RESUMO
BACKGROUND: Interventions for increasing the uptake of COVID-19 vaccination among Black young adults are central to ending the pandemic. Black young adults experience harms from structural forces, such as racism and stigma, that reduce receptivity to traditional public health messaging due to skepticism and distrust. As such, Black young adults continue to represent a priority population on which to focus efforts for promoting COVID-19 vaccine uptake. OBJECTIVE: In aims 1 and 2, the Tough Talks digital health intervention for HIV disclosure will be adapted to address COVID-19 vaccine hesitancy and tailored to the experiences of Black young adults in the southern United States (Tough Talks for COVID-19). In aim 3, the newly adapted Tough Talks for COVID-19 digital health intervention will be tested across the following three southern states: Alabama, Georgia, and North Carolina. METHODS: Our innovative digital health intervention study will include qualitative and quantitative assessments. A unique combination of methodological techniques, including web-based surveys, choose-your-own-adventures, digital storytelling, user acceptability testing, and community-based participatory approaches, will culminate in a 2-arm hybrid type 1 effectiveness implementation randomized controlled trial, wherein participants will be randomized to the Tough Talks for COVID-19 intervention arm or a standard-of-care control condition (N=360). Logistic regression will be used to determine the effect of the treatment arm on the probability of vaccination uptake (primary COVID-19 vaccine series or recommended boosters). Concurrently, the inner and outer contexts of implementation will be ascertained and catalogued to inform future scale-up. Florida State University's institutional review board approved the study (STUDY00003617). RESULTS: Our study was funded at the end of April 2021. Aim 1 data collection concluded in early 2022. The entire study is expected to conclude in January 2025. CONCLUSIONS: If effective, our digital health intervention will be poised for broad, rapid dissemination to reduce COVID-19 mortality among unvaccinated Black young adults in the southern United States. Our findings will have the potential to inform efforts that seek to address medical mistrust through participatory approaches. The lessons learned from the conduct of our study could be instrumental in improving health care engagement among Black young adults for several critical areas that disproportionately harm this community, such as tobacco control and diabetes prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05490329; https://clinicaltrials.gov/ct2/show/NCT05490329. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41240.
RESUMO
Background: This protocol details the adaptation and pilot testing of the Finding Respect and Ending Stigma around HIV (FRESH) intervention in Dominican Republic. FRESH is a healthcare setting stigma-reduction intervention designed to reduce stigmas affecting people living with HIV (PLHIV), focusing on HIV and intersectional stigmas experienced by sexual and gender minority (SGM) people living with HIV. After the successful adaptation of the FRESH intervention, it will be pilot-tested through the conduct of a pilot stepped wedge cluster randomized controlled trial. Methods: Three aims are included in this study; Aim 1 includes exploratory qualitative assessment, specifically the conduct four focus groups with men who have sex with men (MSM) living with HIV (n = 24-32) and in-depth interviews with transgender women living with HIV to explore their experiences with stigma in clinics (n = 9-12). In-depth interviews will also be held with HIV healthcare workers to elucidate their perceptions and behaviors towards their SGM clients (n = 9-12). In Aim 2, informed by Aim 1 data, we will use the sequential phases of the ADAPT-ITT framework to iteratively adapt the FRESH intervention for the Dominican Republic. In Aim 3, the adapted intervention will be pilot-tested via a cluster stepped wedge randomized controlled trial to assess feasibility and acceptability of the intervention and study protocols. Conclusions: If this pilot trial is successful, next steps will include testing the adapted intervention across Dominican Republic or in similar Spanish-speaking Caribbean nations in a larger trial to assess effectiveness in reducing stigma in clinical settings towards PLHIV.
RESUMO
Purpose: The purpose of this NIH-funded protocol is to adapt (Aim 1) and pilot test (Aim 2) an mHealth intervention to improve maternal and child health in Cameroon. We will adapt the 24/7 University of Alabama at Birmingham Medical Information Service via Telephone (MIST) provider support system to mMIST (mobile MIST) for peripheral providers who provide healthcare to pregnant and postpartum women and newborns in Cameroon. Methods: In Aim 1, we apply qualitative and participatory methods (in-depth interviews and focus groups with key stakeholders) to inform the adaptation of mMIST for use in Cameroon. We use the sequential phases of the ADAPT-ITT framework to iteratively adapt mMIST incorporating qualitative findings and tailoring for local contexts. In Aim 2, we test the adapted intervention for feasibility and acceptability in Ndop, Cameroon. Results: This study is ongoing at the time that this protocol is published. Conclusion: The adaptation, refinement, and pilot testing of mMIST will be used to inform a larger-scale stepped wedged cluster randomized controlled effectiveness trial. If successful, this mHealth intervention could be a powerful tool enabling providers in low-resource settings to deliver improved pregnancy care, thereby reducing maternal and fetal deaths.
