AlloCARES

The Allo Hope Foundation

The Allo Hope Foundation (AHF) is a U.S. 501(c)(3) nonprofit led by patients with expertise in education, clinical care, and research. The Allo Hope Foundation is solely dedicated to serving families affected by a rare pregnancy diagnosis of red cell alloimmunization, in which a pregnant person develops antibodies against their child’s blood type. In pregnancy and shortly after birth, these antibodies can cross the placenta, destroying the child’s red blood cells, a rare disease called Hemolytic Disease of the Fetus and Newborn (HDFN). If improperly managed, HDFN can cause significant morbidity and mortality in the child. It is estimated that 160,000 babies die from HDFN per year. This is almost entirely preventable with attentive monitoring and highly specialized care. Many children require intrauterine blood transfusions multiple times during pregnancy and top-up transfusions after birth to ensure survival. As this condition is so rare, the caregiver, in this case the mother, bears a unique and enormous burden to advocate for the necessary care for her child in utero and in the newborn period to ensure their survival. She must educate herself on a rare blood disease, find one of the few highly specialized high risk pregnancy clinicians in the country, and advocate for proper monitoring and prompt treatment across the care continuum of obstetrics, maternal fetal medicine, neonatology, pediatrics and hematology all while pregnant and postpartum herself.

Many women also find themselves up against major systemic barriers, especially in underdeveloped countries, including the simplest parts of the rare disease journey such as diagnosis, but also in finding high quality care to ensure their child’s survival. Common themes within our patient community consistently present themselves; this is a rare disease where clinicians may only see one to two cases throughout their entire career. Due to this, there are major knowledge gaps which can often lead to delayed and incorrect diagnosis, monitoring, and treatment which can then ultimately lead to fetal death. There is also a lack of standardized protocols and siloed care where the mother is the only constant, leading to a high level of burden in educating herself. 

Now termed the AlloCARES program (Caregiver Assistance, Resources and Education Support), this comprehensive caregiver support is led by AHF staff who are patients themselves with significant expertise in HDFN management, all of whom speak to international professional societies, publish on best practices, and provide clinician education and awareness. The program is strategic, measurable and protocol driven, offered to caregivers who join the AHF support group and includes a suite of educational materials which the caregiver (pregnant mother) can bring to her appointments, as well as social support and individual case-specific counsel. AHF has consistently seen that with the education, advocacy and social support offered by the program, mothers go on to have living children even after previously losing children to HDFN and being told that they will never have a living child and has shared such findings at international professional society lectures.

The AlloCARES program empowers the caregiver to become an expert in alloimmunization/HDFN, and bypasses the cumbersome barriers of restricting this comprehensive service to a system level, as it is entirely virtual and functions independently of any mother’s area of residence and insurance status. Enabling the caregiver to ask for the proper monitoring and care can result in her child surviving their HDFN journey, which is the program’s primary, invaluable objective. (All references available upon request)

Among other global patient support and provider education initiatives, AHF maintains a support group of approximately 1,700 members all over the world who have alloimmunization/HDFN, who are grossly underserved as high-risk obstetrical patients with rare disease in a healthcare system that is overburdened and cannot easily or efficiently accommodate rare disease patient care. AHF has researched and published on its caregiver/patient population emphasizing the enormous mental health burden imposed on the mother navigating HDFN due to the isolating nature of managing a rare pregnancy disease. Caregivers (alloimmunized women) navigating HDFN report anxiety (91%), guilt (75%), self-doubt (68%), isolation (71%), depression (68%) and PTSD (61%) at rates multiple times higher than that of even the hospitalized high-risk pregnant population. They report seldom being offered mental health support by their care team (only 25% of mothers) and preventable complications and fetal deaths as a result of substandard care for this nuanced and rare condition. For many years AHF has offered individual and group support to these caregivers, many of them finding AHF only after losing a child preventably to HDFN. The solution will address their needs of comprehensive wraparound support providing education, resources and peer to peer support in an otherwise isolating rare disease journey.

To-date, AHF has offered this comprehensive support to over 1,000 caregivers (alloimmunized mothers whose fetus/newborn has HDFN) over the last 10 years through its global online support group. Peer to peer support, educational resources, and referral to highly skilled providers is currently provided. Educational resources are developed in conjunction with a medical advisory board and reviewed by the patient advisory board for sensitivity. The AlloCARES program is currently only accessible to those who seek out AHF through their own research. There is no formal enrollment process, although this is a goal of the program as it grows beyond the scope of the support group.

