Ethics approval and consent to participate
All procedures performed in the MTN-020/ASPIRE study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. All study participants consented to trial participation per site-specific informed consent forms modified from sample informed consent forms included in the trial protocol, which is available at NEJM.org. The study was approved by the following Institutional Review Boards/Ethics Committees and Drug Regulatory Authorities: Prevention Sciences Research Committee of the US National Institute of Allergy and Infectious Diseases; US Food and Drug Administration; National Health Sciences Research Committee of Malawi; Johns Hopkins University Bloomberg School of Public Health Institutional Review Board; University of North Carolina at Chapel Hill Institutional Review Board; Pharmacy, Medicines and Poisons Board of Malawi; University of Cape Town: Human Research Ethics Committee; Biomedical Research Ethics Committee University of KwaZulu-Natal; South African Medical Research Council Ethics Committee; Human Research Ethics Committee: (Medical), University of Witwatersrand, Johannesburg; Medicines Control Council of South Africa; Joint Clinical Research Centre Institutional Review Board; Uganda National Council for Science and Technology; Johns Hopkins University School of Medicine Institutional Review Board; National Drug Authority of Uganda; Medical Research Council of Zimbabwe; Committee on Human Research, University of California - San Francisco; Joint Parirenyatwa Hospital and College of Health Sciences Research Ethics; Research Council of Zimbabwe; Medicines Control Authority of Zimbabwe.
Consent for publication
Availability of data and materials
All data generated or analyzed as part of the MTN-020/ASPIRE trial are included in this article, Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women, and its supplemental files. Additional data related to implementation of participant engagement events at ASPIRE sites is available from the corresponding author upon reasonable request.
The authors declare that they have no competing interests.
The MTN-020/ASPIRE study was designed and implemented by the Microbicide Trials Network (MTN) funded by the National Institute of Allergy and Infectious Diseases through individual grants (UM1AI068633, UM1AI068615 and UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The vaginal rings used in this study were developed and supplied by the International Partnership for Microbicides (IPM).
JMB, AVDS, LST, TPP, PN, KT, AJM, and RS contributed to the MTN-020/ASPIRE study conception, design, and study operations. FMK, DK, PM, NS, LEM, KW, NSM, NJ, ZG, DKG, YM, and KR managed or supported the management of participant engagement activities and related data collection, as well as closeout and follow-up activities. Material preparation and data analysis for this manuscript were performed by EL and MG. The first draft of this manuscript was written by MG, EL, AJM, and RS and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript; KT provided mentorship throughout the manuscript drafting process.
We would like to acknowledge the Microbicide Trials Network for its support of this work, the International Partnership for Microbicides (IPM) for its discussion and comments, and the participants of the MTN-020/ASPIRE study.
Members of the MTN-020/ASPIRE Study Team:
Study Team Leadership: Jared Baeten, University of Washington (Protocol Chair); Thesla Palanee-Phillips, Wits Reproductive Health and HIV Institute (Protocol Co-chair); Elizabeth Brown, Fred Hutchinson Cancer Research Center (Protocol Statistician); Lydia Soto-Torres, U.S. National Institute of Allergy and Infectious Diseases (Medical Officer); Katie Schwartz, FHI 360 (Clinical Research Manager)
Study sites and site Investigators of Record
Malawi, Blantyre site (Johns Hopkins University, Queen Elizabeth Hospital): Bonus Makanani;
Malawi, Lilongwe site (University of North Carolina, Chapel Hill): Francis Martinson;
South Africa, Cape Town site (University of Cape Town): Linda-Gail Bekker;
South Africa, Durban – Botha’s Hill, Chatsworth, Isipingo, Tongaat, Umkomaas, Verulam sites (South African Medical Research Council): Vaneshree Govender, Samantha Siva, Zakir Gaffoor, Logashvari Naidoo, Arendevi Pather, and Nitesha Jeenarain;
South Africa, Durban, eThekwini site (Center for the AIDS Programme for Research in South Africa): Gonasagrie Nair;
South Africa, Johannesburg site (Wits RHI): Thesla Palanee-Phillips;
Uganda, Kampala site (John Hopkins University, Makerere University): Flavia Matovu;
Zimbabwe, Chitungwiza, Seke South and Zengeza sites (University of Zimbabwe, University of California San Francisco): Nyaradzo Mgodi;
Zimbabwe, Harare, Spilhaus site (University of Zimbabwe, University of California San Francisco): Felix Mhlanga
Data management was provided by The Statistical Center for HIV/AIDS Research & Prevention (Fred Hutchinson Cancer Research Center, Seattle, WA) and site laboratory oversight was provided by the Microbicide Trials Network Laboratory Center (Pittsburgh, PA). For qualitative and participant engagement activity data, management was provided by the Women’s Global Health Imperative Program (RTI International, Berkeley, CA).