2015 PRH RESULTS REVIEW

The project's primary focus was on introducing new contraceptive products, including the Woman's Condom, SILCS diaphragm, and Amphora lubricant, in target countries such as Zambia and Malawi. In April 2015, Population Services International (PSI) presented at the World Social Marketing Conference on the use of commercial marketing techniques to introduce new contraceptive products in Zambia and Malawi. Additionally, PSI was featured in its quarterly magazine, Pulse, with an interactive article on market development for new contraceptive products. The International Center for Research on Women (ICRW) submitted an abstract to the International Conference on Family Planning, which was accepted for presentation in November 2015 in Indonesia. The project also conducted a willingness-to-pay (WTP) study in Zambia and Malawi to determine the degree of subsidy needed to make the products affordable for the target population. The study found that the products would need to be priced to be highly affordable for the target populations, requiring subsidy for most products. In preparation for product registration, a gap assessment was conducted on the availability and format of data and dossier materials for the Progesterone Contraceptive Vaginal Ring (PCVR). The assessment found that although a comprehensive dossier does not currently exist, there is sufficient information available to create a dossier for use in WHO pre-qualification and registration in the target countries. The project also secured a procurement waiver with USAID, which delineates specific QA standards for the EECO project's first phase of procurement for Amphora gel, SILCS diaphragm, and the Woman's Condom. WCG conducted an annual QA audit of Shanghai Dahua, manufacturer of the Woman's Condom, in May 2015, and a Technical Quality Agreement (TQA) was developed between Shanghai Dahua, WCG, and PSI to clarify roles and SOPs for the parties involved in procurement and QA of the Woman's Condom. Initial procurements of the Woman's Condom, SILCS diaphragm, and Amphora lubricant were placed for Zambia and Malawi, with the first shipment of Woman's Condoms for Malawi approved by the independent testing laboratory, shipped to Malawi, and cleared through customs in September 2015. WCG identified and contracted FHI360 as an independent ISO-17025 laboratory for pre-acceptance lot testing of EECO products, and the first lot testing of the Woman's Condom was conducted for the initial Malawi procurement. Amphora completed a Phase III clinical trial for contraceptive efficacy and was submitted by EECO team partner, Evofem, to the United States Federal Drug Administration (FDA) for approval as a contraceptive in April 2015. PSI recruited and trained a cadre of Interpersonal Communication (IPC) Agents in Malawi to conduct outreach and education to community members, and two medical detailers were hired and trained in Malawi to engage providers and increase uptake of the EECO products. A partnership was created between SFH and Every1Mobile (E1M) to engage young people through a sexual health mobile-website that will provide essential information about family planning and serve as a venue for the introduction and promotion of the new methods. The website includes discussion spaces and client testimonials for the new methods, peer-to-peer support, and a moderated Q&A forum. WCG drafted and commenced negotiation with Medicines360, developer of the levonorgestrel intrauterine system (LNG-IUS), to create a regulatory agreement for registration of the LNG-IUS in the EECO countries. The project strategy for Malawi and Zambia was originally built around the vision of multiple product introductions. However, due to the hold on the introduction of SILCS, Amphora, and other products, the project faced implementation issues and constraints, which affected the project's progress and timelines.