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:

March 2022

  • In the last quarter, Unitaid and CHAI continued to support DNO efforts in Senegal and DRC;  DRC DNO outputs will inform optimal placement of procured GeneXpert devices awaiting installation. In Senegal, DNO outputs recommended optimal device placement and increased shift of EID and priority HPV testing to POC to significantly reduce sample transport distances and related result TAT. Zimbabwe has used DNO outputs from earlier update to inform GX16 placements. The team has prepared a presentation of DNO recommendations to be shared by MOHCC at TB Union next month.

  • CHAI supported the global mapping of diagnostic footprint including manual PCR and automated PCR platforms capable of offering HIV, TB, and COVID testing. This footprint has been used to map country, regional, and global molecular capacity and to guide the distribution of supply-constrained testing commodities.

  • CHAI facilitated road map planning sessions and data collection for the DNO exercise in Uganda, as well as  partner coordination in the lead up to the scenario optimization and recommendation phases for the sample network.

October 2021

  • In the last quarter, Unitaid and CHAI continued to support DNO efforts in Senegal and DRC; DRC DNO outputs will inform optimal placement of procured GeneXperts awaiting installation. In Senegal, DNO outputs recommended optimal device placement and increased shift of EID and priority HPV testing to POC to significantly reduce sample transport distances and related result TAT. Zimbabwe has used DNO outputs from earlier update to inform GX16 placements. The team has prepared a presentation of DNO recommendations to be shared by MOHCC at TB Union next month.

  • CHAI supported the global mapping of diagnostic footprint including manual PCR and automated PCR platforms capable of offering HIV, TB, and COVID testing. This footprint has been used to map country, regional, and global molecular capacity and to guide the distribution of supply-constrained testing commodities. 

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:

March 2022

  • ELMA and CHAI through the AIDS Free project continue to support programmatic implementation of a national HIV risk screening tool in Ethiopia which has shown to be a more efficient way of identifying children living with HIV. In Nigeria, we are also supporting Ministry to validate the effectiveness of facility and community-based screening tools for children and adolescents, which were piloted by implementing partners across four states to inform recommendations for national scale-up.

  • ELMA and CHAI through the AIDS Free project continue to support the government of Nigeria to implement caregiver-assisted HIVST for children aged 2-11 years and HIVST for adolescents and PBFW since April 2021. Implementation has been scaled from 15 to 26 facility and community distribution points and routine monitoring and learning sessions with distributor and target populations are being conducted to identify opportunities to maximize uptake of HIVST and inform national recommendations for scale-up of effective distribution models.

  • ELMA and CHAI through the AIDS Free project continue to support the government of Nigeria to demonstrate EID-TB integration on GeneXpert devices in Akwa Ibom state, with technical assistance for implementation and procurement of EID cartridges. Ongoing mentorship and monitoring are being provided to two high-volume hub sites and 16 spoke sites, ultimately informing the national scale up plan. 

  • ELMA and CHAI through the AIDS Free project are supporting the government of Nigeria to develop a harmonized National Package of Care for Adolescents and Young People Living with HIV, which will strengthen health care worker capacity to provide comprehensive adolescent friendly HIV testing, care and treatment services and improve the health and wellbeing of adolescents. The APOC is expected to be finalized by Q2 2022, after which CHAI will specifically support HCWs and adolescent champions with implementation at priority sites across Akwa Ibom and Anambra.  

October 2021

  • CHAI (through the ELMA AIDS Free project) supported implementation and monitoring of a national HIV risk screening tool for children under 15 years at 46 priority sites in Ethiopia.

  • CHAI (through the ELMA AIDS Free project) continues to support the government of Nigeria to implement caregiver-assisted HIVST for children aged 2-11 years and HIVST for adolescents and pregnant women ​ since April 2021 to identify scalable models and monitor impact.

  • CHAI (through the ELMA AIDS Free project) continues to support the government of Nigeria to demonstrate EID-TB integration on GeneXpert devices in Akwa Ibom state, with technical assistance for implementation and procurement of EID cartridges. Ongoing mentorship and monitoring will be provided to two high-volume, hub sites and selected spoke sites which are being identified with Ministry and partners. 

  • CHAI (through the AIDS Free project) is supporting the government of Nigeria to develop a National Package of Care for Adolescents and Young People Living with HIV, which will strengthen health care worker capacity to provide adolescent friendly HIV testing, care and treatment services and improve the health and wellbeing of adolescents.  

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:

March 2022

  • CHAI (through FASTER) supported the commitment to expansion of POC in Tanzania from 40 sites in the Initial HVL/EID implementation plan to 200 sites by 2023.

