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2022 Rome Action Plan on Paediatric HIV & TB

PEPFAR

HIV MEDICINES DURING PREGNANCY AND BREASTFEEDING

Funders commit to promote the implementation of the Call To Action principles through their investments, this includes:

 

53. Support country action and a global platform to strengthen active surveillance of safety of HIV agents (such as TAF, DRV/r and CAB LA) in pregnancy, building harmonization and linkages between surveillance networks, with a focus on the most-affected countries and populations.

Updates

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HIV DIAGNOSTICS

Donors commit to: 

 

105. Work towards reducing disease funding silos for diagnostics in order to encourage and support more comprehensive diagnostic strategies, including person-centred care, diagnostic integration and network optimization. 

 

106. Support improved global and national coordination across donors, including funding mechanisms, pooling procurement volumes in negotiations with diagnostic manufacturers, and other activities.

 

107. Prioritize and re-invigorate paediatric-specific funding for strengthened implementation of HIV and TB diagnostics and support of person-centred diagnostic technologies (ie. point-of-care infant diagnosis, simplified TB sample types). 

 

108. Support current efforts to transition from outright instrument procurement to all-inclusive bundles, or other novel pricing model to ensure in-country harmonization of commodity procurement.

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109. Support in a transparent manner, including key performance indicators, the procurement of commodities and operational costs to maintain and further scale-up POC infant diagnosis, as well as viral load testing for infants, children, and pregnant and breastfeeding women and advanced HIV disease diagnostics, including TB, as an integral part of optimized and integrated national diagnostic networks and in accordance with national plans and targets.

 

110. Continue (and expand) support to WHO PQ to broaden their mandate as planned and to shorten timelines for review and minimize time to national registration. 

 

PEPFAR commits to:

 

116. Work towards reducing disease funding silos for diagnostics in order to encourage and support diagnostic integration and multiplex testing to allow use of current platforms to address multiple diseases.

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117. Accelerate multi-disease diagnostic network optimization at the national level to support increased access to testing and network efficiencies, decrease total cost per test, and improvement in specimen-to-clinical action turnaround.

 

118. Continue engaging governments for policy change in support of all-inclusive pricing models and accelerated complementary use of point-of-care and centralized platforms.

 

119. Ensure implementing agencies and partners are aware of current paediatric diagnostics that can be procured with PEPFAR funds and ensure safe and ethical HIV testing services are offered to all biological children of parents living with HIV and biological siblings of children living with HIV This can include further scaling appropriate/approved use of HIVST assays including caregiver assisted oral self-testing for screening children at home. 

 

120. Expanding case finding modalities to find undiagnosed children and conducting audits of children newly testing positive for HIV––to inform new approaches to find the missing children, including improving demand generation linked to clinical services through multiple avenues.

 

121. Working with partners to improve CLHIV estimates through innovative data collection methods in tandem with household surveys.

 

122. Work with African based institutions to strengthen their capacity for regional regulatory approval of products.

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All partners commit to: 

 

163. Address inequities by tackling the stigma and discrimination in communities, schools, and healthcare settings that prevent children living with HIV from accessing testing and treatment. 

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164. Increase literacy about CD4 testing and viral load and promote a client-centred approach to support expansion of access to viral load for pregnant and breastfeeding women and children on treatment, including at the point-of-care. 

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165. Review and assess emerging co-infections for immunocompromised infants and children, including those with advanced HIV disease, such as severe bacterial infections, fungal infections, and others for country consideration and implementation.

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166. Engage affected communities for input and guidance on investment and programmatic priorities, provide support to in-country civil society organizations to engage in advocacy and demand creation for new tools, and ensure data is publicly available to support communities and civil society to monitor progress regarding uptake and implementation of essential diagnostic tools.

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Updates

107. October 2023: (---support person-centered diagnostic technologies, i.e point-of-care infant diagnosis), PEPFAR is collaborating with the Molbio company  that manufactures the Treunat point-of-care platform for evaluation and eventual use for Early Infant Diagnosis (EID).  This platform is already WHO PQ and being used in 9 countries (over 300 platforms), with four of the countries in Africa (Nigeria, Kenya, Uganda, Zimbabwe) for TB testing.  This will add value to the global community’s efforts for diagnostic integration, multi-disease testing, decentralized testing and community-based testing. 

