Amend 01, N00244-19-S-F002 (PEPFAR Funded Countries).pdf

AMENDMENT 01

FUNDING OPPORTUNITY ANNOUNCEMENT (FOA)

Number N00244-19-S-F002

“FY19 – FY20 Department of Defense HIV/AIDS Prevention Program: Military

Specific HIV/AIDS Prevention, Care, and Treatment Program for PEPFAR (President’s Emergency Plan for AIDS Relief)

Funded Countries” The purpose of this Amendment 01 is to incorporate the following:

DHAPP is accepting “Concept Papers” for Colombia: DHAPP – Support HIV/AIDS Epidemic Control in Venezuelan Migrant Communities as part of the Venezuelan Regional Crisis Response as described below through 31 January 2019

NOTE: Each narrative is a standalone effort and should not be combined with another narrative and all the program elements (tasks) in each specific narrative must be addressed in that concept paper submission.

E-mail address for submission of Concept Papers: usn.nhrc.dhapp@mail.mil

The full solicitation is available at: http://www.grants.gov/

Eligible Applicants are requested to submit Concept Papers following the guidelines and format provided in the N00244-19-S-F002, Section II, D.

All respondents must demonstrate the support of the in-country military and the DoD representative in the corresponding U.S. Embassy in the planning and execution of their proposals. The selected Grantee is the Implementing Partner and will be referred to as IP in this document.

mailto:usn.nhrc.dhapp@mail.mil http://www.grants.gov/

Amendment #01, N00244-19-S-F002 (FY19 – FY20 DHAPP: Military Specific HIV/AIDS Prevention, Care, and Treatment Program for PEPFAR Funded Countries)

Colombia: DHAPP—Support HIV/AIDS Epidemic Control in Venezuelan Migrant Communities in Colombia as part of the Venezuela Regional Crisis Response

Introduction

Venezuela’s ongoing economic crisis has had devastating effects on the country’s health system. Historically Venezuela had one of the most effective HIV programs in the Western hemisphere, but today only 7 percent of Venezuela’s 120,000 PLHIV are virally suppressed, mostly through ad-hoc donations of antiretroviral treatment through NGOs. Available mortality estimates indicate that AIDS-related deaths are up over 100 percent in 2018, with an estimated 30 deaths per day due to lack of treatment. Growing threats of drug resistance and mass migrations out of Venezuela threaten regional health security in the Western hemisphere, making it in the interest of the United States and S/GAC to respond. The US Government has a long history of international collaboration and partnerships in the fight against HIV/AIDS, providing funding, technical assistance, and program support. These collaborations are all contributing to HIV epidemic control.

Venezuela’s internal crisis has also triggered the most significant mass migration in the history of the Western hemisphere. Over 2,000,000 Venezuelans have fled the country over the past two years, many because of a critical lack of medication and health services. An estimated 1.1 million Venezuelans are currently sheltering in Colombia, with populations mostly concentrated along the border regions and near Bogota. The HIV prevalence among this population is currently unknown, though it is estimated to be significant.

The purpose of this funding opportunity announcement is to support test and treatment efforts in the Venezuelan migrant communities in Colombia and collaborate with the Colombian military through DoD HIV/AIDS Prevention Program (DHAPP).

Background

The HIV/AIDS epidemic has been devastating and negatively affected many militaries and other uniformed organizations worldwide by reducing military readiness, limiting deployments, causing physical and emotional decline in infected individuals and their families, posing risks to military personnel and their extended communities, and impeding peacekeeping activities. As HIV management improves, many of these impacts are disappearing, however, militaries now need to sustain life-long HIV treatment for their HIV-infected beneficiaries in addition to other long-term chronic disease management issues.

The US Government has a long history of international collaboration and partnerships in the fight against HIV/AIDS, providing funding, technical assistance, and program support. These collaborations are all contributing to HIV epidemic control.

