Increasing Access and Coverage of HIV-1 Early Infant Diagnosis through Use of Point of Care Testing in Mozambique

Mozambique has demonstrated the feasibility and impact of the use of point of care testing (POCT) for early infant diagnosis (EID), resulting in significantly reduced turnaround times and increased rates of antiretroviral therapy (ART) initiation. Strong partnership between the Ministry of Health (MoH) and other stakeholders was key to successful implementation. The success in Mozambique has been replicated in seven additional countries with partial data analysis showing the cost-effectiveness of initiation of infected infants on ART.

What was the problem?

Access to EID by two months of age remains poor at only about 51% of infants having access to this test globally (Essajee, et al, 2017). HIV infection in infants is aggressive, with the highest morbidity and mortality occurring in the first few months of life for infants not on treatment (Bourne, et al, 2009). Conventional laboratory testing networks requiring specimen referral can limit access to treatment when not optimized. Delays in the lab-clinic interface and systems supporting EID can result in unacceptably long turnaround times (TAT) for the return of results. This in turn contributes to high attrition rates and delays initiation of infants on life-saving ART.  In Mozambique, as in other low-resource settings, errors in sample collection, transport, storage and processing, and cumbersome result return systems ensure that some families never receive the results of infant HIV diagnostic tests. Access to EID by two months of age remains poor at only about 51% of infants having access to this test globally (Essajee, et al, 2017). HIV infection in infants is aggressive, with the highest morbidity and mortality occurring in the first few months of life for infants not on treatment (Bourne, et al, 2009). Conventional laboratory testing networks requiring specimen referral can limit access to treatment when not optimized. Delays in the lab-clinic interface and systems supporting EID can result in unacceptably long turnaround times (TAT) for the return of results. This in turn contributes to high attrition rates and delays initiation of infants on life-saving ART.  In Mozambique, as in other low-resource settings, errors in sample collection, transport, storage and processing, and cumbersome result return systems ensure that some families never receive the results of infant HIV diagnostic tests.

What is the solution?

In Mozambique, the National Health Institute (NHI) together with UNITAID, Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), Clinton Health Access Initiative (CHAI) and UNICEF implemented a project in 16 primary health facilities. This project compared standard of care (SOC) testing (conventional HIV diagnostic testing practices) to point of care (POC) EID testing. In 8 of the facilities providing SOC testing, 1876 infants were enrolled, while another 2034 received POC testing. The primary outcome monitored was the proportion of infants initiating ART within 60 days from specimen collection. POC EID sites demonstrated improved access, reduced TAT for release of results and earlier initiation on ART. This evaluation led to a decision by the Mozambican MoH to nationally scale up EID POC with the support of UNITAID and PEPFAR.

What was the impact?

In the original evaluation in Mozambique, there were significant advantages associated with POC EID compared to the SOC testing (Jani, et al, 2017). There were 2.034 and 1,876 infants enrolled in the POC and SOC arms, respectively. This information is further summarized in the below Figure 1.

 Figure 1. Clinical cascade for POC EID vs. SOC testing

Figure 1. Clinical cascade for POC EID vs. SOC testing

Additionally:

  • All POC EID results were available at the PHC sites while 19% of results obtained through SOC were never returned to the sites.

  • The median TAT from sample collection to results received (in days) was 1 (0-1) day for POC compared to 125 (84-185) days in the SOC arm.

  • 99.5% of results obtain with POC testing were given to infant parents or guardian compared to 65% with the SOC, with only 7.2% and 47.2% of SOC results returned to infant parents or guardians within 2 months and 6 months of testing, respectively.

  • 89.7% of infant who tested positive with POC EID were initiated on ART within 2 months of sample collection compared to only 12.8% on ART in the SOC arm.

  • The median TAT from sample collection to ART initiation (in days) for identified infected infants was 1 (0-1) day for POC EID and 127 (44-154) days for SOC.

  • The proportion of HIV-positive infants’ retention rate after 3 months of ART initiation was higher in the POC arm (61.6%) compared to 42.9% in the SOC arm.

How does it work?

Individual level

The target population is all infants who may have been exposed to HIV. Previously, SOC testing for EID has mostly been carried out in centralized laboratory facilities. POC EID improves access, reduces TAT and allows early initiation on ART, thus preventing infant mortality due to HIV.

Systems and services level

With POC, whole blood is collected directly into cartridges for testing, bypassing the need for multiple consumables. The availability of POC EID results within an hour eliminated the need for mothers to return for results, decreasing loss to follow-up and increasing opportunities for successful enrollment into ART care.

