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Due to the COVID-19 pandemic and to protect study staff and participants, ongoing MTN studies are not screening or enrolling participants, while planned studies are on pause.  Current participants continue to be followed by study teams to the extent this is both feasible and safe.

MTN-034/REACH (Reversing the Epidemic in Africa with Choices in HIV Prevention) – A Phase IIa trial that seeks to understand the HIV prevention needs and preferences of adolescent girls and young women in sub-Saharan Africa, who are among those most vulnerable to HIV. Specifically, REACH is evaluating how adolescent girls and young women use the monthly dapivirine vaginal ring and Truvada® as daily PrEP (pre-exposure prophylaxis), and their preferences for either or both approaches after using each for six months.  REACH will also collect much needed information on the safety of the approaches in these populations. The study, which began in February 2019, will enroll 300 adolescent girls and young women ages 16-21 at four trial sites in South Africa, Uganda and Zimbabwe, and is expected to be completed late 2021.  More info…

MTN-035/DESIRE (Developing and Evaluating Short-acting Innovations for Rectal Use) – An acceptability, tolerability and adherence study of three placebo products for use in the rectum, including a douche, suppository and fast-dissolving rectal insert. The goal of the study is to help answer important questions about preferences for future rectal microbicide products. The products, which contain no active drugs, are currently being evaluated in 210 HIV-negative cisgender men, transgender men and transgender women who have sex with men at sites in Malawi, Peru, South Africa, Thailand and the U.S. Participants are asked to use each product for a 4-week period and report their use, likability and relative acceptability of the products. The study is expected to be completed mid-2020.  More info…

MTN-039 – A Phase I study launched in late 2019 that was designed to evaluate the safety and acceptability of a fast-dissolving rectal insert containing the antiretroviral (ARV) drugs tenofovir and elvitegravir, as well as the degree that each drug concentrates in rectal tissue. The study, the first ever of the tenofovir and elvitegravir insert used rectally, seeks to enroll 20 cisgender and transgender men and women at two sites in the U.S.  More info…

MTN-042/DELIVER – A Phase IIIb open-label study designed to evaluate the safety and acceptability of the monthly dapivirine vaginal ring, which is under regulatory review, and Truvada as daily PrEP in pregnant women. The study, which launched in South Africa in early 2020, will enroll 750 women at different times during pregnancy who will use either the dapivirine ring or Truvada as PrEP until they deliver. Women will be followed for six weeks postpartum, and their babies will be followed for one year. Other trial sites are in Malawi, Uganda and Zimbabwe. The study is the first of the ring in pregnant women and will provide more insight about the safety of Truvada as PrEP during pregnancy, a time when women are at much greater risk of HIV.  More info…

MTN-043/B-PROTECTED – A Phase IIIb open-label study that will evaluate the safety and acceptability of the monthly dapivirine ring, which is under regulatory review, and Truvada as daily PrEP in women who are breastfeeding, a time of heightened vulnerability for acquiring HIV. The study will enroll up to 200 breastfeeding mothers and their 6- to 12-week-old babies. Women will use their assigned product – PrEP or the dapivirine ring – for three months and be followed for an additional two weeks. Researchers will assess how much drug from Truvada and the dapivirine ring passes into breastmilk and how much passes to the baby after breastfeeding, and will measure the effects, if any, this may have on their health. B-PROTECTED will be conducted at the same sites as the DELIVER study, which are in Malawi, South Africa, Uganda and Zimbabwe.  More info…

MTN-045 – A qualitative study that will enroll up to 400 couples in Uganda and Zimbabwe and aims to understand their views of and preferences for dual-purpose products that could feasibly prevent both unintended pregnancy and HIV infection. The study, which began early 2020, will help inform the design and delivery of dual-purpose products, including the role that male partners may play in the decision-making process.