Thursday, December 1, 2022

Advocacy Needed to Reduce Barriers to Accessing Long-Acting Agent Therapies

By: Ranier Simons, ADAP Blog Guest Contributor

Medical science continues to advance at a rate that outpaces healthcare policy and subsequently healthcare practices. This is especially true regarding novel lifesaving therapies and modalities for chronic diseases such as HIV/AIDS. Treatment for people living with HIV/AIDS (PLWHA) is expensive, long-term, and requires consistency in its administration to be effective. Moreover, antiretroviral medications and other related compounds are rapidly evolving. There have already been challenges to ensure equal access, for all, for established and widely used therapies. The situation is even more dire for some of the newest treatments available. That is why the ADAP Advocacy Association created its ADAP Injectables Advisory Committee

ADAP Update
Photo Source: PRC

The advisory committee was a collaboration of patients, as well as representatives from pharmaceutical manufacturers, advocacy groups, healthcare providers, and pharmacy groups. In August 2022, the advisory committee released its report: HIV LONG-ACTING AGENTS: Policy Considerations for Injectable Therapies under the Ryan White HIV/AIDS Program & State AIDS Drug Assistance Programs. It was in response to the need to reduce the operational burdens and other barriers of ensuring that PLWHA dependent upon the State AIDS Drug Assistance Program (ADAP) for their care receive equal access to newly developed injectable treatments in the same manner as people who are fully insured. The report also addressed barriers experienced under private insurance.

Long-acting agents include more than just antiretroviral therapies, such as Cabenuva, which is used to treat HIV. They also include treatments such as Apretude, an injectable used as PrEP, Egrifta used to reduce visceral abdominal fat as a result of lipodystrophy, Serostim for wasting, and Trogarzo which is intravenous therapy for those with multi-drug resistant HIV infections. 

These therapies are proven to be effective. However, not only are they expensive, but they are logistically challenging for supply and administration even for those who are fully insured. The challenge is even greater for those who utilize ADAP. The report described policy considerations to improve equity of care regarding injectables. Those considerations included discussions of how to reduce provider bias in offering injectable therapy as an option, ways to expand the network of facilities where injections and intravenous therapies can be administered for ADAP recipients, and ways to utilize community level resources for peer education and advocacy. 

Long-acting antiretrovirals
Photo Source: Regional Center for Infectious Disease Research

A very important section of the report involved insurance. ADAP’s have formularies just in the same manner as insurance plans. Moreover, ADAP can use private insurance for patients for medication and can now assist with paying insurance premiums for low-income patients. The report discussed ways to navigate ADAP versus Medicaid insurance coverage for injectables. There was also policy discussion of how to maintain drug formularies to ensure consistent coverage.

HIV long acting agents are powerful tools in the fight against HIV and those utilizing ADAP deserve the same equity of care and access as those who are fully insured with more robust financial means. Whether it be geographical logistical challenges, treatment education deficiencies, supply chain issues, or even provider bias; ADAP recipients have many injection therapy barriers to overcome. The work of the ADAP Injectables Advisory Committee was to define necessary policy changes as well as guide discussions on how organizations can provide more ADAP recipient patient-centered care. Click here to read the report's cover letter, executive summary, and full report.

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. 

Tuesday, November 22, 2022

Giving Thanks

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

In 2021, we started a new tradition by "giving thanks" to the things important to our organization, as well as me, personally. All too often we get caught up in the nuances of our advocacy work, and monitoring the dysfunctional legislative logjam that has become commonplace in our nation's capital (especially, keeping an eye out for dangerous legislation, such as S.4395), as well as chasing potential funders so we can keep the proverbial lights on. This tradition was started, in large part, because we lost our Lion of the modern-day HIV/AIDS advocacy movement: Bill Arnold

Eddie Hamilton (l) with Bill Arnold (r)
Eddie Hamilton (l) with Bill Arnold (r)

Sadly, we lost another giant personality in our ongoing fight to end the HIV epidemic. On July 12th, Edward "Eddie" Hamilton passed from this life into the next, but not without leaving his mark on many of our lives. Eddie was special because held state and local health departments to account; he held commercial healthcare providers and retail pharmacies to account; he held community-based organizations to account; he held advocacy coalitions to account; and he also held all of us to account, always reminding anyone who could hear his voice why we are here doing this work…for the patient. But I'm giving thanks for having known such a wonderful, unique, and complicated human being.

