Jan Dyer

What is “trauma-informed care?” Substance Abuse and Mental Health Services Administration (SAMHSA), HHS, the Administration for Children and Families, and the Administration for Community Living, have put together a guide to explain what it is and why understanding and addressing trauma is important for human services programs. The guide is based on SAMHSA’s definition of a trauma-informed program, organization, or system: Realizing the widespread impact of trauma; recognizing signs and symptoms; responding by fulling integrating knowledge about trauma into policies, procedures, and practices; and seeking to “actively resist re-traumatization.”

The Guide to Trauma-Informed Human Services is a web-linked compilation of resources from a range of HHS agencies, federal partners and respected nongovernmental sources. The site will contain information and resources for leaders at the state, tribal, territorial, and local levels on recent advances in understanding of trauma, toxic stress, and resiliency. The topics include PTSD, how exposure to trauma affects brain development, and how adverse childhood experiences differ from trauma experienced at other times in life.

“We hope it will be both immediately helpful,” the authors say, “and a ‘living’ document to be updated over time as our knowledge and experience grow.”

What is “trauma-informed care?” Substance Abuse and Mental Health Services Administration (SAMHSA), HHS, the Administration for Children and Families, and the Administration for Community Living, have put together a guide to explain what it is and why understanding and addressing trauma is important for human services programs. The guide is based on SAMHSA’s definition of a trauma-informed program, organization, or system: Realizing the widespread impact of trauma; recognizing signs and symptoms; responding by fulling integrating knowledge about trauma into policies, procedures, and practices; and seeking to “actively resist re-traumatization.”

The Guide to Trauma-Informed Human Services is a web-linked compilation of resources from a range of HHS agencies, federal partners and respected nongovernmental sources. The site will contain information and resources for leaders at the state, tribal, territorial, and local levels on recent advances in understanding of trauma, toxic stress, and resiliency. The topics include PTSD, how exposure to trauma affects brain development, and how adverse childhood experiences differ from trauma experienced at other times in life.

“We hope it will be both immediately helpful,” the authors say, “and a ‘living’ document to be updated over time as our knowledge and experience grow.”

What is “trauma-informed care?” Substance Abuse and Mental Health Services Administration (SAMHSA), HHS, the Administration for Children and Families, and the Administration for Community Living, have put together a guide to explain what it is and why understanding and addressing trauma is important for human services programs. The guide is based on SAMHSA’s definition of a trauma-informed program, organization, or system: Realizing the widespread impact of trauma; recognizing signs and symptoms; responding by fulling integrating knowledge about trauma into policies, procedures, and practices; and seeking to “actively resist re-traumatization.”

The Guide to Trauma-Informed Human Services is a web-linked compilation of resources from a range of HHS agencies, federal partners and respected nongovernmental sources. The site will contain information and resources for leaders at the state, tribal, territorial, and local levels on recent advances in understanding of trauma, toxic stress, and resiliency. The topics include PTSD, how exposure to trauma affects brain development, and how adverse childhood experiences differ from trauma experienced at other times in life.

“We hope it will be both immediately helpful,” the authors say, “and a ‘living’ document to be updated over time as our knowledge and experience grow.”

Following the directive of the “Military Service by Transgender Individuals” Presidential Memorandum to reinstitute a ban on service for transgender service members, the Secretary of Defense has called for a new study of the impact of transgender service members on “military readiness, lethality, and unit cohesion, with due regard for budgetary constraints and consistent with applicable law.” Secretary of Defense Jim Mattis announced that he will “establish a panel of experts serving within the Departments of Defense and Homeland Security to provide advice and recommendations on the implementation of the president’s direction.”

The study follows on the heels of a July 2016 study issued by the RAND Corporation, which found that there are between 1,300 to 6,600 transgender active duty service members. According to the study, the “costs of gender transition-related health care are relatively low” and they had a “minimal” impact on force readiness.

The new study is due to President Trump by February 21, 2018 and is required to include a plan for implementing the ban. The potential ban on transgender service members is still set to go into effect March 23, 2018. However, there is some disagreement over whether the Presidential Memorandum leave the DoD with latitude to protect currently serving transgender service members or not.

The expected health care costs associated with transgender service members remains a significant factor in the policy decision. The RAND study estimated that health care costs would increase by between $2.4 million and $8.4 million annually with transgender service members out of an estimated $6.2 billion spent on active component health care spending, which would represent a 0.04% to 0.13% of the budget.

Following the directive of the “Military Service by Transgender Individuals” Presidential Memorandum to reinstitute a ban on service for transgender service members, the Secretary of Defense has called for a new study of the impact of transgender service members on “military readiness, lethality, and unit cohesion, with due regard for budgetary constraints and consistent with applicable law.” Secretary of Defense Jim Mattis announced that he will “establish a panel of experts serving within the Departments of Defense and Homeland Security to provide advice and recommendations on the implementation of the president’s direction.”

The study follows on the heels of a July 2016 study issued by the RAND Corporation, which found that there are between 1,300 to 6,600 transgender active duty service members. According to the study, the “costs of gender transition-related health care are relatively low” and they had a “minimal” impact on force readiness.

The new study is due to President Trump by February 21, 2018 and is required to include a plan for implementing the ban. The potential ban on transgender service members is still set to go into effect March 23, 2018. However, there is some disagreement over whether the Presidential Memorandum leave the DoD with latitude to protect currently serving transgender service members or not.

The expected health care costs associated with transgender service members remains a significant factor in the policy decision. The RAND study estimated that health care costs would increase by between $2.4 million and $8.4 million annually with transgender service members out of an estimated $6.2 billion spent on active component health care spending, which would represent a 0.04% to 0.13% of the budget.

Following the directive of the “Military Service by Transgender Individuals” Presidential Memorandum to reinstitute a ban on service for transgender service members, the Secretary of Defense has called for a new study of the impact of transgender service members on “military readiness, lethality, and unit cohesion, with due regard for budgetary constraints and consistent with applicable law.” Secretary of Defense Jim Mattis announced that he will “establish a panel of experts serving within the Departments of Defense and Homeland Security to provide advice and recommendations on the implementation of the president’s direction.”

