Is a One-Shot HIV Therapy on the Horizon?

By: Ranier Simons, ADAP Blog Guest Contributor

The advent of new medicines has been fighting the scourge of the HIV/AIDS epidemic since the world became aware of it in 1981. Since, science has made many advances. Research birthed tests to detect the virus in the blood. Antiviral medications have evolved from AZT, and its serious adverse side effects, to the multi-drug daily one-pill regimens on the market today...and now injectable therapies. Despite all of the advances, there is still no cure. Medical science has made great strides in slowing down the virus and preventing infections in seronegative people. The disease has gone from being lethal to chronic. However, clearing it from the bodies of those currently infected is the goal scientists focus heavily on.

Medical science has turned to exploring genetic interventions when exploring ways to eradicate HIV from the body. Scientists have uncovered the various HIV genes and the viral proteins they produce.[1] This has facilitated the creation of drugs to block some of the virus’ activity inside the body. Now, science is focusing on how to genetically alter the human body to better fight against the virus. 

One such exploratory avenue is the genetic modification of the human immune system. Many people are familiar with the way HIV targets and damages the T-Cells, specifically the CD4 T-Cells. However, other parts of the human immune system are not as well known by the lay public, such as the B-Cells and the complement system. A new study out of Tel-Aviv involves the genetic modification of B-Cells using CRISPR and viral vectors. The future goal is a one-shot treatment for patients with HIV.[2]

Photo Source: Commonwealth Fund

The study examined engineering a person’s own B white blood cells to secrete high levels of anti-HIV antibodies in response to the virus.[2] Scientists have achieved some success in genetically engineering B-cells outside of the body. A few scientists have been able to use B-Cells engineered outside of the body to transplant into disease models with some success. However, the challenge is that using the approach for humans is very complicated. It requires very specialized medical centers, extensive blood compatibility testing of donor cells and recipients, and demanding protocols.[2] 

The promise of the new study out of Tel Aviv is that B-Cells inside one’s own body could be genetically modified. This simplifies the process and guarantees the compatibility of the genetically modified cells. The study was led by Adi Barzel, Ph.D. senior lecturer, and Alessio Nehmad, a Ph.D. student from the school of neurobiology, biochemistry, and biophysics at the George S. Wise faculty of life sciences and the Dotan Center for Advanced Therapies in collaboration with the Sourasky Medical Center.[2]

The process uses viruses in combination with CRISPR technology. CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats.[3] CRISPR technology was developed from how bacteria arm their immune system. The CRISPR technology can specifically identify specific stretches of a genome and cut it open. The Tel-Aviv study involves cutting open the DNA of B-cells and inserting genetic code that makes the cell generate neutralizing anti-HIV antibodies. 

Photo Source: Genetic Engineering & Biotechnology News

Two viral carriers are used to ‘infect’ the B-cells.[4] This is not a harmful infection. The viruses infect the B-Cells then the CRISPR technology cuts into the B-Cell genome and the proper loci (or genetic location). At that point, the genetic “snippet” that codes for the anti-HIV neutralizing antibody is inserted into the genome and closed. Going forward, the cells begin to secrete the new anti-HIV antibodies. Encountering HIV in the blood stimulates the B-Cells replicated and secrete even more neutralizing antibodies. The most crucial note is that when the HIV virus changes or mutates, the newly engineered B-Cells will also change accordingly to fight the new viral variant.

This study is essential as it could lead to a vaccine or one-time treatment. Additionally, the same technology could be developed to treat other infectious diseases or certain cancers caused by viruses, such as cervical cancer.

[1] Li, G., Piampongsant, S., Faria, N.R. et al. An integrated map of HIV genome-wide variation from a population perspective. Retrovirology 12, 18 (2015). https://doi.org/10.1186/s12977-015-0148-6
[2] FCould a One-Shot Treatment for Patients with HIV Be on the Horizon? (2022, June 14). Retrieved from https://www.genengnews.com/virology/hiv/could-a-one-shot-treatment-for-patients-with-hiv-be-on-the-horizon/
[3] Broad Institute. (2022). What is “CRISPR”? Retrieved from https://www.broadinstitute.org/what-broad/areas-focus/project-spotlight/questions-and-answers-about-crispr
[4] Tel-Aviv University. (2022, June 13). A new technology offers treatment for HIV infection through a single injection. Retrieved from https://medicalxpress.com/news/2022-06-technology-treatment-hiv-infection.html

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.   

HIV/AIDS Fireside Chat Retreat in Wilmington, NC Tackles Pressing Issues

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The ADAP Advocacy Association hosted an HIV/AIDS "Fireside Chat" retreat in Wilmington, North Carolina among key stakeholder groups to discuss pertinent issues facing people living with HIV/AIDS. It was the first Fireside Chat in over two and a half years, after they were suspended in response to the ongoing Covid-19 pandemic. The Fireside Chat took place on Thursday, June 16th, and Friday, June 17th. Utilization Management, Ending the HIV/AIDS Epidemic (in the South), and Covid-19's Impact on Public Health were evaluated and discussed by 22 diverse leaders in the fight against the HIV/AIDS epidemic.

