1. PrEP and Condom Use
Keri Broadley and John Del Gaizo

2. Research Question & Hypothesis
Does the use of PrEP reduce the utilization of condoms among men who have sex with men?
Hypothesis:
Men who use PrEP fail to use condoms as a preventative measure due to a false sense of security.
What is unique about our study?
There is a gap in literature about an association between condom and PrEP use. There has been some research done on high risk sexual behavior and contraception in heterosexual females, which may be helpful to look at for our study. Not a ton of research has been done on how PrEP can create a false sense of security about contracting other STIs. After meeting with Adam from Palmetto Community Care, he discussed the issue of PrEP users needing PrEP due to already not using condoms.
What is unique about our study?

3. Study Design
Prospective Cohort Study -Recruit sexually active MSM (PrEP and non-PrEP) from Palmetto Community care -Measure incident STD/STI cases at follow-up -Ask those who have been diagnosed with an STD/STI at follow- up about their condom use and why they are not using them, also ask those who have not been diagnosed if they are using condoms
Using Palmetto Community care

4. Measures of Exposure and Outcome
Exposure: Consistent PrEP Use
Takes pills on time, attends follow up appointments, tests regularly.
Outcome: Condom Use
Do you use condoms? Yes/No
Have you been recently diagnosed with any sort of STD/STI? Yes/No
If Yes, what has prevented you from using condoms?

5. Data Collection
We will collect data through questionnaires during each visit. We will also be testing for STIs through lab work. The main exposure variable is PrEP use, which will be defined as whether the patient takes the medication or not. The main outcome variable is whether or not the patient continues to use condoms during intercourse, which will be collected through follow- up visit questionnaires. In order to keep this study anonymous, we will assign each patient a number that will be used in place of their name which will then be used to associate PrEP usage with their lab work.
This outcome is dichotomous, but we will take their responses to the third question into accord when measuring those who do not use condoms. We will use a risk ratio to find the probability of the risk of getting an STI when using PrEP compared to the risk of those who do not use PrEP. A covariate we may take into account is those men who already have had an STI before the initial visit, as they may be seen as less responsible with their sexual health. 

6. Sample Size

7. Problems, Pitfalls, and Limitations
It is crucial to our study that our study subjects remain anonymous. This will be challenging and could present anonymity bias.
It is also possible we run into loss of follow-up due to patients not returning to the clinic to receive another supply of medication.
Due to our study being mainly self-reported, we may run into recall bias.
Also, those who do not effectively take PrEP medication may skew results.
Condom use is a surrogate measure for risky behavior, not complete prevention

8. Sources https://prepfacts.org/prep/the-basics/