Innovative Measures of Oral Medication Adherence for HIV Treatment and Prevention (R01) | Apply Online

Frequently Asked Questions (FAQs)

What is the NIH funding opportunity RFA-AI-14-071 about?

RFA-AI-14-071, titled "Innovative Measures of Oral Medication Adherence for HIV Treatment and Prevention (R01)," supports research to create and test better ways to measure and improve adherence to oral HIV medications. The emphasis is on developing genuinely innovative, more reliable approaches than traditional methods such as self-report or pill counts.

What medications and use-cases are the focus of this FOA?

The FOA centers on adherence to two major categories of oral antiretrovirals: (1) antiretroviral therapy (ART) for people living with HIV, and (2) pre-exposure prophylaxis (PrEP) for HIV prevention.

What problem is NIH trying to solve with this announcement?

The goal is to move beyond adherence measures that can be inaccurate or easy to misinterpret (for example, self-reported dosing or pill counts) and instead develop tools that more reliably indicate whether medication was taken as prescribed. The FOA also supports approaches that could help sustain or improve adherence behavior over time.

What kinds of approaches does the FOA describe as "innovative"?

The announcement highlights technology-forward and objective measurement approaches, including advanced bioanalytical assays to detect antiretroviral drugs or metabolites in biological samples, pill ingestion sensors that can register an actual swallowing event, and drug metabolite or taggant detection systems that confirm dosing using measurable chemical signatures.

Does this FOA encourage objective or technology-based adherence measurement?

Yes. A core feature of the FOA is its emphasis on technology and objective measurement, including connected (wireless) technologies that can capture adherence-related signals and potentially feed that information into interventions, clinical workflows, or patient-facing support tools.

What are advanced bioanalytical assays in the context of this FOA?

In this FOA, advanced bioanalytical assays refer to laboratory methods that can detect and quantify antiretroviral drugs or their metabolites in biological samples, with the intent of providing more objective evidence of dosing than traditional adherence measures.

What are pill ingestion sensors, and why are they relevant here?

Pill ingestion sensors are systems designed to register an actual swallowing event rather than relying on indirect signals like opening a pill bottle. The FOA points to these tools as a way to improve confidence that a dose was truly ingested.

What are drug metabolite or taggant detection systems?

These are approaches that use measurable chemical signatures to confirm dosing. The FOA mentions them as an avenue for confirming adherence through detection of metabolites or added markers (taggants) associated with the medication or dosing event.

What types of research activities could be supported under this FOA?

Examples described in the FOA include creating new detection techniques, improving the sensitivity or specificity of existing assays, validating tools against real-world dosing behavior, integrating sensor outputs with mobile or wireless platforms, and designing systems that make adherence monitoring feasible and acceptable in everyday settings.

Is the focus only on measuring adherence, or also on improving it?

Both. While a central emphasis is on better measurement, the FOA also describes the potential for these tools to support improved adherence behavior over time, including by linking captured adherence signals into interventions, clinical workflows, or patient-facing supports.

What is the award mechanism for this opportunity?

The mechanism is an R01 research project grant, intended for substantial research projects rather than small pilot-only efforts.

Does the FOA require cost sharing or matching funds?

No. The FOA did not require cost sharing or matching, meaning applicants were not required to contribute a fixed portion of project costs as a condition of the award.

What is the estimated total funding level for the FOA?

The FOA listed an estimated total funding level of $7,000,000 across the announcement.

Which federal agency sponsors this opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

What CFDA listings are associated with this FOA?

The opportunity references CFDA listings that include mental health research grants and multiple infectious disease and microbiology categories: 93.242, 93.855, and 93.856.

Who was eligible to apply from the United States?

Eligibility was broad and included public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses and other for-profits), and many types of government entities such as state, county, city/township, special district governments, and public housing authorities/Indian housing authorities. Independent school districts were also included.

Were tribal governments and tribal organizations eligible?

Yes. The FOA explicitly included tribal governments (federally recognized) and tribal organizations, including those not federally recognized.

Did the FOA encourage applications from institutions serving specific populations?

Yes. The FOA clarified eligibility for organizations such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations.

Were non-U.S. (international) organizations allowed to apply?

Yes. The FOA permitted international participation: non-U.S. entities (foreign organizations and foreign institutions) were eligible to apply; non-U.S. components of U.S. organizations were eligible; and foreign components, as defined by NIH policy, were allowed.

When was this funding opportunity posted and when did it close?

The opportunity was posted/created on December 1, 2014. The original and current closing date was March 25, 2015.

When was the FOA archived?

The archive date listed for the FOA was April 25, 2015.

Where was the full announcement hosted?

The full announcement was hosted on the NIH grants site.

What should someone do if they have trouble accessing the FOA link?

The FOA included contact instructions directing users to the NIH Office of Extramural Research webmaster for access or linking issues.

What is the broader public health goal behind this FOA?

The broader goal is to advance more accurate and practical (potentially real-time or near-real-time) adherence measurement for oral ART and PrEP, improving treatment outcomes for people living with HIV and strengthening HIV prevention effectiveness for people using PrEP.