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

Not Applicable

• Conditions: Hiv; Sexually Transmitted Diseases
• Interventions: Behavioral: Camelia Cohort

• Registration Number: NCT05463692
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-19
• Study Start: 2023-12-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Primary Completion: 2027-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 830

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm - CAMELLIA Cohort	Camelia 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States