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Date of Award

Spring 2020

Degree Name

Master of Medical Science (Physician Assistant)

Department

Physician Assistant; College of Health Sciences

First Advisor

Michael Huber

Abstract

Introduction: Human Immunodeficiency Virus is a disease that has ravaged the LGBT community since the 1980’s. Acquired through contact with blood, semen, pre-seminal fluid, breast milk, and vagina fluid, HIV is a disease that attacks the CD4 cells. Over time, the immune system is weakened so greatly that the body is unable to fend off even the most common opportunistic infections. At this point, individuals are diagnosed with AIDs, defined by either having an AIDS defining infection or having a CD4 count below 200 cells/mm3. In 2012, the FDA approved the use of PrEP (Truvada) as a prophylactic medication taken once a day to prevent the transmission of HIV amongst high risk individuals. Many in the medical community are concerned about the ramifications of such a medication on safe sex practices and STI increases.

Methods: A literature search was conducted in November 2018 using PubMed and Ovid. A total of seven publications consisting of a retrospective cohort study, systemic reviews, a case-crossover study, randomized control studies, and a demonstration study were selected based on publication date, population demographics, relevance to the MSM population. These seven publications were then meticulously studied, analyzing their specific study designs and ultimate findings.

Results: The publications all soundly affirmed the effectiveness of PrEP in preventing HIV transmission amongst MSM. However, the studies differed greatly in their ultimate findings regarding the question in study. One retrospective cohort study found a dramatic increase in STI transmission rates. However, due to the study’s retrospective nature, many extraneous variables were unable to be accounted for. One systemic review of 17 studies found that the use of PrEP was correlated with an increase in Chlamydia infections and increased number of condomless anal sex partners. A case-crossover study however in a Los Angeles LGBT Center found that 72% of study participants on PrEP experienced either no increase or a decrease in STI transmission during the course of the study. A similar finding occurred with a systemic review of 10 randomized control studies which found that there was no significant difference in STI rates between those individuals on PrEP and those who were not. This study goes on to state that participants on PrEP took a more active role in their healthcare and were more likely to participate in testing, treatment, and counseling. Two randomized control studies and a demonstration study further supported this claim finding no change or increase in condomless/unprotected sex amongst individuals after the implementation of PrEP.

Discussion: The lack of long-term randomized control studies makes it difficult to truly test the question of study. While some studies show an increase in STI rates after the implementation of PrEP, the failure to include an adequate randomized sample size and to control extraneous variables makes it very difficult to draw statistically significant clinical conclusions. Additionally, the studies fail to include long-term data. Therefore, it is difficult to make conclusions about lifestyle behavior and long term STI incidence rates. Additionally, the lack of randomized control studies and the failure to control extraneous variables makes it impossible to accurately compare and contrast the different studies. Furthermore, the conflicting findings of each study make it impossible to draw any conclusions and further demonstrate the need for more long-term randomized control studies.

Conclusion: PrEP (Truvada) was approved by the Food and Drug Administration in 2012 as a prophylactic medication to prevent the transmission of HIV infection in high-risk individuals. The MSM (Men who have sex with men) population is considered a high-risk population and has been the target population for PrEP. However, since the medication is so new, minimal studies have been conducted to determine the longstanding effects this medication will have on safe sex behavior and STI transmission rates. The seven studies examined in this review demonstrate conflicting findings and a lack of long-term randomized control studies. Therefore, it is impossible to draw any statistically significant conclusions about this medication’s effects on STI transmission rates in this high-risk group. In the meantime, providers may rely more heavily on patient education and counseling prior to administering this drug to their patients. Long term randomized control studies that allow researchers to control for variables such as race, education level, age, and region of the world will allow researchers to compare results across studies and draw more statistically significant conclusion.

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The Impact of PrEP on STI Incidence Rates Among Men Who Have Sex with Men

Introduction: Human Immunodeficiency Virus is a disease that has ravaged the LGBT community since the 1980’s. Acquired through contact with blood, semen, pre-seminal fluid, breast milk, and vagina fluid, HIV is a disease that attacks the CD4 cells. Over time, the immune system is weakened so greatly that the body is unable to fend off even the most common opportunistic infections. At this point, individuals are diagnosed with AIDs, defined by either having an AIDS defining infection or having a CD4 count below 200 cells/mm3. In 2012, the FDA approved the use of PrEP (Truvada) as a prophylactic medication taken once a day to prevent the transmission of HIV amongst high risk individuals. Many in the medical community are concerned about the ramifications of such a medication on safe sex practices and STI increases.

Methods: A literature search was conducted in November 2018 using PubMed and Ovid. A total of seven publications consisting of a retrospective cohort study, systemic reviews, a case-crossover study, randomized control studies, and a demonstration study were selected based on publication date, population demographics, relevance to the MSM population. These seven publications were then meticulously studied, analyzing their specific study designs and ultimate findings.

Results: The publications all soundly affirmed the effectiveness of PrEP in preventing HIV transmission amongst MSM. However, the studies differed greatly in their ultimate findings regarding the question in study. One retrospective cohort study found a dramatic increase in STI transmission rates. However, due to the study’s retrospective nature, many extraneous variables were unable to be accounted for. One systemic review of 17 studies found that the use of PrEP was correlated with an increase in Chlamydia infections and increased number of condomless anal sex partners. A case-crossover study however in a Los Angeles LGBT Center found that 72% of study participants on PrEP experienced either no increase or a decrease in STI transmission during the course of the study. A similar finding occurred with a systemic review of 10 randomized control studies which found that there was no significant difference in STI rates between those individuals on PrEP and those who were not. This study goes on to state that participants on PrEP took a more active role in their healthcare and were more likely to participate in testing, treatment, and counseling. Two randomized control studies and a demonstration study further supported this claim finding no change or increase in condomless/unprotected sex amongst individuals after the implementation of PrEP.

Discussion: The lack of long-term randomized control studies makes it difficult to truly test the question of study. While some studies show an increase in STI rates after the implementation of PrEP, the failure to include an adequate randomized sample size and to control extraneous variables makes it very difficult to draw statistically significant clinical conclusions. Additionally, the studies fail to include long-term data. Therefore, it is difficult to make conclusions about lifestyle behavior and long term STI incidence rates. Additionally, the lack of randomized control studies and the failure to control extraneous variables makes it impossible to accurately compare and contrast the different studies. Furthermore, the conflicting findings of each study make it impossible to draw any conclusions and further demonstrate the need for more long-term randomized control studies.

Conclusion: PrEP (Truvada) was approved by the Food and Drug Administration in 2012 as a prophylactic medication to prevent the transmission of HIV infection in high-risk individuals. The MSM (Men who have sex with men) population is considered a high-risk population and has been the target population for PrEP. However, since the medication is so new, minimal studies have been conducted to determine the longstanding effects this medication will have on safe sex behavior and STI transmission rates. The seven studies examined in this review demonstrate conflicting findings and a lack of long-term randomized control studies. Therefore, it is impossible to draw any statistically significant conclusions about this medication’s effects on STI transmission rates in this high-risk group. In the meantime, providers may rely more heavily on patient education and counseling prior to administering this drug to their patients. Long term randomized control studies that allow researchers to control for variables such as race, education level, age, and region of the world will allow researchers to compare results across studies and draw more statistically significant conclusion.