Grants Notice: Strengthening HIV/AIDS Research in Kenya

Grants Notice: Strengthening HIV /AIDS Research in Kenya

Deadline: 4 April 2017

The U.S. Department of State’s Centers for Disease Control and Prevention (CDCP) is currently seeking applications from eligible entities for its funding program in order to strengthen HIV /AIDS Research in Kenya. The purpose of this funding opportunity announcement (FOA) is to support a project to conduct clinical trials and public health research for the prevention and treatment of HIV in Kenya.

The NCHHSTP Division of HIV/AIDS Prevention (DHAP) is seeking to initiate a cooperative agreement to support research on HIV prevention with particular emphasis on biomedical interventions, including alternative methods for delivering HIV pre-exposure prophylaxis such as vaginal rings. Additional research studies may include research on: HIV transmission, optimization of HIV care and treatment, alternative biomedical modalities for HIV prevention and safety, HIV treatment cure, risk factors for and the epidemiology of HIV infections, and interventions that prevent or minimize HIV co-morbidities from other infections.

Program Objectives

• Assess the safety, efficacy, acceptability, adherence to, impact and other characteristics of biomedical interventions to prevent HIV, such as intravaginal rings and multipurpose technologies, to include HIV pre-exposure prophylaxis (PrEP).
• Evaluate the feasibility, performance and other characteristics of biomedical interventions, assays and biomarkers to diagnose and monitor HIV infection and its response to treatment.
• Evaluate the acceptance, adherence, feasibility and impact of providing HIV PrEP to individuals at high risk for HIV (for example, adolescent and young women [ADYW], sex workers and men who have sex with men [MSM]) and biomarkers to monitor PrEP.
• Establish a system and protocol for data collection, tabulation, management, cleaning, storage/archiving that comply with Clinical Data Interchange Standards Consortium (CDISC) regulations and standards as well as the Study Data Standards for Regulatory Submissions.
• Establish and/or maintain partnerships with regional/sub-regional ministries of health, provincial and municipal health departments, non-governmental organizations, academic institutions, manufacturers of HIV biomedical interventions and diagnostic/monitoring assays, academic partners and others to facilitate implementation of the priority HIV research.

Expected Outcomes

The expected outcomes include the following:

• Prepare and conduct at least one clinical trial that implements and evaluates use of a biomedical intervention identified as a priority by CDC Division of HIV/AIDS Prevention (DHAP), such as a vaginal ring, including but not restricted to the support of laboratory and epidemiologic aspects of the trial, its monitoring and quality assurance and the procurement of commodities and services required to conduct the trial(s). Evaluate the feasibility, performance and other characteristics of at least one other biomedical intervention, assay and biomarker for the diagnosis and monitoring of HIV infection and its response to treatment that are developed within this cooperative agreement.
• Evaluate the acceptance, adherence, feasibility and impact of providing HIV PrEP to individuals at high risk for HIV (for example, adolescent and young women [ADYW], sex workers and men who have sex with men [MSM]) and biomarkers to monitor PrEP that are developed within this cooperative agreement.
• Establish a system and protocol for Clinical Data Interchange Standards Consortium (CDISC)-compliant data collection, tabulation, management, cleaning, storage/archiving that follows the Study Data Standards for Regulatory Submissions.
• Establish and/or maintain partnerships and relationships needed to support the execution of the priority HIV research activities by this cooperative agreement.

Target Population

All temporary or permanent residents of Western Kenya, particularly the Kisumu/Nyanza area, including groups at high risk for HIV such as: adolescent and young women (ADYW); commercial sex workers (CSW); and men who have sex with men (MSM).

Collaboration/Partnerships

The awardee is expected to maintain the current collaboration and partnership between CDC and the Kenya Medical Research Institute (KEMRI) and the Kenya Ministry of Health and to support experienced and qualified staffing of KEMRI HIV research as approved by the clinical research site advisors and leadership. The awardee is also expected to maintain fiduciary oversite over the use of award funds and to facilitate access and cooperation in meeting research study objectives. The awardee will be responsible for oversight of human subjects protections and any OMB-PRA requirements, in collaboration with CDC scientists.

The application should include documentation indicating a close collaboration with KEMRI as exhibited by a Memorandum of Understanding (MOU).

Funding Available

The estimated total funding allotted to this program is $5,000,000.

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

• Award Ceiling: $1,500,000 Per Budget Period
• Award Floor: $500,000 Per Budget Period
• Total Project Period Length: 5 year(s)

Eligibility Criteria

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education
• Private institutions of higher education
• Foreign Organizations are eligible to apply
• Foreign components of U.S. Organizations are eligible to apply.

How to Apply

Applications must be submitted online via given website.

Eligible Countries: United States and Kenya

For more information, please visit Grants.gov.