Conclusions & Recommendations

TEC congratulates the Zambia program for their excellent work during their recent surveys, particularly in the decision to add the collection of complementary indicators in Kaoma, Luampa, and Nkeyema. TEC is grateful for the fast and diligent work in developing a comprehensive and well thought out plan for how to move forward in the three evaluation units categorized as “persistent” districts. TEC recommends:
- In Kaoma, Luampa, and Nkeyema, given the inconsistency between TF1-9 of 9.16% and a seroconversion rate among children 1-5 years of 0.6%, PCR processing of the already collected conjunctival swabs will provide important information to inform program activities. TEC looks forward to receiving the Ct infection results in due course and a further discussion with the program on next steps in these districts. TEC contingently approves the request for these three districts pending review of Ct infection results and confirmation of funding (R2/R1).
- In Shangombo and Sioma where TF1-9 is 12.5%, TEC approves the request for a modified strategy of two treatments 5 months apart (projected for May and October 2024), pending confirmation of funding (R1), followed by a TIS+ including both serology and infection data collection, subject to available funding.
- In Sikongo and Kalabo where TF1-9 is 7.7%, TEC recommends to ITI to hold further discussions with the Ministry of Health and program partners to discuss recent evidence from the trachoma community on areas with TF1-9 5-9% at the endgame, and explain all options available to the program (including timelines and cost implications) for their consideration. These districts are eligible for the modified MDA strategy proposed by the national program, and if the MOH determines this is the best strategy for their situation, TEC will approve the drug (contingent on confirmation of MDA funding). If, instead, the MOH prefers to adopt an enhanced monitoring strategy (e.g., ‘wait and watch’ followed by a TIS+), TEC and ITI stand ready to provide the program with any technical assistance that they may need, if requested.

Given how quickly data are being generated and trachoma program guidance is changing, TEC recommends that ITI discuss with WHO how best to support the convening of a meeting of program managers in countries with persistent/recrudescent districts to disseminate recent findings and help them understand the range of options for how best to move their programs forward.

TEC has been impressed by the incorporation of complementary indicators for trachoma, and encourages continued inclusion when appropriate. TEC also noted considerable interest in other measures of infection beyond serology. In fact, open meeting discussion noted advantages of having a direct measure of infection, which responds more rapidly to intervention, and could act as a “tie-breaker” when results from district-level TF and serology are inconsistent. Several examples of PCR being used constructively in certain settings were presented. PCR would be an obvious candidate for a third complementary indicator.

TEC congratulates the Federal Ministry of Health of Ethiopia, Amhara Regional Health Bureau, Amhara Public Health Institute, and The Carter Center on the important work they’ve been doing for 10+ years on data collection and analyses supporting the evaluation of the trachoma program.

TEC is grateful for WHO’s swift work to move the guideline development process forward on the use of serology for trachoma assessments. To better support countries’ capacity to utilize serology in their programs, TEC would like to understand the additive costs associated with collection and processing of specimens for serology.
TEC would like to see a similar process for the development of guidelines on the use of infection data so that trachoma programs can benefit from more comprehensive guidance. To support this, TEC would welcome validating large-scale PCR pooling and data on program costs and evidence of comparability across different tests and platforms.

TEC appreciated the detailed update from the Bill & Melinda Gates Foundation on the REACH trials. As results are coming in and the Foundation expresses its interest in scaling up child survival programs, TEC noted the currently inadequate global POS production capacity and would appreciate future updates and coordination between ITI, Pfizer, TEC, and BMGF on this issue and its impact on the trachoma program’s POS needs. TEC welcomes the possibility of future engagement for child survival rollout and further requests clarification of its own role. Recognizing ITI’s excellence in supply chain management, evidence gathering, leadership, and convening, TEC further advocates for ITI to be the primary steward of azithromycin procured and/or donated for trachoma and child survival. TEC notes that ITI would need additional resources to take on this additional workload while maintaining its excellent support to national trachoma programs.

TEC appreciated the update on the ASPECT trial and requests future updates on any changes to study design, funding, and timeline.
Given the delays in possible funding, TEC recommends to ITI to get a revised list of districts where child MDAs are expected in 2024 to facilitate more accurate forecasting.

TEC commends ITI on its work to support countries nearing the end of MDA through their efforts to closely match shipments to expected demand for their anticipated final MDA. Doing so will avoid overstock as MDA finishes.
TEC recommends that ITI:
- investigate reasons for the remaining inventory in Côte d’Ivoire and consider any options to move/use the inventory so it doesn’t go to waste,
- apply lessons learned from Côte d’Ivoire to avoid a large mismatch in the future,
- support countries early in the development of their plans to utilize or destroy (where applicable) in-country Zithromax® as MDA needs decrease or cease altogether,
- update TEC annually on how the process is going, and
- look for opportunities to share lessons learned with other NTD programs.

TEC acknowledges with gratitude the work being done by Pfizer to increase their manufacturing capacity for the trachoma donation. TEC recommends to ITI to review materials (including supply chain training; Zithromax® Management Guide; Memoranda of Understanding with countries) for necessary updates once Pfizer’s production plans are finalized, including the shift from the brand name of Zithromax® to azithromycin and descriptions of the packaging. TEC further recommends to ITI to send letters to all partners and countries immediately upon finalization of these changes to advise them of the details and to request they update all materials as appropriate.

TEC is committed to managing the Zithromax® shortage applying the principles of equity, transparency, and data-driven defensibility. The current allocation approach (80% of Approved; 100% of Surgery; and 95% of Research) will be kept the same for now. Pfizer is actively working to address the supply challenges; however, in the short term, a shortfall will remain resulting in the need for additional reductions to demand and/or delayed shipments. The TEC and ITI are committed to communicating additional information as it becomes available, which may lead to a need to call an extraordinary meeting between TEC, Pfizer, and key partners and donors to address these challenges together.