The AlloCARES program has been available to our current support group with consistent approach and successful outcomes however, this current offering is now ready to be disseminated more broadly and in accordance with a measurable protocol allowing support of more caregivers, as well as targeted follow up to examine effectiveness of this program. 

The AlloCARES program is unique in that it provides wraparound caregiver support that operates independently of location and insurance restrictions. This is especially relevant to the rare disease community as patient volume and hospital/ clinician knowledge is limited. Caregiver support is led by fellow caregivers with specialized experience in disease management and patient advocacy and does not impose any burden on the healthcare system because it focuses instead on amplifying the caregiver’s role

Expert management of rare disease is highly specialized and it is impossible to expect all providers, nurse navigators and social workers to understand how best to support and manage HDFN. Instead, this program serves as a model to other patient advocacy organizations to streamline a low-cost national initiative where the advocacy organization leads highly refined, disease-specific education, advocacy, and social support. It gives the caregiver a unique role in their healthcare journey, empowering them to advocate for high quality care and helping to ensure positive outcomes.

Evidence shows that clinicians welcome the support of advocacy organizations and informed patients especially when minimal burden is placed on their clinical workload and system infrastructure. Such a virtual model led by AHF and, eventually, other similar advocacy organizations could change the market landscape by enhancing the patient journey, improving outcomes, and improving clinician education in an equitable, scalable manner.

The Allo Hope Foundation is a nonprofit organization led by patients who are dedicated to preventing morbidity and mortality due to HDFN. Considering this, AHF staff are often allocating time to individual caregiver/patient counsel in time-sensitive patient journeys as mothers navigate urgent needs with a fetus dying of HDFN. AHF effectively runs the AlloCARES program as its primary goal, and as such, allocating resources to garner additional funding is difficult. AHF  relies on donations and grants, to serve our mission in advocacy, education and global awareness.

           Receiving this award would significantly alleviate the daily burdens of ensuring economic stability for the AHF team and allow for a more focused approach to our program. Conducting program evaluation and results dissemination through this award will allow for a more stabilized future for the AlloCARES program as these results will aide in securing ongoing funding from other organizations and donors. It would contribute to the compensation for AHF patient leadership, who currently work significant hours at reduced salaries much below market value, and,  additionally contribute to the funding AHF sets aside to help underserved caregivers afford necessary laboratory tests for their HDFN child. At this time, the available funding for this is severely limited and AHF often watches as caregivers lose children because they cannot afford diagnostic tests or necessary ultrasound monitoring.

Additionally, with the development of Rh Immunoglobulin (commonly known as RhoGAM) there remains a pervasive market notion that alloimmunization or Rh Disease has been eradicated when this is simply not the case. 50% of the worlds population does not have access to this life saving preventative medication and are suffering devastating consequences due to lack of prevention and also lack of high quality care. We counsel women globally and especially in sub Saharan Africa where there is an immense amount of loss due to lack of prevention, some women losing up to 7 children to HDFN. This program would allow for broader dissemination of education and as a result, awareness regarding this disease helping to save the estimated 160,000 infants that die from HDFN annually. Broadening the program ensures better health equity in reaching patients that may be less resourceful and would not have found us otherwise.

The team lead alongside the executive leadership of AHF are all mothers who have had children with HDFN. The team lead has personally experienced two alloimmunized pregnancies, has counseled many caregivers through their own pregnancy journeys, has conducted and published patient-led research specifically for HDFN, and has advised on patient-centered engagement strategies for the HDFN community in large clinical trials, patient preference studies, and patient outreach initiatives.

The executive leadership, who serves as patient counselors in the AlloCARES program, has become trusted members of the patient community both by caregivers and clinicians alike. AHF already maintains a growing patient support network of 1,700 members with approximately 10-20 new members weekly, hosts a podcast with 7,000 downloads, has a website with 20,000 quarterly visitors, leads multi-stakeholder engagement initiatives and research studies, hosts local blood drives with patients as babies with HDFN require blood transfusions, and deeply engages with the affected population. Numerous letters of support from caregivers, clinicians and industry alike can testify to the unique trust and respect that is fostered within AHF.

AHF is the only global organization dedicated to the alloimmunization/HDFN community and is uniquely positioned to offer this solution because of the leadership’s unique personal experiences and professional areas of expertise. AHF is additional guided by a Board of Directors, Medical Advisory Board, and Patient Advisory Board, all of whom participate in strategic sessions to contribute to the forward movement of AHF’s mission. The team lead for this initiative, AHF leadership, as well as the advisory boards are all morally and contractually in agreement to serve affected families above all else, and move efficiently and collectively towards this shared goal. This has allowed AHF to grow rapidly in such a short period of time since its inception in 2021.

