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Enrolling by Invitation

NCT Number: NCT05463692

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Camelia Cohort

Behavioral

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 outcomes

  1. Annualized Sexually Transmitted Infections (STIs)

    Time frame: From time of enrollment through study completion at 24 months

    We will calculate incidence of gonorrhea and new positive cases of syphilis.

Secondary outcomes

  1. Pre-Exposure Prophylaxis (PrEP) uptake

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: CAMELLIA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 19, 2022
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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