According to UNAIDS, more than 20.2 million women and adolescent girls and young women (AGYW) live with HIV. Along with complications related to pregnancy, HIV is a leading cause of death among women of reproductive age; the highest burden is in sub-Saharan Africa.

In this population, the unmet need for family planning is highest amongst those who face financial, educational, geographic, or social barriers to accessing family planning services. The United Nations has reported the unmet need for family planning is greater than 20 percent in 15 countries in sub-Saharan Africa. Given women and AGYW bear a disproportionate burden of the HIV global epidemic (60% of new infections in 2020, according to UNAIDS), these combined statistics suggest the need for new and innovative prevention options tailored to the specific needs of women and AGYW worldwide.

 

As we look to expand the current HIV prevention toolbox, HPTN researchers are investigating products that may prevent HIV acquisition, other sexually transmitted infections (STIs), and unintended pregnancy through a single application. These products are called multipurpose prevention technologies, or MPTs. To be considered an MPT, the product must prevent at least two sexual and reproductive health events: acquiring HIV or other STIs and unplanned pregnancies.

“MPTs can improve the lives of women and families worldwide and remains a critical component of the HPTN scientific agenda,” said Dr. Myron Cohen, HPTN co-principal investigator and director of the Institute for Global Health at the University of North Carolina in Chapel Hill. “Empowering women, adolescent girls, and young women to decide if and when they want to have children while preventing the acquisition of HIV and other STIs is fundamental to human rights and gender equality.”

At present, condoms are the only MPTs available worldwide. However, (male) condom use is typically determined by male partners. MPTs currently in development are more discreet in their design and administration and can offer women more control. These benefits also may help reduce factors that lead to stigma, intimate partner violence, and gender dynamic perspectives regarding contraption use and STI prevention.

The current MPT development pipeline includes products that combine contraception and HIV prevention. Some of these products are intended to be used systemically daily, while others are long-acting. Systemic product candidates include oral pills, long-acting injectables, implants, and patches. Topical candidates include vaginal rings, vaginal and rectal gels, fast-dissolving inserts, enemas, and vaginal films.

“We are at an early stage in MPT development,” says Dr. Sharon Hillier, the technical liaison for MPTs to HPTN and Director of Reproductive Disease Research at Magee-Womens Research Institute at the University of Pittsburgh. “Most MPT products are either in preclinical development or entering phase 1 studies. I am thrilled that HPTN supports further developing these products to meet women’s needs.”

Because MPTs use two or more active ingredients to protect against unwanted pregnancy and the acquisition of HIV or other STIs, getting each drug to work together (i.e., release time, duration, and efficacy) can be challenging. Plus, drug resistance is always a concern when any PrEP products are used as part of an MPT. In addition, any regulatory approval is likely to involve different review groups, given the multi-agent, multi-indication design of MPTs.

“Preventing HIV and pregnancy using one method for AGYW is the hope for the future,” said Nombeko Mpongo, HPTN 084 Community Working Group member and community liaison administrator at the Desmond Tutu Health Foundation in Cape Town, South Africa. “Unintended pregnancy adds even more complexity to the increasing number of new HIV infections among AGYW. We need MPTs as in yesterday.”

The HPTN is currently developing a study (HPTN 104) to evaluate adherence to a single, dual prevention pill (DPP; co-formulated TDF/FTC for PrEP plus ethynyl estradiol/levonorgestrel for pregnancy prevention), compared with two separate tablets with daily oral TDF/FTC and ethynyl estradiol/levonorgestrel in HIV-uninfected women. The study is expected to open for accrual in Q3 2023. 

“MPTs will provide us an opportunity to better address the needs of women and girls worldwide,” said Dr. Lisa Haddad, HPTN 104 protocol chair and medical director of the Center for Biomedical Research at the Population Council. “The dual prevention pill (DPP) is just the beginning. Through HPTN 104, we will learn more about how this new method is used and can impact how individuals protect themselves. The DPP is only the start. I hope we can soon offer a broad range of options to address the needs of various individuals throughout their reproductive lifespan.”