119. March 2024:

  •  In November 2023, PEPFAR supported a learning visit to Nigeria for three countries (South Sudan, Zambia, and Uganda) to learn about their introduction and scale of programmatic implementation of caregiver-assisted HIVST to support introduction and/or scale in their countries.

  •  In December 2023, results were presented from FASTER’s project using nearly 100,000 HIVSTs to increase HTS access among pediatric and AYP populations, “Evaluating the feasibility and effectiveness of HIV self-testing (HIVST) among children, adolescents, and young adults in Nigeria,” showing a PPV of 88% in assisted-HIVST in children in facility settings and successfully engaging first-time testers.

  •  PEPFAR (with input from WHO) finalized the following document to support assisted HIVST in children: “PEPFAR Operational Considerations: Caregiver-and Lay Staff- Assisted Testing with HIVST Kits for Use in Children and Young Adolescents Aged 2-14 Years”. An accompanying slide deck is currently undergoing GHSD approval for dissemination. 

  •  PEPFAR supported a pediatric index training in South Africa (August 2023), which included National Department of Health, Provincial staff, USG, Clinical, Key Population and Orphans and Vulnerable Children partners.

  • PEPFAR supported a pediatric index testing training for the West Africa Region (October 2023), which included MoH, USG, Clinical and Key Populations partners from Benin, Burkina Faso, Ghana, Liberia, Mali, Senegal, Sierra Leone and Togo. 

  •  In October 2023, PEPFAR’s Guidance on Safe and Ethical Index Training was included on the PEPFAR Virtual Academy which can be accessed here. This is a web-based platform that is no cost for USG and non-USG colleagues to access. The training includes modules on pediatric and adolescent index testing.  

119. June 2023: For pediatric HIVST, shared study information with WHO to inform 2023 HIVST guidance. WHO will issue neutral guidance in 2023, neither recommending for, nor against, caregiver-assisted pediatric HIVST, due to a lack of evidence. PEPFAR included guidance on pediatric HIVST in COP23 guidance and is working to develop implementation resources based on completed studies and demonstration projects. This gives countries great autonomy to expand pediatric HIVST. 

  • October 2023: PEPFAR is  developing operational considerations (with input from WHO) regarding caregiver-assisted and lay worker-assisted testing with HIVST kits to help improved pediatric testing coverage

  • PEPFAR continues to support 6 countries preparing for PEPFAR LIFT UP-funded  activities focused on closing gaps in pediatric case finding.

  • Under Pillar 1 of the Global Alliance, PEPFAR and UNICEF have been collaborating to develop a technical brief on closing the gaps in pediatric case finding, to be released in 2024.

  • Zambia presented preliminary findings for a positive infant audit and pediatric characterization studies that found that: 1) for the 150 positive infants, 50% were due to incident infections during PBF and 50% born to mothers with poor VLS; 2) among 200 children 2-14 years newly diagnosed with HIV, the median age was 7 years and 85% were stage 1, with 78% no history of HIV testing and only 63% of mothers were virally suppressed. 

120. March 2024: 

  • PEPFAR continues to support 6 countries preparing for PEPFAR LIFT UP-funded  activities focused on closing gaps in pediatric case finding.

  • Under Pillar 1 of the Global Alliance, PEPFAR and UNICEF have been collaborating to develop a technical brief on closing the gaps in pediatric case finding, to be released in 2024.

  • Zambia presented preliminary findings for a positive infant audit and pediatric characterization studies that found that: 1) for the 150 positive infants, 50% were due to incident infections during PBF and 50% born to mothers with poor VLS; 2) among 200 children 2-14 years newly diagnosed with HIV, the median age was 7 years and 85% were stage 1, with 78% no history of HIV testing and only 63% of mothers were virally suppressed.  

120. June 2023: Zambia is conducting a newly diagnosed child audit to identify factors contributing to missed opportunities in pediatric case identification to inform interventions that can bring down the age a diagnosis.