Photo Source: Getty Images

The Fireside Chat included moderated white-board style discussion sessions on the following issues:

• Utilization Management: What is its Impact on Patient Access to Care and Treatment — moderated by Murray Penner, U.S. Executive Director, Prevention Access Campaign (PAC)
• Ending the Epidemic (EHE): What is its Impact in the South — moderated by Lee Storrow, National Policy Director, Community Education Group (CEG) & Board Chair, Southern AIDS Coalition (SAC)
• Covid-19: What is its Impact on HIV, Viral Hepatitis, Sexually Transmitted Infections (STIs), and Substance Use Disorder — moderated by Jen Laws, President & CEO, Community Access National Network (CANN) & Board Member, ADAP Advocacy Association

The discussion sessions were designed to capture key observations, suggestions, and thoughts about how best to address the challenges being discussed at the Fireside Chat. The following represents the attendees:

• Guy Anthony, Founder, Black, Gifted & Whole
• De' Shea Coney, HepConnect Coordinator, North Carolina AIDS Action Network
• Tori Cooper, Director of Community Engagement, Human Rights Campaign
• Dawn Patillo Exum, Director of Public Policy, Merck
• Jasmine Ford, HIV Clinical Coordinator, Virginia Department of Health
• Dusty Garner, Board Member, Community Access National Network
• Aquarius D. Gilmer, Associate Director, Corporate Policy & Alliances, Gilead Sciences
• Marcus J. Hopkins, Founder & Executive Director, Appalachian Learning Initiative
• Tim Horn, Director, Health Care Access, National Alliance of State & Territorial AIDS Directors (NASTAD)
• Venton Jones, Chief Executive Officer, Southern Black Policy & Advocacy Network
• Jen Laws, President & CEO, Community Access National Network
• Brandon M. Macsata, CEO, ADAP Advocacy Association
• Judith Montenegro, Program Director, Latino Commission on AIDS
• Murray Penner, Executive Director, North America, Prevention Access Campaign
• Kalvin Pugh, Sr. Manager, Community Engagement at International Association of Providers of AIDS Care
• Alan Richardson, Executive Vice President of Strategic Patient Solutions, Patient Advocate Foundation
• Carl Schmid, Executive Director at HIV + Hepatitis Policy Institute
• Robert Skinner, Advocate — Florida
• Cindy Snyder, Director, Government Relations, ViiV Healthcare
• Lee Storrow, National Policy Director, Community Education Group
• LaWanda Wilkersaon, Advocate — North Carolina
• Joey Wynn, Chairman, Florida HIV/AIDS Advocacy Network (FHAAN)

The Covid-19 pandemic is still ongoing, and accordingly to The New York Times (as of June 14th), “The average number of new cases in the United States fell to 98,867 yesterday, a 2 percent decrease from the day before. Since January 2020, at least 1 in 4 people who live in the United States have been infected, and at least 1 in 330 people have died” (NYT, 2022).

With that in mind, the ADAP Advocacy Association implemented strong Covid-19 safety protocols for the Fireside Chat, which included proof of vaccination/booster, robust self-administered testing (prior to travel, upon arrival, and after returning home), complimentary rapid self-test kits and hand sanitizer for each of the attendees, as well as guidelines for masks on commercial travel to the event, and optional masks during the sessions (which some attendees exercised without feeling shunned). 

At the meeting's outset, a signature fishing vest with its AIDS red ribbon owned by the late Bill Arnold, longtime President & CEO of the Community Access National Network (CANN), was gently placed on one of the chairs in the room. It was meant to symbolize that Bill would always have a seat at the table in an honorary way to pay tribute to the decades of advocacy work done on behalf of people living with HIV/AIDS dating back to the 1980s. There wasn't a dry eye in the room!

Bill Arnold, August 13, 1938 - September 29, 2021

The ADAP Advocacy Association is pleased to share the following brief recap of the Fireside Chat.

Utilization Management (UM):

Murray Penner provided a basic overview on the managed care practice, often referred to as utilization management (or utilization review), used by payers of health services, such as commercial insurance plans, public health programs (i.e., Medicaid, Medicare, Ryan White), Veterans Affairs, and other programs. Today, patients need to be savvy, because the United States has one of the most expensive and fragmented healthcare delivery systems in the world. UM can indeed serve a purpose, but the reality is that purpose if often clouded by the pitfalls.

According to Penner: "UM is a process that payers and healthcare plans utilize to evaluate the medical necessity, appropriateness, and efficiency of the use of health care services (medicines, procedures, etc.). There are valid reasons for UM (particularly medical necessity), but UM is also often used to help contain costs and to deny coverage of high cost meds and procedures in favor of lower cost alternatives. With HIV medications, in particular, it often restricts access to medications that providers and patients have determined as necessary for appropriate care and treatment. UM practices in theory are appropriate for safety and continuity of care, but far too often they have become discriminatory and present challenges to accessing medications and remaining adherent to them."

Penner's discussion on UM started with a broad overview of the practice, including examples, clinical efficacy, and provider feedback. It also included the impacts of UM on patient access, Ending the Epidemic efforts, and viral suppression, as well as the statutory and regulatory protections and limitations. 

