PrEP & Soccer for HIV Prevention

MR
Overseen ByMaria R Velazquez, MPA
Age: 18 - 65
Sex: Male
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a program called PrEP & Soccer helps men learn about and start using PrEP, a medication that can prevent HIV. PrEP & Soccer combines personalized support at select pharmacies with soccer-related activities to make learning about HIV prevention more engaging. The trial will compare this approach to regular health information provided at other pharmacies. Men who might be suitable for this trial include those who have had sex without a condom with multiple partners, have a history of certain sexually transmitted infections, or have shared injection drug equipment. Participants should not have used PrEP in the last six months.

As an unphased trial, this study offers a unique opportunity to engage in innovative prevention strategies and contribute to important research in HIV prevention.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that using soccer as part of a health program is generally safe. In one study, participants in a soccer-based program did not report any major safety issues. Another study found that combining soccer with job training was very engaging and helped reduce substance abuse, indicating it was well-received. While these programs mainly focused on changing behaviors and did not report any negative effects, they do not directly prove the safety of the specific "PrEP & Soccer" treatment. However, PrEP (pre-exposure prophylaxis) is a medication already approved by the FDA for preventing HIV, and its safety is well-documented. This suggests that the components of the intervention are likely safe and well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about using PrEP combined with soccer as a new approach to HIV prevention. Unlike traditional methods that mainly rely on medications or educational brochures, this approach integrates personalized PrEP navigation with engaging, community-focused activities like soccer. This combination not only aims to enhance adherence to PrEP medication but also leverages the social and motivational aspects of sports to encourage healthier behaviors. By making HIV prevention more interactive and supportive, researchers hope to increase PrEP uptake and retention, especially in communities that might not fully engage with standard health information.

What evidence suggests that the PrEP & Soccer intervention could be effective for HIV prevention?

Research shows that using soccer as part of an HIV prevention strategy can be effective. One study found that participants in soccer programs felt more confident about preventing HIV. This confidence, known as "self-efficacy," is crucial because it encourages protective actions. Another study demonstrated that participants were more likely to get tested and receive counseling for HIV due to strong bonds formed between coaches and players. Reviews of multiple studies also support the success of sports-based HIV prevention programs. In this trial, the "PrEP & Soccer" intervention will combine soccer with education about PrEP (a medication to prevent HIV), which could be a promising way to increase awareness and involvement.16789

Who Is on the Research Team?

MR

Mariano R Kanamori, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for men who could benefit from increased knowledge and access to PrEP, a medication that helps prevent HIV. The study will take place at CVS Health pharmacy locations. Specific eligibility criteria are not provided, but typically participants would need to be at risk of HIV infection.

Inclusion Criteria

Provide their informed consent to participate
I haven't had a PrEP prescription for at least 6 months.
I am willing and able to follow all study requirements for its duration.
See 3 more

Exclusion Criteria

Does not self-report any of the following behaviors and/or health conditions: Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia), Sex with a partner who is living with HIV, Sex without a condom with two or more partners whose HIV status were unknown, Injection drug use and sharing injection equipment
Living with HIV (e.g. has received an HIV diagnosis)
Planning to move outside of Miami-Dade or Broward counties in the next 7 months
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Pharmacies assigned to 'PrEP & Soccer' group receive personalized PrEP navigation support

6 months
Regular visits to CVS Health pharmacy locations

Control

Pharmacies assigned to the control group receive a brochure describing services offered by CVS Health

6 months
Regular visits to CVS Health pharmacy locations

Follow-up

Participants are monitored for PrEP knowledge and appointment attendance

6 months
Surveys at baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • PrEP & Soccer
Trial Overview The 'PrEP & Soccer' program aims to boost awareness and attendance for initial PrEP appointments among men through strategies implemented by pharmacy chains. It's being compared with standard information services in a controlled setting where pharmacies are randomly chosen for one approach or the other.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: PrEP & Soccer InterventionExperimental Treatment1 Intervention
Group II: Standard of care (CVS standard health information)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Citations

Utilizing Soccer for Delivery of HIV and Substance Use ...We tested the effectiveness of a behavioral intervention using soccer training to reduce the cluster of risks associated with HIV and substance use.
A randomized clinical trial testing the effectiveness of an ...Results suggest the effectiveness of the intervention on HIV prevention self-efficacy (Table 3). Like other studies, formal education was significantly ...
Effectiveness of Sport-Based HIV Prevention InterventionsRandom-effects meta-analyses were carried out across studies for effects on six categories of HIV-related outcomes. The review identified 952 ...
Using soccer to build confidence and increase HCT uptake ...Overall, significant pre/post improvement was observed (p < 0.001). FGDs suggest participants: valued coach–participant relationship; improved ...
A Cluster Randomized Controlled Trial | AIDS and BehaviorIt is not clear whether 12 month involvement in soccer and prosocial community contact would have better outcomes (less risk and more protective ...
Soccer and Vocational Training are Ineffective Delivery ...These structural interventions were ineffective in addressing young men's substance abuse and risk for HIV. Clinical Trial Registration: This ...
Feasibility of Using Soccer and Job Training to Prevent ...Despite the study's limitations, the soccer intervention with random RDT for alcohol and drugs was highly engaging and successfully reduced substance abuse over ...
A randomized clinical trial testing the effectiveness of an ...Results suggest the effectiveness of the intervention on HIV prevention self-efficacy (Table 3). Like other studies, formal education was ...
(PDF) The outcomes of a sportbased intervention on risky ...There were no significant findigns regarding effect of sport-based HIV prevention programmes on risky sexual behaviours in rural school-going ...
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