Advancing the Science of Multipurpose Technology for the Prevention of HIV and Unintended Pregnancy (R43/R44)

The purpose of this initiative is to invite SBIR applications to stimulate new and innovative multipurpose prevention technologies (MPTs) through the development of new combinations of agents and delivery systems to prevent HIV infection and unintended pregnancy among adolescent girls and young women.  HIV and unintended pregnancy are two major public health problems affecting young women globally. Combination prevention modalities may be more desirable and lead to better adherence in the end user, especially among younger populations. A viable and effective combination prevention modality would be ideal and critical for these young women who are at risk for HIV and who desire protection against pregnancy.

Background

There are over 86 million unintended pregnancies and over 2 million new cases of HIV yearly throughout the world. Adolescent and young women account for 60% of new infections and many of the unintended pregnancies in Sub-Saharan Africa and other regions. MPTs for HIV prevention and contraception are the next generation in prevention, and would encourage adherence and provide an effective option to protect the woman and her partner. Such products are needed for women and girls at high-risk for HIV infection who also need protection from pregnancy. MPTs may also benefit specific at-risk populations such as women in serodiscordant partnerships who are not planning pregnancy.

Currently available methods, such as oral PrEP and dapivirine ring, provide protection only against HIV and have been shown to be effective for individuals who are highly adherent. The results of two biomedical prevention trials, VOICE (Vaginal and Oral Interventions to Control the Epidemic), and ASPIRE (A Study to Prevent Infection with a Ring for Extended Use) have demonstrated that young women’s and girls' adherence to a regimen, be it vagina coital, daily, or sustained release, suffers because of multiple contextual barriers. However, biological mechanisms that interfere with drug absorption, which may reduce drug exposure and prevent adequate protection in the vaginal tract of adolescents and young adult women, may also play a part. The dapivirine ring, for example, was found to be effective against HIV in women over the age of 25 years but not protective in women under the age of 21 years.  

The theorized advantages of combining a longer delivery system for HIV prevention (i.e. the dapivirine ring) with a long acting contraceptive (i.e levonorgestrel) or a non-hormonal contraceptive device such as the copper IUD, is to allow the products to fit into a woman’s schedule seamlessly without having to remember to use daily medication, and to provide a reliable effective method of delivery that could be used on-demand as women's circumstances change. It is anticipated that the addition of an effective contraceptive, would expand the utility of the HIV prevention method and therefore its appeal to the young adult and adolescent end users. However, the appropriate dosing of anti-retroviral drugs and contraceptives to confer the protection must be determined, especially among younger populations who are growing and whose physiology is changing and cannot be extrapolated from studies in older individuals. There is limited information on endogenous hormonal factors, drug-drug interactions, vaginal microbiota, and immune factors that could interfere with achieving the dosing needed to deliver that protection and this knowledge gap must be addressed if effective MPTs are to be developed. Currently, there are two dual protection products in phase I clinical trials. Additional innovative, novel and viable alternatives (excluding agents and/or platforms already in study) need to be developed and added to the product development pipeline.

Research Objectives and Scope

The primary aim of this initiative is to support new and innovative MPTs that contain effective anti-HIV and contraceptive properties that will be desirable for young people to use. The specific goals of this initiative are to advance knowledge for the development of innovative delivery systems or approaches that combine effective HIV prevention and contraception methodologies in a single use-friendly platform with potential to advance into future clinical studies.

Each application submitted for this FOA must include one or more of the focus areas below to be responsive and focus on adolescent girls and young adults:

Development of MPTs that include effective non-hormonal or novel hormonal contraceptives as components

• Projects that address the female genital tract microbiome interactions on the PK/PD and therapeutic levels of hormonal contraceptives and/or HIV preventive drugs
• Projects that evaluate the immune response to hormonal contraceptives and HIV prevention technologies
• Nanotechnology and other approaches or delivery platforms for MPT candidates
• Early phase and demonstration projects to expand and apply our understanding of the feasibility, usability, uptake, adherence and safety of promising biomedical, dual HIV prevention and contraception interventions and the impact of these on sexual behaviors of at-risk youth

Non-responsive areas:

• Studies focused on single prevention technologies
• Studies focused on short acting (e.g., requiring daily administration) contraceptive or antiviral agents
• Further development of MPTs incorporating tenofovir, dapivirine, or levonorgestrel
• Development of MPT focused on STI other than anti-HIV

See Section VIII. Other Information for award authorities and regulations.