121. March 2024: PEPFAR is conducting an activity in Tanzania to leverage PHIA participants to understand status of implementation pediatric index case testing. 

121. June 2023: PEPFAR supported pediatric target setting and review in COP23 to ensure appropriate and ambitious targets aligned with countries treatment gaps to allocate sufficient testing commodities to identify undiagnosed children; PEPFAR updated the Pediatric index testing module and developed an Adolescent index testing module. Trainings are planned for South Africa in July 2023 and other priority countries later this year; Through LIFT UP, 5 PEPFAR OUs proposed activities focusing on improving case finding in children and 5 OU’s proposed CLHIV estimation work. ​

122. October 2023: The Expert Review Panel for Diagnostic Products (ERPD) for HIV rapid diagnostic tests manufactured in Africa was launched by the Global Fund on August 8, 2023, with support from PEPFAR, WHO, and other partners. The ERPD is a mechanism to review the risks and benefits associated with procurement and use of diagnostic products that may have a high public health impact but have not yet undergone a stringent regulatory assessment. The ERPD is intended to provide an interim solution to facilitate procurement of African manufactured HIV rapid tests for a time-limited period, in anticipation of the completion of a stringent review process. The ERPD will move us closer to achieving the target of 15 million rapid HIV tests procured from Africa based manufacturers by 2025 announced by the Ambassador during the Africa Leaders' Summit in December 2022."

164. March 2024: PEPFAR as of October 2023 has requested countries report MER   or programmatic data on CD4 coverage among those newly initiated on ART and returning to treatment after an interruption. This data captures proportion of those with a CD4 including categories for CD4<200 and CD4≥200. Reporting and analysis of this data is intended to effectincreased focus and improvements in CD4 coverage and AHD service implementation across PEPFAR-supported sites.

TB DIAGNOSTICS

PEPFAR commits to:

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197. See the HIV commitments

Updates

197. March 2024: 

  • PEPFAR countries are actively developing TB acceleration plans (TAPs) to increase TB detection to 2 million active TB cases over the next 5 years and prevent ≥ 500,000 TB-related deaths among PLHIV.TAPs will focus primarily on PLHIV most at risk to die of TB, including children, and will focus on country-specific gaps and barriers. Many draft TAPs include increasing access to TB diagnostic testing and strategies, as well as TP preventative therapy and TB treatment for children. 

  • PEPFAR supported an activity in Uganda to introduce TB services into OVC programs, including linkage to diagnostic TB testing and monitoring treatment initiation and completion among OVC and the members of their households. 

  • Beginning in 2024, PEPFAR has requested countries to collect MER or programmatic data on TB symptom screening for children by new fine age stratifications (<1, 1-4, 5-9, 10-14 years). Formerly these data were only collected by a coarse age stratification (<15 and ≥15 years). This updated reporting will allow PEPFAR to better understand TB screening trends for the youngest children who are most at risk for TB and poor outcomes related to TB. ​

197. October 2023: 

  • PEPFAR directly supported the introduction of the new WHO recommended Tuberculosis Preventive Therapy regimen (TPT) 3HP. This shorter regimen is available for older adolescents as well as children on certain ART regimens in PEPFAR supported countries.

  • PEPFAR introduced new disaggregation by fine age bands in its reporting system to better account for TB screening and treatment initiation for pediatric populations.

  • PEPFAR has supported massive scale-up of LF-LAM and Xpert, including ability to collect and process child-friendly samples, like stool

  • Detect two million active tuberculosis (TB) cases over the next five years and prevent at least 500,000 TB-related deaths among people living with HIV. According to estimates, more than half of the current TB cases among people living with HIV go undiagnosed. PEPFAR and its partners are committed to using new tools and new approaches that dramatically increase TB diagnosis and treatment coverage for people living with HIV.

  • The first phase of this initiative will prioritize PEPFAR-supported countries with a high burden of HIV and TB, such as South Africa, Nigeria, Kenya, Tanzania, and Mozambique. The effort will focus primarily on people living with HIV most at risk to die of TB such as children, older adults, and people with advanced HIV

197. June 2023: PEPFAR is making strides in improving the number of CLHIV screened for TB (overall coverage) and the number of TB diagnoses in the last year, although there are still many gaps to address. 

