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

Hiv Clinical Trial

— CAMELLIA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05463692
• Other study ID #: 4662864
• Secondary ID: Accession Number
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: July 2028

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 830
• Est. completion date: July 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Sexually Transmitted Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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).	From time of enrollment through study completion at 24 months