2020 HIV DIAGNOSTICS

9. Prioritize integration of systems and device-sharing across HIV and TB programs, including mapping of systems and diagnostic network optimization.

10. Work with Ministries of Health to improve and expand case-finding strategies and focus on priority entry points and index testing.

11. Incorporate LF-LAM and CrAg testing for infants and children with advanced HIV disease.

Updates

Commitment 9:

April 2021

  • Unitaid and CHAI have supported DNO efforts in DRC and Zimbabwe through which we have identified available network capacity to conduct 100% of EID on POC, considering anticipated TB, priority HIV VL, and HPV volumes. As a next step, CHAI country teams along with in country partners and program counterparts will consider the operational changes to accommodate for this referral adjustment. Similarly, CHAI and FIND have supported DNO efforts in Rwanda resulting in a recommended network design shifting of 100% of EID to POC. In Rwanda this network recommendation has been approved by MOH SMT and will be reflected in future quantifications.

  • CHAI supported the WHO Guideline Development Group with evidence and analyses in support of integrated testing, leading to a good practice statement on integrated testing in the 2021 WHO HIV Treatment Guidelines. 

  •  Published research in JIAS (publication) demonstrating POC early infant diagnosis (EID) of HIV improves time to results delivery and treatment initiation. Building on this work and the broader Pont-of-Care literature, WHO updated their HIV testing guidelines (guidance document), including a strong recommendation for POC for Early Infant Diagnosis and a conditional recommendation for POC VL testing.

 

Commitment 10:

April 2021

  • ELMA and CHAI through the AIDS Free project supported the government in Ethiopia to develop a national HIV risk screening tool for children below 15 years, focused on assessment maternal HIV status for children <18 months and signs and symptoms for children >18 months. CHAI Ethiopia is supporting roll out to 61 priority sites through provision of job aids, reporting tools, on-site training and mentorship and monitoring and evaluation to optimize implementation and inform scale up. 

  • ELMA and CHAI through the AIDS Free project are supporting the government of Nigeria to implement and monitor caregiver-assisted HIVST for children aged 2-11 years, following MOH adoption of the strategy for demonstration during the COVID-19 period to sustain case finding, and HIVST for adolescents and young women in Akwa Ibom and Anambra states, utilizing peer champions and traditional birth attendants, aiming to monitor uptake, yields, and enablers and barriers to implementation through routine program monitoring and evaluation. 

  • ELMA and CHAI through the AIDS Free project are supporting the government of Nigeria to demonstrate EID-TB integration on GeneXpert devices in Akwa Ibom state, and conducted site service readiness assessments, assessing site availability of ART, TB and PMTCT services, availability of GeneXpert devices, test turnaround time, basic infrastructure and HR capacity, and spare capacity on GeneXpert devices, to inform site selection and demonstration.

2018 HIV DIAGNOSTICS

42. Support POC EID as well as case-finding through enhanced testing in inpatient, TB, and nutrition wards through the development of clear policies as well as program and operational guidance, and through implementation support.

43. Promote broader uptake of new sample types for laboratory systems and multiplex testing to improve cost efficiencies.

44. Invest in data management to provide more visibility to optimized laboratory networks for faster corrective actions and better quality testing.

45. Support Country Governments with 1) the latest data on performance and regulatory status of new diagnostics; 2) implementation of global guidance on product approvals and post market surveillance; and 3) once the WHO Collaborative Procedure for IVDs is established, promote rapid adoption, shifting the focus of quality assurance to post-market instead of pre-market.

46. Support the development of programmatic and operational guidance on POC VL for children, adolescents, and pregnant and breastfeeding women including by building evidence to support these policies.

Updates

Commitment 42:

April 2021

  • CHAI (through FASTER) facilitated m-PIMA POC EID scale-up in Uganda across 100 new sites, through training, mentorships and progress monitoring

 

Commitment 43:

April 2021

  • CHAI (through FASTER) is supporting the introduction of Plasma separation cards for expansion of HVL access in Nigeria, CHAI will implement a programmatic demo in 2021

  • CHAI (through FASTER) is supporting Tanzania to introduce whole POC EID sample utilization, as means of expanding multiplex testing on GeneXpert machines with spare testing capacity

  • Unitaid and CHAI have supported the integration of HPV testing with existing devices conducting TB and TB/HIV in 7 countries.

  • Unitaid and CHAI are supporting validation of conventional TB assays on Abbott devices in Zimbabwe. This could lead to future integration efforts where conventional capacity is readily available for TB volumes.

 

Commitment 44:

April 2021

  • CHAI (through FASTER) is supporting the development of an EID dashboard in Zambia and update of HVL Dashboards in at least 2 countries (Zambia, Nigeria) to include POC tests

  • CHAI (through FASTER) designed and rolled-out a remote sample logging system in Nigeria, reducing intra-lab TAT by more than 51%.

 

Commitment 45:

April 2021

  • CHAI, with WHO and ASLM, is planning webinars to further disseminate information available on the new Diagnostics Evidence Hub to global laboratory stakeholders to facilitate access to the latest performance data for POC diagnostics.