HIV MEDICINES FOR CHILDREN

PEPFAR commits to:

 

275. Procuring only optimal Paediatric ART formulations (per optimal formulary) and ensuring implementing Agencies and partners are informed of the formulations that can be procured with PEPFAR funding. 

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276. Ensuring implementing agencies and partners are prepared for the introduction of pALD by not overstocking ABC/3TC  120/60 mg and DTG 10 mg. 

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277. Ensuring implementing agencies and partners are prepared for co-formulated DRV/r introduction and transition from other PI based regimens in children 3 and older.¨ 

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278. Addressing preventable deaths in CLHIV by implementing the STOP AIDS WHO package of care for all children with AHD; supporting mortality surveillance systems and cause of death audits, in collaboration with country governments, to allow for targeted mortality prevention efforts; ensuring CLHIV newly initiating on ART are provided with intensive case management until VLS is achieved; and ensuring malnutrition is diagnosed and treated early in CLHIV. 

Updates

 

276. March 2024: 

  • During COP23 mid-term review planning, PEPFAR countries incorporated planning for pALD into national strategies and supply plans. 

  • Two countries have placed orders for pALD, #180, namely Zambia and Zimbabwe. Several countries will begin introduction of pALD towards the end of CY2024; the majority of countries will introduce this product in CY2025. Reasons cited for delayed introduction include requirement to update national treatment guidelines, transition fatigue, and overstock of DTG 10 mg and overstock of ABC/3TC 120/60 mg.

276. October 2023: With the tentative FDA approval of pALD, PEPFAR encourages the procurement and use of this product for all eligible children and will begin close review of all upcoming pDTG  10 mg and ABC/3TC 120/60 mg orders. 

278. March 2024: PEPFAR supported an analysis of pediatric mortality in CLHIV <5 years on ART highlighting the disparities they experience compared to all ohterother age groups supported by PEPFAR, which was published on World AIDS Day 2023 in CDC’s Morbidity and Mortality Weekly Report (MMWR)

275 to 278. June 2023: 

  • PEPFAR has provided guidance to all PEPFAR countries that it will no longer being procuring LPV/r formulations when there are available pediatric DRV/r formulations as well as the 400/50 mg formulation once it becomes available for CLHIV 25+ kg. 

  • PEPFAR has Provided guidance to all PEPFAR countries not to overstock ABC/3TC and DTG 10 mg  before pALD introduction

  • ​ Child mortality recommendations included in COP23 guidance to help countries reduce <5 mortality among PEPFAR-supported clients. PEPFAR HQ has also drafted several tools to support countries in implementation of these recommendations

  • Countries have been re-permitted to use PEPFAR funds to procure RUTF and nutritional supplementation for malnourished CLHIV especially those <5

  • PEPFAR has been working with multiple countries to leverage and review data from their mortality surveillance systems (like verbal autopsy and case based surveillance (electronic medical records)) to better understand mortality among CLHIV and inform program to help further reduce mortality.

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TB TREATMENT for CHILDREN, PREGNANT, POST-PARTUM AND BREASTFEEDING WOMEN

PEPFAR commits to: 

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422. Through COP, closing the remaining gap in contact investigation and TPT for household contacts and for all children and adolescents living with HIV.

Updates

422. March 2024: As noted below (June 2023), TAPs will address closing gaps in TPT in priority populations such as children. 

422. June 2023: 

  • COP 23 guidance stressed the importance of expanding coverage of TPT among child contacts. PEPFAR IPs are working toward routinely implementing this through country office commitment, engagement with NTPs, and procurement of additional TPT courses. Since FY17, PEPFAR has supported 586,099 TPT completions among children and adolescents living with HIV, including 37,259 TPT completions in FY23 Q2 . The most recent data suggest that around 42% of new ART patients under 15 years of age in PEPFAR-supported programs initiated a course of TPT. Reported TPT completion rates remain high in this age group, at 88% in FY23 Q2. 

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