[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05463692":3,"trial-entities:NCT05463692":83,"trial-summary:NCT05463692":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":64,"locations":67,"central_contacts":76,"overall_officials":77,"references":81,"see_also_links":82},"NCT05463692","4662864","CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama","ENROLLING_BY_INVITATION","2027-08-30","2025-09","2025-09-10","2023-12-12","University of Alabama at Birmingham","OTHER",true,"Pre-exposure prophylaxis (PrEP) is an important biomedical human immunodeficiency virus (HIV) prevention tool and may particularly benefit black, cis and trans-gender women, who are at an increased risk for HIV and Sexually Transmitted Infections (STIs). The purpose of this study is to use a population-based approach to create a cohort of cis and trans-gender women at risk for future HIV acquisition to better understand the factors associated with the risk of STIs and HIV diagnosis and predictors of PrEP use.","To better understand contextual factors among people who identify as women in Alabama that predict STI\u002FHIV infection and PrEP use, we will refine an existing evidence-based mobile health app (HealthMpowerment or HMP) to optimally engage and retain a digital cohort of women at-risk for HIV infection (i.e. prior infection in the past 3 months with gonorrhea or syphilis). Using a sampling strategy based on geospatial analysis of HIV-risk, we will enroll and follow our cohort longitudinally to assess factors associated with incident STI\u002FHIV infection as well as utilization of PrEP through iterative self-collected STI\u002FHIV testing and survey assessments.",[18,19],"Hiv","Sexually Transmitted Diseases",[21,22,23],"HIV prevention education","STI prevention education","Pre-exposure prophylaxis (PrEP)","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},830,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Camelia Cohort","Through the HealthMpowerment (HMP) app tailored for women, we will be able to provide informational content, access to resources, PrEP locators and additional gamification features to optimally engage and retain our cohort, which may support linkage to PrEP care.",[37],"Single Arm - CAMELLIA Cohort",[39],{"measure":40,"description":41,"timeFrame":42},"Annualized Sexually Transmitted Infections (STIs)","We will calculate incidence of gonorrhea and new positive cases of syphilis.","From time of enrollment through study completion at 24 months",[44],{"measure":45,"description":46,"timeFrame":42},"Pre-Exposure Prophylaxis (PrEP) uptake","We will calculate incidence of PrEP initiation, as reported by participants and confirmed through medical record review or through Dried Blood Spot (DBS) sampling confirmed presence of tenofovir-base PrEP (TFV-dp).","ALL","18 Years","89 Years",false,{"inclusion":52,"exclusion":60,"raw_text":63},[53,54,55,56,57,58,59],"Self identify as a Cis-gender or Trans-gender woman","Age 18 - 89","Reported STI in past 3 months by the Alabama Department of Public Health (ADPH)","Gonorrhea and Syphilis negative","HIV negative at screening encounter","Live in Alabama","Have access to a private smart phone",[61,62],"Live outside of Alabama","Positive diagnosis for HIV, Gonorrhea, or Syphilis","Inclusion Criteria:\n\n* Self identify as a Cis-gender or Trans-gender woman\n* Age 18 - 89\n* Reported STI in past 3 months by the Alabama Department of Public Health (ADPH)\n* Gonorrhea and Syphilis negative\n* HIV negative at screening encounter\n* Live in Alabama\n* Have access to a private smart phone\n\nExclusion Criteria:\n\n* Live outside of Alabama\n* Positive diagnosis for HIV, Gonorrhea, or Syphilis",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":12,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"Birmingham","Alabama","35233","United States",{"lat":74,"lon":75},33.52066,-86.80249,[],[78],{"name":79,"affiliation":12,"role":80},"Lynn T. Matthews, MD, MPH","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":84,"biomarkers":87},[85,86],"HIV Infection","Sexually Transmitted Disorder",[],{"nct_id":4,"found":50,"summary":89,"prompt_version":89},null]