Next, I'm giving thanks to the VOTERS (...well, a majority of them) because they rejected the politics of anger, division, hate, and violence! Our Democracy is too sacred, too important. Two years ago, we witness a former president desperately clinging to power incite a seditious mob to attack the very symbol of our government. The law enforcement sworn to protect our government officials were beaten; people died. Yet, we didn't forget about it and on November 8th, America said...enough!!!

That statement was pretty intense, but it needed to be made.

I'm also giving thanks to Phil, Wanda, Jen, Eric, Lyne, Hilary, Lisa, Glen, Jennifer, Theresa, and Guy. As my board of directors, they embody a commitment to excellence. Some of these folks have served in their leadership role for many years; others, only a few. Collectively they have contributed so much of their experience, knowledge and passion into making the ADAP Advocacy Association more effective as a patient advocacy organization. I'm also giving thanks to our longtime board member, Elmer Cerano, who recently stepped-down from our board of directors after serving for fourteen years! He was our compass, always ensuring that we never veered from the path our mission.

HIV Long-Acting Agents

This year, we embarked on an ambitious project to advance better patient advocacy surrounding access to HIV Long-Acting Agents (LAAs). Our ADAP Injectables Advisory Committee included Michelle Anderson with the Afiya Center, Tori Cooper with the Human Rights Campaign Foundation, Donna Sabatino with The AIDS Institute, Jennifer Eliasi MS, RD, CDN with Theratechnologies, Marcus Hopkins with Appalachian Learning Initiative, Jen Laws with the Community Access National Network (CANN), Warren Alexander O'Meara-Dates with The 6:52 Project Foundation, Dawn Patillo-Exum with Merck, Glen Pietrandoni, R.Ph with Avita Pharmacy, Cindy Snyder with  ViiV Healthcare, Alex Vance with the International Association of Providers of AIDS Care (IAPAC), Marcus Wilson with Janssen Pharmaceutical Companies of Johnson & Johnson, and Joey Wynn with the Florida HIV/AIDS Advocacy Network (FHAAN). I'm giving thanks to each and every one of you for the amazing work you completed on our behalf!

In last year's thankful reflection, I said: "The dogmatic claims that industry funding is paramount to a bride are not only unfounded, they're also unhelpful to our collective efforts to improve access to care and treatment." It still holds quite true, and thus why I'm giving thanks to our industry, and non-industry funders, including AbbVie, AIDS Alabama, Avita Pharmacy, Bender Consulting Services, Brii Biosciences, Bristol-Myers Squibb, Community Access National Network, Gilead Sciences, Janssen Pharmaceutical Companies of Johnson & Johnson, Magellan Rx Management, Maxor National Pharmacy Services Company, MedData Services, Merck, Napo Pharmaceuticals, North Carolina AIDS Action Network, Novartis, Partnership for Safe Medicines, Patient Access Network Foundation, Patient Advocate Foundation, PayPal Giving Fund, Pharmaceutical Research and Manufacturers of America, Ramsell Corporation, ScriptGuideRx, Theratechnologies, ViiV Healthcare, and Walgreens. Giving thanks to our small donors, too. You could donate to so many other charities, yet you choose to support us!

Pa Pa holding Sebastian
Sebastian Ryan Macsata

And once again, I'm giving thanks to my four-year son, Sebastian. Being your Pa Pa is the most joyous part of my life and I couldn't imagine a day without your smile starting off my day. I'm thankful for being able to witness your innocence, because it reminds me that there is still good in this crazy world.

Finally, giving thanks to YOU for reading our blogs every week. Happy Thanksgiving!

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.  

Thursday, November 17, 2022

Gay and Bisexual Youth Account for Almost 80% of all New HIV Infections Among Their Age Cohort

By: Ranier Simons, ADAP Blog Guest Contributor

The HIV epidemic is far from over. In spite of advances in antiretroviral drug treatment regimens, public-private funding partnerships, and continued outreach and education efforts; the number of new HIV infections each year remains unacceptable. In 2020, 30,635 people aged 13 and older received an HIV diagnosis in the United States.[1] The age group 13-24 accounted for 57% of new diagnoses.[1] Moreover, among teens, gay and bisexual youth account for almost 80% of all new HIV infections.[2] Public health initiatives and advertising have targeted adults but have been lacking in regard to teens and youth.

