Opportunity Information: Apply for RFA PS 16 006
Apply for RFA PS 16 006
- The HHS-CDC-HHSCDCERA in the health sector is offering a public funding opportunity titled "Early HIV Treatment to Optimize Patient Health and HIV Prevention" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.941.
- This funding opportunity was created on Dec 10, 2015 and posted on Dec 10, 2015.
- Applicants must submit their applications by Feb 19, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $495,000.00 in funding.
- The number of recipients for this funding is limited to 3 candidate(s).
- Eligible applicants include: 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 that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The grant opportunity titled "Early HIV Treatment to Optimize Patient Health and HIV Prevention" (Funding Opportunity Number RFA PS 16 006) is a CDC cooperative agreement focused on testing how practical it is to start antiretroviral therapy (ART) almost immediately after someone is diagnosed with acute or early HIV infection. The central idea is to move treatment initiation up to the earliest window possible, ideally within days of diagnosis, and to evaluate whether rapid-start approaches can be implemented successfully in real-world clinical settings. Because this is a prospective study, recipients would follow individuals forward in time after diagnosis and treatment initiation, tracking clinical and behavioral outcomes as the rapid-start strategies are put into practice.
The main outcomes the project is designed to measure are straightforward and closely tied to both patient health and prevention impact. First, the study looks at time to viral suppression, meaning how quickly a person reaches an undetectable viral load after being diagnosed and started on ART. Second, it measures the proportion of patients who remain virally suppressed 12 months after diagnosis, which serves as an indicator of sustained treatment success over the first year. These outcomes matter because faster and durable viral suppression improves individual health outcomes and also reduces the likelihood of onward HIV transmission.
Beyond the primary endpoints, the opportunity encourages a broader evaluation of how early treatment initiation affects the full care experience and longer-term engagement in services. Additional outcomes may include retention in HIV care (whether patients stay connected to clinical services over time), patient satisfaction with clinical care (how patients perceive access, communication, and quality of the rapid-start process), and changes in HIV transmission risk behavior (whether behaviors that influence transmission risk shift after early diagnosis and immediate treatment). The description also highlights evaluating laboratory markers related to viral suppression, suggesting the study can incorporate clinical lab monitoring beyond a simple suppressed/not-suppressed measure, potentially examining patterns that help explain why rapid-start works well for some patients and not others.
A notable feature of the grant is that it explicitly allows for other outcomes as determined by patient input and the study investigators. That emphasis signals an interest in patient-centered evaluation, where participants perspectives can shape what the program measures and how success is defined. In practice, that could mean incorporating outcomes tied to barriers and facilitators of rapid ART start, acceptability of same-day or near-same-day initiation, and practical issues that affect early engagement such as linkage processes, appointment timing, navigation support, medication access, and follow-up intensity.
Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism, meaning the funding agency (HHS/CDC) is typically more involved in programmatic oversight and collaboration than under a standard grant. The activity category is health, and the CFDA number is 93.941. The opportunity anticipated making about three awards, with an award ceiling of $495,000. The funding announcement was posted on December 10, 2015, created the same day, and had an original and current closing date of February 19, 2016.
Eligibility is broad and includes many types of public and private entities that could realistically run clinical or public health research and demonstration projects. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities/Indian housing authorities; and nonprofit organizations both with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories). The listing also includes an "Others" category with a note to consult the announcement for additional eligibility clarification, which is common when agencies want flexibility for specialized implementing organizations.
Overall, this opportunity is aimed at generating practical evidence on rapid ART initiation for people diagnosed during acute or early infection, with a dual focus on clinical outcomes (speed and durability of viral suppression) and implementation-related outcomes (retention, satisfaction, behavior change, and lab indicators). The intent is to determine whether innovative rapid-start models can be deployed quickly after diagnosis and sustained over time in a way that improves patient health while also contributing to HIV prevention goals.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Early HIV Treatment to Optimize Patient Health and HIV Prevention". The Funding Opportunity Number (FON) is RFA PS 16 006.
What federal agency is offering this opportunity?
This is a CDC cooperative agreement under HHS/CDC.
What type of funding mechanism is being used?
The mechanism is a cooperative agreement, which generally means the funding agency is more involved in programmatic collaboration and oversight than it would be under a standard grant.
