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CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama (CAMELLIA)

Primary Purpose

Hiv, Sexually Transmitted Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Camelia Cohort
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hiv focused on measuring HIV prevention education, STI prevention education, Pre-exposure prophylaxis (PrEP)

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Self identify as a Cis-gender or Trans-gender woman
  • Age 18 - 44
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single Arm - CAMELLIA Cohort

    Arm 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 factors associated with incident STI/HIV infection as well as utilization of PrEP through self-collected STI/HIV testing and survey assessments.

    Outcomes

    Primary Outcome Measures

    Annualized Sexually Transmitted Infections (STIs)
    We will calculate incidence of gonorrhea and new positive cases of syphilis.

    Secondary Outcome Measures

    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).

    Full Information

    First Posted
    July 13, 2022
    Last Updated
    October 18, 2023
    Sponsor
    University of Alabama at Birmingham
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05463692
    Brief Title
    CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama
    Acronym
    CAMELLIA
    Official Title
    CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    January 2028 (Anticipated)
    Study Completion Date
    July 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hiv, Sexually Transmitted Diseases
    Keywords
    HIV prevention education, STI prevention education, Pre-exposure prophylaxis (PrEP)

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    830 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Arm - CAMELLIA Cohort
    Arm Type
    Experimental
    Arm 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 factors associated with incident STI/HIV infection as well as utilization of PrEP through self-collected STI/HIV testing and survey assessments.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Camelia Cohort
    Intervention Description
    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 Measure Information:
    Title
    Annualized Sexually Transmitted Infections (STIs)
    Description
    We will calculate incidence of gonorrhea and new positive cases of syphilis.
    Time Frame
    From time of enrollment through study completion at 24 months
    Secondary Outcome Measure Information:
    Title
    Pre-Exposure Prophylaxis (PrEP) uptake
    Description
    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).
    Time Frame
    From time of enrollment through study completion at 24 months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    Eligible persons for screening include those who identify as women.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Self identify as a Cis-gender or Trans-gender woman Age 18 - 50 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tammi Thomas
    Phone
    205-934-7839
    Email
    tamms@uabmc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bernadette Johnson
    Phone
    205-934-7329
    Email
    mailto:bajohnson@uabmc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Latesha Elopre, MD, MSPH
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama

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