Three gay, young men sitting on the floor
Photo Source: HIV Plus Magazine

A recent three-month study, published in the journal AIDS and Behavior, attempts to explore ways to effectively reach part of this group, specifically gay and bisexual young men. The premise is that parents can be used as an effective resource to prevent HIV in this demographic. David Huebner, Professor of Prevention and Community Health at the Milken Institute School of Public Health, George Washington University with a team gathered 61 parents of cisgender sons aged 14-22 who had come out as gay or bisexual at least one month before the study. Set up as a randomized trial, the study split the parents into two groups. In the control group, parents watched a 35-minute documentary that was designed to help parents understand and accept their gay children.  The other group was enrolled in an online program called PATHS (Parents and Adolescents Talking about Healthy Sexuality).[2] The program consisted of videos and structured instruction to help parents more effectively communicate with their gay or bisexual sons about staying healthy and how encourage sexual health. 

Infographic on "What Young Men Who Have Sex  With Men Need"
Photo Source: National Minority AIDS Council

The instruction took into consideration that the parents were not a monolith and had differing levels of comfort in communicating with their children. Thus, the tasks the parents were given allowed some parents to be more indirect and others to be more direct. For example, for educating their sons about condom usage, parents could either text their sons an instructional video or they could physically demonstrate how to properly apply a condom using a banana. In regards to HIV, parents had the option of sending their sons a fact sheet about the risks of HIV or actually sitting down with them and reviewing it together. Most importantly, parents were educated on how to help their sons get HIV tests and why regular testing is important.

The study showed that parents who were engaged in the online program had more quality interactions talking with their sons about sexual health and helped their sons obtain HIV tests than the parents who were simply shown the documentary on acceptance. The research team wants to show that direct intervention with parents will result in better sexual health outcomes for the gay and bisexual sons. With funding from the National Institute of Mental Health, a larger study will be done. This study will be a year-long study of 350 parent-adolescent dyads to see if structured parental instruction actually reduces HIV risk for gay and bisexual adolescent men.

National Youth HIV/AIDS Awareness Day
Photo Source: HIV.gov

April 10 is National Youth HIV/AIDS Awareness Day (NYHAAD). It is designed to raise awareness about the impact of HIV on young people. HIV.gov offers numerous resources and tools to leverage digital communication tools and social media to reach out to youth with prevention, testing, and care messages.

Parents are a previously untapped resource to utilize in HIV prevention efforts among young gay and bisexual males. It is important to not only facilitate changing parents attitudes and understanding of their gay and bisexual sons, but to teach them the actual tools necessary to effectively intervene in the youth’s lives. Multilevel life skills intervention in the home will hopefully lead to better sexual health choices and outcomes as the youth navigate the world around them.

[1] HIV.gov.(2022, October 27). U.S. Statistics. Retrieved from https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics
[2] Henderson, E. (2022, November 2022). Parents represent a promising resource in preventing HIV among gay and bisexual male youth. Retrieved from https://www.news-medical.net/news/20221110/Parents-represent-a-promising-resource-in-preventing-HIV-among-gay-and-bisexual-male-youth.aspx
[3] 
Huebner, D.M., Barnett, A.P., Baucom, B.R.W. et al. Effects of a Parent-Focused HIV Prevention Intervention for Young Men Who have Sex with Men: A Pilot Randomized Clinical Trial. AIDS Behav (2022). https://doi.org/10.1007/s10461-022-03885-1

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. 

Thursday, November 10, 2022

Non-AIDS-defining Cancers Among People Living with HIV/AIDS

By: Ranier Simons, ADAP Blog Guest Contributor

The advent of combination antiretroviral therapy (ART) has greatly improved the lives of people living with HIV/AIDS (PLWHA). ART has reduced HIV infection related morbidity and mortality overall and reduced the rates of AIDS defining cancers.[1] AIDS defining cancers are those that PLWHA are at a high risk for developing. When they develop these cancers, it usually means they have advanced from HIV to AIDS. Kaposi sarcoma, certain types of non-Hodgkin lymphoma, and cervical cancer are examples of AIDS-defining cancers.[2] In contrast to ART’s reduction of AIDS-defining cancers, while the risk is decreasing, the incidence of non-AIDS-defining cancers remains.[2] Non-AIDS-defining cancers are those that are more likely to appear in HIV-positive people. Lung cancer is the non-AIDS-defining cancer that appears the most. A recent study indicates that PLWHA remains at a higher risk and incidence of lung cancer compared to the population at large.[3]

Cancer
Photo Source: pratidintime.com

The study does not fully explain the causality of the higher incidence, however it does shed more light onto what is occurring. The U.S. National Cancer Institute performed a population-based registry linkage study using 2001–2016 data from the HIV/AIDS Cancer Match study, which links data from HIV and cancer registries from 13 regions in the USA.[4] There were 4,310,304 subjects followed in the study. During the study span 3,426 developed lung cancer. Compared to the general population, the data showed that PLWHA in their 40’s have twice the risk of developing lung cancer, PLWHA in their 50’s were 61% more likely, and PLWHA in their 60’s were 30% more likely to develop lung cancer.[3] It also noted that lung cancer surpasses Kaposi’s Sarcoma and Hodgkin’s Lymphoma as the leading cancer in PLWHA over the age of 50. That is a notable distinction given that Kaposi’s Sarcoma and Hodgkin’s Lymphoma are AIDS-defining cancers.