Over the years, the United States Department of Defense (DoD) HIV/AIDS Prevention Program (DHAPP) has successfully engaged over 80 countries in an effort to control the HIV epidemic among their respective military services. DHAPP is the DoD implementing agency collaborating

Amendment #01, N00244-19-S-F002 (FY19 – FY20 DHAPP: Military Specific HIV/AIDS Prevention, Care, and Treatment Program for with the US Department of State, the Health Resources and Services Administration, Peace Corps, US Agency for International Development (USAID), and the Centers for Disease Control and Prevention (CDC), in the US President’s Emergency Plan for AIDS Relief (PEPFAR).

DHAPP receives funding for its programs from two sources: a congressional plus-up to the Defense Health Program (DHP) and funding transfers from the Department of State for PEPFAR. Working closely with DoD, U.S. Unified Combatant Commanders, Joint United Nations Programme on HIV/AIDS (UNAIDS), university collaborators, and other nongovernmental organizations (NGOs), DHAPP’s mission is to build capable military partners through military-specific, culturally focused, HIV/AIDS cooperation and assistance.

In the Defense Security Cooperation Agency guidance, the US Secretary of Defense has identified HIV/AIDS in foreign militaries as a national security issue. Pursuing HIV/AIDS activities with foreign militaries is clearly tied to security interests, regional stability, humanitarian concerns, counterterrorism, and peacekeeping efforts due to the impact of HIV/AIDS as a destabilizing factor in developing societies. DHAPP employs an integrated bilateral and regional strategy for HIV/AIDS cooperation and security assistance. DHAPP implements bilateral and regional strategies in coordination with respective Combatant Commands (COCOMs) and Country Support Teams to offer military-to-military HIV/AIDS program assistance using country priorities set by the US Under Secretary of Defense for Policy and by the Office of the Global AIDS Coordinator. DHAPP provides strategic information and supports defense forces in HIV prevention, care, and treatment for HIV-infected individuals and their families.

On October 1, 2013, DoD established the Defense Health Agency (DHA) as part of the U.S.

Military Health System governance reform. DHA is a joint, integrated Combat Support Agency that enables the Army, Navy, and Air Force medical services to provide a medically ready force and ready medical force to COCOMs in both peacetime and wartime. In July 2014, the Deputy Secretary of Defense approved the realignment of medical Executive Agent organizations to DHA, including DHAPP. The transition to DHA from the Secretary of the Navy was completed on August 20, 2017. DHAPP is now a division under the Research and Development (J-9) Directorate and continues to be cornerstone of the global health engagement portfolio delivering solutions to COCOMs. The DHAPP headquarters office remains at Naval Base Point Loma in San Diego, California.

In 2014, PEPFAR moved from an “emergency” response to a strategy focused on sustainable control of the HIV epidemic. In doing so, PEPFAR adopted the United Nations Programme on HIV/AIDS (UNAIDS) global 90-90-90 goals that state by 2020: 90% of people with HIV are diagnosed, 90% of them are on ART and 90% of them are virally suppressed. DHAPP shifted with PEPFAR in how Monitoring, Evaluation, and Reporting (MER) indicators are collected and reported to efficiently use data to drive decision-making and focus HIV programming in the right geographic areas. DHAPP collects MER indicator results on a quarterly and semi-annual basis, and data is reported at the site level. This data allows DHAPP to understand the gaps in programming and needs for shifts to reach our shared goals.

In fiscal year (FY) 2017, DHAPP supported 56 national HIV programs, mainly through direct military-to-military cooperation in addition to support from contracting external organizations and academic institutions to assist with specific aspects of proposed programs. Partners in FY17 included 54 NGOs and universities working in 55 countries.

Amendment #01, N00244-19-S-F002 (FY19 – FY20 DHAPP: Military Specific HIV/AIDS Prevention, Care, and Treatment Program for

Budget

Total Care & Treatment HVCT- HIV Testing Services HTXS- Adult Treatment

$ 50,000 $350,000

Health Systems Strengthening HLAB- Laboratory Infrastructure HVSI- Strategic Information

$ 50,000 $ 50,000

TOTAL $500,000

Approaches to Reaching Sustainable Epidemic Control

Proposals are requested by any NGO who is currently working in Colombia, including local NGOs to support test and treatment efforts in Venezuelan migrant communities in Colombia and collaborate with the Colombian military through DoD HIV/AIDS Prevention Program

(DHAPP).

