of those surveys over the phone, with the remaining over email or mail correspondence. Most participants use text messaging regularly and can access the Web on their phones. Our ongoing RCT (N=73 participants completed) of an mHealth intervention on women's health shows this modality is feasible for delivering information and engaging participants. Specifically, we found that 81% of women who initiate can complete the intervention. The average time for completion of one module, for example on sexually transmitted infections, took 19 minutes, whereas cervical cancer took 13 minutes to complete. We estimate the proposed module on COVID-19 testing and vaccine will take on average between 15 to 20 minutes to complete. This time for intervention completion, combined with text message information about any new COVID-19 mitigation news (e.g., boosters, vaccine for children, new testing recommendations, testing locations, etc.), should result in about 30-60 minutes of total formal engagement during the study. What we propose will be brief, but targeted messaging intervention from verified sources, delivered in an adequate lay language and using spokespersons that are relatable and familiar, and can be trusted, has been proven effective in changing targeted behaviors.32,33 Our intervention design also draws on lessons learned from evidence-based interventions to improve vaccination uptake among adults, for example a meta-analysis conducted in 2021 on public response to health messages encouraging vaccination.34 Our mHealth intervention allows participants to attend to the information at their own pace, while ensuring that they are prompted to complete the module. To avoid unidirectionality and promote engagement, they will be able to use an asynchronous messaging component to ask questions and receive answers from the research team. There is no question that such an intervention is necessary for a population with likely low uptake of both testing and vaccination, especially when that population is not the explicit target of most public health messaging. To the critique of whether the intervention is sufficient, we don't know. We hypothesize that the intervention will be effective at boosting COVID-19 testing and vaccine literacy, access, and uptake, and the goal of this study is to test that hypothesis. One advantage of this approach is the ability for nimbleness, that is, being able to adapt in real-time to new information about the pandemic and being able to push that new information out to women using the proposed intervention platform. Another unique advantage is the scalability of such an intervention, and its ability to be made widely available to all CLSI women in the United States ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05582746
Study type Interventional
Source University of Kansas Medical Center
Contact
Status Active, not recruiting
Phase N/A
Start date September 15, 2022
Completion date November 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT05197634 - The Impact of Covid-19 Pandemic On The Children With Autism Spectrum Disorder
Recruiting NCT05918939 - UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster (Immunobridging Study) Early Phase 1
Completed NCT05383560 - Safety and Immunogenicity of Omicron Variant-Matched Vaccine Booster in Adults Phase 2
Active, not recruiting NCT05125874 - Clinical Study for Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Booster Immunization N/A
Completed NCT05517148 - Effects of an Immersive Virtual Reality Intervention Combined With Mindfulness-based Stress Reduction N/A
Completed NCT05552989 - Towards Better Preparedness for Future Catastrophes - Local Lessons-learned From COVID-19
Completed NCT05543551 - Effects of Diagrammatic Breathing With and Without Resistance in Post Covid Patients on ADLs N/A
Active, not recruiting NCT06272253 - UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects Early Phase 1
Active, not recruiting NCT05585567 - A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5 Early Phase 1
Not yet recruiting NCT05381883 - Mental Health of Professionals of the Silver Economy of New Aquitaine : Online Survey of Accommodation Establishments for Old People and Home Assistance Establishments N/A
Recruiting NCT05062681 - RCT on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow Phase 4
Completed NCT04697030 - Burnout Among Adolescent Population During Covid-19 Lockdown in Pakistan
Active, not recruiting NCT05419167 - STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic Phase 1
Completed NCT06435390 - Coronavirus Disease 2019 (COVID-19) Pandemic on the Oral Hygiene Status of Children
Terminated NCT05553964 - SARS-CoV-2 OTC At Home Test N/A
Completed NCT05596032 - Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2
Completed NCT05583812 - A Study of FB2001 for Inhalation in Healthy Chinese Adults Phase 1
Completed NCT05844410 - Evaluation of Corticosteroids Use and Clinical Outcomes in Hospitalized COVID-19 Patients: A Retrospective Study
Completed NCT05123573 - Self-Perceived in Medical Students Undergoing Distance Learning
Completed NCT05305300 - A Phase I Study to Evaluate Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Individuals Phase 1