One factor contributing to the increased lung cancer incidence is smoking. Tobacco smoking rates are much higher among PLWHA than the general population.[5] There is evidence-based consensus that the lungs of PLWHA are especially susceptible to the harmful effects of cigarette smoke.[6] Additionally, due to HIV infection, their bodies are already in a constant state of inflammation. Cigarette smoking does not completely explain the higher lung cancer risk. Immunosuppression is also a factor. Although ART is very effective, there is still some immunosuppression due to HIV infection. By 2013-2016, half the study population had been living with HIV for at least ten years.[7] Researchers also found that the prognosis was worse and risk high for PLWHA who at any point previously had an AIDS diagnosis.[3] 

Don't Burn Through Your Meds
Photo Source: DCTCF

Medical research is continuing to investigate the etiology of lung cancer in PLWHA. Meanwhile, prevention is paramount. Most early lung cancer is asymptomatic. Thus, discovering cases early through screening before symptoms are seen will result in better outcomes. For some types of lung cancer, the survival rate is around 90% when tumors are discovered while small.[3] In the U.S., screening of adults with a smoking history, aged 50-80, is already recommended. The growing consensus is that screening of PLWHA needs to start earlier. Moreover, HIV status should be considered for inclusion in the entry criteria for lung cancer screening programs.[8]

[1] Moltó, J., Moran, T., Sirera, G., & Clotet, B. (2015). Lung cancer in HIV-infected patients in the combination antiretroviral treatment era. Translational Lung Cancer Research, 4(6), 678-688. doi:10.3978/j.issn.2218-6751.2015.08.10
[2] Cedars Sinai. (2022). AIDS-Related Cancers. Retrieved from https://www.cedars-sinai.org/health-library/diseases-and-conditions/a/aids-related-cancers.html
[3] 
Hudson, D. (2022, October 16). People with HIV are at twice the risk of lung cancer, study finds. Retrieved from https://www.queerty.com/people-hiv-twice-risk-lung-cancer-study-finds-20221016#.Y2J6PmVsaPA.twitter
[4] 
Engels, A. et al. (2022). Trends and risk of lung cancer among people living with HIV in the USA: a population-based registry linkage study. Lancent HIV, 9(10), 700-708. https://doi.org/10.1016/S2352-3018(22)00219-3
[5] Centers for Disease Control. (2022). People Living with HIV. Retrieved from https://www.cdc.gov/tobacco/campaign/tips/groups/hiv.html
[6] Rahmanian, S. et al. (2011). Cigarette smoking in the HIV-infected population. Proceedings of the American Thoracic Society, 8(3), 313-319. https://doi.org/10.1513/pats.201009-058WR
[7] Alcorn, K. (2022, October 11). Risk of lung cancer is higher for people with HIV. Retrieved from https://www.aidsmap.com/news/oct-2022/risk-lung-cancer-higher-people-hiv
[8] Hein, I. (2022, October 6). Lung cancer declining in people with HIV, but still high. Retrieved from https://www.medpagetoday.com/hivaids/hivaids/101100

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. 

Thursday, November 3, 2022

Start Antiretroviral Therapy Sooner Than Later

By: Ranier Simons, ADAP Blog Guest Contributor

As medical science strives towards eradicating HIV, research and discourse regarding treatment and prevention continue to evolve. Antiretroviral therapy (ART) is the primary method of treatment. ART is drug therapy consisting of various combinations of medications whose purpose is reducing the HIV viral load in the body. The ultimate goal is to reduce the viral levels in the body to the point of being undetectable. Undetectable means that the viral load is so low that a viral load test cannot detect it.[1] Reaching undetectable status means that a person has no risk of sexually transmitting HIV to others, commonly referred to as "U=U" (undetectable equals untransmittable). Research has also shown that maintaining undetectable status enables people living with HIV/AIDS (PLWHA) to live long, healthy lives. 

Antiretroviral therapy for HIV
Photo Source: Very Well Health

The timeline of starting patients on treatment is an ongoing inquiry at the forefront of ART discourse. In addition to viral load, historically, many other factors have been considered when starting PLWHA on drug therapy. Those who are asymptomatic and seemingly very healthy with good CD4 counts sometimes don’t see the benefits of starting early treatment out of concerns about possible long-term side effects and emotionally handling the prospect of lifetime medication adherence.[2] Notwithstanding various psychosocial, financial, and logistical issues, the main clinical criteria inquiry is the CD4 count. 

