Experience with DMPA-SC: Delivery Points – Part Two Dr. Bagrey Ngwira, University of Malawi Tuesday, January 31, 2017 COLLEGE OF MEDICINE

Malawi home and self-injection (HSI) study Malawi’s first experience with Sayana® Press: lays groundwork for national introduction of Sayana Press and scale-up of HSI Answers whether HSI improves continuation rates Provides evidence on the safety and feasibility of community-based provision of injectables for HSI Sample size 700+ adult women seeking FP services; study will be completed by mid-2017 Research Question: Do continuation rates differ between women who self-inject Sayana® Press (SP) as compared to those receiving SP injected by a provider, including community health workers (CHWs)? Approach One-year, prospective randomized clinical trial with 700+ adult women seeking family planning services, randomized to: Receive SP from a provider (including CHWs), or Receive training on SP self-injection and product to self-inject at home Quarterly visits after each re-injection date to assess continuation rates, acceptability, adverse events, and pregnancy Qualitative component: 30 self-injectors & 12 providers Impact Inform decision-making for procurement and distribution in Malawi Inform global guidelines on self-injection; provide evidence on safety and feasibility of community-based provision of injectables for HSI; inform self-injection training materials and messaging for clients and providers

Key FP Stakeholders in Malawi National MOH Reproductive Health Dept. Safe Motherhood Technical Working Group (TWG) Family Planning Sub TWG District District Exec. Committee MOH District Health Management Team headed by DHO Community Traditional Authority Group Village Head Men Village Head Men Village Health Committee Safe Motherhood TWG consists of all MCH partners and is coordinated by the MOH RH Department. FP sub-TWG consists of FP partners and UNFPA who procures methods for Malawi. To reach community members with information about the RCT we conducted community awareness meetings that began with a drummer group and discussion about health theme.

What should countries consider? Engage stakeholders early and often Key questions from Malawi stakeholders: How will men be engaged? Why conduct the RCT in Mangochi District? How will used SP units be disposed of in community? Incorporated feedback into study design and implementation Key questions from Malawi family planning stakeholders: How will men be engaged? Through community level engagement (community sensitization meetings prior to study launch) Why conduct the RCT in Mangochi District? Rural, fewer resources for FP  High potential benefit from HSI Established CHWs  RCT will provide evidence on safety and feasibility of community-based provision of injectables for HSI How will used SP units be disposed of in community? Disposal in pit latrine against Malawi’s waste management policy which requires all sharps be incinerated Stakeholders approved disposal in pit latrines for RCT

What’s next for policy development to increase access? Engage key stakeholders in interpretation and analysis prior to broader dissemination Disseminate findings and seek endorsement from MOH and national stakeholders Engage Waste Management Team to change disposal policy We can accomplish this through one-on-one meetings with the key stakeholders at MOH. Go through the slide deck of findings and discuss them and they may have questions or additional analysis they want done. This fosters ownership prior to the broader dissemination. Waste Management Team is located in the MOH’s Environmental Health Department

For More information Holly Burke, Principal Investigator hburke@fhi360.org Bagrey Ngwira, Site Investigator bagreyngwira@gmail.com