The U.S. Agency for International Development's (USAID's) Office of HIV/AIDS is very pleased to announce the award of five cooperative agreements through Round Three of the Annual Program Statement for Microbicide Research, Development, and Introduction. These awards continue and expand USAID support for microbicide introduction and access in the context of current advances in biomedical technologies and approaches for HIV prevention. These cooperative agreements were awarded with funding from U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) to five implementing partners for a period of five years.The Round Three Objectives, with brief details of the corresponding awards, are provided below. Please contact Dr. Nagesh Borse, lead technical advisor on the MPii project, with any questions regarding these awards using the subject line "Ask Microbicides."

Objective: Expedite and sustain access to microbicides in countries and among populations where most needed

Project Title: OPTIONS – Optimizing Prevention Technology Introduction ON Schedule

Implementing Partner: FHI 360 (Kristine Torjesen, Project Director) with Wits RHI and AVAC

Objective: To develop a streamlined and adaptable product delivery platform for current and future microbicide and antiretroviral (ARV)-based HIV prevention options by 1) developing evidence-based business cases and coordinated investment strategies for introduction; 2) supporting country level regulatory approval, policy development, program planning, and marketing and implementation strategies; 3) facilitating and conducting implementation science; and 4) providing technical assistance and support for health systems strengthening with rapid use of data to identify and address implementation bottlenecks throughout the value chain.

Objective: Develop cost-effective and scalable models for implementation of microbicides and other forms of PrEP for women

Project Title: POWER – Prevention Options for Women Evaluation Research

Implementing Partner: University of Washington (Connie Celum and Jared Baeten, Co-Project Directors)

Objective: To develop and evaluate effective, scalable strategies that are context-specific and gender responsive and address critical gaps in microbicide and pre-exposure prophylaxis (PrEP) delivery for African women in high HIV incidence settings by 1) conducting formative research among African women and healthcare providers, focusing on motivators and obstacles for initiation of and adherence to microbicides and PrEP, to inform development of effective communications, decision tools, and delivery strategies that meet women’s needs and are integrated with established programs, including regular HIV testing; 2) establishing open cohorts of women for delivery of microbicides and PrEP; 3) piloting optimized and scalable microbicide and PrEP adherence support and delivery strategies; 4) analyzing cost-effectiveness and modeling delivery approaches; and 5) translating successful approaches to other programmatic settings.

Objective: Increase uptake and correct and consistent use of microbicides by women at high risk for HIV infection

Project Title: EMOTION – Enhancing Microbicide Uptake in High-risk End Users

Implementing Partner: CONRAD (Gustavo Doncel, Project Director)

Objective: Focusing on high-risk end users, to identify individual, couple, and community-based motivations for and barriers to product use, and to define and test product changes at the design, packaging, access, and messaging levels to increase demand, use, and adherence by 1) conducting a human-centered design (HCD) study; 2) implementing HCD-based changes in microbicide/PrEP products and messaging; 3) quantifying the user experience of accessing and adhering to microbicide/PrEP products in a socio-behavioral study with objective biomarkers of adherence; and 4) developing an introduction package and a campaign for marketing, distribution, and outreach for microbicide/PrEP products that are desirable to use and enhance health and partnerships.

Objective: Support women’s agency to safely use microbicides and reduce vulnerability to intimate partner violence

Project Title: CHARISMA – Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence intervention

Implementing Partner: RTI International (Elizabeth Montgomery, Project Director)

Objective: To synthesize data from a variety of sources, including secondary analyses of key microbicide trials, cross-sectional studies and intimate partner violence (IPV) interventions, and collect primary data from former trial participants, their male partners, and providers to 1) inform development of a novel social benefits-harms tool that will facilitate assessment of and response to the range of positive and negative effects of microbicide use experienced by these women; and 2) to inform development and pilot testing of an intervention, Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA), which is designed to increase women’s agency to use microbicides consistently and safely, while simultaneously optimizing partner relationships and mitigating the risk of IPV.

Objective: Inform policies and define programmatic considerations related to use of microbicides and risk of resistance

Project Title: GEMS (Global Evaluation of Microbicide Sensitivity) – Comprehensive Assessment of Resistance Risk and Development of Policy Recommendations for Microbicide/PrEP Roll-out

Implementing Partner: University of Pittsburgh (John Mellors, Project Director)

Objective: To address policy and programmatic considerations related to the use of microbicides and risk of resistance by 1) conducting research to better characterize risk of resistance with topical ARV-based microbicides and PrEP agents and the possible effects on future HIV treatment options; 2) modeling and analyzing potential public health harms, benefits, and costs of different intervals and requirements for HIV testing for users of microbicides in resource-constrained settings; 3) developing and evaluating evidence-based policy recommendations for the frequency of HIV testing and resistance monitoring; and 4) monitoring seroconverters in ARV-based prevention programs for resistance.