The study follows on the heels of a July 2016 study issued by the RAND Corporation, which found that there are between 1,300 to 6,600 transgender active duty service members. According to the study, the “costs of gender transition-related health care are relatively low” and they had a “minimal” impact on force readiness.

The new study is due to President Trump by February 21, 2018 and is required to include a plan for implementing the ban. The potential ban on transgender service members is still set to go into effect March 23, 2018. However, there is some disagreement over whether the Presidential Memorandum leave the DoD with latitude to protect currently serving transgender service members or not.

The expected health care costs associated with transgender service members remains a significant factor in the policy decision. The RAND study estimated that health care costs would increase by between $2.4 million and $8.4 million annually with transgender service members out of an estimated $6.2 billion spent on active component health care spending, which would represent a 0.04% to 0.13% of the budget.

The VA  announced medical centers open in Houston and central Arkansas are providing assistance to veterans affected by Hurricane Harvey across southeastern Texas, Arkansas, Mississippi, Louisiana, and Oklahoma. It also has deployed Mobile Vet Centers to veterans in Corpus Christi, Texas and other effected areas to provide counselling services.

Due to the State of Emergency declared in Louisiana and Texas, TRICARE has implemented emergency refill procedures from August 23^rd - September 5^th. Phone numbers and advice have been provided to assist in refilling prescriptions. The referral requirement also has been waived for those who have been evacuated in southeastern Texas counties from August 24^th- September 5^th.

The DoD has deployed about 3,000 Texas National Guardsmen and Guardsmen from other states for search and rescue. Director of domestic operations for the National Guard Bureau, Air Force Maj Gen. James C. Witham, says the bureau has identified “20,000 to 30,000 additional soldiers and airmen that could be used.” The Texas National Guardsmen has its personnel and about 16 aircrafts conducting day and night searches. National Guardsmen from all over the country have been involved in the rescue of more than 3,500 people and 300 pets through boats, vehicles, and helicopters. The DoD also is providing 11 generators, and 50,000 gallons of gasoline and diesel fuel through the Defense Logistics Agency for.  

On Tuesday alone, 2 U.S. Navy helicopter squadron detachments rescued 227 flood victims while flying from Fort Worth, Texas. Helicopter Sea Combat Squadrons 7 and 28 have relocated to be closer to the epicenter of the flooding in and around Houston.

In order to drastically reduce response time, the 112 Sailors from the Dusty Dogs and Ghostriders of Helicopter Sea Combat Squadrons (HSC) 7 and 28 (respectively) moved their staging site and six MH-60S Knighthawk helicopters in order to be even closer to the disaster zone in the wake of Hurricane Harvey. USA.gov has provided resources on what to do now that the hurricane has subsided for residents in the affected areas. A list of recommendations from federal officials, advice on how to replace vital documents, and the latest news on the storm are provided with links.

FEMA has provided a list of emergency phone numbers to County Emergency Operation centers and the U.S. Coast Guard Sector Huston Command Center for life-threating situations. Other resources for safety tips, the National Flood Insurance Program, how to apply for assistance, and how to help others needing assistance are provided as well.

The VA  announced medical centers open in Houston and central Arkansas are providing assistance to veterans affected by Hurricane Harvey across southeastern Texas, Arkansas, Mississippi, Louisiana, and Oklahoma. It also has deployed Mobile Vet Centers to veterans in Corpus Christi, Texas and other effected areas to provide counselling services.

Due to the State of Emergency declared in Louisiana and Texas, TRICARE has implemented emergency refill procedures from August 23^rd - September 5^th. Phone numbers and advice have been provided to assist in refilling prescriptions. The referral requirement also has been waived for those who have been evacuated in southeastern Texas counties from August 24^th- September 5^th.

The DoD has deployed about 3,000 Texas National Guardsmen and Guardsmen from other states for search and rescue. Director of domestic operations for the National Guard Bureau, Air Force Maj Gen. James C. Witham, says the bureau has identified “20,000 to 30,000 additional soldiers and airmen that could be used.” The Texas National Guardsmen has its personnel and about 16 aircrafts conducting day and night searches. National Guardsmen from all over the country have been involved in the rescue of more than 3,500 people and 300 pets through boats, vehicles, and helicopters. The DoD also is providing 11 generators, and 50,000 gallons of gasoline and diesel fuel through the Defense Logistics Agency for.  

On Tuesday alone, 2 U.S. Navy helicopter squadron detachments rescued 227 flood victims while flying from Fort Worth, Texas. Helicopter Sea Combat Squadrons 7 and 28 have relocated to be closer to the epicenter of the flooding in and around Houston.

In order to drastically reduce response time, the 112 Sailors from the Dusty Dogs and Ghostriders of Helicopter Sea Combat Squadrons (HSC) 7 and 28 (respectively) moved their staging site and six MH-60S Knighthawk helicopters in order to be even closer to the disaster zone in the wake of Hurricane Harvey. USA.gov has provided resources on what to do now that the hurricane has subsided for residents in the affected areas. A list of recommendations from federal officials, advice on how to replace vital documents, and the latest news on the storm are provided with links.

FEMA has provided a list of emergency phone numbers to County Emergency Operation centers and the U.S. Coast Guard Sector Huston Command Center for life-threating situations. Other resources for safety tips, the National Flood Insurance Program, how to apply for assistance, and how to help others needing assistance are provided as well.

The VA  announced medical centers open in Houston and central Arkansas are providing assistance to veterans affected by Hurricane Harvey across southeastern Texas, Arkansas, Mississippi, Louisiana, and Oklahoma. It also has deployed Mobile Vet Centers to veterans in Corpus Christi, Texas and other effected areas to provide counselling services.

