Meeting the HIV Prevention Needs of Pregnant Women
In April 2018, AVAC and the Microbicide Trials Network (MTN) hosted a regional stakeholders’ consultative meeting in Johannesburg about proposed HIV prevention studies involving pregnant and breastfeeding women.
While the development of safe and effective prevention methods for women has long been a priority, much less attention has been paid to women’s HIV prevention needs during periods of pregnancy or breastfeeding, when the risk of infection is estimated to be three to four times greater than when not pregnant or nursing. As a global priority, women need safe and effective biomedical HIV prevention strategies for use throughout their lifespan. Indeed, their babies deserve to be protected, too.
The Microbicide Trials Network (MTN) is planning two studies that will take place at trial sites in Malawi, Uganda, South Africa and Zimbabwe.
- MTN-042, or the DELIVER study, will evaluate the dapivirine vaginal ring and Truvada as daily PrEP (pre-exposure prophylaxis) in pregnant women to determine whether use of these products is safe for both women and their infants. Of the 750 women who will be enrolled, 500 will use the vaginal ring. The study is the first to be conducted of the dapivirine ring during pregnancy.
- MTN-043, or the B-PROTECTED study, will evaluate whether the dapivirine ring and PrEP are safe to use by women who are breastfeeding and will enroll up to 200 mothers and their breastfed babies.
Pending ethics and in-country approvals, MTN-042 is expected to start by mid-2019, and MTN-043 could begin soon after.
About the Meetings
The regional consultation took place on 5 & 6 April 2018 and was preceded by a preparatory meeting for civil society convened by AVAC. Those attending included stakeholders with expertise in bioethics, maternal and fetal medicine, HIV prevention clinical trial design, regulatory affairs and community engagement. The consultation took place early in the protocol development process and was timed such that feedback received could help define the study’s scientific framework and design and suggestions made could be considered by the protocol team in its upcoming meeting scheduled a few days after the consultation.
Follow-up stakeholder workshops took place in March 2019 in Blantyre, Malawi in partnership with MaiKhanda Trust in close coordination with the Blantyre CRS; in Johannesburg, South Africa in partnership with Soul City Institute for Social Justice close coordination with the Wits RHI CRS; and in Kampala, Uganda in partnership with ICW-EA and White Ribbon Alliance in close coordination with MUHJU. Each meeting were preceded by preparatory community meetings. A fourth workshop is being planned for Zimbabwe in September.
Below, please find meeting objectives, presentations and resources from the regional consultation and country workshops:
- Regional Consultation in Johannesburg – April 2018
- Malawi Stakeholders Meeting – March 2019
- South Africa Stakeholders Meeting – March 2019
- Uganda Stakeholders Meeting – June 2019
- Stakeholder Meeting in Zimbabwe – January 2020
- Resources
About the Dapivirine Vaginal Ring Regulatory Status
Currently, the International Partnership for Microbicides (IPM), which developed the dapivirine ring, is seeking its regulatory approval for women ages 18-45. IPM’s first application was to the European Medicines Agency (EMA), under a procedure called Article 58 in which the EMA, in cooperation with the World Health Organization (WHO), is asked to provide a scientific opinion on the safety, efficacy and quality of the dapivirine ring for use specifically in low- and middle-income countries.
Should the EMA grant a favorable opinion, IPM will then seek WHO pre-qualification, which regulatory authorities in many developing countries often rely on to determine which new products or drugs to consider for approval.
Separately, IPM plans to submit applications to the South African Health Products Regulatory Authority (formerly the Medicines Control Council) and to the US Food and Drug Administration (FDA). And, if WHO pre-qualification is granted, IPM will also proceed with applications to drug authorities in several African countries.
If the ring is approved, it will be important to know that it is safe for women to use during pregnancy and breastfeeding, when the risk of acquiring HIV is especially high. MTN-042 will also contribute additional safety data about the use of oral PrEP during pregnancy. Information provided by the studies should help countries develop and/or refine guidance on the use of these products by pregnant and breastfeeding women.
Regional Stakeholders Consultation
5-6 April 2018 — Balalaika Hotel, Johannesburg
Regional Consultation Objectives
- To engage with key stakeholders as part of the protocol development process in order to seek their views and input about the MTN-042 study overall and specific aspects of its proposed design.
- To assess how stakeholders view MTN-042 within the context of the current HIV prevention landscape, especially with regard to PrEP and differing opinions about its use during pregnancy.
- To solicit stakeholders’ views about how best to overcome the ethical, sociocultural and structural challenges inherent in a study of this kind as well as challenges unique to MTN-042.