The partner must work in complete coordination with Colombian government HIV prevention and health services, as well as the DHAPP/DoD Program Manager based at the US Embassy in Peru, other DHAPP supported implementing partners working in Colombia, other bilateral and multilateral agencies with similar objectives and the DHAPP Headquarters Team. The Grantee is the Implementing Partner and will be referred to as IP in this document.

Capacity

The IP must have documented capacity and experience to deliver the services outlined in this document. Letters of support and documentation of a proven track record delivering test and treat services for HIV are highly desired. The IP must already be working in Colombia and have an office in the country.

Targets

Progress towards epidemic control will be successfully measured, in part, through an effective strategic information framework that not only monitors program outputs, but also key outcomes and programmatic impact.

Collection and use of disaggregated data that characterizes the populations served in the lowest geographic areas where HIV services are being provided is critical in understanding current program performance and planning for future performance. Consequently, the Monitoring, Evaluation, and Reporting (MER) indicators continue to evolve in order to reflect the progression of U.S. government (USG) support and global HIV response guidelines.

Measuring the impact of support at national and regional above-site levels down to direct

Amendment #01, N00244-19-S-F002 (FY19 – FY20 DHAPP: Military Specific HIV/AIDS Prevention, Care, and Treatment Program for services at the site-level is paramount to DHAPP’s program implementation and monitoring approach.

MER indicators are not an exhaustive list of all metrics that should be monitored by DHAPP-supported programs. These programs should continually monitor and assess any acute programmatic issues and collect additional data to inform program improvement.

The indicators listed below strives to drive program monitoring to a more patient-centered approach. Per the 2017 WHO “Consolidated Guidelines on Person-Centred HIV Patient Monitoring and Case Surveillance,” person-centered monitoring refers to a shift from monitoring measuring services (e.g., the number of individuals tested or people on treatment) to monitoring people at the center of their access to linked HIV and health services. In essence, this marks a shift to better support the clients accessing services by focusing more on their individual health outcomes.

The proposal will address approaches to reaching the following targets for civilian populations.

Testing

Technical Area Targets, Year 1

Indicator Description Civilian

13. HTS_INDEX

14. HTS_RECENT

16. HTS_TST

Number of individuals who were identified and tested using Index testing services and received their results.

Percentage of persons aged ≥15 years newly diagnosed with HIV-1 infection who have a test for recent infection result of ‘recent infection’ during the reporting period.

Number of individuals who received HIV Testing Services (HTS) and received their test results.

Treatment

26. TX_CURR

27. TX_ML

28. TX_NEW

29. TX_TB

Number of adults and children currently receiving antiretroviral therapy (ART).

Number of ART patients with no clinical contact since their last expected contact.

Number of adults and children newly enrolled on antiretroviral therapy (ART).

Proportion of ART patients screened for TB in the semiannual reporting period who start TB treatment.

Amendment #01, N00244-19-S-F002 (FY19 – FY20 DHAPP: Military Specific HIV/AIDS Prevention, Care, and Treatment Program for

Viral Suppression

30. TX_PVLS Percentage of ART patients with a suppressed viral load

(VL) result (<1000 copies/ml) documented in the medical or laboratory records/laboratory information systems (LIS) within the past 12 months.

Technical Narrative

The IP will address the technical approach to each area. The IP will be responsible for providing the following services in close collaboration with other DHAPP-funded implementing partners and the host military. Please note that no support will be given for HIV testing or treatment commodities. Support for necessary laboratory supplies will be considered as detailed in the laboratory section below.