Due to the State of Emergency declared in Louisiana and Texas, TRICARE has implemented emergency refill procedures from August 23^rd - September 5^th. Phone numbers and advice have been provided to assist in refilling prescriptions. The referral requirement also has been waived for those who have been evacuated in southeastern Texas counties from August 24^th- September 5^th.

The DoD has deployed about 3,000 Texas National Guardsmen and Guardsmen from other states for search and rescue. Director of domestic operations for the National Guard Bureau, Air Force Maj Gen. James C. Witham, says the bureau has identified “20,000 to 30,000 additional soldiers and airmen that could be used.” The Texas National Guardsmen has its personnel and about 16 aircrafts conducting day and night searches. National Guardsmen from all over the country have been involved in the rescue of more than 3,500 people and 300 pets through boats, vehicles, and helicopters. The DoD also is providing 11 generators, and 50,000 gallons of gasoline and diesel fuel through the Defense Logistics Agency for.  

On Tuesday alone, 2 U.S. Navy helicopter squadron detachments rescued 227 flood victims while flying from Fort Worth, Texas. Helicopter Sea Combat Squadrons 7 and 28 have relocated to be closer to the epicenter of the flooding in and around Houston.

In order to drastically reduce response time, the 112 Sailors from the Dusty Dogs and Ghostriders of Helicopter Sea Combat Squadrons (HSC) 7 and 28 (respectively) moved their staging site and six MH-60S Knighthawk helicopters in order to be even closer to the disaster zone in the wake of Hurricane Harvey. USA.gov has provided resources on what to do now that the hurricane has subsided for residents in the affected areas. A list of recommendations from federal officials, advice on how to replace vital documents, and the latest news on the storm are provided with links.

FEMA has provided a list of emergency phone numbers to County Emergency Operation centers and the U.S. Coast Guard Sector Huston Command Center for life-threating situations. Other resources for safety tips, the National Flood Insurance Program, how to apply for assistance, and how to help others needing assistance are provided as well.

“HIV” has become a more common internet search term than “AIDS.” That change reflects the fact that more people now are living with HIV than with AIDS. What’s more, the number of annual HIV infections fell 18% between 2008 - 2014. In honor of the progress made in changing AIDS from an almost universally fatal disease to a manageable condition, AIDS.gov has changed its name to HIV.gov.

The name change comes 36 years after the CDC’s first report of the initial cases of what became known as acquired immune deficiency syndrome. “Much progress has been made in HIV/AIDS research since the disease was first recognized in 1981,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. “Today, lifesaving antiretroviral therapies allow those living with HIV to enjoy longer, healthier lives—an outcome that once seemed unattainable.”

Organizations from the HIV/AIDS community are pleased with the name change. National Minority AIDS Council Executive Director Paul Kawata applauds it, saying it “honors the past while recognizing the power of words and acknowledging that their meanings change over time.”

“HIV” has become a more common internet search term than “AIDS.” That change reflects the fact that more people now are living with HIV than with AIDS. What’s more, the number of annual HIV infections fell 18% between 2008 - 2014. In honor of the progress made in changing AIDS from an almost universally fatal disease to a manageable condition, AIDS.gov has changed its name to HIV.gov.

The name change comes 36 years after the CDC’s first report of the initial cases of what became known as acquired immune deficiency syndrome. “Much progress has been made in HIV/AIDS research since the disease was first recognized in 1981,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. “Today, lifesaving antiretroviral therapies allow those living with HIV to enjoy longer, healthier lives—an outcome that once seemed unattainable.”

Organizations from the HIV/AIDS community are pleased with the name change. National Minority AIDS Council Executive Director Paul Kawata applauds it, saying it “honors the past while recognizing the power of words and acknowledging that their meanings change over time.”

“HIV” has become a more common internet search term than “AIDS.” That change reflects the fact that more people now are living with HIV than with AIDS. What’s more, the number of annual HIV infections fell 18% between 2008 - 2014. In honor of the progress made in changing AIDS from an almost universally fatal disease to a manageable condition, AIDS.gov has changed its name to HIV.gov.

The name change comes 36 years after the CDC’s first report of the initial cases of what became known as acquired immune deficiency syndrome. “Much progress has been made in HIV/AIDS research since the disease was first recognized in 1981,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. “Today, lifesaving antiretroviral therapies allow those living with HIV to enjoy longer, healthier lives—an outcome that once seemed unattainable.”

Organizations from the HIV/AIDS community are pleased with the name change. National Minority AIDS Council Executive Director Paul Kawata applauds it, saying it “honors the past while recognizing the power of words and acknowledging that their meanings change over time.”

In 2012, the IHS National Prescription Drug Workgroup began focusing its attention on the ongoing threat posed by the opioid epidemic. The Workgroup was tasked with promoting appropriate and effective pain management, reducing prescription pain medication misuse and overdose deaths, focusing efforts on pregnant women with opioid use disorder, and improving access to culturally appropriate treatment.

From that platform, IHS established the multidisciplinary IHS National Committee on Heroin, Opioid, and Pain Efforts (HOPE Committee) in March. The committee will address 6 elements: establishing policies, training health care providers, ensuring effective pain management, increasing access to naloxone, expanding medication-assisted treatment, and reducing the inappropriate use of methadone. Among other things, that has meant updating the Indian Health Manual chapter on chronic non-cancer pain to align with the CDC Guideline for Prescribing Opioids for Chronic Pain.

The IHS also also instituted a mandatory no-cost training course, “IHS Essential Training on Pain and Addiction,” and to date has trained 96% of providers required to attend, including many tribal and urban Indian providers.

Since December 2015, when IHS signed a memorandum of agreement with the Bureau of Indian Affairs to increase access to naloxone, 284 BIA law enforcement officers have been trained and provided with emergency naloxone kits.