Local Environment

Provincial governments have been engaged since the start of planning, and through determination of final allocation of POC EID instruments based on site recommendations. Through the provincial government, Provincial Focal Points were identified, trained and responsible for engaging with the PHC to provide mentorship. Site leadership was also actively involved in site enrollment and training, as well as routine monitoring and evaluation.

National Environment

The MoH has been instrumental in the introduction and implementation of POC EID. Through NHI, early evaluations (including field evaluations) were performed. These early evaluation results contributed to both the WHO considerations on POC EID and the evaluations results for WHO pre-qualification. The MoH endorsed the use of the innovative technology, and has facilitated collaboration between the Mozambican NHI, MOH PMTCT TWG and PMTCT program to provide governance for the scale up process, and to oversee procurement.

Scalability

Following the successful evaluation as described above, the Mozambican MoH launched a national scale up of EID POC.  PEPFAR Mozambique has invested in the rollout of POC EID to priority sites located in Zambezia Province. Site selection and assessment have already been completed with approval of 30 POC instruments. POC EID scale up is being implemented in 7 other countries (with minor adjustment based on country context) including Cameroon, Ethiopia, Kenya, Malawi, Uganda, Tanzania and Zimbabwe.

Management & Oversight

Monitoring:

With the different parties (manufacturers and stakeholders) involved in setting up POC EID sites, proposed indicators to monitor the various phases of implementation are summarized in Table 1.

BUDGET

Cost of innovative solution: 

A full cost-effectiveness analysis is underway. However, preliminary analysis of the Mozambique and Malawi implementation indicated POC EID was less expensive compared to conventional laboratory testing. The cost per test results received by caregiver for conventional laboratory test for EID ranged from USD $24-$43 compared to $21-$33 for POC EID.

Resources 

Key Considerations for Introducing New HIV Point-of-Care Diagnostic Technologies in National Health Systems    

HIV Point-of-Care Diagnostics Toolkit

Improving the Quality of HIV-Related Point of Care Testing: Ensuring the Reliability and Accuracy of Test Results

References

Essajee S, Bhairavabhotla R, Penazzato M, Kiragu K, Jani I, Carmona S, Rewari B, Kiyaga C, Nkengasong J, Peter T. 2017. Scale-up of Early Infant HIV Diagnosis and Improving Access to Pediatric HIV Care in Global Plan Countries: Past and Future Perspectives. J Acquir Immune Defic Syndr 75 Suppl 1:S51-S58.https://www.ncbi.nlm.nih.gov/pubmed/28398997.

Bourne DE, Thompson M, Brody LL, Cotton M, Draper B, Laubscher R, Abdullah MF, Myers JE. 2009. Emergence of a peak in early infant mortality due to HIV/AIDS in South Africa. AIDS 23:101-106.https://www.ncbi.nlm.nih.gov/pubmed/19065753.

Jani IV, Meggi B, Mabunda N, Vubil A, Sitoe NE, Tobaiwa O, Quevedo JI, Lehe JD, Loquiha O, Vojnov L, Peter TF. 2014. Accurate Early Infant HIV Diagnosis in Primary Health Clinics Using a Point-Of-Care Nucleic Acid Test. J Acquir Immune Defic Syndr doi:10.1097/QAI.0000000000000250.http://www.ncbi.nlm.nih.gov/pubmed/24933096.

Ilesh Jani BM, Osvaldo Loquiha, Ocean Tobaiwa, Chishamiso Mudenyanga, Dadirayi Mutsaka, Nedio Mabunda, Adolfo Vubil, Lara Vojnov, Trevor Peter. 2017. Point-of-care test improves infant HIV diagnosis rate, treatment starts and retention in care.https://www.medicalbrief.co.za/archives/point-care-test-improves-infant-hiv-diagnosis-rate-treatment-starts-retention-care/. CROI 2017 abstract. Accessed 4 January 2018

Mwenda R, Fong Y, Magombo T, Saka E, Midian D, Mwase C, Kandulu J, Wang M, Thomas R, Sherman J, Vojnov L. 2018. Significant Patient Impact Observed Upon Implementation of Point-Of-Care Early Infant Diagnosis Technologies in an Observational Study in Malawi. Clin Infect Dis doi:10.1093/cid/ciy169.https://www.ncbi.nlm.nih.gov/pubmed/29490026.

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