CD4 cells are white blood cells in the body that help the immune system to fight infection. HIV attacks and destroys CD4 cells.[3] An insufficient number of CD4 cells leaves the body susceptible to many forms of illness that healthy HIV-negative people are protected against. PLWHA are diagnosed with AIDS when the CD4 count reaches 200 cells/mm3.AIDS diagnosis means a high risk of developing life-threatening illnesses or even cancers.

Over time consensus has evolved regarding the appropriate CD4 count threshold for beginning ART. For a long time, the established guidelines recommended ART to begin when CD4 counts dropped below 350 cells/mm3 or if a patient had symptoms of AIDS. In December 2009, U.S. guidelines were issued, including a recommendation that ART commences if the CD4 count is between 350 and 500 cells/mm3.[4] However, that recommendation was based on observational studies, not randomized trials, in the manner that previous guidelines were developed. A randomized trial results in more definitive information since randomization means groups tested are very similar except for received treatment.[4]

To obtain randomized trial results concerning early ART intervention, the Strategic Timing of Antiretroviral Therapy (START) trial was first initiated in 2009, enrolling 4,684 HIV-positive patients (median age 36, 27% women), who had a CD4 count of ≥500 cells/mm3 (median 651 cells/mm3 ) at least two weeks apart within the 60 days before enrollment. Of these patients, 2,325 were randomized to start ART immediately, and 2,359 were randomized to defer treatment until their CD4 count was ≤350 cells/mm3.[5] Subjects were followed for a minimum of three years. START is a multinational endeavor.

Image of medications and a syringe
Photo Source: everydayhealth.com

In 2015, results were published in the New England Journal of Medicine. Data showed that early initiation of ART lowered the risk of severe AIDS-related outcomes, serious non-AIDS-related outcomes, and death by 57%.[4] When the results were published, the subjects who had previously been in the deferred ART group started drug therapy. Another analysis was done in October 2022, which included 4,436 patients who were followed from January 2016 through December 2021. This analysis supported the benefits of starting ART early, even for patients with CD4 counts over 500 cells/mm3 at diagnosis. An additional finding was that adverse outcomes of delayed treatment were more pronounced in patients aged 35 and younger.[4] Research is continuing to examine the outcome difference by age.

Given that the START study shows the importance of early initiation of ART, it is imperative to increase efforts to identify HIV-positive patients. Many people don’t find out until clinically, a lot of damage has occurred. By increasing testing efforts, especially for those in higher-risk groups, HIV infection can be caught at earlier stages, and patients can initiate therapy. Early therapy means a much lower risk of AIDS progression, fewer instances of non-AIDS-related serious issues, and shorter time spans to reaching undetectable status. Diagnosing people earlier means a better quality of life for those infected and an expedited reduction in the number of people with viral loads high enough to be a transmission risk.

[1] National Institute of Health. (2021, August 16). HIV Treatment. Retrieved from https://hivinfo.nih.gov/understanding-hiv/fact-sheets/when-start-hiv-medicines#:~:text=When%20is%20it%20time%20to,possible%20after%20HIV%20is%20diagnosed
[2] Ross, J. et al. (2021) How early is too early? Challenges in ART initiation and engaging in HIV care under Treat All in Rwanda-A qualitative study. PloS one, 16(5), e0251645. https://doi.org/10.1371/journal.pone.0251645
[3] 
National Institute of Health. (2022, August 22). CD4 Lymphocyte Count. Retrieved from https://medlineplus.gov/lab-tests/cd4-lymphocyte-count/
[4] 
Hein, I. (2022, October 25). Start HIV Antiretroviral Therapy ASAP, Experts Urge. Retrieved from https://www.medpagetoday.com/meetingcoverage/idweek/101419
[5] National Institute of Health. (October 4, 2022). Strategic Timing of Antiretroviral Treatment (START). Retrieved from https://clinicaltrials.gov/ct2/show/study/NCT00867048

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. 

Thursday, October 27, 2022

HRSA Releases Annual Ryan White Client-Level Report, 2020 - Program Enrollment Varies

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

The Health Resources and Services Administration (HRSA) has released the AIDS Drug Assistance Program (ADAP) Annual Client-Level Data Report, 2020. These data reflect the demographic characteristics of clients served by the ADAP program from 2016-2020. This is the second Annual Client-Level Report released in 2020, with the first covering years 2016-2019, and is the first report to include client-level information from the first year of the COVID-19 global pandemic.