Prior authorization is probably the most commonly-known technique exercised by payers, but many others exist. An important part of the conversation centered around a recent survey on prior authorization released by the American Medical Association (AMA), 2021 AMA prior authorization (PA) physician survey.  

The survey found, sadly, that one in four patients often abandon their recommended course of treatment, and a staggering "82% report that PA can at least sometimes lead to treatment abandonment." The survey focused on patient impact, but it also featured relevant information on physician impact and employer impact. The survey results can be found online at https://www.ama-assn.org/system/files/prior-authorization-survey.pdf.

Photo Source: American Medical Association

Patients needing to complete eligibly "recertification" under the State AIDS Drug Assistance Program (ADAP) was also a hot topic of conversation. Most States require the bureaucratic red tape be rolled-out every six months, which is widely accepted as unnecessary. Fortunately, some flexibility was recently authorized by the Health Resources & Services Administration (HRSA) on the ADAP recertification process. The Virginia Department of Health, for example, is extending their program recertification to every 24 months!!!

Other UM-related issues discussed included drug formularies, convoluted Rx refill cycles, safety protections afforded to patients (i.e., drug contraindications), and the "prescriber prevails" provisions under New York Medicaid.

The following materials (partial list) were shared with retreat attendees:

• American Medical Association - 2021 AMA prior authorization (PA) physician survey. American Medical Association
• American Medical Association - Prior Authorization and Utilization
• Centers for Medicare and Medicaid - CCIIO Regulations and Guidance
• Harvard Health Publishing - Do generic drugs compromise on quality? 
• Health Affairs - Quantifying The Economic Burden Of Drug Utilization Management On Payers, Manufacturers, Physicians, And Patients
• Journal of Managed Care & Specialty Pharmacy - The Effect of Formulary Restrictions on Patient and Payer Outcomes: A Systematic Literature Review
• AIDS and Behavior - The Demand for Antiretroviral Drugs in the Illicit Marketplace: Implications for HIV Disease Management Among Vulnerable Populations 
• NBC News - Transgender people report years of battles for health insurance coverage 

The ADAP Advocacy Association would like to publicly acknowledge and thank Murray for facilitating this important discussion.

Ending the HIV Epidemic (in the South):

The Ending the HIV Epidemic (EHE) in the United States initiative has been front and center among HIV advocacy circles since it was announced during a previous president's State of the Union. According to the U.S. Centers for Disease Control & Prevention (CDC), "The EHE initiative is scaling up four science-based strategies that can end the epidemic: Diagnose, Treat, Prevent, and Respond. For maximum impact, CDC is continuing to invest in communities most affected by HIV — to help local HIV programs recover, rebuild, and begin to expand EHE strategies in the wake of COVID-19."

Lee Storrow summarized it more clearly as, "Refocusing limited resources to target the hot spots." Despite the EHE initiative being characterized by some advocates as off to a middling start, it does still represent the first new influx of significant federal dollars in quite some time. Of particular importance to this discussion was EHE's footprint in the South (and Appalachia), which is disproportionately impacted by HIV/AIDS.

Of course, one of the biggest - and still ongoing - topics of intense conversation center around why some apparent hot spots are included under the EHE initiative, while others were excluded. For example, West Virginia. Neither West Virginia nor any of its 55 counties were included as Phase 1 jurisdictions of the EHE initiative. Considering the state has two enduring, intertwined epidemics, West Virginia's exclusion highlighted some of the initiative's shortcomings.

According to Storrow: "The participants of the fireside chat had a wealth of big ideas about how we could make a big impact when it comes to HIV rates in the South and Appalachia. Ending the Epidemic isn’t just a reference to the plan and funding source, it’s a mindset to catalyze new energy and bring new resources to bare to combat HIV. When I was working in HIV advocacy in North Carolina, we took advantage of the moment in time the announcement of the federal EHE created to get new state funding from the NC General Assembly. We’ve got to leave it all on the line and leave no stone unturned to make sure the HIV advocacy community has the resources and tools to get this work done."

Storrow's discussion on EHE (in the South) included a history of the initiative, as well as where we are today fighting the epidemic in the South and in Appalachia. Discussions centered around targets (and whether they'll be met), disruptions caused by Covid-19, state-level EHE plans, and future federal EHE expansion to include other jurisdictions.

Photo Source: ADAP Advocacy Association

Storrow also used the session to raise awareness about the Opioid Settlement Plans that are currently unfolding nationwide. It led to a lively conversation about how those settlement dollars could be leveraged to boost public health programs that specifically impact HIV, viral hepatitis, sexually-transmitted infections, and substance use disorder programs.

Other EHE-related issues discussed included social determinants of health, and ongoing challenges to achieve better health equity.