October 2020

  • Launched an online Diagnostics Evidence Hub (https://aslm.org/diagnostic-hub/) hosted by African Society for Laboratory Medicine (ASLM) that serves as a repository for technical and performance data on WHO-prequalified, innovative diagnostics including Point-of-Care devices and HIV self-tests. This resource will allow country stakeholders to more easily access prior evaluations and validations to expedite in-country registration and scale up of innovative diagnostic technologies. Information hosted on the hub will include intended use, WHO PQ details and links to PQ reports, and summarized and linked data from relevant peer-reviewed studies and abstracts, including performance evaluations and feasibility studies. Under FASTER, CHAI will continue to work with ASLM and WHO to socialize the Diagnostics Evidence Hub through virtual meetings and webinars.

Previous

Working with CRS on in-country registration processes; building a consolidated database on paediatric diagnostic guidelines and technical evaluations with WHO and ASLM.

2020 HIV TREATMENT

9. Advance the field of research in collaboration with Monell, MMV, and donors to identify a universal bitter blocker that can be used in pediatric formulations to improve palatability. 

56. Through the Unitaid Optimal grant, accelerating access to optimal pediatric ARVs for children, including DTG 10 mg dispersible tablets, across focal countries.

57. With the support of Unitaid, support catalytic procurement of generic DTG 10 mg dispersible tablets across several focal countries to rapidly bring this optimal product to children by late Q1 2021. 

Updates

Commitment 56:

April 2021

  • Through the development incentive program funded by Unitaid for Optimal, two suppliers, Viatris and Macleods have US FDA tentative approval for pediatric DTG, 10 mg scored dispersible tablets, thus opening the ability for global procurement. Country registrations are on-going with both companies. Viatris received tentative approval on November 19, 2020 and Macleods received tentative approval on March 16, 2021. 

  • Through the Unitaid Optimal grant, CHAI has continued to support partner Ministries of Health (MOHs) with their pediatric optimization efforts. In six Optimal focal countries (Benin, Kenya, Malawi, Nigeria, Uganda, Zimbabwe), CHAI is catalytically procuring pediatric DTG 10mg dispersible scored tablets (pDTG) to accelerate access to the optimal commodity with deliveries expected by end Q2 2021. In all Unitaid Optimal ARV focal countries, CHAI continues to support MOHs in developing new product introduction plans for pDTG to ensure all CLHIV have rapid access to the product. 

  • The Unitaid Optimal grant has also been extended to include EGPAF, who will serve as a sub-grantee focusing on service delivery and generating evidence to support the rapid uptake of optimal pediatric formulations, including pDTG, at the site-level in Cote d’Ivoire, Eswatini, Lesotho, and Mozambique

  • At the global level, CHAI has been working closely with numerous stakeholders including the PEPFAR, the Global Fund, and many others, to ensure coordinated pDTG implementation support to partner MOHs  

  • Lastly, CHAI has developed a suite of resources to support national decision-making on and implementation for pDTG, including am implementation memo, healthcare worker training curriculum template, and job aids. All materials are posted on CHAI’s HIV New Product Introduction Toolkit.

Commitment 57:

April 2021

  • With the support of Unitaid, CHAI has placed catalytic procurements orders accounting for 100K packs of DTG 10mg dispersible scored tablets for six countries: Benin, Kenya, Nigeria, Malawi, Uganda, and Zimbabwe. Across all six countries, product delivery is expected by end Q2 2021 and will support the first phase of rollout in advance of the national transitions.

2018 HIV TREATMENT

32. Collaborate with WHO to house and incubate the GAP-f partnership through its start-up phase.

Updates

Commitment 32:

April 2021

  • Work continues with GAP-f. GAP-f is now a formal WHO Network and housed in the Research Sciences Division of WHO. CHAI is co-chair of the GAP-f Secretariat and provides additional staff to lead or co-lead GAP-f Working Groups.

October 2020

  • With CRS’s support of CHAI through the FASTER grant, CHAI has been able to engage with multiple GAP-f partners to establish the consortium as a formal WHO network; expand the scope of diseases that GAP-f will be focusing on beyond HIV, TB and Hep C; and identify and convene an advisory committee for GAP-f to assist in strategic decision-making and fundraising. 

2017 HIV TREATMENT

3. (individual commitment) CHAI will commit full-time staff to assist EGPAF, WHO, PEPFAR, UNITAID and others to develop, coordinate and implement a detailed work plan to achieve the goals of the initiative; to assist with reaching agreements with companies, governments, donors and regulators to accelerate the introduction of optimal formulations and diagnostics for children and adolescents both short term and long term; and to work with governments and faith based organizations to scale up identification and treatment of HIV infected children and adolescents in the target countries.

Updates

CHAI has developed draft plans to accelerate in-country uptake of new pediatric ARVs in collaboration with other stakeholders.

Update on pediatrics DTG: All activities are on track including confidential, official correspondence with the FDA regarding the filing strategy for the DTG 10 mg scored DT.

June 2020

CHAI is implementing the FASTER project under the leadership of Catholic Relief Services, funded by PEPFAR through CDC. This is an initiative between government, civil society organizations, FBOs and others to catalyze progress towards achieving 95-95-95 targets for children and adolescents. FASTER is being implemented in Nigeria, Uganda, Tanzania, Zambia, and Zimbabwe. The project focuses on 6 priority actions across the pediatric and adolescent testing and treatment cascade, agreed upon by a core set of stakeholders as a follow up to the 2017 Rome Action Plan. FASTER has also supported early GAP-f activities through support to the secretariat and expects to continue doing so until FY’21.