You are here

Multipurpose Prevention Technology: Novel Systemic Options for Young Adults (R43/R44 Clinical Trial Not Allowed)


The objective of this Funding Opportunity Announcement (FOA) is to support the development of new and innovative long-acting systemic and non-systemic multipurpose prevention technologies (MPT). It supports development of MPTs that prevent HIV infection and pregnancy (hormonal and non-hormonal methods) in adolescent and young women. Applications for MPT development may involve pharmacokinetic (PK), pharmacodynamic (PD), safety, and drug-drug interactions (DDI) studies. It also encourages biobehavioral and behavioral/social studies to identify MPT end user preferences factors (look, feel, effectiveness, safety and duration of action) and other behavioral/social factors that could promote increased MPT use in adolescent and young women. Purpose and Background The objective of this FOA is to support development of novel long-acting, systemic and potentially non-systemic Multipurpose Prevention Technologies (MPTs) for the purposes of pregnancy and HIV infection prevention in adolescent and young women, as appropriate. Of special interest are health disparity populations that are disproportionately infected by HIV and individuals who would desire the convenience of a multi-component prevention strategy. Recent advancements in long-acting HIV products allows for the possibility of long-acting combination products. The goal of this initiative is to stimulate research that advances alternative routes of drug delivery systems for multipurpose prevention technologies for use by adolescent girls and young women (AGYW), such as injectable, implantable, or transdermal. Specifically, this initiative will advance knowledge that would result in innovative delivery systems or approaches so that adolescent girls and young adult women can have effective and reliable options that align with their preferred mode of delivery. Specific Areas of Research Interest Applicants are encouraged to consider specifying clinical and nonclinical research milestones and timelines for their proposed research. Inclusion of biobehavioral research, integrated into an MPT drug development program, focused on optimizing the rheological and biophysical properties of the product for use by target populations is encouraged. Applications may address one or more of the following interest topics. Development of MPT formulations, systemic for HIV and pregnancy prevention in formulations and/or drug platforms that are appropriate for administration to adolescent and young adults. Studies involving the investigation of pharmacologic properties of proposed formulations in animal models to understand the interaction of the formulation with endocrine, physiologic and other biochemical changes experienced among, adolescent and young adult populations. Development of sustained/extended release MPTs that provide months to years of protection from pregnancy and HIV and in women using a single dose or a constant delivery DDS. Understanding the PK and PD of MPT products by mapping the contraceptive, antiviral lag period (time to establish effective concentrations) and tails (time to loss of effective concentrations) for sustained/extended release MPTs. Understanding the potential for and identifying/characterizing DDI that could compromise a pregnancy prevention and HIV and MPT safety and effectiveness. The NIAID specific areas of scientific interest for the FOA will be: Development of episodic dosed MPTs for use during periods of sexual activity with a minimum of 7 days protection from a single dose for MPTs targeting HIV and Sexually Transmitted Infections (STIs) for cis and trans males and females. Development of sustained/extended release MPTs that provide months to years of protection from HIV and/or STI infection and pregnancy in women using a single dose or a constant drug delivery system (DDS), which may be modeled after the highly effective long-acting reversible contraceptive (LARC) strategies for durations and use patterns. Development of animal models (single model or separate harmonized animal models) that evaluate the efficacy and safety of the active ingredients of a multiple indication MPT product. Understanding the potential for and identifying/characterizing drug-drug interactions (DDI) that could compromise MPT safety and effectiveness. Understanding the pharmacokinetics (PK) and pharmacodynamics (PD) of MPT products by mapping the antiviral and/or contraceptive duration, lag period (time to establish effective concentrations) and low-level drug tails (time to loss of effective concentrations) during non-use periods, such as menstruation or between dose renewals for episodic and sustained/extended release MPTs. Development MPTs that deliver effective HIV and STI drug concentrations to both the female reproductive tract (FRT) and the gastrointestinal (GI) tract of males and females. Understanding the biobehavioral factors which govern decisions made by individuals to use MPTs (look, feel, and duration). For this FOA, biobehavioral factors are defined as the rheological/biophysical properties of the MPT DDS that invoke user judgments, leading to decisions for first, subsequent use or non-use and/or early termination. NIMH Areas of Research Interest NIMH is interested in studies that propose an MPT with an HIV prevention component, and that include a strong behavioral science component integrated into the development of the MPT. The behavioral science component may include research to: Assess preferred user characteristics Understand how partner, situational, or contextual factors influence product preferences And/or identify product attributes and other behavioral, social, and healthcare system determinants that may affect adherence to and persistence on the product. Applications will be deemed non-responsive if the applications: Propose non-HIV related projects Propose clinical trials for first in human, safety and efficacy is included Propose projects involving vaginal rings for drug delivery
US Flag An Official Website of the United States Government