Project

Dual Prevention Pill for the Prevention of HIV and Unintended Pregnancy

Council researchers are working with partners to fast track the development of a single product to prevent unintended pregnancy and HIV.

The Issue

Young women worldwide are confronted with two significant health risks: unintended pregnancy and HIV infection. Oral pre-exposure prophylaxis (PrEP) is a highly effective method of HIV prevention, yet uptake of and adherence to PrEP in high-risk countries remains low. Women in sub-Saharan Africa disproportionately shoulder the burden of the HIV epidemic, where adolescent girls and young women account for two-thirds of new HIV infections.  

Growing evidence suggests many women would be more likely to use an HIV prevention method if it also provided protection against pregnancy. There is an urgent and continued need to develop innovative sexual and reproductive health technologies that women and girls can control, and we must find ways to do this as quickly as possible. 

The Progress

Several novel contraceptive multi-purpose prevention technologies (MPTs) are in development, yet it will be many years before one is available. The Population Council and other groups are developing a dual prevention pill (DPP) regimen by co-formulating the active ingredients in oral PrEP and generic oral contraceptives into one tablet to be taken every day. A DPP regimen, which combines two marketed and approved products, is likely to be the fastest pathway to contraceptive MPT introduction.  

In addition to the product formulation work, the Population Council is conducting two acceptability studies in Zimbabwe and South Africa to inform the development and introduction of the DPP. The two studies will test acceptability of an over-encapsulated version of the DPP as a proxy for the co-formulated tablet among women (ages 16–40). In both countries, women currently using oral contraceptives who are at risk of HIV infection will use the over-encapsulated DPP for 3 menstrual cycles and will take PrEP and oral contraceptives separately for 3 cycles. At the end of 6 months, women will be asked if they preferred the single DPP or the two separate pills and, in South Africa, participants will have the option of taking either the DPP or two separate pills for an additional 6-month Choice period.   

The acceptability study results will be important for informing product introduction. In particular, these studies will provide the opportunity to test out counseling strategies, learn which women prefer the DPP versus two separate pills, and prime the community for scaling up this new technology once the co-formulated DPP is available. 

The Impact

A DPP, if available in family planning and HIV clinics, has the potential to play an important role in meeting the sexual and reproductive health needs of women. The Population Council is committed to continuing research and development of products that give women and girls choice, convenience, and control over their sexual and reproductive health. 

Principal Investigator

  • Sanyukta Mathur Senior Associate and DREAMS Implementation Science Project Director, Washington, DC
  • Lisa Haddad Medical Director, Center for Biomedical Research
  • Bruce Variano Senior Scientist, Head of Pharmaceutical Development, Center for Biomedical Research
  • Barbara Friedland Associate II, New York

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