Boa Vista

Researchers are evaluating how active health education methods affect adherence to the HPV vaccine among schoolchildren aged 9 to 14 years in Brazil. The study addresses recent declines in HPV vaccination among young people and aims to provide strong evidence on the effectiveness of direct educational interventions in schools. The trial involves approximately 5,000 students from 80 schools randomized into clusters. The study uses a stepped-wedge, cluster randomized design where clusters of schools switch to one of four intervention groups every two months. These groups include: active student education combined with teacher training and Basic Health Unit actions, active student education without teacher training plus Basic Health Unit actions, Basic Health Unit active orientation sessions led by nurses, and usual care with no specific intervention. Teacher training involves 30 hours of online self-instruction about vaccination. Participants will be monitored over 12 months to measure the proportion of children and adolescents receiving at least one dose of the HPV vaccine after the interventions. Researchers will assess vaccination coverage changes resulting from the different educational approaches. The study also includes training for teachers and health workers, school-based education for students, and community health unit involvement to promote vaccination.

Researchers are evaluating the use of adjuvant chemotherapy in patients with locally advanced cervical cancer who test positive for cell-free human papillomavirus deoxyribonucleic acid (cfHPV-DNA) in their plasma after standard treatment. This Phase 3, randomized, multicenter clinical trial aims to determine if patients with persistent cfHPV-DNA expression after chemoradiotherapy can benefit from additional chemotherapy. The study includes patients with cervical cancer stages IB3 to IVA who have completed standard concomitant chemoradiotherapy.

This research aims to evaluate the safety and effectiveness of a single high dose of liposomal amphotericin B compared to standard dosing for treating disseminated histoplasmosis in patients with AIDS. Histoplasmosis is a serious fungal infection common in the American continent, especially Brazil, and can spread in people with weakened immune systems like those with advanced HIV. The study is a Phase III trial designed to compare 10 mg/kg single-dose therapy to the usual 3 mg/kg daily dose for two weeks, focusing on two-week mortality and overall treatment outcomes using a special ranking system. Participants will be randomly assigned to receive either a single high dose of liposomal amphotericin B or the standard two-week dosing regimen. After this induction therapy, all patients will continue with oral itraconazole for one year. The study includes oversight by multiple committees to ensure safety and quality, with the Data Safety Monitoring Board reviewing data yearly and study teams meeting regularly. Statistical analyses will assess survival rates, treatment safety, and effectiveness. During the study, participants will undergo various assessments including survival monitoring over 14 days and evaluations of laboratory toxicity and treatment outcomes. Data will be analyzed for differences between treatment groups, with safety monitoring ongoing. The total study will involve close follow-up, with participants receiving oral medication for a year after initial treatment. This trial aims to determine if the simpler single-dose approach is as safe and effective as the standard therapy.

Researchers are evaluating treatments for women with locally advanced cervical cancer, specifically those with adenocarcinoma or squamous cell carcinoma at certain advanced stages (FIGO Stage IB2-IB3 node positive or Stage IIB-IVA). The study compares standard cisplatin-based chemoradiation therapy to a newer approach that adds immunotherapy drugs nivolumab and ipilimumab before and during chemoradiation. This is a Phase II trial focused on improving 3-year progression-free survival for these patients. Participants will be randomly assigned to one of two groups: one receiving the standard treatment of cisplatin-based chemoradiation, and the other receiving four cycles of induction immunotherapy with nivolumab and ipilimumab every three weeks followed by cisplatin chemoradiation combined with nivolumab every two weeks. Radiation treatment includes a total dose of 45 Gy over 25 fractions plus brachytherapy, with concurrent weekly chemotherapy using cisplatin or carboplatin. Throughout the study, participants will undergo evaluations to monitor treatment effects, including imaging to assess target lesions per RECIST 1.1, and laboratory tests to track blood counts and organ function. Researchers will measure 3-year progression-free survival as the primary outcome. Safety, disease progression, and treatment adherence will be closely followed during and after therapy, with total participation lasting at least three years.