HIV PrEP Framework

Federal Efforts to Scale Up PrEP and Reduce New HIV Infections

The federal government’s comprehensive framework to improve access to pre-exposure prophylaxis (HIV PrEP Framework) serves as a blueprint for federal activities to scale up PrEP as a strategy to prevent HIV transmission and reduce new infections in the United States.

PrEP is a highly effective prevention strategy for people who are at very high risk of getting HIV. It involves taking a pill every day. Daily PrEP can reduce the risk of HIV by more than 90 percent. Given the strength of the scientific evidence and its ability to reduce new HIV infections, the National HIV/AIDS Strategy recognizes the importance of PrEP. It calls for full access to comprehensive PrEP services for those for whom it is appropriate and desired, along with support for medication adherence for those using PrEP. The indicators used to monitor annual progress toward achieving the goals of the Strategy now includes a measure of the number of persons prescribed PrEP. It calls for an increase of at least 500 percent, from the baseline of 9,375 persons in 2014 to 56,250 persons in 2020.

The HIV PrEP Framework is a model that highlights what is currently being done across federal agencies and programs and what additional activities need to be implemented to improve the awareness, use, and monitoring of PrEP and decrease new HIV infections among those persons at very high risk who aim to take personal responsibility for protecting their health.

There has been concerted effort across the federal government to scale up PrEP. Subject matter experts in HIV prevention and care from 12 Federal departments and agencies developed the HIV PrEP Framework under the direction of the National HIV/AIDS Strategy Federal Interagency Workgroup. These experts provided information about major PrEP-related activities that were planned or already underway within their agencies and programs, reviewed these activities and identified new opportunities for collaboration, and defined the essential components of a comprehensive effort to increase the effective use of PrEP.

 

 

The resulting HIV PrEP Framework has seven essential components describing the major elements of a comprehensive federal response. The Framework allows for these activities and the roles of each department and agency to be easily described, opportunities for collaboration and potential duplication to be discovered, and potential gaps to be identified and addressed going forward. The essential components of the HIV PrEP Framework are:

Policy, Practice Guidelines, and Program Guidance

Communications to the General Public and Persons at Increased Risk of Acquiring or Transmitting HIV

Training and Technical Assistance to Health Care Providers, Grantees, and Others

PrEP Programs to Improve Access, Use, and Adherence

Monitoring and Evaluation

Research

Finance

Federal departments and agencies have implemented a wide range of activities related to all seven of the essential components of the HIV PrEP Framework. More than 60 PrEP-related activities were identified. Some of these actions, as well as the development of the HIV PrEP Framework itself, were previously committed to as part of the National HIV/AIDS Strategy Federal Action Plan. Other actions represent additional activities that complement and go beyond those in the Federal Action Plan. A subset of these activities, organized by the essential components, is described in this document (PDF 217 KB).

Potential Gaps

An important feature of the HIV PrEP Framework is that it helps identify potential gaps in federal efforts to scale up PrEP. The list of selected activities for each of the essential components reveals the following potential gaps and areas for further improvement:

Increase provider training to improve

• Willingness of providers to engage patients about PrEP
• Ability of providers to better identify and screen people who may benefit from PrEP

Improve PrEP uptake by

• Expanding PrEP navigation services
• Addressing disparities across race/ethnicity and age groups

Reduce barriers to PrEP medication by

• Working to Increase the number of effective PrEP formulations that are approved for use (researching, reviewing, and approving other formulations of PrEP; including generic medications)
• Addressing the cost of PrEP, which can be a barrier for those without insurance or with high copays
• Supporting work to assess whether the strength of the evidence suggests that PrEP should be a covered preventive service

In addition, the HIV PrEP Framework suggests potential gaps in Federal efforts to support PrEP adherence among persons who are prescribed PrEP and to expand implementation research to identify best practices and evidence-based models.

Future Directions

A broad array of PrEP-related activities are currently underway across the Federal government. These activities address all seven of the essential components in the HIV PrEP Framework. These activities and other existing data show, however, that there is a continued need to improve these efforts and their reach in order to ensure that our national goals are achieved and that all persons for whom PrEP is appropriate and desired are able to obtain it and use it effectively.

This will require that future PrEP-related efforts must address concerns and issues at the consumer, provider, and system levels. Specifically, interventions must be developed to make it easier for at-risk populations to obtain and adhere to PrEP and to support the efforts of health care providers to identify patients who may benefit from PrEP, assess their need and readiness to take PrEP, and support their adherence to daily medication use. In addition, in developing future activities it is important to continue to solicit input and feedback from stakeholders, grantees, and consumers.

Successfully increasing access to and use of PrEP is a key element for reducing new HIV infections. Indeed, if combined with HIV care and treatment that leads to increasing the number of people living with HIV who are virally suppressed, as many as 185,000 infections could be prevented by 2020.

The HIV PrEP Framework will be maintained and used for planning and assessing progress by the HHS Office of HIV/AIDS and Infectious Disease Policy in coordination with the White House Office of National AIDS Policy as part of ongoing work of the National HIV/AIDS Strategy Federal Interagency Workgroup (co-chaired by OHAIDP and ONAP).

NHAS Federal Interagency Workgroup – PrEP Workgroup

A time-limited subgroup of the National HIV/AIDS Strategy Federal Interagency Workgroup was established in early 2016 to develop the HIV PrEP Framework.

The PrEP Workgroup was comprised of representatives with knowledge of PrEP and related department/agency activities and plans from the following:

The White House

• Office of National AIDS Policy (ONAP)
• Office of National Drug Control Policy (ONDCP)

Department of Defense (DOD)

Department of Health and Human Services (HHS)

• Office of the Assistant Secretary for Health
  • Office of HIV/AIDS and Infectious Disease Policy (OHAIDP)
  • Office on Women’s Health (OWH)
• Centers for Disease Control and Prevention (CDC)
• Centers for Medicare and Medicaid Services (CMS)
• Health Resources and Services Administration (HRSA)
• Indian Health Service (IHS)
• National Institutes of Health (NIH)
• Substance Abuse and Mental Health Services Administration (SAMHSA)

Department of Veterans Affairs (VA)