Category 1: PrEP Support Demonstration Projects prioritizing men who have sex with men and transgender persons at high risk for HIV infection, particularly persons of color

Early strategies and activities (within the first project year) include:

• Create new or expand existing partnerships with CBOs, LGBT organizations, private health care providers, clinics and community health centers to increase PrEP implementation
• Identify and convene Community Advisory Boards and other community engagement activities with goal of increasing PrEP implementation
• Develop provider buy in and support for PrEP implementation
• Develop local evaluation framework for activities
• Assure compliance with CDC/NCHHSTP Security and Confidentiality Guidelines across all programs

Later strategies and activities include:

• Training clinicians and counselors to provide education on PrEP
• Develop policies that facilitate PrEP implementation
• Create PrEP educational and online/mobile tools for provider and consumer
• Develop and conduct PrEP media campaigns for providers and consumers
• Use Disease Intervention Specialist to refer consumers to PrEP services
• Refer consumers to PrEP services
• Provide screening for indications for PrEP as a routine procedure in conjunction with receiving HIV-negative test results
• Enhance PrEP activities through integration with STD and Hepatitis screening services
• Refer consumers to PrEP services
• Developing procedures for HD staff to help providers and consumers navigate public/private programs that provide or reimburse for PrEP

Category 2: Data to Care Demonstration Projects that use surveillance data that prioritize identifying HIV-diagnosed men who have sex with men and transgender persons who have sex with men

Early strategies and activities (within the first project year):

• Create new or expand existing partnerships with CBOs, LGBT organizations, private health care providers, clinics and community health centers to increase linkage and re-engagement efforts
• Identify and convene Community Advisory Boards and other community engagement activities to increase awareness of the importance of linkage and re-engagement in achieving viral suppression
• Develop provider buy in and support for using HIV surveillance data to link and re-engage HIV-diagnosed MSM and transgender persons in HIV care and achieve viral suppression
• Develop local evaluation framework for activities
• Assure compliance with CDC/NCHHSTP Security and Confidentiality Guidelines across all programs
• Review state or local laws and regulations affecting collection and use of HIV surveillance data if funded for data to care activities

Later strategies and activities include:

• Develop organizational procedures, policies and protocols to use HIV surveillance data to link and re-engage HIV-diagnosed MSM and transgender persons in HIV care and achieve viral suppressio
• Develop confidential lists of persons not in HIV medical care from routinely collected HIV surveillance data (Data to Care)
• Develop agreements for data sharing across programs when necessary for the purposes of Data to Care
• Enhance Data to Care activities through integration with STD and Hepatitis surveillance data and referrals via existing programs to help identify MSM and transgender persons who are not in HIV care
• Enhance capacity to implement Data to Care activities through staff training, hiring new staff or redirecting staff activities, working with CBO or other efforts that build capacity to implement robust Data to Care activities

Grantees allocated 10 percent of their total award towards conducting monitoring and evaluation activities. Program performance will be assessed using short and intermediate outcome measures. CDC is working collaboratively with grantees to develop key evaluation questions, establish relevant measures, and identify data sources for routine reporting. Guidance on program monitoring and evaluation and evaluation measures will be provided throughout the project period.

As a demonstration project, Project PrIDE provides additional support to participating grantees to identify promising strategies that may be implemented or scaled up in other jurisdictions. Consistent with the National HIV/AIDS Strategy, CDC’s Division of HIV/AIDS Prevention has supported many projects that advance CDC’s High Impact Prevention strategy. This approach encourages using evidence-based strategies when available and improving targeting of resources to achieve a greater population impact (see Purcell, McCray & Mermin, 2016).

This project will expand upon efforts to scale up and implement promising public health strategies to improve outcomes along the HIV continuum of care and prevent new HIV infections. Lessons learned from this project will inform other grantees about implementing PrEP and Data-to-Care activities as part of their local HIV prevention efforts. This project builds upon current DHAP HIV prevention programs, projects, and technical assistance efforts including:

• CDC-RFA-PS-12-1201, “Comprehensive HIV Prevention Programs for Health Departments”
• CDC-RFA-PS10-10181, “Enhanced Comprehensive HIV Prevention Planning and Implementation for Metropolitan Statistical Areas Most Affected by HIV/AIDS”
• CDC-RFA-PS-12-1210, “Secretary’s Minority AIDS Initiative Funding for Care and Prevention in the United States (CAPUS) Demonstration Project”
• CDC-RFA-PS13-1302, “ National HIV Surveillance System (NHSS)”
• CDC-RFA-PS14-1403, “Capacity Building Assistance for High-Impact HIV Prevention”
• CDC-RFA-PS14-1410, “Secretary’s Minority AIDS Initiative Funding to Increase HIV Prevention and Care Service Delivery among Health Centers Serving High HIV Prevalence Jurisdictions” (expired)
• CDC–HCVJB2X2–2013-60075, “Data to Care: Providing technical assistance to state and local public health jurisdictions in their use of HIV surveillance data to support continuous, high-quality care for persons living with HIV
• CDC-RFA-PS15-1509: Health Department Demonstration Projects for Comprehensive Prevention, Care, Behavioral Health, and Social Services for Men Who Have Sex with Men (MSM) of Color at Risk for and Living with HIV Infection”
• CDC-RFA-PS15-1510: “Health Department Demonstration Projects for Comprehensive Prevention, Care, Behavioral Health, and Social Services for Men Who Have Sex with Men (MSM) of Color at Risk for and Living with HIV Infection”

CDC’s Capacity Building Branch (CBB) funds multiple organizations (CBA providers) to deliver assistance that will build the capacity of health departments to provide PrEP services and Data to Care strategies. The following organizations have been funded by CBB (under Program Announcement PS14-1403) to offer capacity building assistance to Health Departments on PrEP and Data to Care:

PrEP

PrEP CBA providers include the City and County of San Francisco and the University of Rochester.
PrEP-related technical assistance and capacity building includes behavioral risk screening, planning, implementation and adaptation, recruitment and retention of clients, and monitoring and evaluation.

