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The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability: Study protocol in Nigeria

Iwelunmor, Juliet; Tucker, Joseph D; Obiezu-Umeh, Chisom; Gbaja-Biamila, Titilola; Oladele, David; Nwaozuru, Ucheoma; Musa, Adesola Z; Airhihenbuwa, Collins O; Muessig, Kathryn; Rosenberg, Nora; BeLue, Rhonda; Xian, Hong; Conserve, Donaldson F; Ong, Jason J; Zhang, Lei; Curley, Jamie; Nkengasong, Susan; Mason, Stacey; Tang, Weiming; Bayus, Barry; Ogedegbe, Gbenga; Ezechi, Oliver
BACKGROUND:The World Health Organization recommends HIV self-testing (HIVST) as an additional approach to HIV testing and the Nigerian government is supportive of this policy recommendation. However, effectively increasing uptake and sustainability among Nigerian youth is unknown. The goal of this study is to conduct a full-powered type I hybrid effectiveness-implementation trial to test the effectiveness of youth-friendly implementation science strategies in increasing uptake and sustainability of HIVST led by and for Nigerian youth. METHODS:Our 4 Youth by Youth (4YBY) strategy combines four core elements: 1) HIVST bundle consisting of HIVST kits and photo verification system; 2) a participatory learning community; 3) peer to peer support and technical assistance; and 4) on-site supervision and performance feedback to improve uptake and sustainability of HIVST and enhance linkage to youth-friendly health clinics for confirmatory HIV testing where needed, sexually transmitted infection (STI) testing (i.e. syphilis, gonorrhea, chlamydia, and hepatitis, STI treatment, and PrEP referral. Utilizing a stepped-wedge, cluster-randomized controlled trial, a national cohort of youth aged 14-24 recruited from 30 local government areas across 14 states and four geo-political zones in Nigeria will receive the 4YBY implementation strategy. In addition, an economic evaluation will explore the incremental cost per quality adjusted life year gained. DISCUSSION/CONCLUSIONS:This study will add to the limited "how-to-do it literature" on implementation science strategies in a resource-limited setting targeting youth population traditionally underrepresented in implementation science literature. Study findings will also optimize uptake and sustainability of HIVST led by and for young people themselves. TRIAL REGISTRATION/BACKGROUND:This study is registered in ClinicalTrials.govNCT04710784 (on January 15, 2021).
PMID: 34800699
ISSN: 1559-2030
CID: 5049872

Integration of a task strengthening strategy for hypertension management into HIV care in Nigeria: a cluster randomized controlled trial study protocol

Aifah, Angela A; Odubela, Oluwatosin; Rakhra, Ashlin; Onakomaiya, Deborah; Hu, Jiyuan; Nwaozuru, Ucheoma; Oladele, David A; Odusola, Aina Olufemi; Idigbe, Ifeoma; Musa, Adesola Z; Akere, Ayodeji; Tayo, Bamidele; Ogedegbe, Gbenga; Iwelunmor, Juliet; Ezechi, Oliver
BACKGROUND:In regions with weak healthcare systems, critical shortages of the healthcare workforce, and increasing prevalence of dual disease burdens, there is an urgent need for the implementation of proven effective interventions and strategies to address these challenges. Our mixed-methods hybrid type II effectiveness-implementation study is designed to fill this evidence-to-practice gap. This study protocol describes a cluster randomized controlled trial which evaluates the effectiveness of an implementation strategy, practice facilitation (PF), on the integration, adoption, and sustainability of a task-strengthening strategy for hypertension control (TASSH) intervention within primary healthcare centers (PHCs) in Lagos State, Nigeria. DESIGN/METHODS:Guided by the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM), this study tests the impact of a proven effective implementation strategy to integrate hypertension management into the HIV care cascade, across 30 PHCs. The study will be conducted in three phases: (1) a pre-implementation phase that will use CFIR to develop a tailored PF intervention for integrating TASSH into HIV clinics; (2) an implementation phase that will use RE-AIM to compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and (3) a post-implementation phase that will use RE-AIM to evaluate the effect of PF vs. self-directed condition on adoption and sustainability of TASSH. The PF intervention components comprise (a) an advisory board to provide leadership support for implementing TASSH in PHCs; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses. DISCUSSION/CONCLUSIONS:This study is one of few, if any trials, to evaluate the impact of an implementation strategy for integrating hypertension management into HIV care, on clinical and implementation outcomes. Findings from this study will advance implementation science research on the effectiveness of tailoring an implementation strategy for the integration of an evidence-based, system-level hypertension control intervention into HIV care and treatment. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov ( NCT04704336 ). Registered on 11 January 2021.
PMCID:8597211
PMID: 34789277
ISSN: 1748-5908
CID: 5049252

