Towards a roadmap to advance non-hormonal contraceptive multipurpose prevention technologies: strategic insights from key stakeholders†

Abstract

<jats:title>Abstract</jats:title> <jats:p>The development of non-hormonal contraceptives is critical to increase options for women. In combination with prevention against sexually transmitted infections, they can become an important component of multipurpose prevention technologies (MPTs) which address multiple reproductive health needs with a single product. Resulting from multiple rounds of expert consultations, this framework aims to guide the development of non-hormonal contraceptive MPTs. Key informant interviews with experts in family planning and HIV and STI prevention and MPT product developers and funders from around the globe were conducted, reviewed, and coded. Identified key themes were discussed by experts at the November 2019 Eunice Kennedy Shriver National Institute of Child Health and Human Development Contraceptive Development Meeting in Houston, Texas. Seven action strategies were identified to address key research gaps and priorities for advancing the field. They highlight the importance of identifying target populations, a systematic approach to collaborative research, and leveraging knowledge from other fields, including regulatory and patenting, manufacturing, and commercialization expertise. Employing expanded target product profiles and setting go/no-go decisions for non-hormonal MPTs will help to prioritize the most promising candidates in the drug development pipeline. Further, they call for optimizing investments and engagement of stakeholders from public and private sectors. These action strategies aim to facilitate collaboration and innovation amongst multidisciplinary MPT stakeholders. Paramount to success will be enhancing strategic alliances and reconciling the essential social–behavioral context and market forces that drive product use with the complexities of research and development, regulatory approval, and commercialization.</jats:p>

Multipurpose Prevention Technologies: Oral, Parenteral, and Vaginal Dosage Forms for Prevention of HIV/STIs and Unplanned Pregnancy

“…Hormonal contraceptives can have a myriad of side effects such as irregular bleeding, weight gain, pulmonary embolism, and increased risk for cervical and breast cancer [ 139 , 140 ]. These side effects, along with misconceptions of infertility caused by hormonal contraceptives, are driving forces to their discontinuation [ 141 ]. Current commercial nonhormonal contraceptives are often ineffective due to low patient compliance or poor partner cooperation (e.g., condoms and spermicide gels) or require surgery for insertion/removal (e.g., copper intrauterine device).…”

“…The development of a user accepted nonhormonal contraceptive in an MPT will benefit from a high throughput systemic screening approach to discover new drug candidates. The initiative for MPTs suggests utilizing a DNA barcoding technology for genes critical to reproductive pathways, a high throughput screening method [ 141 ]. As more nonhormonal contraceptives are discovered, they must be and able to be combined with antivirals with no drug–drug interactions.…”

Barriers and Enablers Influencing Women's Adoption and Continuation of Vaginally Inserted Contraceptive Methods: A Literature Review

“…2019). Many women also say they want more nonhormonal contraceptive choices and methods with milder or no side effects (Hemmerling, Christopher, and Holt 2020). Others want more “on demand” options that can be used only when needed rather than continuously (Raymond et al.…”

Evaluation of the novel vaginal contraceptive agent PPCM in preclinical studies using sperm hyaluronan binding and acrosome status assays

“…[13][14][15][16][17] It is clear that safer contraceptive choices are needed, 11,18,19 including vaginal contraceptives that are not systemically absorbed, available over-the-counter (OTC), and can be used on an as-needed basis. 20 Novel vaginal contraceptive products face a difficult development path. Vaginal products must be active in a complex environment.…”

“…Current non‐hormonal vaginal products offer a reversible alternative, but most of them contain the spermicide nonoxynol‐9 (N‐9), which is cytotoxic to vaginal tissues and can cause significant tissue damage, even increasing risk of STIs, including HIV 13–17 . It is clear that safer contraceptive choices are needed, 11,18,19 including vaginal contraceptives that are not systemically absorbed, available over‐the‐counter (OTC), and can be used on an as‐needed basis 20 …”