Regional Consultation Information
Regional Meeting Presentations
Presentations – Day 1
- Pregnancy and HIV Risk – Renee Heffron
- MTN-042: An overview – Katie Bunge, Bonus Makanani, Lee Fairlie
- Ethics Questions to Address
- International Perspectives and Guidance on Pregnant Women as Participants in Clinical Trials – Paul Ndebele
- Pregnant Women as Participants in Clinical Trials: Ethical framework and perspectives from Malawi – Joseph Mfutso-Bengo
- Research Involving Pregnant Women in Uganda – Henry Mugerwa
- Zimbabwe Perspective: Pregnant women as clinical trial participants – Sithembile Ruzario
Presentations – Day 2
- MTN-042: A quick review – Sharon Hillier
- PrEP in Pregnant Women: Current data, experiences and guidelines – Renee Heffron
- What We Will Learn About PrEP from IMPAACT 2009 – Frank Taulo
- Dapivirine Vaginal Ring-004 Overview and Regulatory Pathway – John Steytler
- MTN Research & International Considerations: Foundation for MTN-042 – Richard Beigi
- What We Hope to Learn in the MTN-041 Qualitative Study – Petina Musara
- MTN-042: Key questions
- MTN-042: Summary and next steps – Sharon Hillier
Stakeholders Country Meeting — Malawi
21-22 March 2019 — Ryalls Hotel, Blantyre
Partners: AVAC, MTN and MaiKhanda Trust in close coordination with the Blantyre CRS
Malawi Meeting Information
Malawi Meeting Presentations
Day 1
- Johns Hopkins Research Project
- Pregnancy and Breastfeeding and HIV Risk
- How Do We Know That a Medicine is Safe During Pregnancy or Breastfeeding?
- Overview of Oral PrEP and the Dapivirine Vaginal Ring
- Status of PrEP in Malawi
- What We Know and Don’t Know About PrEP and the Dapivirine Ring in Pregnant and Breastfeeding Women
- Two Studies Seeking Answers: Overview of the DELIVER and B-PROTECTED studies
- Stakeholders Meeting: Day one recap
- Ethical & Regulatory Overview in Malawi: Who decides?
- Whose Opinions Matter?
- Different Views About Pregnant Women Using PrEP and the Ring: What we have learned from MTN-041
- Pregnancy: A special journey
- It’s All About Safety! DELIVER and B-PROTECTED studies
- What Do You Think? Malawi stakeholders meeting for the DELIVER and B-PROTECTED studies
- Stakeholder Scenarios
Stakeholders Country Meeting – South Africa
25-26 March 2019 – Balalaika Hotel, Johannesburg, South Africa
Partners: AVAC, MTN and Soul City Institute for Social Justice in close coordination with the Wits RHI CRS
South Africa Meeting Information
South Africa Meeting Presentations
Day 1
- Wits RHI Shankdukani
- Pregnancy and Breastfeeding and HIV Risk
- How Do We Know That a Medicine is Safe During Pregnancy or Breastfeeding?
- Overview of Oral PrEP and the Dapivirine Vaginal Ring
- Let Our Actions Count
- What We Know and Don’t Know About PrEP and the Dapivirine Ring in Pregnant and Breastfeeding Women
- Two Studies Seeking Answers: Overview of the DELIVER and B-PROTECTED studies
Day 2
- Stakeholders Meetings: Day one recap
- MTN Stakeholders Meeting
- Whose Opinion Matters?
- What Have We Learned from MTN-o41 (MAMMA)? Views about pregnant women using PrEP and the dapivirine vaginal ring
- Pregnancy: A special journey
- It’s All About Safety! DELIVER and B-PROTECTED studies
- What Do You Think? South Africa stakeholders meeting on the DELIVER and B-PROTECTED studies
- Stakeholder Scenarios
Stakeholders Country Meeting – Uganda
17-19 June 2019 — MU-JHU, Kampala
Partners: AVAC, MTN, International Community of Women Living with HIV — Eastern Africa and the White Ribbon Alliance in close coordination with MUHJU Research Collaborative
Uganda Meeting Information
Uganda Meeting Presentations
Day 1
- Pregnancy and Breastfeeding and HIV Risk
- A Quick Snapshot: PrEP, the vaginal ring and the DELIVER and B-PROTECTED studies
- Overview of Oral PrEP and the Dapivirine Vaginal Ring
- Updates of PrEP Program Implementation in Uganda
- What We Know and Don’t Know About PrEP and the Dapivirine Ring in Pregnant and Breastfeeding Women
- Overview of the DELIVER and B-PROTECTED Studies
- The Research Review Process: Whose opinions matter? Who decides?
- What We Have Learned from MTN-041
Day 2
- Day One Recap
- Complications of pregnancy and maternal & infant outcomes in Uganda
- It’s All About Safety! DELIVER and B-PROTECTED Studies
- What Do You Think?
- What Do You Think? (Results)
- Stakeholder Scenarios
Stakeholders Country Meeting — Zimbabwe
28-29 January 2020 — Cresta Lodge Hotel, Harare
Zimbabwe Meeting Information
Day 1
- Welcome
- Pregnancy and Breastfeeding HIV Risk
- How Do We Know That a Medicine is Safe During Pregnancy or Breastfeeding?
- Overview of Oral PrEP and the Dapivirine Vaginal Ring
- PrEP Update in Zimbabwe
- What We Know and Don’t Know About PrEP and the Dapivirine Ring in Pregnant and Breastfeeding Women
- Two Studies Seeking Answers: Overview of the DELIVER and B-PROTECTED Studies
- The Research Review Process
- Whose Opinions Matter?
- What We Have Learned from MTN-041 (MAMMA)
Day 2
- Day One Recap
- Pregnancy: The complications that may arise
- It’s All About Safety: DELIVER and B-Protected studies
- What Do You Think? Zimbabwe stakeholders meeting on the DELIVER and B-PROTECTED studies
- Stakeholder Scenarios