COVID-19 and Social Determinants of Health in Gastroenterology and Hepatology [Comment]

Balzora, Sophie; May, Folasade P; Ogedegbe, Gbenga
PMID: 34454917
ISSN: 1528-0012
CID: 5039352

Correction to: Bridging the evidence-to-practice gap: a stepped-wedge cluster randomized controlled trial evaluating practice facilitation as a strategy to accelerate translation of a multi-level adherence intervention into safety net practices

Schoenthaler, Antoinette; De La Calle, Franzenith; Soto, Amanda; Barrett, Derrel; Cruz, Jocelyn; Payano, Leydi; Rosado, Marina; Adhikari, Samrachana; Ogedegbe, Gbenga; Rosal, Milagros
PMID: 34674755
ISSN: 2662-2211
CID: 5080342

Aligning Payment and Policies With Health Care Value and Equity: Blood Pressure as a National Vital Sign

Fiscella, Kevin; Tobin, Jonathan N; Ogedegbe, Gbenga
PMID: 36218887
ISSN: 2689-0186
CID: 5359932

Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: US Preventive Services Task Force Recommendation Statement

Davidson, Karina W; Barry, Michael J; Mangione, Carol M; Cabana, Michael; Caughey, Aaron B; Davis, Esa M; Donahue, Katrina E; Doubeni, Chyke A; Kubik, Martha; Li, Li; Ogedegbe, Gbenga; Pbert, Lori; Silverstein, Michael; Simon, Melissa A; Stevermer, James; Tseng, Chien-Wen; Wong, John B
Importance:Preeclampsia is one of the most serious health problems that affect pregnant persons. It is a complication in approximately 4% of pregnancies in the US and contributes to both maternal and infant morbidity and mortality. Preeclampsia also accounts for 6% of preterm births and 19% of medically indicated preterm births in the US. There are racial and ethnic disparities in the prevalence of and mortality from preeclampsia. Non-Hispanic Black women are at greater risk for developing preeclampsia than other women and experience higher rates of maternal and infant morbidity and perinatal mortality. Objective:To update its 2014 recommendation, the USPSTF commissioned a systematic review to evaluate the effectiveness of low-dose aspirin use to prevent preeclampsia. Population:Pregnant persons at high risk for preeclampsia who have no prior adverse effects with or contraindications to low-dose aspirin. Evidence Assessment:The USPSTF concludes with moderate certainty that there is a substantial net benefit of daily low-dose aspirin use to reduce the risk for preeclampsia, preterm birth, small for gestational age/intrauterine growth restriction, and perinatal mortality in pregnant persons at high risk for preeclampsia. Recommendation:The USPSTF recommends the use of low-dose aspirin (81 mg/d) as preventive medication for preeclampsia after 12 weeks of gestation in persons who are at high risk for preeclampsia. (B recommendation).
PMID: 34581729
ISSN: 1538-3598
CID: 5080332

Screening for Chlamydia and Gonorrhea: US Preventive Services Task Force Recommendation Statement

Davidson, Karina W; Barry, Michael J; Mangione, Carol M; Cabana, Michael; Caughey, Aaron B; Davis, Esa M; Donahue, Katrina E; Doubeni, Chyke A; Krist, Alex H; Kubik, Martha; Li, Li; Ogedegbe, Gbenga; Pbert, Lori; Silverstein, Michael; Simon, Melissa A; Stevermer, James; Tseng, Chien-Wen; Wong, John B
Importance:Chlamydia and gonorrhea are among the most common sexually transmitted infections in the US. Infection rates are highest among adolescents and young adults of both sexes. Chlamydial and gonococcal infections in women are usually asymptomatic and may lead to pelvic inflammatory disease and its associated complications. Newborns of pregnant persons with untreated infection may develop neonatal chlamydial pneumonia or gonococcal or chlamydial ophthalmia. Infection in men may lead to urethritis and epididymitis. Both types of infection can increase risk of acquiring or transmitting HIV. Objective:To update its 2014 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of screening for chlamydia and gonorrhea in sexually active adolescents and adults, including pregnant persons. Population:Asymptomatic, sexually active adolescents and adults, including pregnant persons. Evidence Assessment:The USPSTF concludes with moderate certainty that screening for chlamydia in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection has moderate net benefit. The USPSTF concludes with moderate certainty that screening for gonorrhea in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection has moderate net benefit. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men. Recommendation:The USPSTF recommends screening for chlamydia in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection. (B recommendation) The USPSTF recommends screening for gonorrhea in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men. (I statement).
PMID: 34519796
ISSN: 1538-3598
CID: 5080322