Next year: offer a systematic comprehensive caregiver support program (AlloCARES) with measurable effectiveness. This means shifting the AlloCARES program into a more standardized offering where caregivers are asked for their feedback and to report on their HDFN outcomes in order to formally assess the effectiveness of the program. In order to assess the transformational impact of the program, caregivers will be asked if they felt the social support they received reduced their psychosocial burden, and whether they feel that the education they received resulted in better HDFN outcomes. The survival rate of HDFN babies whose caregivers were supported in the program will be compared to that of the published literature.

Five years: reach national adoption of the AlloCARES program such that enrollment in the program happens at the point of diagnosis in the obstetrician’s office. At this time, only caregivers who self-educate and seek out AHF are able to access the program. Bolstering the program and evaluating its effectiveness in year one will allow for AHF to launch a clinician awareness initiative through outreach and speaking engagements at professional societies. This will lead to broader clinician adoption and awareness such that they can refer newly diagnosed caregivers to AHF, therefore allowing for a more equitable, accessible participation opportunity for caregivers who may not otherwise self-educate and seek the program on their own. Participation numbers and participant demographics can be utilized to track the effectiveness of this broadened reach.

It is well-demonstrated that peer support and patient advocacy significantly improve birth outcomes and maternal mental health. Wraparound support services are utilized often in specific populations such as low-income minority pregnant populations, people seeking mental health treatment, and pregnant people at risk for certain complications. To-date none have been evaluated systematically for the comprehensive support of a rare disease patient advocacy program. However, coupled with the known success of other similar programs in adjacent populations as well as the anecdotal success that has been seen and reported by caregivers receiving support from AHF, the AlloCARES program is expected to significantly alleviate caregiver psychosocial burden and reduce unnecessary morbidity and mortality to HDFN.         

The solution is expected to directly impact the problem of significant caregiver burden and HDFN morbidity and mortality for multiple reasons. First, peer support has been demonstrated to reduce psychosocial burden patients/caregivers and this is something that is consistently reported in AHF’s support group, and also provided in an IRB-approved caregiver questionnaire study conducted by AHF (available upon request). Second, unlike many rare diseases, HDFN is a treatable disease with proper care. For example, many cases of HDFN result in the development of ascites, hydrops, heart failure and death simply because the clinician was not aware that weekly ultrasounds are required to monitor for advancing disease, or because they thought that waiting over the weekend to offer life-saving intrauterine blood transfusion would be safe. AHF continuously sees these problems dissolve when the caregiver brings literature and educational materials to the clinician and offers to facilitate a treatment planning discussion with members of AHF’s Medical Advisory Board. Third, HDFN is a temporary disease with a finite endpoint. Once the newborn is approximately 12 weeks old, the maternal antibodies clear from the newborn’s circulation and the child can continue to make their own new blood without it being destroyed by the mother’s antibodies. This allows for a definitive, short-term marker of success – did the HDFN child survive their disease?

In order to examine these theories of change, the team lead has experience in conducting program evaluation for multi-site clinical programs and will employ an implementation research logic model (IRLM) approach to evaluating the program’s effectiveness. (All references available upon request).

Full Time Staff: 2

Part Time Staff: 3 

Contractors: 2

The team has been informally supporting caregivers using this comprehensive method for nearly 10 years, since AHF’s executive director lost her child preventably to HDFN at 19 weeks gestation. She began a personal blog which rapidly grew as caregivers were searching for support and education and found her blog as the only accessible resource. This transformed into years of caregiver education and advocacy and grew into what is now the Allo Hope Foundation.

The Allo Hope Foundation is a unique patient advocacy organization with leadership team all having direct patient experience in this disease and whose mission is furthered by their experience in education, healthcare and research. AHF also maintains a Patient Advisory Board and Board of Directors who all have a deep and personal connection to HDFN and includes people of all backgrounds.

The goal of the AlloCARES program is to further our solution that is primarily designed to reach the most vulnerable populations; those with lower socioeconomic status, less education and especially those in underdeveloped countries with very little resources. We have already demonstrated our commitment to diversity and equity with our global outreach initiatives, especially in Sub Saharan African where significant systemic barriers make care extremely difficult to access.