The following materials were shared with retreat attendees:

• The Hill - Pandemic disrupted HIV prevention efforts, CDC report says
• NPR - Lessons From HIV On Ending The COVID Pandemic
• Office of the Honorable Shelley Moore Capito - CAPITO URGES HHS SECRETARY TO INCLUDE WEST VIRGINIA IN INITIATIVE TACKLING HIV EPIDEMIC; WV initially excluded from federal program aimed at helping communities most affected by HIV
• North Carolina Health News - Mecklenburg among top focus locations in Trump HIV plan
• North Carolina Health News - Zero new HIV cases: the goal for Mecklenburg County
• North Carolina Department of Health and Human Services - NCDHHS Urges Testing During National HIV Testing Day, Releases End the HIV Epidemic Plan
• North Carolina Department of Health and Human Services - NC ENDING THE EPIDEMIC: A Plan to End HIV Together Community-by-Community Hand-in-Hand
• Opioid Settlement Tracker - STATES' OPIOID SETTLEMENT ALLOCATION PLANS

The ADAP Advocacy Association would like to publicly acknowledge and thank Lee for facilitating this important discussion.

Editor's Note: In May 2014, the ADAP Advocacy Association published an issue brief, "THE SOUTHERN EPIDEMIC: Are the South's cultural, political and societal barriers making it difficult for public health programs, such as the AIDS Drug Assistance Programs, to function effectively in this region?" Ironically, many of the topics raised during the EHE (in the South) session were raised nearly ten years ago in our issue brief. The issue brief can be downloaded here.

Covid-19's Impact on Public Health:

In early 2021, Jen Laws penned a blog evaluating the mess being caused by the Covid-19 pandemic. At that time, Laws argued, "Covid-19 has also clearly highlighted the impact of social determinants of health and health disparities of which HIV and HCV [Hepatitis C] advocates have long been aware." He was right, and unfortunately not much as changed 18 months later.

According to Laws: "Public health has taken on new, both exciting and unfortunate, shapes as a result of our collective responses to Covid-19. The expanded use of telemedicine has helped modernize our access to care while also leaving those in more rural areas and impoverished communities of the country at distinct disadvantage due to lack of infrastructure, threatening to widen already existing health disparities. Defining a still shifting landscape as Covid-19 related flexibilities and legal changes, presents numerous challenges to public health as an industry and public health professionals will be digesting these changes and challenges for years, if not decades, to come. This is as true, if not more true, for pre-Covid-19 public health programs focused on infectious disease, including STIs, HIV, and viral hepatitis, as these infrastructures and personnel continue to face uncertain futures in politically hostile environments."

Laws' discussion on Covid-19 impact included background context on the state of public health programs pre-Covid-19, as well as related changes to public health and public health programs. It included discussion on the current and future state of the public health programs important to the HIV community. Some of the key questions asked included: What changes do we want to keep? What changes do we need to do away with? How do we evaluate the paradigm shift in publics' mood toward public health (i.e., anti-science, anti-vaccination)?

Photo Source: CDC

The stated goal of the session was "to define the impacts of COVID-19 on public health infrastructure and programs." It celebrated flexibility and innovation offered by various temporary governmental regulation and the “forced modernization” of health care in many situations – namely, telehealth. Of dire concern, however, are these flexibilities are threatened to end as the public health emergency winds down, including the continuous coverage requirement for Medicaid programs under the public health emergency declaration. Some attendees also stressed that there are downsides to relying on telehealth, especially for rural communities lacking the necessary infrastructure to make health care accessible.

CDC's own HIV surveillance data proves earlier Covid-19 concerns, which was regularly noted.

The following materials (partial list) were shared with retreat attendees: 

• Community Access National Network - Community Roundtable Emphasizes Impacts of COVID-19 (2021) 
• Community Access National Network - Community Roundtable Defines the Shape of Public Health Advocacy Amid COVID-19 (2022) 
• Centers for Disease Control and Prevention - Impact of COVID-19 on STDs. Sexually Transmitted Disease Surveillance 2020
• National Association of County and City Health Officials - NACCHO Requests Protection of Public Health department Officials and Staff from Harassment, Intimidation, and Threats of Violence
• NBC News - Because of Covid, 2020 was a ‘lost year’ in the fight against HIV, report suggests
• Kaiser Health News - Strides Against HIV/AIDS Falter, especially in the South as Nation Battles COVID
• Kaiser Family Foundation - Delivering HIV Care and Prevention in the COVID Era: A National Survey of Ryan White Providers

The ADAP Advocacy Association would like to publicly acknowledge and thank Jen for facilitating this important discussion.

Additional Fireside Chats are planned in September 2022 (Chicago, Illinois).

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Housing Opportunities Missed and Lost

By: Marcus J. Hopkins, Founder & Executive Director, Appalachian Learning Initiative

In December 2021, a Ryan White Part B caseworker contacted me to ask whom I knew in the West Virginia Housing Opportunities for Persons With AIDS (HOPWA) state's office. In the few months prior to this request, the Part B office had been beset with clients reaching out to their Ryan White HIV/AIDS Program (Ryan White) caseworkers in frustration and desperation:

"I've been trying to reach my HOPWA caseworker for three months, and nobody will call me back."

"I filled out the paperwork in June, but I haven't heard anything back, and it’s October."

"My electricity was just disconnected after HOPWA didn't pay the bill for three months."

"I've received an eviction notice after HOPWA didn't pay the rent for two months in a row."

