CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Camelia Cohort.
- Who it may be relevant to
- Registry conditions: Hiv, Sexually Transmitted Diseases. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
To better understand contextual factors among people who identify as women in Alabama that predict STI/HIV 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/HIV infection as well as utilization of PrEP through iterative self-collected STI/HIV testing and survey assessments.
Interventions
- 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.
Primary outcome measures
- Annualized Sexually Transmitted Infections (STIs) [Time frame: From time of enrollment through study completion at 24 months]
Secondary outcome measures (1)
- Pre-Exposure Prophylaxis (PrEP) uptake [Time frame: From time of enrollment through study completion at 24 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Live outside of Alabama
- Positive diagnosis for HIV, Gonorrhea, or Syphilis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT05463692 · 4662864 · Accession Number:4662864