In September of 2016, AVAC and the Microbicide Trials Network (MTN) hosted a regional stakeholders’ consultation about a proposed study involving adolescent girls and young women. The consultation, held in Johannesburg, South Africa, was coordinated in close partnership with Impact Research and Development Organization in Kenya, Soul City Institute for Social Justice in South Africa and Pangaea Zimbabwe AIDS Trust.
The design of the study, called REACH (Reversing the Epidemic in Africa with Choices in HIV prevention), or MTN-034/IPM 045, has since been finalized and preparations are underway for it to begin recruiting by the end of this year at four sites in Kenya, South Africa, Zimbabwe and Uganda. REACH will evaluate how young women ages 16-21 use the monthly dapivirine vaginal ring and Truvada as daily PrEP, and their preferences for either or both approaches. Importantly, the study will collect much needed information on the safety of these products in this population.
At the first consultation meeting on MTN-034/IPM045, stakeholders expressed the importance of having follow-up meetings in each of the trial-site countries. Therefore, on 24 February and 28 February 2017, respectively, AVAC and the MTN facilitated meetings in Harare, Zimbabwe (in partnership with Pangaea and UZ-UCSF) and in Johannesburg, South Africa (in partnership with Soul City Institute). Then in August 24-25th, for the first time, a workshop was held in Kampala, Uganda in partnership with the Society for Adolescent Health in Uganda (SAHU). The final follow-up consultation was held in Kisumu, Kenya (in partnerships with IRDO, NIGEE and Kemri) on February 8-9th, 2018.
Below are meeting objectives, presentations and resources from:
- Follow-up meeting in Kenya – February 2018
- Follow-up meeting in Uganda – August 2017
- Follow-up meeting in South Africa – February 2017
- Follow-up meeting in Zimbabwe – February 2017
- First consultation meeting in South Africa – September 2016
Kenya Stakeholders Workshop on the REACH Study
8-9 February 2018 – Sovereign Hotel, Kisumu, Kenya
The workshop was facilitated by MTN, AVAC, KEMRI, in partnership with the Nyanza Initiative for Girls’ Education and Empowerment: NIGEE and Impact, Research & Development Organization: IRDO in Kenya. Nearly a third of the 65 participants were young women under the age of 25. Other attendees included civil society, researchers, advocates and government representatives. Participants had the opportunity to learn about the REACH study, ask questions and raise concerns.
Meeting Objectives
- To provide an overview of the PrEP and ring landscape in Kenya.
- To explain the study design of REACH.
- To seek views on contraception requirements for enrollment and to explain and discuss the different methods of contraception that will be offered in REACH, especially long-acting reversible contraceptives (LARCs), i.e., IUDs and implants.
- To identify strategies to better engage schools, combat stigma and gender based violence, and engage community and parents.
Meeting information – Kenya Workshop
Kenya Presentations
- A Quick Snapshot: PrEP, the vaginal ring and the REACH study – Kenneth Ngure
- Setting the Stage: Overview of the dapivirine vaginal ring – Sharon Hillier
- Overview and Status of PrEP in Kenya – Elizabeth Irungu
- About the TRIO Study – Kawango Agot
- But What About… Key questions about the ring and PrEP in adolescent girls and young women – Sharon Hillier
- Looking for Answers: The REACH study – Nelly Mugo and Kenneth Ngure
- Contraception Choices and Questions – Nelly Mugo and Sharon Hillier
Uganda Stakeholders Workshop on the REACH and DREAM Study
24-25 August 2017 – Makere University-Johns Hopkins University, Uganda
The workshop was facilitated by MTN, MU-JHU, IPM and AVAC, in partnership with the Society for Adolescent Health in Uganda. Nearly a third of the 60 meeting participants were young women under the age of 25. Others attending included advocates, civil society, government representatives and researchers. Participants had the opportunity to hear from researchers about the REACH and DREAM study, ask questions and raise concerns.
Meeting Objectives
- To provide an overview of the PrEP and ring landscape in Uganda.
- To explain the study design of REACH and DREAM.
- To seek views on contraception requirements for enrollment and to explain and discuss the different methods of contraception that will be offered in REACH, especially long-acting reversible contraceptives (LARCs), i.e., IUDs and implants.
- To identify strategies to disseminate information to parents and involve young women in the study.
Meeting information – Uganda Workshop
- Agenda
- Participant List
- Evaluation Form
- Photos
Uganda Presentations
- Setting the Stage: Overview and Status of PrEP in Uganda – Andrew Mujugira
- Do We Need More Than PrEP? Does Choice Matter? – Sharon Hillier and Clemensia Nakabiito
- Dapivirine Vaginal Ring Programme – Sylvia Kusemererwa and Leonard Solai
- Video on the Dapivirine Ring
- Looking for Answers: The REACH Study – Carolyne Akello
- But What About….? Key Questions About the Ring and PrEP in Adolescent Girls and Young Women–Sharon Hillier
- Contraception Choices and Questions – Betty Kamira
- Contraception Choices and Questions (results using an Audience Response System)
South Africa Follow-up Stakeholders Workshop on the REACH Study
28 February 2017 – Wits RHI, Johannesburg, South Africa
The follow-up workshop was facilitated by MTN and AVAC, in partnership with Soul City Institute. Almost 30 researchers and advocates attended the day long meeting, of which 9 were young women. Participants had the opportunity to hear from South African researchers and to ask questions and raise concerns. After the meeting, a number of young women were invited to take part in a closed meeting of the MTN Contraceptive Action Team to help researchers better understand views about the types of contraception being offered in REACH.