"The sober living facility has told me that if HOPWA doesn’t come through with my rent payments, I’ll have to find another place to live."

It turned out that this inability to reach HOPWA caseworkers was not isolated to clients—the Ryan White caseworkers and West Virginia state officials were unable to get responses, either. In the midst of a global pandemic, when having stable housing meant the difference between being able to quarantine and being out in the elements with no protection, one of West Virginia's HOPWA grantees has all but collapsed, leaving clients scrambling to find solutions to problems they were promised would be solved and other state and federal programs scrambling just as desperately to pick up the pieces.

What is HOPWA, and How Does it Work for Grantees and Patients…or Not?

The HOPWA program was created in 1992 through the AIDS Housing Opportunity Act to address the critical housing needs of lower-income Americans living with HIV and their families (AIDS Housing Opportunity Act, 1992). This Act situated the HOPWA program in the U.S. Department of Housing and Urban Development (HUD), making it one of the only HIV-related services and assistance programs situated outside of the U.S. Department of Health and Human Service (HHS). It is also the only program dedicated to the housing needs of People Living with HIV/AIDS (PLWHA).

HOPWA is funded through two mechanisms:

1. Formula Grants:

Ninety percent (90%) of the allocated HOPWA funds are dedicated to what HUD defines as formula grantees, including states and cities within metropolitan statistical areas or jurisdictions, which either administer the funds themselves or sub-contract with local agencies. Health Centers can partner with these local grantees and agencies. THESE GRANTS ARE NON-COMPETITIVE!

2. Competitive Grants:

Ten percent (10%) of the funds fall under competitive grants, which can be awarded to state and local governments and non-profit organizations. Competitive grants are only awarded when funds are available after formula contracted grants are renewed. This means that funds can be administered by a range of entities for each community, from local HIV/AIDS service providers to city and state housing and community development departments or public health departments, and/or partnerships with health centers. (Corporation for Supportive Housing, 2018).

The funds, themselves, are designated for the following purposes:

• The acquisition, rehabilitation, or new construction of housing units
• Costs for facility operations
• Rental assistance and short-term payments to prevent homelessness.
• The coordination and delivery of support services including (but not limited to):
• Assessment and case management
• Substance abuse treatment
• Mental health treatment
• Nutritional services
• Job training and placement assistance
• Assistance with daily living (HUD Exchange, 2022a)

In 2016, outgoing President Barack Obama signed the Housing Opportunity Through Modernization Act (HOTMA) in an effort to better address housing needs across the various HUD-situated housing programs, including HOPWA (HOTMA, 2016). One of the primary changes to HOPWA included revising the statute to include “people living with HIV” rather than just those living with a clinical diagnosis of "AIDS". This effectively changed the formula from:

• Original Formula - # of cumulative AIDS cases

to:

• Modernized Formula - # of people living with HIV/AIDS (and other factors)

The change to the formula that determines funding essentially means that funds can and will shift according to the geographic jurisdictions with the highest incidence of people living with HIV from year to year. It also set a new baseline for eligible jurisdictions of 2,000 living HIV/AIDS cases. Additionally, it removed the requirement that 25% of funds be distributed to cities based on AIDS incidence and introduced a new requirement that 25% of funds be distributed based on local Fair Market Rents (FMRs) and poverty rates (HUD Exchange, 2017)

Figure 1. HOPWA Formula Modernization Through the Housing Opportunities Through Modernization Act

Source: HUD Exchange, 2017

How HOPWA Works for Grantees But Fails People Living With HIV

From the very outset, it should be made clear that the HOPWA program, along with virtually every resource available on the Internet, is geared not toward PLWHA (read: "clients" or "patients"), but toward Grantees. From the patient's perspective, finding even basic information about the HOPWA program, one’s eligibility for the program, how to apply, whom to contact, or how to resolve issues with grantees is a Sisyphean task. This issue is further complicated by the fact that there are no comprehensive lists of grantees, contact information, service provision, application processes, or housing availability.

Approximately 7% of Ryan White HIV/AIDS Program (RWHAP) clients had temporary housing, and nearly 5% had unstable housing in 2020, with the highest reported housing-insecure age groups being those aged 20-39. Just 72.7% of RWHAP clients experiencing housing insecurity are retained in care. 76.8% of patients experiencing housing insecurity achieved viral suppression in 2020 (Health Resources and Services Administration, 2021). Because of this, stable housing is vital for achieving and maintaining viral suppression in order to decrease the transmission of HIV in the United States.

Most HOPWA grants are non-competitive, meaning that the funds are automatically awarded to specific jurisdictions based on the formula outlined in Figure 1. Those funds are then either administered directly by those jurisdictional governments or regranted and disbursed to contracted organizations within the jurisdiction to provide direct services. The competitive granting process is contingent upon whether or not any funds remain after the non-competitive grants are awarded.

Part of what makes this process frustrating for both patients and grantees is that federal allocations for HOPWA are low relative to the actual cost of housing. For the 2017-2018 Fiscal Year (FY 2017-2018), total HUD funding amounted to $54.66 billion (HUD, 2019b). Of that, $351.5 million—just 0.6% of the total HUD Congressional allocation (Figure 2)—was dedicated to the HOPWA Program (HUD, 2019a).