Our current patient support group is open to any woman with red cell antibodies and globally has reached countries including USA, Canada, Australia, Kenya, Nigeria, Ireland, UK, and India, among others. We provide direct patient counsel to everyone and help to navigate the systemic barriers that may present in their respective home country often making referral to our international patient and provider network. We have gone as far as relocating pregnant women who have lost babies in their home country, who go on to have their first living child due to our counsel and support. Our mission is quite clear; help anyone, no matter their background have a successful alloimmunized pregnancy and eliminate any unnecessary death due to the disease.

The objective of the AlloCARES program is to act as an organized, scalable implementation of AHF’s mission, which is to prevent morbidity and mortality due to HDFN. The model is unique in that it is led by a network of patients and clinicians with a dedicated ethical commitment to guiding caregivers through their child’s HDFN journey. AHF staff is fortunate in that it has lived firsthand and watched as thousands of these diagnoses evolve around the world, a privilege which most healthcare providers do not have in the management of a rare disease. The program is designed to systematically guide the caregiver through their diagnosis and management journey in a supportive, empathetic, and educated manner based on the leadership’s extensive lived experiences.

          An additional benefit to the AlloCARES program is that the beneficiaries are alloimmunized mothers who are experiencing a rare, high-risk pregnancy condition which causes HDFN in their child. A mother’s desire to support and protect her child cannot be compared to a simple desire for a product or service – it transcends any of her other needs. For this reason the beneficiaries are exceedingly thankful for the support and education they receive. The number of beneficiaries at this time is only limited to the number of caregivers who succeed in finding the AHF’s support program on their own. With additional funding AHF can better promote and increase accessibility to the program through concerted clinician education initiatives and targeted online and social reach.

          The AlloCARES program provides its services entirely virtually and at no charge to the caregiver who needs them. As demand grows, additional patient leaders provide program support while they undergo education and training as members of the Patient Advisory Board, lending itself to a sustainable growth pattern to continue to meet the needs of the caregivers navigating HDFN. Additionally, AHF has begun an international ambassador program where a patient expert from their respective country serves as the primary point of contact for social support. This has so far been deployed in Kenya with ongoing success, with a growing network of caregivers and clinicians local to Kenya seeking this AHF staff member for education and support (the evolution of this story is available on The Allo Podcast titled Rose’s Story in Season 2).

The costs of sustaining the AlloCARES program are low as it is entirely virtual. However, necessary costs do include periodic literature searches and expert consensus meetings to update educational materials, salary support for staff who provides comprehensive support to caregivers, as well as support for program evaluation and follow-up and social media/marketing to promote the program’s participation and its results. To-date this has been successfully covered through a combination of leadership salaries and volunteers.

Funding for this program will continue to be supported in several ways including grants, sponsorships, and donations. AHF staff actively participates in grant funding from  large organizations including the Patient Centered Outcomes Research Institute (PCORI), NIH, BARDA, and other research institutions’ existing funding programs. Additionally, some of the recommended aspects of care for HDFN include utilizing specific diagnostic tests or interventions which, as is common in rare disease, are offered only by one or two private healthcare companies. AHF has previously received sponsorship from such entities to publish and disseminate educational materials, as it is mutually beneficial for these entities to have their product recommended for management of HDFN to clinicians. Also, AHF runs multiple fundraisers annually for affected families and their communities to support AHF’s education and advocacy work. It is AHF’s hope that grant funding offered herein can bolster the program to allow for broader dissemination and meaningful program evaluation, which in turn increases its visibility and known success, making adoption more streamline long-term and continued sponsorships from other entities easier to attain with the proven success of the program.

AHF has a successful history of achieving sponsorship and grant funding since its inception. AHF has received annual corporate sponsorship from several industry leaders who, for example, are developing a drug to treat HDFN, who are utilizing plasma donations to develop preventable treatments for HDFN, or who are targeting solutions for mothers with postpartum mental health complications. While not all partners are available publicly, some can be found on the AHF partners page of the Allo Hope Foundation website.

AHF’s mission and reach is extremely compelling to those who are exposed to our initiatives during our rapidly growing number of speaking engagements, which has in turn evolved into fruitful funding opportunities. Importantly, AHF is led by impassioned patients who are also experts in their respective roles in the organization. AHF is led by a team who works seamlessly together and with support from its various advisory boards. Because of the shared passions and extremely capable stakeholders involved in AHF, AHF is positioned to succeed long-term in its goal even when operating within the natural challenges of nonprofit business management.