Data to Care

Data to Care CBA providers include the City and County of San Francisco, University of Rochester, University of Washington, NASTAD and New York City Department of Health (NYCDOH).
Data to Care-related technical assistance and capacity building include using HIV surveillance to identify persons not engaged in medical care, planning and implementation, and monitoring and evaluation.

What national efforts are being made to support young people’s confidentiality taking PrEP while on their parents/guardians health insurance, as PrEP related services are disclosed on Explanation of Benefits to insurance policy holders?

• State insurance regulations apply to this situation. It not only affects PrEP but all services received by young adults being covered by parental insurance. This should be discussed with the state insurance officials.

Are there any national updates or timelines expected in permitting the prescribing of PrEP to young people under the age of 18?

• The major issue is about the circumstances in which each state/jurisdiction permits non-adult persons to autonomously consent to medical care without parental/guardian consent. Your health department can tell you the age at which parental/guardian consent is no longer required, and the specific conditions for which it is waived in your respective state.
• Safety data on PrEP use in persons younger than 18 is being collected now in safety trials. When the trials are concluded, FDA will consider whether to approve a labelling indication for adolescents and of what ages. Until FDA approves it, medication assistance programs do not cover adolescents.

How is PrEP being promoted by the CDC for use in women (marketing strategies, etc.)?

• CDC is providing webinars and provider training about PrEP for women.

Does the CDC anticipate there will be barriers for women’s access to PrEP and financial assistance? If so, what are they, and how will they be addressed?

• The major barrier at the moment is low awareness of PrEP among women who might benefit from its use. Women are more likely to be insured and since both public (e.g., Medicaid) and private insurers are covering PrEP, they do not appear to have any special financial barriers to PrEP.

What are CDC’s ideas about increasing the capacity among the provider community to assess and provide PrEP to those eligible?

• See responses below regarding training and technical support.

What can be done to address the spike in STIs seen in those on PrEP?

• There is no spike in STIs seen in those on PrEP. STI rates in MSM particularly have been rising rapidly well before PrEP started being used. STIs are an indication for prescribing PrEP and those taking it continue to have substantial rates of STIs. This is in part because persons taking PrEP are being tested more frequently because of the regular screening recommended (most GC, CT, and syphilis doesn’t cause symptoms) and more sensitive tests are recommended. STI rates are not falling among PrEP users despite treatment likely because of further decline in condom use. Condom use was also falling well before PrEP use began and PrEP is generally not indicated for persons who always use condoms.
• Clinicians should encourage condom use for STI (and pregnancy) prevention in PrEP users.

What are the CDC recommendations for supporting individuals on PrEP who do not want to use condoms as a part of their PrEP program?

• Clinicians should encourage condom use for STI (and pregnancy) prevention in PrEP users.

What does the CDC see as the future of community-based HIV/STI testing programs in the environment of PrEP treatment?

• It is critical to closely ally these two important health services. Community-based HIV/STI testing programs can effectively identify persons who would benefit from PrEP and link them to STI, PrEP, or HIV care as testing indicates.

Is the CDC seeing PrEP use evenly distributed around the country or concentrated in certain geographic areas?

• PrEP use is increasing in all regions of the US. It is not increasing as much in some high incidence populations, for example, in African American and Hispanic MSM in the southern states.

What training and technical support does the CDC offer to medical facilities/doctors (outside of Infectious Disease doctors) to understand PrEP?

• CDC is working with primary care associations, journals, and conferences to increase awareness of PrEP and how to deliver PrEP care.
• CDC is conducting webinars for clinicians through medical education channels (e.g., MEDSCAPE), through federal training centers (e.g., AETC and PTC), and through funded partners (e.g., NACCHO, NASTAD, health departments).
• CDC has funded the National Clinician’s Consultation Center to operate a website (http://nccc.ucsf.edu/clinician-consultation/prep-pre-exposure-prophylaxis/) and toll-free advice line for clinicians (PrEPline, 855-HIV-PrEP, 855-448-7737) to get near real time answers to questions about PrEP, how to determine indications for it, and how to provide the care associated with PrEP.
• CDC has funded national CBA providers for health care organizations who all conduct trainings on PrEP for clinicians.
• CDC has published clinical practice guidelines for PrEP and other resources for clinicians (e.g., patient handouts and brochures) on its website

What are the general CDC strategies planned to reach out to People of Color (POC) in need of PrEP?

• CDC is including PrEP messages in all of its prevention media campaigns including those targeting communities of color.
• CDC is funding health departments (15-1509) to make PrEP more available to African American and Hispanic MSM in jurisdictions with high burden of new HIV infections in these populations

What does CDC know about the lack of candid and truthful discussions around non-condom use for MSM at all levels of our healthcare system, as being the biggest barrier to reducing, if not eliminating HIV and new infections of other STIs? And what is being done about it?

• CDC assesses barriers/facilitators and rates of condom use in many ways, for MSM and other sexually active populations.
• CDC provides training for HIV prevention workforce on condom education and promotion
• CDC provides funding to health departments to increase the availability of free condoms at both clinical and community sites.

How does the CDC support men who have sex with men who are informed about PrEP, but who chose not to follow CDC recommendations of condoms and/or PrEP?

• CDC’s activities are focused on making prevention options available to all who will benefit from then and increasing awareness of the options and how to access them. Individuals make the choice of which method or mix of methods they use to protect themselves. This decision making will often be done in discussion with HIV prevention counselors and/or health care providers.