IHS is also “actively working” to reduce the use of methadone for pain management, which is associated with a high number of overdose deaths, compared with other opioid pain relievers. IHS policy states that methadone should not be used as a first-line pain management therapy. In an ongoing partnership with the University of New Mexico Pain Center, IHS also offers IHS, tribal, and urban Indian providers weekly real-time consultation with pain-management experts and additional web-based educational services. To help providers provide effective and optimal pain management, IHS maintains 2 websites: on Pain Management (https://www.ihs.gov/painmanagement) and Opioid Use Disorder management (https://www.ihs.gov/odm).

In 2012, the IHS National Prescription Drug Workgroup began focusing its attention on the ongoing threat posed by the opioid epidemic. The Workgroup was tasked with promoting appropriate and effective pain management, reducing prescription pain medication misuse and overdose deaths, focusing efforts on pregnant women with opioid use disorder, and improving access to culturally appropriate treatment.

From that platform, IHS established the multidisciplinary IHS National Committee on Heroin, Opioid, and Pain Efforts (HOPE Committee) in March. The committee will address 6 elements: establishing policies, training health care providers, ensuring effective pain management, increasing access to naloxone, expanding medication-assisted treatment, and reducing the inappropriate use of methadone. Among other things, that has meant updating the Indian Health Manual chapter on chronic non-cancer pain to align with the CDC Guideline for Prescribing Opioids for Chronic Pain.

The IHS also also instituted a mandatory no-cost training course, “IHS Essential Training on Pain and Addiction,” and to date has trained 96% of providers required to attend, including many tribal and urban Indian providers.

Since December 2015, when IHS signed a memorandum of agreement with the Bureau of Indian Affairs to increase access to naloxone, 284 BIA law enforcement officers have been trained and provided with emergency naloxone kits.

IHS is also “actively working” to reduce the use of methadone for pain management, which is associated with a high number of overdose deaths, compared with other opioid pain relievers. IHS policy states that methadone should not be used as a first-line pain management therapy. In an ongoing partnership with the University of New Mexico Pain Center, IHS also offers IHS, tribal, and urban Indian providers weekly real-time consultation with pain-management experts and additional web-based educational services. To help providers provide effective and optimal pain management, IHS maintains 2 websites: on Pain Management (https://www.ihs.gov/painmanagement) and Opioid Use Disorder management (https://www.ihs.gov/odm).

In 2012, the IHS National Prescription Drug Workgroup began focusing its attention on the ongoing threat posed by the opioid epidemic. The Workgroup was tasked with promoting appropriate and effective pain management, reducing prescription pain medication misuse and overdose deaths, focusing efforts on pregnant women with opioid use disorder, and improving access to culturally appropriate treatment.

From that platform, IHS established the multidisciplinary IHS National Committee on Heroin, Opioid, and Pain Efforts (HOPE Committee) in March. The committee will address 6 elements: establishing policies, training health care providers, ensuring effective pain management, increasing access to naloxone, expanding medication-assisted treatment, and reducing the inappropriate use of methadone. Among other things, that has meant updating the Indian Health Manual chapter on chronic non-cancer pain to align with the CDC Guideline for Prescribing Opioids for Chronic Pain.

The IHS also also instituted a mandatory no-cost training course, “IHS Essential Training on Pain and Addiction,” and to date has trained 96% of providers required to attend, including many tribal and urban Indian providers.

Since December 2015, when IHS signed a memorandum of agreement with the Bureau of Indian Affairs to increase access to naloxone, 284 BIA law enforcement officers have been trained and provided with emergency naloxone kits.

IHS is also “actively working” to reduce the use of methadone for pain management, which is associated with a high number of overdose deaths, compared with other opioid pain relievers. IHS policy states that methadone should not be used as a first-line pain management therapy. In an ongoing partnership with the University of New Mexico Pain Center, IHS also offers IHS, tribal, and urban Indian providers weekly real-time consultation with pain-management experts and additional web-based educational services. To help providers provide effective and optimal pain management, IHS maintains 2 websites: on Pain Management (https://www.ihs.gov/painmanagement) and Opioid Use Disorder management (https://www.ihs.gov/odm).

A historic trial to test safety and efficacy of an experimental HIV vaccine is under way at 15 sites in South Africa, where more than 1,000 people become infected with HIV every day, says the NIH.

The Phase2b/3 study, HVTN 702, is the first HIV vaccine efficacy study in 8 years. The regimen involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. That vaccine, tested in the 2009 RV144 clinical trial in Thailand, led by the U.S. military HIV Research program and the Thai Ministry of Health, delivered “landmark results.”

RV144 found for the first time that a vaccine could prevent HIV infection, “albeit modestly.” The vaccine was 31.2% effective at preventing infection over the nearly 4-year follow-up. HVTN 702, researchers hope, will provide more sustained protection; the components of the RV144 regimen have been modified to try to increase the magnitude and duration of immune responses. Recently, interim results were reported for HVTN 100, the predecessor clinical trial, which found the new vaccine regimen was safe for the 252 study participants and induced immune responses comparable with those in RV144.

Researchers aim to enroll 5,400 men and women in HVTN 702, which will make it the largest and most advanced HIV vaccine clinical trial to take place in South Africa. “If an HIV vaccine were found to work in South Africa, it could dramatically alter the course of the pandemic,” said HVTN 702 Protocol Chair Glenda Gray, MBBCH, FC Paed (SA).

“[A] safe and effective vaccine could be the final nail in the coffin for HIV,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, a cofunder of the study. Results from HVTN 702 are expected in 2020.

Source:
First new HIV vaccine efficacy study in seven years has begun [news release]. National Institute of Allergy and Infectious Disease; November 27, 2016.  https://www.niaid.nih.gov/news-events/first-new-hiv-vaccine-efficacy-study-seven-years-has-begun. Accessed August 23, 2017.

A historic trial to test safety and efficacy of an experimental HIV vaccine is under way at 15 sites in South Africa, where more than 1,000 people become infected with HIV every day, says the NIH.