Figure 2. United States Department of Housing and Urban Development Funding, FY 2018

Sources: HUD, 2019a and 2019b

This low level of federal funding for the only housing program designed explicitly for PLWHA means that grantees are only able to serve a limited number of households (meaning one patient per household). Even if patients are lucky enough to figure out how to apply for the HOPWA program, they are very likely to encounter waiting lists in virtually every jurisdiction. An excellent example of this exists in the state of Delaware:

In 2021, Delaware received a total of $1,951,658 in HOPWA funding (HUD Exchange, 2022b):

• $1,160,648 in Formula grants
• Delaware (Balance of the State) – $336,185
• Wilmington, DE – $824,463
• $791,010 in Competitive grants
• Ministry of Caring (Wilmington, DE)

While Delaware has 3,483 PLWHA living in the state (Delaware Department of Health and Social Services, 2021), its HOPWA program currently serves approximately 150 households—just 4% of the state’s PLWHA population (Delaware HIV Consortium, n.d.). Despite serving just 150 households.

Delaware is one of the more straightforward states to examine. In Ft. Lauderdale, FL, we received reports of 8-year-long waiting lists to fill just a handful of spots. These waiting lists will only grow as PLWHA live longer, earn less, and remain financially eligible for the program.

Attempting to Find Patient-Friendly HOPWA Information

As part of this research effort, the Appalachian Learning Initiative (APPLI, pronounced "apply") conducted a web search to find state-level information about HOPWA programs across the United States and Puerto Rico. Using the search term "[STATE NAME] apply for HOPWA", APPLI searched for state-sponsored websites that provide patient-centered content, including: 

• HOPWA Program Information
• Services Provided
• Eligibility Criteria
• Application Processes
• Required Documentation (e.g., identification, income verification, proof of HIV status, et cetera)
• Regional Office Contact Information
• State Office Listing and Contact Information
• Grantee Listing and Contact Information
• Processes for Client-Initiated Complaints

This search was restricted to state-level sites rather than jurisdiction- and grantee-level websites. While 27 states had websites with patient-centered content, just 8 states (FL, GA, IA, ME, NM, OR, SC, and WA) met at least 6 of the 8 information criteria. Twelve (12) states had no state-level HOPWA information (Figure 3 & Appendix 1). Download Appendix 1.

Figure 3. State Housing Opportunities for Persons With AIDS (HOPWA) Websites

Source: Appalachian Learning Initiative

While most states had some HOPWA information available on state-level websites, just 21 state websites listed the names of HOPWA grantees and subgrantees in the state, and only 18 provided contact information for those grantees. Moreover, only 12 state websites provided information about the application process and/or the documents required to apply. Virtually no website mentioned the number of clients served, the status of waitlists or the current wait times on those lists, or outlined a complaint process for client-initiated grievances (e.g., reporting grantees that fail to remit payments in a timely manner). Another unique factor to illustrate was that, for many states, finding these information points required downloading and searching multipage documents filled with complicated processes clearly designed for grantees, rather than patients (APPLI, 2022).

The Need for a Better Resource

The primary issue that APPLI’s research has uncovered is a vast dearth of patient-centered and patient-friendly information available to PLWHA about the HOPWA program. It is, essentially, a program that serves relatively few clients compared to the number of patients in need of housing assistance. This has created an environment where HIV advocates consistently highlight the need for more funding but rarely examine how PLWHA are impacted by how those funds are allocated, disbursed, and utilized.

With this in mind, the Appalachian Learning Initiative has entered into the planning phase of developing a national HOPWA Directory and a patient-centric HOPWA research initiative.

This idea is in its infancy, but I firmly believe that the patient voice is vital to initiating change, as with most public health issues. There will be obstacles to overcome—funding for these initiatives being one of the greatest—but ensuring that patients are easily able to access information about housing assistance for PLWHA is most certainly worth the effort.

Stay tuned for more information as it becomes available.

References:

