FALLS CHURCH, VA—The Defense Health Agency (DHA) has released interim guidance designed to optimize clinical use of human immunodeficiency virus (HIV) pre-exposure prophylaxis and reduce variability in access to prophylactic medication.
The directive in early November comes just months after a study in Morbidity and Mortality Weekly Report found that nearly half of military healthcare providers rated their knowledge of pre-exposure prophylaxis (PrEP) as poor and that only 6% of servicemembers likely to be eligible for PrEP had received prescriptions.1
About 350 servicemembers receive a new diagnosis of HIV infection each year. PrEP—a combination of emtricitabine and tenofovir disoproxil fumarate sold under the name Truvada—has a 92% effectiveness rate in preventing HIV infection when taken as directed, according to the U.S. Centers for Disease Control and Prevention (CDC).
“A key goal of the national HIV prevention strategy is effective use of HIV prevention services, including PrEP,” the authors noted.
Researchers led by Jason M. Blaylock, MD, of the Infectious Disease Service at Walter Reed National Military Medical Center in Bethesda, MD, sought to determine how the DoD performed in terms of PrEP use for HIV prevention. They examined military health system records to determine key characteristics of individuals prescribed PrEP between February 1, 2014 and June 10, 2016. The study team also conducted a survey of military healthcare providers about PrEP.
Of the 769 service members without HIV prescribed emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), all but 10 were male and 42% were older than 28, with 57 older than age 40. Forty-seven percent of PrEP recipients were white and 19% were black.
Based on the number of male servicemembers who report having sex with other men (MSM) and the 25% of MSM who typically have a significantly increased risk for HIV, the researchers estimated that 12,000 service members would be eligible for PrEP.
Access Issues
The researchers suggested that several factors might account for the sharp discrepancy between the number of individuals eligible for PrEP and the number who have started it, particularly given the universal access to care provided by the military health system. They noted that “the availability of PrEP services is heterogeneous, based on the individual patient’s geographic location.”
Medical centers located in just three locations—Maryland/District of Columbia; Portsmouth, Virginia; and San Diego, California—accounted for 41% of all PrEP prescriptions. Smaller military medical treatment facilities might not have the access to expedited laboratory testing for HIV required before prescribing PrEP or to ensure that individuals on the therapy have not contracted HIV prior to reauthorizing FTC/TDF, the researchers noted.
Smaller pharmacies also might not have sufficient FTC/TDF on hand to meet patient needs for PrEP, they added. FTC/TDF is also used in HIV treatment and in post-exposure prophylaxis.
The DHA guidance directly addressed some of these issues, calling for all military treatment facility commanders or directors to “provide a pathway for access to HIV PrEP and equal access for military and non-military beneficiaries who are high risk for HIV [acquisition] as detailed in the current Centers for Disease Control guidelines.” The interim procedures memorandum also instructs commanders or directors to provide and document in the electronic medical record the reasons for any denial of PrEP requested by a patient.
While the memorandum calls on all medical treatment facility leaders to ensure that their pharmacies have FTC/TDF available for PrEP, “DHA Pharmacy Operations Division is not aware of any individuals reporting difficulty filling Truvada prescriptions” through the home delivery, retail or military treatment facility channels, said Edward Norton, MSC, acting chief of DHA’s Integrated Utilization Branch, Pharmacy Operations Division in Bethesda, Maryland.
Risk assessment
Sticking to the CDC guidelines to determine which servicemembers have an elevated risk of HIV could present unique challenges within the Military Health Service, the MMWR authors said. Most—but far from all—of the men who began PrEP during the study period did meet the cutoff established to prioritize intensive HIV prevention efforts such as PrEP in the CDC’s guidance for use of the HIV incidence risk index for men who have sex with men (MSM).
Almost nine out of 10 (87%) of those who started PrEP were MSM; 73% reported condomless sex and 30% had exposure to sexual partners with diagnosed HIV infection. The CDC risk index also factors in age and, over the preceding six months, the total number of male sex partners, frequency of unprotected anal receptive sex with any male partner, frequency of insertive anal sex with an HIV-positive male partner, use of amphetamines and use of inhaled nitrites or “poppers.”2
Of the 20% of servicemembers with a recorded MSM risk index score who started PrEP, 72% had a score of 10 or more, indicating a significant risk of HIV infection.