The Phase2b/3 study, HVTN 702, is the first HIV vaccine efficacy study in 8 years. The regimen involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. That vaccine, tested in the 2009 RV144 clinical trial in Thailand, led by the U.S. military HIV Research program and the Thai Ministry of Health, delivered “landmark results.”

RV144 found for the first time that a vaccine could prevent HIV infection, “albeit modestly.” The vaccine was 31.2% effective at preventing infection over the nearly 4-year follow-up. HVTN 702, researchers hope, will provide more sustained protection; the components of the RV144 regimen have been modified to try to increase the magnitude and duration of immune responses. Recently, interim results were reported for HVTN 100, the predecessor clinical trial, which found the new vaccine regimen was safe for the 252 study participants and induced immune responses comparable with those in RV144.

Researchers aim to enroll 5,400 men and women in HVTN 702, which will make it the largest and most advanced HIV vaccine clinical trial to take place in South Africa. “If an HIV vaccine were found to work in South Africa, it could dramatically alter the course of the pandemic,” said HVTN 702 Protocol Chair Glenda Gray, MBBCH, FC Paed (SA).

“[A] safe and effective vaccine could be the final nail in the coffin for HIV,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, a cofunder of the study. Results from HVTN 702 are expected in 2020.

Source:
First new HIV vaccine efficacy study in seven years has begun [news release]. National Institute of Allergy and Infectious Disease; November 27, 2016.  https://www.niaid.nih.gov/news-events/first-new-hiv-vaccine-efficacy-study-seven-years-has-begun. Accessed August 23, 2017.

A historic trial to test safety and efficacy of an experimental HIV vaccine is under way at 15 sites in South Africa, where more than 1,000 people become infected with HIV every day, says the NIH.

The Phase2b/3 study, HVTN 702, is the first HIV vaccine efficacy study in 8 years. The regimen involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. That vaccine, tested in the 2009 RV144 clinical trial in Thailand, led by the U.S. military HIV Research program and the Thai Ministry of Health, delivered “landmark results.”

RV144 found for the first time that a vaccine could prevent HIV infection, “albeit modestly.” The vaccine was 31.2% effective at preventing infection over the nearly 4-year follow-up. HVTN 702, researchers hope, will provide more sustained protection; the components of the RV144 regimen have been modified to try to increase the magnitude and duration of immune responses. Recently, interim results were reported for HVTN 100, the predecessor clinical trial, which found the new vaccine regimen was safe for the 252 study participants and induced immune responses comparable with those in RV144.

Researchers aim to enroll 5,400 men and women in HVTN 702, which will make it the largest and most advanced HIV vaccine clinical trial to take place in South Africa. “If an HIV vaccine were found to work in South Africa, it could dramatically alter the course of the pandemic,” said HVTN 702 Protocol Chair Glenda Gray, MBBCH, FC Paed (SA).

“[A] safe and effective vaccine could be the final nail in the coffin for HIV,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, a cofunder of the study. Results from HVTN 702 are expected in 2020.

Source:
First new HIV vaccine efficacy study in seven years has begun [news release]. National Institute of Allergy and Infectious Disease; November 27, 2016.  https://www.niaid.nih.gov/news-events/first-new-hiv-vaccine-efficacy-study-seven-years-has-begun. Accessed August 23, 2017.

Patients who are on hemodialysis and who have cancer present a “unique challenge,” say clinicians from Dartmouth-Hitchcock in New Hampshire.

Patients with end-stage renal disease (ESRD) are at risk of drug accumulation and toxicity. Many anticancer drugs and their metabolites are excreted by the kidney, but data to guide dose and schedule adjustments in renal dialysis are “scant,” the clinicians say. They cite a study that found 72% of dialysis patients receiving anticancer drugs needed dosage adjustments for at least 1 drug. The study researchers also found a significant number of chemotherapy drugs for which there were no available recommendations in dialysis patients.

However, a safe and effective alternative for these patients may exist. The clinicians report on a case—to the best of their knowledge, the first such—of a patient with metastatic melanoma who was successfully treated with pembrolizumab while on hemodialysis.

The patient, who had diabetes and ESRD, also had melanoma in his ear, which metastasized. After discussing his therapeutic options—including the limited data on available immunotherapy drugs—clinicians and the patient agreed to proceed with pembrolizumab, an IgG4-κ human antiprogrammed cell death protein 1 (PD-1) monoclonal antibody. Pembrolizumab has been shown to improve survival rates in patients with melanoma, although it had not been reported in patients with melanoma on dialysis.

The patient received pembrolizumab 2 mg/kg/dose, repeated every 3 weeks. After 1 dose, his abdominal pain and appetite improved. Serum lactate dehydrogenase dropped from 1,182 to 354 units/L. He continued on dialysis 3 times a week with stable serum creatinine levels. After 3 cycles, the computerized tomography scan showed the pulmonary nodules had resolved,  and retroperitoneal lymphadenopathy was significantly reduced. After 10 cycles, he was in complete remission.

Pembrolizumab has distinct benefits for patients like theirs, the clinicians suggest. For one, the molecular weight of the antibody means it is not dialysable, so ultrafiltration (reducing drug exposure) is not the issue it might be. The drug can likely be given without regard to the timing of dialysis. Another benefit for these patients who are usually immunocompromised is that PD-1 antibodies “disrupt” the interactions that create an “immune-suppressive tumor microenvironment” and allow T-cell antitumor activity, the clinicians say.

Their report demonstrates that PD-1 antibodies can be effective in dialysis-dependent ESRD, they say, but add that further research into the induced immune response is warranted. In clinical trials, a small number of patients on pembrolizumab (0.4%) developed immune-mediated nephritis. That might not be as crucial for patients who are already on hemodialysis, the clinicians note, but they caution that the adverse effect (AE) could be a risk for patients with normal renal function or chronic kidney disease. However, their patient experienced no pembrolizumab-related AEs other than mild fatigue.

Source:

Chang R, Shirai K. BMJ Case Rep. 2016; pii: bcr2016216426.

doi: 10.1136/bcr-2016-216426.

