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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05463692
Acronym
CAMELLIA
Enrollment
830
Registered
2022-07-19
Start date
2023-12-12
Completion date
2027-08-30
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv, Sexually Transmitted Diseases

Keywords

HIV prevention education, STI prevention education, Pre-exposure prophylaxis (PrEP)

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.

Interventions

BEHAVIORALCamelia 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Annualized Sexually Transmitted Infections (STIs)From time of enrollment through study completion at 24 monthsWe will calculate incidence of gonorrhea and new positive cases of syphilis.

Secondary

MeasureTime frameDescription
Pre-Exposure Prophylaxis (PrEP) uptakeFrom time of enrollment through study completion at 24 monthsWe 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026