Increasing ADAP Enrollment

In 2020, 300,785 clients were served by state ADAP programs across the United States—an increase of more than 3,500 clients from 2019. While this represents a 1.3% increase in national enrollment numbers from 2019 to 2020, 7 states and 2 territories (Guam & U.S. Virginia Islands) saw enrollment increases or decreases of greater than 10% (Figure 1). 

Client enrollment regularly decreases and increases based on a number of factors, including but not limited to:

  • Clients becoming newly eligible or ineligible based upon their income
  • Clients moving from state ADAP programs to state Medicaid programs
  • An increase in new HIV diagnoses and, with the delivery of competent case management services, being enrolled in the program
  • Clients moving into or out of states
  • Clients passing away

2020, however, was unique due to the impacts of the onset of the COVID-19 global pandemic. The original expectation was that increases in unemployment would drive large increases in ADAP enrollment across the U.S. While national enrollment did increase by 1.6%, 31 jurisdictions actually saw decreases in ADAP enrollment from 2019 to 2020 (Table 1).

Because no one state’s ADAP program is identical to another, the reasons for enrollment increases and decreases are highly specific to each state. That said, significant increases and decreases should be carefully examined to identify service disparities, particularly in states where patients face numerous barriers to accessing care and treatment.

Figure 1. Change in State AIDS Drug Assistance Programs (ADAPs) Enrollment, 2019 to 2020

Map showing change in State AIDS Drug Assistance Programs (ADAPs) enrollment 2020
Photo Source: HRSA, 2022

The Demographics of ADAP

78.1% of ADAP clients are cisgender male (i.e., non-transgender male; hereafter referred to as “male”)—a figure that has remained largely unchanged since 2015, and 20.4% were cisgender female (i.e., non-transgender female; hereafter referred to as “female”). 1.6% of ADAP clients identified as transgender (1.3% as transgender female, 0.1% as transgender male, and 0.1% as another gender identity; the total does not equal 1.6% due to rounding). 

Similarly, the racial and ethnic demographics of ADAP clients have remained largely unchanged since 2015, with 39.5% of enrollees being Black Americans, 27.6% being Hispanic/Latino, 29.6% being White, and less than 2% each are Asian, American Indian/Alaska Native, Native Hawaiian/Pacific Islander, and people of multiple races. Of the women who are clients of ADAP, over half (56.5%) are Black. ADAP clients from non-White demographics are consistently younger than White enrollees. 60.5% of White enrollees are aged 50+ years, compared with just 48% of clients who are American Indian/Alaska Native, 40.3% of Native Hawaiians/Pacific Islanders, 39.6% of Black Americans, 38.8% of multiracial clients, 37.8% of Hispanic/Latino clients, and 34.4% of Asian clients.

Additionally, ADAP enrollees have continued to overwhelmingly be at the lowest end of the income eligibility scale, with 49.1% of clients earning between 0% - 100% of the Federal Poverty Level (FPL)—$12,760/year for an individual in 2020.

These demographics have all remained largely unchanged over the past decade in no small part because they are reflective of the HIV epidemic, in and of itself. New HIV diagnoses continue to be disproportionately identified in Black, Brown, and lower-income communities. As a result, those clients compose the majority of ADAP clients.

Health Coverage of ADAP Clients

In 2020, 37.4% of all ADAP clients had no healthcare coverage, whatsoever, including private and employer-sponsored insurance, Medicaid coverage, Medicare coverage, Veterans Administration coverage, Indian Health Services coverage, and other types of coverage. This varies by race, with just 20.7% of White clients lacking healthcare coverage compared with 48.2% of Hispanic clients and 42.8% of Black clients. It also varies by gender, with 37.8% of male clients lacking coverage and 36.2% for females. Trans folx and gender non-conforming individuals were disproportionately impacted by a lack of healthcare coverage, with 34.9% of transgender male clients, 52.6% of transgender female clients, and 59.5% of clients with different gender identities lacking coverage.

With the exception of persons who identify as transgender females, every gender demographic saw at least a 1% increase in the number of clients with private individual insurance from 2019 to 2020. Transgender men saw the largest increased in the number of privately insured clients from 2019 to 2020, with just 16.4% of transgender men being privately insured in 2019 and 26.2% being insured in 2020.

