HivCAMELLIANCT05463692
CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama
A study testing Camelia Cohort in people with Hiv and Sexually Transmitted Diseases, run by University of Alabama at Birmingham at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hiv, Sexually Transmitted Diseases
- What is being tested?
- Camelia Cohort
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to 30 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Live outside of Alabama
- Positive diagnosis for HIV, Gonorrhea, or Syphilis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
Read the 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.
- Conditions
- Hiv, Sexually Transmitted Diseases
- Being tested
- Camelia Cohort
- Keywords
- HIV prevention education, STI prevention education, Pre-exposure prophylaxis (PrEP)
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camelia CohortBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - CAMELLIA Cohort | Experimental | 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. Receives: Behavioral: Camelia Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Sexually Transmitted Infections (STIs)
We will calculate incidence of gonorrhea and new positive cases of syphilis.
Measured: From time of enrollment through study completion at 24 months
Secondary outcomes (1)
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).
Measured: From time of enrollment through study completion at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start12 Dec 2023
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Lynn T. Matthews, University of Alabama at Birmingham
- Investigators
- Lynn T. Matthews, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463692
- Sponsor's protocol ID
- UAB IRB-300009250
- Other IDs
- R01HD110097, Accession Number:4662864
- Acronym
- CAMELLIA
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No