Patients who are on hemodialysis and who have cancer present a “unique challenge,” say clinicians from Dartmouth-Hitchcock in New Hampshire.

Patients with end-stage renal disease (ESRD) are at risk of drug accumulation and toxicity. Many anticancer drugs and their metabolites are excreted by the kidney, but data to guide dose and schedule adjustments in renal dialysis are “scant,” the clinicians say. They cite a study that found 72% of dialysis patients receiving anticancer drugs needed dosage adjustments for at least 1 drug. The study researchers also found a significant number of chemotherapy drugs for which there were no available recommendations in dialysis patients.

However, a safe and effective alternative for these patients may exist. The clinicians report on a case—to the best of their knowledge, the first such—of a patient with metastatic melanoma who was successfully treated with pembrolizumab while on hemodialysis.

The patient, who had diabetes and ESRD, also had melanoma in his ear, which metastasized. After discussing his therapeutic options—including the limited data on available immunotherapy drugs—clinicians and the patient agreed to proceed with pembrolizumab, an IgG4-κ human antiprogrammed cell death protein 1 (PD-1) monoclonal antibody. Pembrolizumab has been shown to improve survival rates in patients with melanoma, although it had not been reported in patients with melanoma on dialysis.

The patient received pembrolizumab 2 mg/kg/dose, repeated every 3 weeks. After 1 dose, his abdominal pain and appetite improved. Serum lactate dehydrogenase dropped from 1,182 to 354 units/L. He continued on dialysis 3 times a week with stable serum creatinine levels. After 3 cycles, the computerized tomography scan showed the pulmonary nodules had resolved,  and retroperitoneal lymphadenopathy was significantly reduced. After 10 cycles, he was in complete remission.

Pembrolizumab has distinct benefits for patients like theirs, the clinicians suggest. For one, the molecular weight of the antibody means it is not dialysable, so ultrafiltration (reducing drug exposure) is not the issue it might be. The drug can likely be given without regard to the timing of dialysis. Another benefit for these patients who are usually immunocompromised is that PD-1 antibodies “disrupt” the interactions that create an “immune-suppressive tumor microenvironment” and allow T-cell antitumor activity, the clinicians say.

Their report demonstrates that PD-1 antibodies can be effective in dialysis-dependent ESRD, they say, but add that further research into the induced immune response is warranted. In clinical trials, a small number of patients on pembrolizumab (0.4%) developed immune-mediated nephritis. That might not be as crucial for patients who are already on hemodialysis, the clinicians note, but they caution that the adverse effect (AE) could be a risk for patients with normal renal function or chronic kidney disease. However, their patient experienced no pembrolizumab-related AEs other than mild fatigue.

Source:

Chang R, Shirai K. BMJ Case Rep. 2016; pii: bcr2016216426.

doi: 10.1136/bcr-2016-216426.

Patients who are on hemodialysis and who have cancer present a “unique challenge,” say clinicians from Dartmouth-Hitchcock in New Hampshire.

Patients with end-stage renal disease (ESRD) are at risk of drug accumulation and toxicity. Many anticancer drugs and their metabolites are excreted by the kidney, but data to guide dose and schedule adjustments in renal dialysis are “scant,” the clinicians say. They cite a study that found 72% of dialysis patients receiving anticancer drugs needed dosage adjustments for at least 1 drug. The study researchers also found a significant number of chemotherapy drugs for which there were no available recommendations in dialysis patients.

However, a safe and effective alternative for these patients may exist. The clinicians report on a case—to the best of their knowledge, the first such—of a patient with metastatic melanoma who was successfully treated with pembrolizumab while on hemodialysis.

The patient, who had diabetes and ESRD, also had melanoma in his ear, which metastasized. After discussing his therapeutic options—including the limited data on available immunotherapy drugs—clinicians and the patient agreed to proceed with pembrolizumab, an IgG4-κ human antiprogrammed cell death protein 1 (PD-1) monoclonal antibody. Pembrolizumab has been shown to improve survival rates in patients with melanoma, although it had not been reported in patients with melanoma on dialysis.

The patient received pembrolizumab 2 mg/kg/dose, repeated every 3 weeks. After 1 dose, his abdominal pain and appetite improved. Serum lactate dehydrogenase dropped from 1,182 to 354 units/L. He continued on dialysis 3 times a week with stable serum creatinine levels. After 3 cycles, the computerized tomography scan showed the pulmonary nodules had resolved,  and retroperitoneal lymphadenopathy was significantly reduced. After 10 cycles, he was in complete remission.

Pembrolizumab has distinct benefits for patients like theirs, the clinicians suggest. For one, the molecular weight of the antibody means it is not dialysable, so ultrafiltration (reducing drug exposure) is not the issue it might be. The drug can likely be given without regard to the timing of dialysis. Another benefit for these patients who are usually immunocompromised is that PD-1 antibodies “disrupt” the interactions that create an “immune-suppressive tumor microenvironment” and allow T-cell antitumor activity, the clinicians say.

Their report demonstrates that PD-1 antibodies can be effective in dialysis-dependent ESRD, they say, but add that further research into the induced immune response is warranted. In clinical trials, a small number of patients on pembrolizumab (0.4%) developed immune-mediated nephritis. That might not be as crucial for patients who are already on hemodialysis, the clinicians note, but they caution that the adverse effect (AE) could be a risk for patients with normal renal function or chronic kidney disease. However, their patient experienced no pembrolizumab-related AEs other than mild fatigue.

Source:

Chang R, Shirai K. BMJ Case Rep. 2016; pii: bcr2016216426.

doi: 10.1136/bcr-2016-216426.