• AIDS Housing Opportunity Act, 42 U.S.C. Ch. 131 §§12901-12912 (1992). http://uscode.house.gov/view.xhtml?path=/prelim@title42/chapter131&edition=prelim
• Appalachian Learning Initiative. (2022, June 07). State Housing Opportunity for Persons with AIDS Websites. Unpublished.
• Corporation for Supportive Housing. (2018). HUD Policy Brief: Understanding the Impact and Potential for Health Centers. New York, NY: Corporation for Supportive Housing. https://www.csh.org/wp-content/uploads/2018/03/CSH_HUD-Briefs_-HOPWA.pdf
• Delaware Department of Health and Social Services. (2021, January 22). DELAWARE HIV SURVEILLANCE REPORT FOR CASES DIAGNOSED THROUGH DECEMBER 2019. New Castle, DE: Delaware Department of Health and Social Services: Department of Public Health: Health Data and Statistics: HIV Statistics – Epidemiology/Surveillance Profile. https://www.dhss.delaware.gov/dhss/dph/epi/files/2020hivepiprofile.pdf
• Delaware HIV Consortium. (n.d.). HIV Housing Programs. Wilmington, DE: Delaware HIV Consortium: Housing Programs. https://www.delawarehiv.org/housing-programs/
• Department of Housing and Urban Development. (2019a). FY 2020 CONGRESSIONAL JUSTIFICATIONS: COMMUNITY PLANNING AND DEVELOPMENT: HOUSING OPPORTUNITIES FOR PERSONS WITH AIDS (HOPWA). Washington, DC: United States Department of Housing and Urban Development: Program Offices: Chief Financial Officer: Reports. https://www.hud.gov/sites/dfiles/CFO/documents/2020CJ-HOPWA.pdf
• Department of Housing and Urban Development. (2019b). FY 2020 CONGRESSIONAL JUSTIFICATIONS: INTRODUCTION. Washington, DC: United States Department of Housing and Urban Development: Program Offices: Chief Financial Officer: Reports. https://www.hud.gov/sites/dfiles/CFO/documents/2020CJ-INTRODUCTION.pdf
• Health Resources and Services Administration. (2021, December). Ryan White HIV/AIDS Program Annual Client-Level Data Report 2020. Rockville, MD: United States Department of Health and Human Services: Health Resources and Services Administration: HIV/AIDS Bureau: Division of Policy and Data. https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2020.pdf
• Housing Opportunities Through Modernization Act, Pub. L. No. 114-201, § (a) 130 Stat. 782 (2016). https://uscode.house.gov/view.xhtml?req=%22Housing+Opportunity+Through+Modernization+Act%22&f=treesort&fq=true&num=0&hl=true&edition=prelim&granuleId=USC-prelim-title42-section1437
• HUD Exchange. (2017, July 17). HOPWA Modernization: What Communities Need to Know. Washington, DC: United States Department of Housing and Urban Development: HUD Exchange: Trainings. http://www.meeting-support.com/downloads/244402/10944/PPT%20V2.pdf
• HUD Exchange. (2022a). HOPWA Eligibility Requirements. Washington, DC: United States Department of Housing and Urban Development: HUD Exchange: Programs: Housing Opportunities for Persons With AIDS. https://www.hudexchange.info/programs/hopwa/hopwa-eligibility-requirements/
• HUD Exchange. (2022b). HUD Awards and Allocations: HOPWA. Washington, DC: United States Department of Housing and Urban Development: HUD Exchange: About Grantees: Awards and Allocations. https://www.hudexchange.info/grantees/allocations-awards/?params=%7B%22limit%22%3A20%2C%22COC%22%3Afalse%2C%22sort%22%3A%22%22%2C%22min%22%3A%22%22%2C%22years%22%3A%5B%5D%2C%22dir%22%3A%22%22%2C%22grantees%22%3A%5B%5D%2C%22state%22%3A%22%22%2C%22programs% 

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Ramifications of Pharmaceutical Supply Chain Challenges

By: Ranier Simons, ADAP Blog Guest Contributor

The COVID-19 pandemic has globally brought awareness to many aspects of daily life that previously remained in the shadows, discussed only by select groups of people in siloed industries and centers of knowledge. A spotlight has been shone on food insecurity, lack of infrastructure to effectively manage global public health crises, inequalities regarding social determinants of health, and supply chain issues affecting everything from housing building materials to Starbucks menu ingredients. One serious supply chain pain point is the pharmaceutical supply chain. Drug supply chain issues are more than just an inconvenience, and they can lead to grave harm or death.

Photo Source: theworldcreate.net

Drug supply chain issues come in many forms: production limits, storage, and distribution problems, reduced shipping capacity, and even transportation problems.[1] These problems lead to drug price inflation, the proliferation of counterfeit drugs, the dissemination of contaminated or poorly manufactured drugs, and even extreme shortages, leaving people without needed pharmaceuticals.

Zebra Technologies Corporation conducted a study called the Pharmaceutical Supply Chain Vision, releasing the results on February 8, 2022. The company specializes in technological solutions to workflow concerns. Zebra surveyed over 3,500 patients and pharmaceutical executives to gauge perceptions of the drug supply chain in terms of its resilience, responsibility, and trust and examine ways to improve visibility and transparency.[1] 

The most important issue identified by patients regarding drug supply chain issues is the quality of the pharmaceuticals. Ninety percent desired a guarantee that their medications were not counterfeit, were stored at correct temperatures, and had not been tampered with.[1] Eighty percent of the patients desired to know the country of origin of their medications and the manufacturing standards of those countries.[1] Other significant concerns were drug affordability and shortages. Many reported that their needed medications were often out of stock, and 69% said they feared taking the improper dosage due to misleading or incorrect label information.[1] Seventy percent reported changing medications, pharmacies, or healthcare providers due to drug supply chain issues.[1]

It is of the utmost importance to keep medications safe throughout the supply chain. Patients, healthcare professionals, and pharmaceutical executives agree that transparency and traceability in the drug supply chain are potent solutions to many present problems. Technology can be leveraged to provide tracking of medication shipments, pharmaceutical production workflow from raw material to final product, and even improvements in the ways drugs are produced. 