  • CHAI (through FASTER) facilitated the activation of four additional POC EID sites in Zambia, and supported commodity procurement, training and mentorships at these sites along with 12 additional sites activated through the CDC-Provincial Health Office (PHO) mechanism. 

  • CHAI (through FASTER) facilitated implementation of a POC EID demo at 7 priority sites in Nigeria, through commodity procurement and training. CHAI supported obtaining of commitment to expand POC EID to all states and POC contribution of up to 20% at the national level (through COP planning)

October 2021

  • CHAI (through FASTER) supported the commitment to expansion of POC in Tanzania from 40 sites in the Initial HVL/EID implementation plan to 200 sites by 2023. 

  • CHAI (through FASTER) facilitated the activation of 6 additional POC EID sites in Zambia, through commodity procurement, training and mentorships 

  • CHAI (through FASTER) facilitated the kick off of a POC EID demo at 7 priority sites in Nigeria, through commodity procurement and training.

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:

March 2022

  • 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. CHAI convened stakeholders to review training materials, phased introduction and operational plans. CHAI supported the phased introduction of routine utilization of fresh whole blood sample testing for EID at GeneXpert sites planned to reach 102 POC EID health facilities in three phases. First phase is currently active at 20 sites:  January 2022 – March 2022 (through FASTER), 2nd phase to included 40 additional sites and 3rd phase will expand to 42 additional sites (through COP22).

  • CHAI has led the development of the first multiplexing pricing database for molecular platforms across HIV, TB, HPV, Hepatitis, and COVID on behalf of IDC and published by ASLM. This pricing database includes new all-inclusive pricing offers for HPV from Abbott and lower price HPV and Hepatitis pricing from Roche by leveraging the existing device footprints for integrated testing.

  • CHAI (through the Unitaid Cervical Cancer Project) has introduced HPV testing on existing testing platforms leveraging multiplexing and improving cost efficiencies across the lab system in 8 countries in SSA (Kenya, Malawi, Nigeria, Rwanda, Senegal, Uganda, Zambia, Zimbabwe) as well as introducing self-sampling as a new sample type across all 8 countries.

October 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. CHAI convened stakeholders to review training materials, phased introduction and operational plans. Plan to kick off programmatic implementation at 20 sites submitted to MOH top management for approval.

  • CHAI has led the development of the first multiplexing pricing database for molecular platforms across HIV, TB, HPV, Hepatitis, and Covid on behalf of IDC and published by ASLM. This pricing database includes new all-inclusive pricing offers for HPV from Abbott and lower price HPV and Hepatitis pricing from Roche by leveraging the existing device footprints for integrated testing. 

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:

March 2022

  • CHAI (through FASTER) supported the development, deployment and updating of an EID dashboard in Zambia, the live EID dashboard was launched in July 2021 and update of HVL Dashboards in at least 2 countries (Zambia, Nigeria) to include POC tests.

  • CHAI (through FASTER) facilitated POC EID connectivity to central level dashboard at 80/133 sites in Uganda, enabling electronic data transmission needed for programmatic monitoring and central level planning.

October 2021

  • CHAI (through FASTER) supported the development of an EID dashboard in Zambia, the live EID dashboard was launched in July 2021 and update of HVL Dashboards in at least 2 countries (Zambia, Nigeria) to include POC tests

 

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:

October 2021

  • CHAI (through FASTER) is supporting further prioritization of POC VL testing for CALHIV & PBFW in Tanzania

  • CHAI (through FASTER & FCDO) supported the site assessments of potential POC VL sites in Zambia expected to be activated in the last quarter of 2021.

  • CHAI (through FASTER) supported the quantification and planning process for expected roll-out of POC VL for up to 25% of PBFW in Uganda.

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.

Commitment 46:

March 2022

  • CHAI (through FASTER) is supporting further prioritization of POC VL testing for CALHIV & PBFW in Tanzania.

  • CHAI (through FASTER & FCDO) supported the site assessments and site selection process of potential POC VL sites in Zambia expected to be activated in the first quarter of 2022.

  • CHAI (through FASTER) supported the quantification and planning process for expected roll-out of POC VL for up to 25% of PBFW in Uganda

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:

 

March 2022

  • Through the Unitaid Optimal grant, CHAI has supported catalytic procurement and introduction of pDTG across six focal countries – Benin, Kenya, Malawi, Nigeria, Uganda, and Zimbabwe.

  • CHAI, through the Unitaid Optimal and FASTER grants, has also supported the development and dissemination of community literacy materials for pDTG, developed in close collaboration with Pediatric and Adolescent Community Advisory Boards (CABs)

  • CHAI and CRS under the FASTER project, supported governments in Nigeria, Tanzania, Uganda, and Zambia to scale up uptake of optimal ARV formulations for children and adolescents living with HIV, achievingsubstantial increases in optimal ARV use across all weight bands and concurrent increases in VLS over time through better data use, targeted mentorship and QI interventions, and treatment literacy efforts in communities. 