“A good understanding of the diverse veteran populations is imperative if the VA is to genuinely resolve the inequities for those at high risk and with the most need,” says the introduction to the first-ever National Veteran Health Equity Report. The report, which contains demographic information on veterans who received VHA care in Fiscal Year (FY) 2013, is designed to provide that comparative information on minorities, women, and other veteran groups. For example:

• Although women represented only about 7% of patients in FY2013, their numbers in VHA have more than doubled since 2000—140% growth, far outstripping the 63% growth among men over the same period;
• In FY2013, 46% of veterans were aged ≥ 65 years;
• More than one-third of veterans lived in rural areas;
• Almost one-half of VHA patients had a service-connected disability. All racial/ethnic minority patient groups, compared with whites, were more likely to have a service-connected disability;

• A higher proportion of women had a service-connected disability, and women are twice as likely to be diagnosed with depression;
• Overall, 33% of VHA patients had ≥ 1 mental health diagnoses. Women and blacks/African Americans were “over-represented” among patients diagnosed with serious mental illness;

• Veterans with serious mental illness also had higher diagnosis rates for musculoskeletal disorders (60% vs 43%) and gastrointestinal conditions (48% vs 30%). In fact, among the top 20 diagnosed conditions, rates for the SMI group exceeded that for the veterans with no mental health diagnosis for 17 conditions by a margin of > 10% for 7. The largest disparities were in tobacco use disorder, psychosocial factors, spine disorders, and housing insufficiency; and
• The only condition in which the diagnosed rate in a racial/ethnic group exceeded that for whites by a margin of 10% was PTSD, diagnosed in 21% of American Indian/Alaska Natives, versus 11% of whites.

Although the report targeted  6 million veterans accessing VA care in FY13, the estimated number of living veterans is about 22 million. It is a “starting place,” the developers promise. Next iterations will continue to evolve to meet the unique needs of diverse veterans.

“A good understanding of the diverse veteran populations is imperative if the VA is to genuinely resolve the inequities for those at high risk and with the most need,” says the introduction to the first-ever National Veteran Health Equity Report. The report, which contains demographic information on veterans who received VHA care in Fiscal Year (FY) 2013, is designed to provide that comparative information on minorities, women, and other veteran groups. For example:

• Although women represented only about 7% of patients in FY2013, their numbers in VHA have more than doubled since 2000—140% growth, far outstripping the 63% growth among men over the same period;
• In FY2013, 46% of veterans were aged ≥ 65 years;
• More than one-third of veterans lived in rural areas;
• Almost one-half of VHA patients had a service-connected disability. All racial/ethnic minority patient groups, compared with whites, were more likely to have a service-connected disability;

• A higher proportion of women had a service-connected disability, and women are twice as likely to be diagnosed with depression;
• Overall, 33% of VHA patients had ≥ 1 mental health diagnoses. Women and blacks/African Americans were “over-represented” among patients diagnosed with serious mental illness;

• Veterans with serious mental illness also had higher diagnosis rates for musculoskeletal disorders (60% vs 43%) and gastrointestinal conditions (48% vs 30%). In fact, among the top 20 diagnosed conditions, rates for the SMI group exceeded that for the veterans with no mental health diagnosis for 17 conditions by a margin of > 10% for 7. The largest disparities were in tobacco use disorder, psychosocial factors, spine disorders, and housing insufficiency; and
• The only condition in which the diagnosed rate in a racial/ethnic group exceeded that for whites by a margin of 10% was PTSD, diagnosed in 21% of American Indian/Alaska Natives, versus 11% of whites.

Although the report targeted  6 million veterans accessing VA care in FY13, the estimated number of living veterans is about 22 million. It is a “starting place,” the developers promise. Next iterations will continue to evolve to meet the unique needs of diverse veterans.

“A good understanding of the diverse veteran populations is imperative if the VA is to genuinely resolve the inequities for those at high risk and with the most need,” says the introduction to the first-ever National Veteran Health Equity Report. The report, which contains demographic information on veterans who received VHA care in Fiscal Year (FY) 2013, is designed to provide that comparative information on minorities, women, and other veteran groups. For example:

• Although women represented only about 7% of patients in FY2013, their numbers in VHA have more than doubled since 2000—140% growth, far outstripping the 63% growth among men over the same period;
• In FY2013, 46% of veterans were aged ≥ 65 years;
• More than one-third of veterans lived in rural areas;
• Almost one-half of VHA patients had a service-connected disability. All racial/ethnic minority patient groups, compared with whites, were more likely to have a service-connected disability;

• A higher proportion of women had a service-connected disability, and women are twice as likely to be diagnosed with depression;
• Overall, 33% of VHA patients had ≥ 1 mental health diagnoses. Women and blacks/African Americans were “over-represented” among patients diagnosed with serious mental illness;

• Veterans with serious mental illness also had higher diagnosis rates for musculoskeletal disorders (60% vs 43%) and gastrointestinal conditions (48% vs 30%). In fact, among the top 20 diagnosed conditions, rates for the SMI group exceeded that for the veterans with no mental health diagnosis for 17 conditions by a margin of > 10% for 7. The largest disparities were in tobacco use disorder, psychosocial factors, spine disorders, and housing insufficiency; and
• The only condition in which the diagnosed rate in a racial/ethnic group exceeded that for whites by a margin of 10% was PTSD, diagnosed in 21% of American Indian/Alaska Natives, versus 11% of whites.

Although the report targeted  6 million veterans accessing VA care in FY13, the estimated number of living veterans is about 22 million. It is a “starting place,” the developers promise. Next iterations will continue to evolve to meet the unique needs of diverse veterans.

We already know quite a lot about how brachial blood pressure (BP) varies by day and time—might chronology also influence arterial occlusion pressure? To their knowledge, say researchers from the University of Mississippi and National Institute of Fitness and Sports in Kanoya, Japan, no study has examined that. They hypothesized that arterial occlusion measurements would oscillate in a pattern that mimicked diurnal variation in brachial systolic blood pressure (bSBP)—specifically, that the measurements would be higher in the evening than in the morning.