The only way to improve the status quo is a group concerted effort to report and gather the data. This sort of data needs to be in publicly accessible databases. These databases would bolster consumer confidence as well as enforce accountability for those along the supply chain. The National Academies of Sciences, Engineering, and Medicine (NASEM) recommends that “the FDA make sourcing, quality, volume, and capacity information publicly available for all medical products approved or cleared for sale in the U.S.”[2] 

This sort of information would make it possible to monitor weaknesses in the supply chain and address them. It would also enable predictions of shortages. Moreover, just like credit bureaus, third-party companies could use the data to create rating systems. Rating systems would enable healthcare systems and other large purchasers to make informed decisions to purchase the best possible medications for their populations. This would also create competition among manufacturers giving the incentive to create the best environment for producing and transporting high-quality medicines to patients.[2] There are legal regulatory hurdles to be overcome for such a public repository of information, but it is a very practical solution.

Photo Source: Association for Accessible Medicines

During the pandemic, people living with HIV have been especially concerned about drug shortages for their life-saving antiretroviral medications. In 2020, the ADAP Advocacy Association took action to address those concerns. It contacted antiretroviral drug manufacturers directly to inquire about what steps they were taking to secure the supply.[3] 

The ADAP Advocacy Association contacted AbbVie, Jansen Pharmaceuticals, Gilead Sciences, Merck, Theratechnologies, and ViiV Healthcare, all manufacturers of HIV antiretrovirals. Discussions with the companies resulted in the optimistic projection of no foreseen disruption in their drug supply chain. Brandon M. Macsata, CEO of the ADAP Advocacy Association, stated that “their combined assurances provided significant peace of mind for the people living with HIV/AIDS who we represent, and who rely on these life-saving medications.” 

Continuing to innovate to improve the drug supply chain is not just good for manufacturers' bottom line. It also means improved quality of life and lowered mortality for the global population.

[1] Beusekom, M. (2022, February 24) Patients, pharma execs express low trust in drug supply chains. Retrieved from https://www.cidrap.umn.edu/news-perspective/2022/02/patients-pharma-execs-express-low-trust-drug-supply-chains
[2] Frieden, J. (2022, March 4). How can the U.S. preserve its medical supply chain? Retrieved from https://www.medpagetoday.com/publichealthpolicy/healthpolicy/97524
[3] Macsata, B. (2020, April 24). Nation's HIV drug supply secure despite coronavirus pandemic. Retrieved from https://adapadvocacyassociation.blogspot.com/2020/03/nations-hiv-drug-supply-secure-despite.html

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

The HIV Epidemic Has Not Ended

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

CNN, in collaboration with Gilead Sciences, has produced an inspiring docuseries reminding us that the HIV epidemic has not ended. Blind Angels is "a story of courage, family, and love," according to its producers. It highlights the disproportionate impact in the American South, through the lease of the "leaders working within their communities to fight for the access, education, and resources that will help end the epidemic."

Photo Source: CNN

Blind Angels features six episodes, each dissecting how HIV disproportionately affects already marginalized communities in the South. African Americans, Latino Americans, and transgender women are among the featured populations. 

EPISODE 1: Birmingham, Alabama

Tony Christon-Walker has been living with HIV since a time when treatment options were limited. But he survived. Now, he wants to ensure that the younger generation has access to the tools that can help them live longer, healthier lives.[1] Play Episode 1.

EPISODE 2: Durham, North Carolina

For Latino communities in the South, language barriers, immigration concerns, and other factors can create outsize risk for HIV. But in Durham, North Carolina, two friends are working to see that their community isn’t overlooked.[2] Play Episode 2.

EPISODE 3: Richmond, Virginia

For this activist, making change means wearing many hats. Whether she’s taking the testing to the streets in a custom RV or fighting for political change in city hall, Zakia McKensey never loses sight of her purpose.[3] Play Episode 3.

EPISODE 4: Atlanta, Georgia

Antoinette Jones was born with HIV in 1994. For years, she kept her status a secret. Then she met SisterLove founder Dázon Dixon Diallo, who recognized the devastating impact of HIV on Black women. Today, under Dázon’s mentorship, Antoinette has found her voice, and has joined a community of Black women empowering others to take control of their sexual health.[4] Play Episode 4.

EPISODE 5: Memphis, Tennessee

After facing homelessness, assault, and discrimination, Kayla Gore knows firsthand what it will take to change the startling statistics about HIV in the trans community. Today, in Memphis, she’s making that mission her own—and she’s doing it with a hammer and nails, one tiny house at a time.[5] Play Episode 5.

EPISODE 6: Mississippi

Episode six is not yet available, but it is coming soon!

It is estimated that over 1 million people living with HIV reside in the United States. Disproportionately, it has impacted the American South, but even more profoundly among marginalized communities. CNN's Blind Angels lifts the veil on health equity and the social determinants of health most relevant to providing HIV-related supports and services to these communities.

[1] CNN (2022), Blind Angels. 
[2] CNN (2022), Blind Angels.
[3] CNN (2022), Blind Angels.
[4] CNN (2022), Blind Angels.
[5] CNN (2022), Blind Angels.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.