Case Studies

Using Prophylactic HIV Medicine to Reduce Infection Risk

The Pre-Exposure Prophylaxis for HIV (PrEP) Among African American Men Who Have Sex With Men (MSM) study investigated the usage of PrEP among young high-risk men. Rupa Patel, MD, MPH, DTM&H, was awarded ICTS pilot funding in 2015 to conduct a quantitative and qualitative study of PrEP uptake by high-risks persons.

Human immunodeficiency virus (HIV) prevention now includes using HIV medications for pre-exposure prophylactics (PrEP) to prevent infection before the exposure happens in high-risk populations.  African American (AA) men, ages 13-35 years, who have sex with men (MSM) have the highest rates of new HIV infections. When taken consistently, PrEP has been shown to reduce the risk of HIV infection in people who are at high risk by up to 92%.1 Little is known about PrEP use by high-risk persons.

The goal of the study was to learn more about PrEP uptake and the reasons for PrEP uptake among young African American high-risk men who were offered PrEP at four different clinics in St. Louis.

Overall, the PrEP study led to expansion of the Washington University School of Medicine in St. Louis HIV Program for additional studies on PrEP uptake, adherence, and utilization leading to opportunities for patients. The PrEP clinic has also served as a model for other clinics in the local St. Louis area, other states, and international settings.

Research Team

Rupa Patel, MD, MPH, DTM&H, Assistant Professor of Medicine, Department of Internal Medicine, Washington University School of Medicine

PrEP service delivery care program was established as a clinic and now serves as a site for PrEP adherence testing using urine and blood biomarkers for pre-exposure prophylaxis. The clinic is also a site for the HIV Prevention Trials Network (HPTN) HPTN 083 Study, a Phase 2b /3 trial.

Benefit Domain Indicator
New diagnostic procedures using urine biomarkers for monitoring of pre-exposure prophylaxis identified. Clinical Icon Diagnostic Procedures
Missouri Pre-Exposure Prophylaxis (PrEP) Implementation Toolkit provides guidance for providers and administrators for PrEP use. Clinical Icon Guidelines
Missouri Pre-Exposure Prophylaxis (PrEP) provides guidance for consumers and providers. Available in English and Spanish. Clinical Icon Guidelines
Rupa Patel helped review the World Health Organization (WHO) Implementation Tool for Pre-Exposure Prophylaxis of HIV Infection. Clinical Icon Guidelines
HIV ORAL PrEP (Mobile Application) contains the WHO PrEP Implementation Tool. Community Icon Software Technologies
Pre-Exposure Prophylaxis (PrEP) contains guidance for consumers and providers. Missouri Department of Health and Senior Services. Available in English and Spanish. Community Icon Health Education Resources
PrEP has the ability to halt transmission of the virus among certain populations and sexual networks. Community Icon Disease Prevention & Reduction
Lack of insurance coverage was identified as a barrier to PrEP utilization. Quantifying how insurance coverage affects PrEP allows for modeling of cost savings and HIV incidence reduction. Community Icon Disease Prevention & Reduction
The Washington University PrEP Clinic is a site for the HIV Prevention Trials Network (HPTN) HPTN 083 Study, a Phase 2b/3 trial. HPTN 083 is evaluating the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for pre-exposure prophylaxis in HIV-uninfected men and transgender women who have sex with men (MSM and TGW). Community Icon Disease Prevention & Reduction
The PrEP clinic site has been used to advise other clinics in the local St. Louis area, state-level Missouri area, and also in African international settings. Community Icon Community Health Services
Established a simplified renal monitoring baseline to allow for same-day PrEP prescribing and reducing the need for testing procedures, staffing, and cost burden during PrEP implementation. Community Icon Health Care Accessibility
Developed and tested PrEP@Home, a home care system that includes all components of a PrEP follow-up visit and is designed to reduce annual in-person PrEP clinician visits from 4 per year to 1 per year. Community Icon Health Care Accessibility
Developed a pharmacy-based model for delivery of PrEP based on collaboration with Gateway Apothecary, a community pharmacy. Gateway Apothecary conducts HIV testing, kidney monitoring, PrEP adherence, and risk reduction counseling. Community Icon Health Care Delivery
Dr. Patel is a member of the World Health Organization (WHO) Technical Advisory Group (TAG) for PrEP. Community Icon Committee Participation
Dr. Patel is an advisor for PrEP Clinical Services to JHPIEGO, BRIDGE to SCALE grant (Gates Foundation). Community Icon Committee Participation
Dr. Patel served as an expert witness for a criminal trial case. Policy Icon Expert Testimony

Benefits of the PrEP study have been observed in three TSBM domains since 2015. The PrEP study led to development of guidelines and a mobile application2 for health care providers,3,4 administrators and consumers,5 and identification of strategies for successful implementation of PrEP uptake and prevention of disease as well as barriers to PrEP usage. New investigative and diagnostic procedures using urine biomarkers for pre-exposure prophylaxis have been identified.6 Tools for adherence-pharmacy measures using urine and blood biomarkers to determine the level of protection a patient has from acquiring HIV are in process. PrEP@Home, a home care system that includes all components of a PrEP follow-up visit was developed and tested.7 The study also established a simplified renal monitoring baseline to allow for same-day PrEP prescribing, and reducing the need for testing procedures, staffing and cost burden during PrEP implementation.8 The PrEP clinic is now a site for the HIV Prevention Trials Network (HPTN) HPTN 083 Study, a Phase 2b /3 trial.  HPTN 083 is evaluating the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for pre-exposure prophylaxis in HIV-uninfected men and transgender women who have sex with men (MSM and TGW).