The authors suggested that both the low percentage of PrEP recipients with a recorded MSM risk index score and the 28% of PrEP users with scores below 10 might be attributed to a reluctance to disclose MSM status. “As a result, in the military setting, the risk index alone might not be a reliable discriminator of candidacy for PrEP services,” they wrote.
Other factors that indicate a greater risk of HIV seroconversion include Hispanic or African-American ethnicity, a history of chlamydia, gonorrhea or syphilis; having more than three sexual partners in the preceding month or more than five partners in the previous three months; having the same ethnicity as the last sexual partner; experiencing intimate partner violence; and using methamphetamines or inhaled nitrates in the previous 12 months.3
Not Just a Prescription
As the MMWR authors noted, challenges in expanding access include the need for pre-prescription verification that a patient is HIV negative and reverification of negative HIV status every three months. Those requirements make starting and refilling prescriptions for FTC/TDF more complex than most other medications.
“PrEP is a program—not a simple prescription—so screening is required before someone can obtain it,” explained Eric Garges, MD, MPH, MTM&H, director of Sexually Transmitted Infections Research at the Uniformed Services University of the Health Sciences in Bethesda, Maryland.
In part because of the specific requirements before starting PrEP, the majority of servicemembers who initiated PrEP (60%) did so at an infectious disease clinic. Not all military personnel have easy access to an infectious disease clinic or an infectious disease specialist.
That should not matter, however, Garges told U.S. Medicine. “Servicemembers can and should ask their medical provider about how to access PrEP from their location if they feel that their HIV risk is high enough to warrant a PrEP prescription.” Further, he noted, “an ID provider on site is not a requirement for a PrEP program.”
The DHA memo provides additional clarification, saying that “an optimal HIV PrEP program” should have “a qualified HIV PrEP provider.” Programs should also include clinic staff and providers who can counsel patients on adherence and risk reduction and are culturally competent to provide care to individuals in the lesbian, gay, bisexual and transgendered community. In addition, programs should have administrative and reception staff who know about PrEP services and can direct and schedule patients appropriately. Programs should also have access to the requisite laboratory facilities.
The DHA guidance puts the responsibility for ensuring access to laboratories squarely on the military services. It calls for the services to “provide a pathway, via MTF, service/DoD clinical, reference, or contract lab, for DoD providers and patient beneficiaries to have access to the lab services required for clinical evaluation and monitoring of HIV PrEP.”
At the same time, the guidance recognizes the responsibility of patients, stating that those that agree “to start and continue on HIV PrEP must be available to follow-up with the HIV PrEP provider at the appropriate intervals.”
While PrEP generally would not be initiated during deployments, being on PrEP does not negatively impact a servicemember’s medical readiness status, according to the memo, as the medication can be discontinued. The guidance also notes that taking PrEP “will not be used to deny re-enlistment to members on continuous active duty or deny eligibility for accession.”
1. Blaylock JM, Hakre S, Okulicz JF, et al. HIV Preexposure Prophylaxis in the U.S. Military Services — 2014–2016. MMWR Morb Mortal Wkly Rep 2018;67:569–574.
2. Smith DK, Pals SL, Herbst JH, Shinde S, Carey JW. Development of a clinical screening index predictive of incident HIV infection among men who have sex with men in the United States. J Acquir Immune Defic Syndr. 2012 Aug 1;60(4):421-7.
3. Beymer MR, Weiss RE, Sugar CA, Bourque LB, Gee GC, Morisky DE, Shu SB, Javanbakht M, Bolan RK. Are Centers for Disease Control and Prevention Guidelines for Preexposure Prophylaxis Specific Enough? Formulation of a Personalized HIV Risk Score for Pre-Exposure Prophylaxis Initiation. Sex Transm Dis. 2017 Jan;44(1):48-56.