In their study of 22 participants, the researchers conducted 4 testing sessions, at 8 am and 6 pm, 48 hours apart. They measured arm circumference, bSBP, and bSBP at rest. They measured arterial occlusion pressure using a cuff inflated on the proximal portion of the upper arm, with a Doppler probe placed over the radial artery.

Pressure varied not only between days but within a day. They found significant difference between morning on day 1 and all other visits, although they say that may have been due to anxiousness during the first visit. But they also found a time effect for morning day 2 compared with all other visits. On day 1 there were no differences from morning to evening; on day 2, occlusion pressure increased from morning to evening.

“The interrelationship between the oscillating nature of different variables is extremely difficult to study,” the researchers say, “and makes it hard to ascertain the rhythm of one physiological variable in the absence of others, due to the inability to isolate variables from temporal progression.” To get the most accurate readings, they advise taking multiple measurements.

We already know quite a lot about how brachial blood pressure (BP) varies by day and time—might chronology also influence arterial occlusion pressure? To their knowledge, say researchers from the University of Mississippi and National Institute of Fitness and Sports in Kanoya, Japan, no study has examined that. They hypothesized that arterial occlusion measurements would oscillate in a pattern that mimicked diurnal variation in brachial systolic blood pressure (bSBP)—specifically, that the measurements would be higher in the evening than in the morning.

In their study of 22 participants, the researchers conducted 4 testing sessions, at 8 am and 6 pm, 48 hours apart. They measured arm circumference, bSBP, and bSBP at rest. They measured arterial occlusion pressure using a cuff inflated on the proximal portion of the upper arm, with a Doppler probe placed over the radial artery.

Pressure varied not only between days but within a day. They found significant difference between morning on day 1 and all other visits, although they say that may have been due to anxiousness during the first visit. But they also found a time effect for morning day 2 compared with all other visits. On day 1 there were no differences from morning to evening; on day 2, occlusion pressure increased from morning to evening.

“The interrelationship between the oscillating nature of different variables is extremely difficult to study,” the researchers say, “and makes it hard to ascertain the rhythm of one physiological variable in the absence of others, due to the inability to isolate variables from temporal progression.” To get the most accurate readings, they advise taking multiple measurements.

We already know quite a lot about how brachial blood pressure (BP) varies by day and time—might chronology also influence arterial occlusion pressure? To their knowledge, say researchers from the University of Mississippi and National Institute of Fitness and Sports in Kanoya, Japan, no study has examined that. They hypothesized that arterial occlusion measurements would oscillate in a pattern that mimicked diurnal variation in brachial systolic blood pressure (bSBP)—specifically, that the measurements would be higher in the evening than in the morning.

In their study of 22 participants, the researchers conducted 4 testing sessions, at 8 am and 6 pm, 48 hours apart. They measured arm circumference, bSBP, and bSBP at rest. They measured arterial occlusion pressure using a cuff inflated on the proximal portion of the upper arm, with a Doppler probe placed over the radial artery.

Pressure varied not only between days but within a day. They found significant difference between morning on day 1 and all other visits, although they say that may have been due to anxiousness during the first visit. But they also found a time effect for morning day 2 compared with all other visits. On day 1 there were no differences from morning to evening; on day 2, occlusion pressure increased from morning to evening.

“The interrelationship between the oscillating nature of different variables is extremely difficult to study,” the researchers say, “and makes it hard to ascertain the rhythm of one physiological variable in the absence of others, due to the inability to isolate variables from temporal progression.” To get the most accurate readings, they advise taking multiple measurements.

Exsanguination—bleeding to death—is the most common cause of potentially survivable death among wounded military. But a caulk gun–like device loaded with foam could extend valuable time to trauma patients and provide a “bridge to surgery,” says Leigh Anne Alexander, product manager for the U.S. Army Medical Materiel Agency (USAMMA). The foam is intended to stop massive intracavitary abdominal bleeding until the patient can get surgical care. 

The device contains expandable foam that is injected into the patient. Two separate chemicals, when mixed, cause the foam to swell rapidly to about 35 times its original volume. It expands around the internal organs and can be left inside the patient for up to 3 hours.

The USAMMA, a subordinate organization of the U.S. Army Medical Research and Materiel Command, is supporting a “pivotal” clinical trial to test the safety and effectiveness of the device, which received an Investigational Device Exemption earlier this year from the FDA. The clinical trial will start in 2018.

Exsanguination—bleeding to death—is the most common cause of potentially survivable death among wounded military. But a caulk gun–like device loaded with foam could extend valuable time to trauma patients and provide a “bridge to surgery,” says Leigh Anne Alexander, product manager for the U.S. Army Medical Materiel Agency (USAMMA). The foam is intended to stop massive intracavitary abdominal bleeding until the patient can get surgical care. 

The device contains expandable foam that is injected into the patient. Two separate chemicals, when mixed, cause the foam to swell rapidly to about 35 times its original volume. It expands around the internal organs and can be left inside the patient for up to 3 hours.

The USAMMA, a subordinate organization of the U.S. Army Medical Research and Materiel Command, is supporting a “pivotal” clinical trial to test the safety and effectiveness of the device, which received an Investigational Device Exemption earlier this year from the FDA. The clinical trial will start in 2018.

Exsanguination—bleeding to death—is the most common cause of potentially survivable death among wounded military. But a caulk gun–like device loaded with foam could extend valuable time to trauma patients and provide a “bridge to surgery,” says Leigh Anne Alexander, product manager for the U.S. Army Medical Materiel Agency (USAMMA). The foam is intended to stop massive intracavitary abdominal bleeding until the patient can get surgical care. 

The device contains expandable foam that is injected into the patient. Two separate chemicals, when mixed, cause the foam to swell rapidly to about 35 times its original volume. It expands around the internal organs and can be left inside the patient for up to 3 hours.

The USAMMA, a subordinate organization of the U.S. Army Medical Research and Materiel Command, is supporting a “pivotal” clinical trial to test the safety and effectiveness of the device, which received an Investigational Device Exemption earlier this year from the FDA. The clinical trial will start in 2018.