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

830 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Camelia Cohort for HIV and STIs prevention?

Research shows that HIV pre-exposure prophylaxis (PrEP) is effective in reducing HIV incidence and has high retention rates in clinical settings, which suggests that similar treatments like Camelia Cohort could also be effective. Additionally, studies indicate that PrEP users often receive appropriate preventive care, such as immunizations and STI testing, which supports its overall effectiveness in real-world settings. ^{1 2 3 4 5}

Is PrEP safe for humans?

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. ^{2 3 6 7 8}

How does PrEP differ from other HIV prevention drugs?

PrEP (pre-exposure prophylaxis) is unique because it is taken by HIV-negative individuals to prevent infection, unlike other treatments that are used after infection. It can be administered as a daily oral pill or through long-acting injectables, offering flexibility in prevention strategies. ^{6 8 9 10 11}

What is the purpose of this trial?

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.

Research Team

Latesha Elopre, MD, MSPH

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study. [2020]

2. Canada pubmed.ncbi.nlm.nih.gov

Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

PrEP Continuation, HIV and STI Testing Rates, and Delivery of Preventive Care in a Clinic-Based Cohort. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Understanding Retention in Pre-Exposure Prophylaxis Care in the South: Insights from an Academic HIV Prevention Clinic. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Systematic review of alternative HIV preexposure prophylaxis care delivery models to improve preexposure prophylaxis services. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Can we screen less frequently for STI among PrEP users? Assessing the effect of biannual STI screening on timing of diagnosis and transmission risk in the AMPrEP Study. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for recurrent sexually transmitted infections among MSM on HIV pre-exposure prophylaxis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

"Yes, I'm interested in taking PrEP!": PrEP interest among women respondents to the European community-based survey "Flash! PrEP in Europe". [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention in Women: Current Status and Future Directions. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

High Adherence to HIV Pre-exposure Prophylaxis and No HIV Seroconversions Despite High Levels of Risk Behaviour and STIs: The Australian Demonstration Study PrELUDE. [2019]