NCT05463692

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
830

participants targeted

Target at P75+ for not_applicable hiv

Timeline
16mo left

Started Dec 2023

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Dec 2023Aug 2027

First Submitted

Initial submission to the registry

July 13, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 12, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

3.7 years

First QC Date

July 13, 2022

Last Update Submit

September 3, 2025

Conditions

HivSexually Transmitted Diseases

Keywords

HIV prevention educationSTI prevention educationPre-exposure prophylaxis (PrEP)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pre-Exposure Prophylaxis (PrEP) uptake

    From time of enrollment through study completion at 24 months

Study Arms (1)

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.

Behavioral: Camelia Cohort

Interventions

Camelia CohortBEHAVIORAL

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.

Single Arm - CAMELLIA Cohort

Eligibility Criteria

Age18 Years - 89 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsEligible persons for screening include those who identify as women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Live outside of Alabama
  • Positive diagnosis for HIV, Gonorrhea, or Syphilis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lynn T. Matthews, MD, MPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 19, 2022

Study Start

December 12, 2023

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations

US(1)