HIV Testing Services

For the purpose of this funding opportunity, testing for HIV will be limited to 1) confirm status of persons known or suspected to have HIV as part of initiation or continuing care and treatment and 2) to test partners as part of index testing.

Ensuring that any positives identified are linked to HIV care and treatment is essential to the success of the program. The IP should work to achieve 100% linkage of HIV+ individuals identified. The IP will monitor HIV testing yield; modifying strategies or locations that are not identifying and/or linking significant numbers of HIV positive persons to HIV care and treatment.

Referred HIV positive persons should be retested as part of same day initiation of treatment.

Documented processes for index testing should be applied to all new or newly rerolled PLHIV.

HIV Treatment

Dolutegravir (DTG)-containing regimens are the preferred first-line antiretroviral therapies (ART) due to superior efficacy, tolerability and higher threshold for resistance compared to efavirenz (EFV)-containing regimens. The fixed dose combination (FDC) of tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) is currently priced as the least expensive FDC, and it is expected that prices will go down as generic manufacturing scales up. For these reasons, DHAPP now recommends TLD as the preferred option for ART, and further recommends that DHAPP-supported programs switch over to TLD as soon as possible in a coordinated fashion as supply becomes available.

Amendment #01, N00244-19-S-F002 (FY19 – FY20 DHAPP: Military Specific HIV/AIDS Prevention, Care, and Treatment Program for

Programs should carefully assess the risk and benefit of TLD in child-bearing age women.

See published updated from PEPFAR to further understand the high benefits in the face of a potential NTD signal.

Children (< 30kg) are not expected to be included in the initial roll-out of TLD. Development of pediatric DTG formulations and evaluation of appropriate DTG dosing in infants and children are underway.

A priority of HIV programs is to find, diagnose and treat people with tuberculosis (TB) disease and ensure that they become non-infectious. For all those who do not have active TB, prevention of TB is a priority.

TB preventive therapy (TPT) must be scaled up for all PLHIVs that do not have active disease as an integral part of the clinical care package. DHAPP-supported care and treatment programs need to catalyze the introduction and scale-up of TPT. IPs are expected to increase the use of TB diagnostic testing within DHAPP-supported HIV care and treatment facilities and promote the use of TPT as a routine part of HIV care. As a consequence, programs should have clear policies and/or guidelines for the use of TPT, and should plan for programmatic and clinical trainings, procurement and supply management, adequate diagnostic capacity (including specimen transportation) and development of appropriate data collection systems.

In Global Fund high-impact countries implementing joint TB/HIV grants, IPs should also seek opportunities to support effective joint program implementation. Additionally, IPs should implement TB infection prevention and control activities to minimize the risk of TB transmission and provide safe health seeking environment. This is critical in DHAPP-supported settings where clients at high risk for TB and HIV often co-mingle. It also puts the health care workers at the highest risk of contracting TB disease. Activities aimed at preventing transmission at facility-level include administrative and environmental controls, and the availability and use of personal protective equipment. Infection prevention and control basics will also be important for ART adherence clubs and other community clinical work.

Laboratory capacity building

The IP will be responsible for ensuring that:

• Inventory control, forecasting, and ensuring the procurement of laboratory reagents to ensure that laboratory services are uninterrupted

• Procurement of service maintenance contracts, calibration of equipment, and training of the laboratory staff on the use of the equipment

• Monitoring laboratory quality and adherence to quality systems, method validation, provision of proficiency testing panels for rapid HIV testing, viral load, TB, and other tests critical to HIV epidemic control.

• Conduct routine visits to laboratories to assess achievements, review/evaluate activities, and provide recommendations with the development of improvement plans to resolve any identified problems.

• Linking facility laboratory services to other laboratory resources at the district, provincial, and national levels.

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Site Improvement through Monitoring System (SIMS)

The purpose of SIMS is to provide a standardized approach and set of tools for monitoring program quality at DHAPP-supported sites and entities that guide and support service delivery.