Services Utilization of ADAP Clients

The percentage of clients who received only full-pay medication assistance (where ADAP pays the full cost of medications) decreased from 52.6% in 2015 to 47.5% in 2020. This number is expected to decrease as more ADAP programs begin transitioning clients over to other payor models, such as insurance continuation programs, medication co-pay/deductible assistance, or insurance premium assistance. Each of these models represents cost savings for ADAP programs over the full-pay medication assistance service, as the ADAP programs are no longer paying the full cost of medications.

Breaking these services down by Health and Human Services (HHS) Region (Figure 2):

  • Region 1, which comprises the New England states, had the highest percentage of ADAP clients using medication co-pay/deductible services, with 42.2% of clients using that service.
  • Region 6, which comprises the American South-Central part of the U.S., had the highest percentage of ADAP clients receiving full-pay medication assistance (69.7%), followed by Region 4, which comprises most of the rest of the American South (60.1%)
  • Regions 7 and 8, which comprise the central Midwest and Mountain West, had the highest percentages of ADAP clients utilizing multiple ADAP services (49.6% and 46.3%, respectively).

Figure 2. Map of United States Department of Health and Human Services Regions

United States Department of Health & Human Services Region Map
Photo Source: HRSA, 2022

Potential Concerns for ADAPs

An emergent concern for state ADAP programs has presented itself in the form of the Monkeypox Virus (MPV) outbreak in the United States.

According to a paper published in September 2022, among 1,969 persons diagnosed with MPV in eight U.S. jurisdictions—California, Los Angeles County, San Francisco, the District of Columbia, Georgia, Illinois, Chicago, and New York state—38% were identified in People Living with HIV/AIDS (PLWHA). Additionally, 41% of those diagnosed had been diagnosed with a Sexually Transmitted Infection (STI) in the preceding year. Among persons with MPV, hospitalization was more common in PLWHA than in those without HIV infection (Curran, et al., 2022).

The concern among many HIV advocates is that MPV may become endemic in the MSM community, particularly among those living with HIV. This aligns with additional concerns on the part of infectious disease and public health experts that COVID-19 may end up becoming endemic.

(Editor's Note: The following portion of this post remains unchanged from our coverage of the 2019 ADAP Client-Level Report in June/July 2022 as circumstances have remained the same since that time).

There are some concerns being circulated that ADAP enrollment may begin increasing in the near future. The onset of the COVID-19 global pandemic resulted in the Secretary of HHS declaring quarterly national Public Health Emergencies (PHEs) beginning in January 2020 (Office of the Assistant Secretary for Preparedness and Response, 2022). One of the provisions of the PHE declarations required states to keep people enrolled in state Medicaid programs throughout the PHE in order to receive the temporary increase in the federal share of Medicaid costs. 

When the Secretary fails to renew the PHE, this provision, along with the increased federal funding, will end, meaning that state Medicaid programs will likely begin redetermining eligibility. This could result in an influx of clients moving off of Medicaid and back onto state ADAP programs, which are statutorily required to be the “payor of last resort.”

Additional concerns exist around the reauthorization of the Ryan White HIV/AIDS Program (RWHAP), which has not been reauthorized since 2009. Because the law has no sunset provision, meaning that it can be funded in perpetuity. There have been consistent concerns about reopening RWHAP for reauthorization for fear that Republicans in Congress will gut the program. These concerns have been voiced since at least 2013. As a result, there is little advocacy in favor of reauthorization.

Ultimately, the ADAP program is currently as “safe” as it’s ever been. Waitlists are virtually a thing of the past, meaning that eligible patients are able to gain access to the medications that they need. The ADAP Advocacy Association will continue to monitor the program for both successes and challenges.

To download Table 1 - ADAP enrollment from 2019 to 2020, click here.

References:

  • Curran, K.G., Eberly, K., Russell, O.O., et al. (2022, September 09). HIV and Sexually Transmitted Infections Among Persons with Monkeypox — Eight U.S. Jurisdictions, May 17–July 22, 2022. MMWR Weekly 71(36), 1141-1147. http://dx.doi.org/10.15585/mmwr.mm7136a1
  • Health Resources and Services Administration. (2022, August). Ryan White HIV/AIDS Program AIDS Drug Assistance Program (ADAP) 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/hrsa-adap-data-report-2020.pdf
  • Office of the Assistant Secretary for Preparedness and Response. (2022, April 12). Renewal of Determination That A Public Health Emergency Exists. Washington, DC: United States Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response: Public Health Emergency Declarations. https://aspr.hhs.gov/legal/PHE/Pages/COVID19-12Apr2022.aspx 

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. 