Meeting Objectives
- To explain the rationale for and provide an update on the study’s design and current status, in particular how researchers incorporated earlier feedback.
- To discuss important aspects of the study that may affect in-country approvals and study implementation.
- To seek views on contraception requirements for enrollment and to explain and discuss the different methods of contraception that will be offered in REACH, especially long-acting reversible contraceptives (LARCs), i.e., IUDs and implants.
- To identify key concerns and challenges for engaging adolescents in HIV prevention research generally and REACH in particular, and possible solutions to overcoming these.
- To consider ongoing ways to provide feedback during the trial.
Meeting Information – South Africa Follow-up Workshop
South Africa Presentations
- REACH: Overview and Rationale – Lulu Nair
- Feedback: Then and Now – Sharon Hillier and Lulu Nair
- Realities and Requirements of Research – Thesla Palanee-Phillips
- REACH: A Requirement to Use Contraception, with Choices in Contraceptives – Lulu Nair
- Understanding the Contraceptive Methods Offered in REACH – Melanie Pleaner
- From the Contraception Action Team (CAT) Meeting: VOICES that Matter in REACH (including results using an Audience Response System
Zimbabwe Follow-up Stakeholders Workshop on the REACH Study
24 February 2017 – Rainbow Towers, Harare, Zimbabwe
The follow-up consultation was facilitated by MTN and AVAC, in partnership with Pangea and UZ-UCSF. Thirty-nine researchers and advocates attended the day long meeting, of which 13 were young women. Participants not only heard from researchers, but had the opportunity to ask questions and raise concerns. At the end of the meeting, participants created break-out groups to discuss best ways to involve parents and guardians, engage youth, create good messaging and dispel myths about contraception. In addition, a pre-meeting was held the day before with the young women to discuss research literacy.
Meeting Objectives
- To explain the rationale for and provide an update on the study’s design and current status, in particular how researchers incorporated earlier feedback.
- To discuss important aspects of the study that may affect in-country approvals and study implementation.
- To seek views on contraception requirements for enrollment and to explain and discuss the different methods of contraception that will be offered in REACH, especially long-acting reversible contraceptives (LARCs), i.e., IUDs and implants.
- To identify key concerns and challenges for engaging adolescents in HIV prevention research generally and REACH in particular, and possible solutions to overcoming these.
- To consider ongoing ways to provide feedback during the trial.
Meeting information – Zimbabwe Follow-up Workshop
Zimbabwe Presentations
- The Outlook in Zimbabwe: Preventing HIV in Girls and Young Women – Gertrude Ncube
- REACH: Overview and Rationale – Sharon Hillier and Felix Muhlanga
- Feedback: Then and Now – Sharon Hillier
- Realities and Requirements of Research – Felix Muhlanga and Charles Chasakara
- Contraception: Choices and Questions – Felix Muhlanga
- Remarks about LARCs (including results using an interactive Audience Response System).
Regional Stakeholders Consultation on the REACH Study
29 – 30 September, 2016 – Crowne Plaza, Rosebank, South Africa
More than 40 stakeholders, including advocates, researchers, adolescent girls and young women came together in Johannesburg, South Africa for a stakeholders’ consultation meeting on MTN034/IPM045 open-label safety and adherence study of the dapivirine vaginal ring and oral PrEP. With the new trial looking to enroll adolescent girls and young women (16-21 years) from Kenya, South Africa and Zimbabwe – it was crucial to have a space where researchers explained the trials and where young women and adolescent girls voiced their concerns, opinions and recommendations. Included among the stakeholders were 15 young women ages 17-25 from Kenya, South Africa and Zimbabwe. A pre-meeting was organized with the young women to help them prepare for the meeting.
Read the final meeting report: Stakeholders consultation on the MTN-034/IPM 045 (REACH) open-label safety and adherence study of the dapivirine vaginal ring and oral PrEP
Meeting Objectives
- To provide an overview of the dapivirine vaginal ring and oral PrEP in women – particularly, in adolescent girls and young women.
- To provide the rationale and overview of the MTN-034 (REACH) study to fill important knowledge gaps and address key questions about these products in this population.
- To solicit stakeholders’ views of MTN-034 generally and feedback on specific aspects of the study’s design and its implementation.
- To consider how MTN-034 fits within sub-Saharan Africa’s broader HIV prevention landscape (including PrEP rollout) and socio-cultural contexts.
- To identify key concerns and challenges, including legal and ethical, for engaging adolescents in HIV prevention research generally and MTN-034 in particular, and possible solutions to overcoming these.
- To consider other and/or ongoing ways to provide feedback to the trial design.
Below, please find the presentations from the meeting as well as useful materials.
Meeting information
Presentations
- Dapivirine Ring Regulatory Process and Timelines: Who might be able to use the ring? – Leonard Solai
- PrEP: What’s happening where and when? – Saiqa Mullick
- Ethical-Legal Norms for Adolescent HIV Prevention Trials in South Africa – Catherine Slack and Ann Strode
- Setting the Stage: Overview and status of the dapivirine ring – Sharon Hillier
- Understanding the Ethical and Legal Framework in Kenya – Ambrose Rachier
- MTN 034 in Context: Understanding the Legal and Ethical considerations: Zimbabwe – Paul Ndebele
- Understanding the Landscape – Mitchell Warren
Useful Resources