SIMS assessment results are used to strengthen alignment with global and national standards and facilitate program improvement as a component of an overall quality management strategy. SIMS is also used to identify performance issues that may impact patient outcomes or the integrity of reporting for MER targets or disaggregates. Low final scores (reds and yellows) from these core essential elements (CEEs) highlight potential issues with service delivery, site performance or oversight, and/or documentation of patient results. Site-level triangulation of MER and SIMS data can be used to contextualize performance and could be useful to determine if performance challenges at a site are due to issues related to the underlying quality of service provision.

Site Improvement through Monitoring System (SIMS) aims to: (1) facilitate improvement in the quality of DHAPP-supported services and technical assistance, (2) ensure accountability of U.S. government investments, and (3) maximize impact on the HIV epidemic.

SIMS assessment results confirm compliance to minimum quality assurance standards and identify areas where improvements in DHAPP-supported programs can be made.

Programs should conduct SIMS assessments in accordance with DHAPP guidance and implementing partners are responsible for taking corrective action for items within the IP SOW and per discussion with DHAPP USG staff.

Data Monitoring

Successful tracking of patient level data is critical to the success of the partner military HIV program’s ability to monitor progress towards epidemic control. The Grantee will work with the respective partners to support the collection of patient-level data, the clinical and programmatic use of data, and the reporting of site-level data to DHAPP HQ.

The IP will be responsible for:

• Staffing support and mentoring of existing partner staff for data entry

• Ensuring confidentiality and security of data, in line with national guidelines

• Timely, accurate reporting of all indicators required by the government and DHAPP.

• Securing all patient-level and site-level data from dissemination outside of the government and DHAPP without prior approval.

• Support for data entry, cleaning, reporting, and use.

Amendment #01, N00244-19-S-F002 (FY19 – FY20 DHAPP: Military Specific HIV/AIDS Prevention, Care, and Treatment Program for

Data Quality

Measuring the success of HIV/AIDS initiatives requires strong monitoring and evaluation (M&E) systems that produce high quality data. Efforts to ensure data quality, therefore, are not singular events occurring randomly. Rather, these processes need to become institutionalized as part routine data management processes. Once achieved, data quality helps to ensure that limited resources are used effectively, progress toward established goals are accurately monitored, and that decisions are based on strong evidence. Attention to data quality ensures that target-setting and results reporting are informed by valid and sensitive information, and that all partners are thinking about and collecting and organizing this information in the same manner. In this way, attention to data quality leads to improved program performance and to more efficient resource management.

Data quality has always been a focus of global HIV monitoring and reporting efforts.

Specifically, all countries conducting programming supported by DHAPP are expected to have a data quality strategy in place. For example, data quality assessments should be conducted routinely and action should be taken as a result of these DQAs. If errors are identified in data, these should be remediated at the point of service delivery as well as in the DHAPP and host-country reporting systems as soon as possible. Standard operating procedures for routine data quality review should also be in place. Data should be routinely reviewed for errors before submission to ensure that the data passes the data quality checks outlined within the guidance and the Data Review Tool available in DATIM.

Work Plans

The Grantee must submit annual, programmatic and financial, work plans to the DHAPP Program Manager and DHAPP HQ (budget breakdown per activity and for program management is required). Work plans should include an activities implementation timeline as well as monitoring and evaluation timeline.

Reporting

• Quarterly Fiscal Reports: The grantee must submit quarterly programmatic and financial reports to DHAPP in order to monitor expenditures according to the program budget codes. The report template will be provided by DHAPP. Submit data within 30 calendar days following each reporting period (3/31, 6/30, 9/30, and 12/31).

• Interim Progress/Monitoring, Evaluation, and Reporting (MER) Report: This report shall summarize progress in relation to the approved work plan as well as monitor grant deliverables. The Grantee shall submit quarterly indicator reports in accordance with the format provided by the Program Office within 45 calendar days following the end of the reporting period: 12/31, 3/31, 6/30 and 9/30. The Grantee shall provide reports in accordance with the template provided by DHAPP

• Reports will follow DHAPP Headquarters and Country Team Templates