PrEP for HIV and STIs Prevention

(CAMELLIA Trial)

Overseen By Bernadette Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: HIV, Gonorrhea, Syphilis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to understand how pre-exposure prophylaxis (PrEP) can prevent HIV and STIs, focusing on black, cisgender, and transgender women at higher risk. The researchers aim to create a group of women in Alabama at risk for HIV to study factors affecting their chances of contracting HIV or other STIs and what predicts their use of PrEP. Participants will use a mobile health app to stay engaged and provide self-collected testing and surveys. Women who have had an STI in the past three months and own a smartphone may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to important research that could lead to better prevention strategies for at-risk communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for participants?

Research has shown that PrEP (pre-exposure prophylaxis) is generally safe for reducing the risk of HIV. This treatment is easy for most people to handle, with studies indicating it effectively lowers HIV infection rates and has few side effects. Reports confirm its safety for different groups, including those at higher risk for HIV.

In previous studies, most people using PrEP did not experience serious side effects. Some common, mild side effects like nausea or headaches may occur, but they usually resolve over time. The continued use of PrEP in clinical settings suggests that users do not face major issues.

Overall, PrEP is considered a reliable and safe way to prevent HIV, especially for those more likely to get infected. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PrEP for HIV and STIs Prevention trial because it aims to refine a mobile health app called HealthMpowerment (HMP) to better engage and retain women at risk of HIV in Alabama. Unlike traditional methods that rely heavily on in-person interactions or routine medical visits, this approach uses digital technology to provide ongoing support and education. The app's ability to focus on geospatial analysis of HIV risk and self-collected testing empowers users with personalized insights and proactive health management, potentially increasing the effectiveness of PrEP usage and decreasing new infections.

What evidence suggests that this trial's treatment could be effective for preventing HIV and STIs?

Research has shown that pre-exposure prophylaxis (PrEP) is a strong method for preventing HIV, especially for those at higher risk, such as black, cisgender, and transgender women. Studies have found that taking PrEP daily can lower the chance of getting HIV from sex by about 99%. The Camellia Cohort study, which is the focus of this trial, aims to learn how women at high risk use PrEP and what factors influence its use. This research seeks to improve HIV prevention and guide future efforts. Early results from the study suggest that using technology, like mobile health apps, can help keep women involved in their PrEP care. ^{1 3 4 6 7}

Who Is on the Research Team?

Lynn T. Matthews, MD, MPH

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This study is for cis and trans-gender women aged 18-50 living in Alabama who have had an STI recently but are currently HIV negative, gonorrhea and syphilis free, and own a private smartphone.

Inclusion Criteria

I identify as a cisgender or transgender woman.

You live in Alabama.

You do not have HIV when tested during the screening process.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Assessment

Participants are enrolled and baseline data is collected using a mobile health app

4 weeks

1 visit (virtual)

Longitudinal Follow-up

Participants are followed longitudinally to assess factors associated with STI/HIV infection and PrEP use

24 months

Ongoing virtual assessments

Follow-up

Participants are monitored for safety and effectiveness after the main study period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Camelia Cohort

Trial Overview The CAMELLIA Cohort study aims to understand sexual health better by tracking the use of PrEP—a medication that prevents HIV—and identifying factors linked to STI risk and HIV prevention among at-risk women.

How Is the Trial Designed?

Group I: Single Arm - CAMELLIA Cohort Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A systematic review identified 16 studies on alternative HIV preexposure prophylaxis (PrEP) care delivery models, highlighting promising approaches like pharmacist prescribers, telePrEP, and mail-in testing to enhance access to PrEP services.

Despite the low risk of bias in most studies, none met the established criteria for evidence-based interventions, indicating a need for further research to validate these alternative models in improving PrEP delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of alternative HIV preexposure prophylaxis care delivery models to improve preexposure prophylaxis services. Kamitani, E., Mizuno, Y., DeLuca, JB., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05463692

CAMELLIA Cohort: A Longitudinal Study to Understand ... 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 ...

2. healthmpowerment.org healthmpowerment.org/wp-content/uploads/2023/05/Camellia-Cohort-Study-Summary-05.09.2023.pdf

Camellia Cohort Study Summary Pre-exposure prophylaxis (PrEP) is an important biomedical HIV prevention tool and may particularly benefit black, cis and.

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1521455/full

Leveraging public health infrastructures to support sexual ... Conclusion: The Camellia Cohort integrates epidemiologic methods, mHealth technology, and data science to better characterize HIV transmission ...

4. reporter.nih.gov reporter.nih.gov/project-details/11172487

RePORT RePORTER - National Institutes of Health (NIH) | Outcomes from this study will help identify gaps in reaching Southern women at highest risk for acquiring HIV and guide future intervention development. NIH ...

5. reporter.nih.gov reporter.nih.gov/search/gVgvM6YLMEKjE_V5-vN_LQ/project-details/10908368

CAMELLIA Cohort: A longitudinal study to ... - NIH RePORTER Outcomes from this study will help identify gaps in Ending the HIV Epidemic initiatives in reaching Southern women at highest risk for acquiring HIV and guide ...

6. reporter.nih.gov reporter.nih.gov/search/U_drVUxUmUCar_zMAMDEBg/project-details/10701932

CAMELLIA Cohort - NIH RePORTER This novel research proposal utilizes a population-based approach to establish a geographically representative cohort of cis- and trans-gender women ('Camellia ...

7. withpower.com withpower.com/trial/phase-sexually-transmitted-diseases-2023-34452

PrEP for HIV and STIs Prevention (CAMELLIA Trial) PrEP has been shown to be a safe method for reducing HIV incidence in various studies, with high rates of retention and preventive care in clinical settings.