What is the main purpose of the project?
The project is focused on testing how practical it is to start antiretroviral therapy (ART) almost immediately after someone is diagnosed with acute or early HIV infection. The intent is to move ART initiation into the earliest window possible, ideally within days of diagnosis, and evaluate whether rapid-start approaches can work in real-world clinical settings.
What does "rapid-start" ART mean in this opportunity?
In the context of this opportunity, "rapid-start" refers to initiating ART very soon after diagnosis (ideally within days), rather than waiting for longer, more traditional initiation timelines.
What kind of study design is expected?
The opportunity describes a prospective study, meaning recipients would follow individuals forward in time after diagnosis and treatment initiation to track clinical and behavioral outcomes as rapid-start strategies are implemented.
Who is the target population for the study?
The focus is on people diagnosed with acute or early HIV infection, with ART initiation occurring very soon after diagnosis.
What are the primary outcomes the project is designed to measure?
The main outcomes are:
- Time to viral suppression (how quickly participants reach an undetectable viral load after diagnosis and ART initiation).
- Viral suppression at 12 months (the proportion of patients who remain virally suppressed 12 months after diagnosis).
Why are these primary outcomes important?
Faster and sustained viral suppression supports better individual health outcomes and reduces the likelihood of onward HIV transmission, linking patient care benefits with HIV prevention impact.
Are there additional outcomes that may be evaluated beyond the primary endpoints?
Yes. The opportunity encourages broader evaluation of the care experience and longer-term engagement, including outcomes such as:
- Retention in HIV care (whether patients stay connected to clinical services over time).
- Patient satisfaction with clinical care (perceptions of access, communication, and quality of the rapid-start process).
- Changes in HIV transmission risk behavior (whether behaviors that influence transmission risk change after early diagnosis and immediate treatment).
Does the opportunity mention laboratory monitoring beyond a simple suppressed/not-suppressed measure?
Yes. The description highlights evaluating laboratory markers related to viral suppression, suggesting recipients may incorporate clinical lab monitoring beyond a binary viral suppression outcome, potentially examining patterns that help explain differences in how well rapid-start works across participants.
Can projects include other outcomes not listed explicitly?
Yes. A notable feature is that it explicitly allows for other outcomes as determined by patient input and the study investigators, signaling an emphasis on patient-centered evaluation.
What does "patient-centered evaluation" mean in this context?
Based on the description provided, it means participant perspectives can help shape what is measured and how success is defined. This could include outcomes related to acceptability, barriers, and facilitators of starting ART on the same day or near the same day as diagnosis.
What kinds of real-world implementation factors could be examined under this opportunity?
The description points toward practical issues that affect early engagement and rapid initiation, such as linkage processes, appointment timing, navigation support, medication access, and follow-up intensity, as well as barriers and facilitators identified by patients and investigators.
How many awards were anticipated?
The announcement anticipated making about three awards.
What is the award ceiling mentioned for this opportunity?
The award ceiling listed is $495,000.
What is the activity category for this funding opportunity?
The activity category is health.
What is the CFDA number associated with this opportunity?
The CFDA number is 93.941.
When was the funding announcement posted?
The funding announcement was posted on December 10, 2015, and it was also created on the same date.
What were the original and current closing dates?
Both the original closing date and the current closing date are listed as February 19, 2016.
Who is eligible to apply?
Eligibility is broad and includes many public and private entities, including:
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Other Native American tribal organizations
- Public housing authorities/Indian housing authorities
- Nonprofit organizations with 501(c)(3) status (excluding institutions of higher education in this nonprofit category)
- Nonprofit organizations without 501(c)(3) status (excluding institutions of higher education in this nonprofit category)
What does the "Others" eligibility category mean?
The listing includes an "Others" category with a note to consult the announcement for additional eligibility clarification, which is commonly used when agencies want flexibility for specialized implementing organizations.
What is the overall goal of the opportunity?
The overall goal is to generate practical evidence on rapid ART initiation for people diagnosed during acute or early infection, combining clinical outcomes (speed and durability of viral suppression) with implementation-related outcomes (retention, satisfaction, behavior change, and lab indicators), to determine whether rapid-start models can be deployed quickly and sustained over time to improve health and support HIV prevention.
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