CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm - CAMELLIA Cohort 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 factors associated with incident STI/HIV infection as well as utilization of PrEP through self-collected STI/HIV testing and survey assessments. |
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.
|
Outcome Measures
Primary Outcome Measures
- Annualized Sexually Transmitted Infections (STIs) [From time of enrollment through study completion at 24 months]
We will calculate incidence of gonorrhea and new positive cases of syphilis.
Secondary Outcome Measures
- Pre-Exposure Prophylaxis (PrEP) uptake [From time of enrollment through study completion at 24 months]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Self identify as a Cis-gender or Trans-gender woman
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Age 18 - 44
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Reported STI in past 3 months by the Alabama Department of Public Health (ADPH)
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Gonorrhea and Syphilis negative
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HIV negative at screening encounter
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Live in Alabama
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Have access to a private smart phone
Exclusion Criteria:
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Live outside of Alabama
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Positive diagnosis for HIV, Gonorrhea, or Syphilis
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Alabama at Birmingham
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Latesha Elopre, MD, MSPH, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4662864
- Accession Number:4662864