Thursday, October 20, 2022

Rapid HIV Transmission Clusters

By: Ranier Simons, ADAP Blog Guest Contributor

Despite the many medical and scientific advances in the fight against HIV/AIDS, the numbers of new infections and AIDS-related deaths remain markedly high. Globally, in 2021, there were 1.5 million new infections and 650,000 AIDS deaths.[1] Avoidable HIV infections occur among developing and first-world countries, including the United States. The U.S. Centers for Disease Control & Prevention (CDC) reported one such troubling trend in the September 23, 2022, Morbidity and Mortality Weekly Report (MMWR): clusters of rapid HIV transmission among gay, bisexual and other MSM (men who have sex with men).

MSM accounted for 68 percent of new HIV diagnoses in the United States, in 2020. The recent MMWR report examined clusters of rapid HIV transmission identified by the National HIV Surveillance System (NHSS). The NHSS is the primary source for monitoring HIV in the United States. The surveillance system gathers, analyzes, and reports a plethora of information regarding new and existing HIV infections. The CDC provides funding and partners with local and state health departments to collect the data.[2] Part of this data includes HIV-1 nucleotide sequences taken from the bloodwork of infected individuals. Utilizing this database, researchers identified large molecular clusters of rapid transmission. In other words, they could identify clusters of people who shared the same ‘flavor’ of the HIV virus.

TABLE 1. Characteristics of persons in large HIV clusters primarily among gay, bisexual, and other men who have sex with men (N = 29) — United States, 2021*
Photo Source: CDC, MMWR

But as the ADAP Advocacy Association noted several years ago, NHSS also is associated with numerous patient concerns, namely privacy infringement and fueling stigma. Whereas some public health advocates may argue such surveillance is necessary in the fight against HIV/AIDS, others remain skeptical whether the benefits outweigh the risks. For the purpose of this particular blog, that debate will be set aside.

Identifying clusters enables public health professionals to identify demographic and geographic areas of HIV transmission. One hundred and thirty-six rapid transmission clusters were identified during 2018-2019 and followed through to December 2021. Rapid transmission was defined as a cluster with five or more diagnoses in the most recent 12 months.[3] A large cluster was defined as one that grew to contain more than 25 people as of December 2021. Thirty-eight large clusters were detected in 2018-2019. MSM comprised the majority of 29 of those 38 clusters. Also, most clusters of rapid HIV transmission were among MSM. The median growth rate was nine people added to a cluster per year.[3] The MSM majority clusters existed in many different regions of the country, most involving multiple states.

There were 2,901 people in the 136 molecular clusters with rapid transmission. The 38 large clusters contained 1,533 (53%) of the 2,901. The 29 clusters of those 38, which were primarily MSM, contained 985 people. Six clusters were primarily people who injected drugs, and three had no defined transmission category.

HIV Test
Photo Source: POZ

Concerning racial or ethnic groups, as of December 2021, African-Americans were the largest group in 13 of the large MSM clusters, Caucasians were the largest group in nine of the clusters, and Hispanic people were the largest in seven of them.[3] Geographically, the most common region in 14 of the 29 MSM clusters was the South, and 23 clusters included people from multiple regions.[3] As a whole, 70 % lived in large centralized metropolitan areas or large fringe metropolitan areas, and 20% lived in medium metropolitan regions.[3]

Clusters indicate areas where intervention efforts are not successful. Continuing cluster analysis will demonstrate how treatment, prevention, and testing efforts must be modified to be more effective in the affected communities. The rate of transmission in the large MSM clusters was six times the overall U.S. population average for transmission.[3] Approximately 80% of new HIV transmissions are from people unaware of their status or not receiving regular care.[4] The September report is a wake-up call to the desperate need for an effective concerted, multi-pronged social, political, and financial revolution if we are to reach the goal of eradicating HIV.

[1] UNAIDS. (2022) Millions of lives at risk as progress against AIDS falters. Retrieved from https://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2022/july/20220727_global-aids-update
[2] Centers for Disease Control and Prevention. (2021, August 9). HIV Statistics Center. Retrived from https://www.cdc.gov/hiv/statistics/index.html
[3] 
Perez, S. PhD et. al (2022). Clusters of Rapid HIV Transmission Among Gay, Bisexual, and Other Men Who Have Sex with Men — United States, 2018–2021. Morbidity and Mortality Weekly Report, 71(38), 1201-1206, https://doi.org/10.15585/mmwr.mm7138a1
[4] 
Li, Zihao PhD et. al. (2019). Vital Signs: HIV Transmission Along the Continuum of Care — United States, 2016. Morbidity and Mortality Weekly Report, 68(11), 267-272, https://doi.org/10.15585/mmwr.mm6811e1

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.