Motivation to move fast, motivation to wait and see: The association of prevention and promotion focus with clinicians' implementation of the JNC-7 hypertension treatment guidelines

Sanders, Mechelle; Fiscella, Kevin; Hill, Elaine; Ogedegbe, Olugbenga; Cassells, Andrea; Tobin, Jonathan N; Williams, Stephen; Veazie, Peter
Roughly half of the adults in the United States are diagnosed with hypertension (HTN). Unfortunately, less than one-third have their condition under control. Clinicians generally have positive regard for the use of HTN guidelines to achieve HTN treatment goals; however, actual uptake remains low. Factors underpinning clinician variation in practice are poorly understood. To understand the relationship between clinicians' personal motivation to complete goals and their uptake of the Joint National Commission's HTN guidelines. The authors used Regulatory Focus Theory (RFT, ie, prevention and promotion focus), an empirically supported motivational theory, as a guiding framework to examine the relationship. The authors hypothesized that clinicians with high prevention focus would report following guidelines more often and have shorter follow-up visit intervals for patients with uncontrolled blood pressure. Clinicians (n  = 27) caring for adult patients diagnosed with HTN (n = 8605) in Federally Qualified Health Centers (n = 8). Clinicians' prevention and promotion focus scores and the number of days between visits for their patients with uncontrolled systolic blood pressure (SBP) (≥ 140 mm Hg). Consistent with RFT, 60% of prevention focused clinicians reported they always followed the monthly visit guideline for the patients with uncontrolled blood pressure, compared with 38% of promotion focused clinicians (p = .254). The unadjusted probability of returning for a follow-up visit within 30 days was greater among patients whose clinician was higher in prevention focus (p = .009), but there was no evidence at the 0.05 significance level in our adjusted model. These findings provide some limited evidence that RFT is a useful framework to understand clinician adherence to HTN treatment guidelines.
PMCID:8463494
PMID: 34374204
ISSN: 1751-7176
CID: 5039322

Uprooting race-based assumptions in biomedical journal articles

Aifah, Angela; Onakomaiya, Deborah; Rakhra, Ashlin; Ogedegbe, Gbenga
Coronavirus disease 2019 (COVID-19) has exacerbated the structural inequities in healthcare and the challenges of translating research into public discourse. This article highlights key antiracist considerations, presents previously noted core challenges, and provides recommendations for writing and reporting. Importantly, this article contributes to combating racialized science in the biomedical community.
PMCID:8219490
PMID: 34172389
ISSN: 1471-499x
CID: 4936942

The CircumVent Project: a CPAP/O2 helmet solution for non-invasive ventilation using an implementation research framework

Ahonkhai, Aimalohi A; Musa, Adesola Z; Fenton, André A; Aliyu, Muktar H; Ofotokun, Igho; Hornstein, Alex; Musa, Baba M; Nwosu, Nnamdi; Ulasi, Ifeoma; Ajayi, Samuel; Falade, Catherine; Dada, Adedamola; Abdu, Aliyu; Sunday, Mogaji; Odewabi, Adenike; Rotimi, Muyiwa K; Ogueh, Onome; Steinbach, Alan; Ogedegbe, Gbenga; Salako, Babatunde L; Ezechi, Oliver C
BACKGROUND:helmet solution for non-invasive ventilation among patients with COVID-19 and health workers in eight COVID-19 treatment and isolation centers in Nigeria. METHODS:helmet solution for non-invasive ventilation, pilot test the implementation strategy, and assess feasibility of its use and acceptability that includes monitoring altered risk of SARS-CoV-2 infection among healthcare workers. DISCUSSION/CONCLUSIONS:helmet solution for non-invasive ventilation in Nigeria can serve as a scalable model for resource-poor countries, and beyond the COVID-19 pandemic, has the potential to be deployed for the treatment of pneumonia and other respiratory diseases. TRIAL REGISTRATION/BACKGROUND:NCT04929691. Registered June 18, 2021-retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04929691.
PMCID:8390034
PMID: 34446110
ISSN: 2662-2211
CID: 5080312