  • Through the ELMA AIDS Free project, CHAI is supporting ministries in Nigeria and Ethiopia to promote and institutionalize national weight-based ART monitoring and improve uptake of optimal ARVs, and is strengthening the engagement and leadership of adolescents and young people in designing, implementing and assessing HIV services with Ministries, including regarding HIVST, psychosocial support, peer-to-peer models, and client satisfaction, to improve engagement and retention in care.

October 2021

  • Through the Unitaid Optimal Grant, CHAI has continued to support Ministries of Health (MoHs) with their pediatric optimization efforts. In six Optimal focal countries (Benin, Kenya, Malawi, Nigeria, Uganda and Zimbabwe), CHAI catalytically procured pediatric DTG 10 mg and the product has arrived in country for targeted implementation. In all Unitaid Optimal ARV focal countries, CHAI continues to support MoHs and local partners with smooth product introduction and transition plans, and ensure all CLHIV have rapid access to optimized products  

  • With the inclusion of EGPAF as a sub-grantee on the Unitaid Optimal grant, CHAI and EGPAF have been coordinating closely to share early learnings and experiences of pDTG transition planning and rollout. EGPAF is 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

  • CHAI developed a second round of resources to support national decision-making on and implementation for pDTG. CHAI has worked with partners, including PEPFAR, to incorporate feedback on the materials. These collaborations with stakeholders and open access through the HIV New Product Introduction Toolkit are promoting efficiencies and avoiding redundancies in development of resources globally. CHAI is also working with local partners to build the capacity of health care workers to manage and coordinate product phase-in at the health facility level and use various resources including  pDTG HCW overview videos, DTG prescribing algorithms for children, pediatric dosing wheels, and job aids. 

  • The Optimal Community Advisory Board (CAB) is working with communities, national stakeholders, and MOHs, to increase awareness of pDTG and support demand generation in line with product rollout. Optimal and FASTER CAB members, with support from CHAI, developed a multi-media package of community resources for pDTG to expand access to information on pDTG. The materials include posters, patient pocket guides, FAQs, administration poster, social media graphics, and a jingle. Materials are available in English and French and can be found on the HIV New Product Introduction toolkit (https://www.newhivdrugs.org/ ).  

 

Additional updates on CHAI’s work on treatment optimization, outside of the Unitaid Optimal grant:

  • CHAI and CRS under the FASTER project, funded by PEPFAR through CDC, are supporting governments in Nigeria, Tanzania, Uganda, and Zambia to scale up uptake of optimal ARV formulations for children and adolescents through institutionalizing site-level weight-based ART regimen monitoring, scaling up MMD for children and adolescents, facilitating comprehensive mentorships on management of ART, leading to substantial improvements in optimal regimen uptake particularly DTG50mg for children 20-30kg as well as improvements in viral suppression.  

  • FASTER established Pediatric and Adolescent Community Advisory Boards (CABs) comprised of caregivers of children and adolescents to engage and elevate community voices in generating demand for optimal drugs and diagnostics; reached hundreds of caregivers/ALHIV through community sensitizations and IEC materials and supported development of comprehensive package of community literacy materials for DTG 10mg.

  • To enhance quality of care, FASTER has launched electronic dashboards for Pediatric ART Optimization/Quality of Care in Nigeria, Tanzania and Zambia, allowing for ministries to comprehensively monitor key pediatric and adolescent quality indicators and inform targeted quality improvement. 

  • CHAI (through the ELMA AIDS Free project) is supporting ministries in Nigeria and Ethiopia to promote national weight-based ART monitoring by demonstrating it within priority states, in conjunction with facilitating data review meetings with key stakeholders to inform targeted action. For example, this has contributed to improvements in TLD uptake for adolescents aged 15-19 years (65 percent to 82 percent) and young women aged 20-24 years (34 percent to 75 percent) in Ethiopia. Community Advisory Boards were also launched in both countries to improve demand generation and provision of psychosocial support through peer-to-peer support and development of relevant IEC materials.  

 

 

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:

October 2021

  • Across all six catalytic procurement countries, deliveries of pDTG have arrived and rollout of pDTG is ongoing. To share one highlight that came about as a result of a previous Vatican update call: in Kenya, CHAI and Sister Mary Owens partnered to introduce pDTG in Nyumbani Children’s Home. A media session was held there on the 21st of September to highlight progress made so far in the country as well as the benefits of DTG-based therapy among children and adolescents living with HIV. 

 

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.