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

The University of Alabama at Birmingham

Status: Invitation-only

Conditions: Sexually Transmitted Diseases; Hiv

Treatments: Behavioral: Camelia Cohort

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05463692

4662864

Accession Number:4662864 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 830 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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830 participants in 1 patient group

Single Arm - CAMELLIA Cohort

Experimental group

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.

Treatment:

Behavioral: Camelia Cohort