The PrEP study also led to studies on barriers to PrEP utilization and disparities in insurance coverage. Quantifying how insurance coverage affects PrEP allows for modeling of cost savings and HIV incidence reduction to enhance implementation and PrEP utilization.9 Dr. Patel also collaborated with Gateway Apothecary, a community pharmacy, to develop a pharmacy-based model for delivery of PrEP. Gateway Apothecary conducts HIV testing, kidney monitoring, PrEP adherence and risk reduction counseling.10

Dr. Patel serves on several committees: the World Health Organization technical advisory group for Pre-Exposure Prophylaxis (PrEP);11 and the HIV pre-exposure prophylaxis (PrEP) Clinical Services Advisor to JHPIEGO, a non-profit organization affiliated with Johns Hopkins University, for the BRIDGE to SCALE grant (Bill and Melinda Gates Foundation).12

Dr. Patel’s involvement in PrEP has resulted in a consulting position for the DREAMS Project in Namibia, a partnership to reduce HIV infections among adolescent girls and young women in 10 sub-Saharan  African countries.13 She also consults for PrEP programs in Brazil, South Africa, Kenya and India. Dr. Patel’s roles on these efforts include creating clinic protocols, provider training, and revising international PrEP guidelines.14 She has also testified as an expert witness about HIV and PrEP for legal cases involving the transmission of HIV.15


References

  1. United States Public Health Service: Pre-Exposure Prophylaxis for the Prevention of HIV. Available from https://www.cdc.gov/hiv/risk/prep/.
  2. HIV ORAL PrEP (Mobile Application), 2008. Available from https://itunes.apple.com/us/app/hiv-oral-prep/id1233271674?mt=8.
  3. Missouri Pre-Exposure Prophylaxis (PrEP) Implementation Toolkit. Washington University in St. Louis School of Medicine. August 2017. Available from https://infectiousdiseases.wustl.edu/wp-content/uploads/2017/08/Missouri-PrEP-Implementation-Toolkit_WashU_8-23-17_rev.pdf.
  4. World Health Organization. WHO Implementation Tool for Pre-Exposure Prophylaxis of HIV Infection, 2017. Available from http://www.who.int/hiv/pub/prep/prep-implementation-tool/en/.
  5. Missouri Department of Health and Senior Services. Pre-Exposure Prophylaxis (PrEP). No date. Available from https://health.mo.gov/living/healthcondiseases/communicable/hivaids/prep.php.
  6. Patel R, Amico R, Harrison L, et al. Associations between Urine Tenofovir Levels, Pharmacy Measures, and Self-Report for HIV Pre-Exposure Prophylaxis Adherence Monitoring. 12th International Conference on HIV Treatment and Prevention Adherence. June 2017, Miami, Floriday. Available from https://www.iapac.org/AdherenceConference/assets/Adherence2017_Abstracts3.pdf.
  7. Siegler A, Mayer K, Lie A, et al. Developing and assessing the feasibility of a home-based preexposure prophylaxis monitoring and support program. Clinical Infectious Diseases, 2018. Available from https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciy529/5049132.
  8. Hevey M, Crane J, Patil S, Patel R. No Discontinuations of TDF-based PrEP Use Due to Changes in Renal Function in a Longitudinal Clinical Cohort. Abstract presented at the 2018 HIVR4P Conference, Madrid, Spain. 
  9. Patel RR, Mena L, Nunn A, et al. Impact of insurance coverage on utilization of pre-exposure prophylaxis for HIV prevention. PLoS One. 2017 May 30; 12(5): e0178737.
  10. Rupa Patel, MD, will be a speaker at CDC and CPN PrEP webinar, June 22. June 2, 2017. Available from https://infectiousdiseases.wustl.edu/rupa-patel-mdmph-dtmh-assistant-professor-director-prep-program-will-speaker-cdc-cpn-sponsored-webinar-pharmacy-based-preexposure-prophylaxis-prevention-h/.
  11. Dr. Rupa Patel Joins WHO Technical Advisory Group as PrEP Expert. August 29, 2016. Available from https://infectiousdiseases.wustl.edu/dr-rupa-patel-joins-technical-advisory-group-prep-expert/.
  12. Rupa Patel, MD, MPH, DTM&H named advisor to the pre-exposure (PrEP) Clinical Services of JHPIEGO. September 27, 2016. Available from https://infectiousdiseases.wustl.edu/rupa-patel-md-mph-dtmh-named-advisor-pre-exposure-prep-clinical-services-jhpiego/.
  13. Patel recognized in Business Journal’s ’40 Under 40′. March 31, 2018. Available from https://infectiousdiseases.wustl.edu/wp-content/uploads/2018/06/vol-13-no-1.pdf.
  14. Gateway to Care: Rupa Patel, MD is fighting social stigma and barriers to prevent HIV infections worldwide. June 28, 2017. Available from https://infectiousdiseases.wustl.edu/gateway-care-rupa-patel-md-fighting-social-stigma-barriers-prevent-hiv-infections-worldwide/.
  15. State of Missouri v. Michael L Johnson, Case No. 1311-CR05915-02, (Criminal Court for the 11th Judicial Circuit, St. Charles County, Missouri).


 

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