Improving Laboratory Capacity and Quality in the Scale-up of HIV Diagnosis, Care, Treatment, and Monitoring in Malawi under the President's Emergency Plan for AIDS Relief (PEPFAR) | CDC RFA GH19 1910

Opportunity Information: Apply for CDC RFA GH19 1910

The grant opportunity titled "Improving Laboratory Capacity and Quality in the Scale-up of HIV Diagnosis, Care, Treatment, and Monitoring in Malawi under the President's Emergency Plan for AIDS Relief (PEPFAR)" is a CDC-funded cooperative agreement designed to strengthen Malawi's laboratory systems so they can deliver the testing volume, quality, and speed needed to reach and sustain HIV epidemic control. The program is positioned as a health systems investment focused on laboratory performance as a backbone for HIV diagnosis, care, treatment monitoring, and broader public health surveillance. By improving both capacity (how much testing can be done) and quality (how reliably it is done and acted upon), the award aims to produce measurable improvements that directly support national HIV outcomes.

A central priority is ensuring that more than 95 percent of patients receive viral load (VL) testing and Early Infant Diagnosis (EID) testing, and that results are not just generated but used for clinical action. This "taken and acted upon" emphasis highlights a key goal: linking laboratory outputs to clinical decision-making so that patients with unsuppressed viral load can receive timely adherence support or regimen changes, and HIV-exposed infants can be diagnosed early enough to start life-saving treatment. The opportunity also emphasizes systematic Quality Assurance (QA) and Quality Improvement (QI) approaches to track and improve performance at both laboratory and health facility levels, meaning implementers are expected to put in place routines, dashboards, audits, and feedback loops that identify bottlenecks and correct them consistently rather than through one-off fixes.

TB and HIV integration is another major focus area. The grant calls for building laboratory capacity to diagnose TB, improving the overall TB/HIV diagnostic cascade, and strengthening the ability to monitor TB drug resistance. In practical terms, this points to investments that increase access to appropriate TB diagnostics, ensure that specimens move efficiently from clinics to testing sites, results return quickly, and that drug resistance information is captured and used to guide treatment and public health responses. Because TB remains a leading cause of illness and death among people living with HIV, improving TB diagnostic performance is treated as an essential component of HIV epidemic control rather than a separate laboratory agenda.

The opportunity also sets a clear quality benchmark for molecular testing sites: 90 percent of molecular laboratories are expected to reach International Organization for Standardization (ISO) accreditation. That requirement signals a strong push toward internationally recognized laboratory quality management systems, standardized procedures, documented competence, and continuous quality monitoring. Alongside HIV and TB, the program scope explicitly includes building laboratory capacity for HIV-related co-morbidities, including Non-Communicable Diseases (NCDs). This reflects the growing reality that as people with HIV live longer on effective treatment, conditions such as diabetes, hypertension, and other chronic diseases increasingly affect outcomes and require reliable diagnostic support. Finally, the grant includes support for laboratory-based surveillance capacity to monitor progress toward epidemic control, implying a need for strong data systems and the ability to analyze trends, identify gaps, and support timely public health decision-making.

The approach described in the opportunity is largely systems strengthening, with several enabling components working together. These include implementing QA/QI systems, improving collaboration and alignment between laboratory services and the broader HIV program, building and maintaining a capable laboratory workforce, and improving the use and management of laboratory data so results can be tracked, turned into actionable information, and used for performance improvement. The NOFO also highlights the importance of reinforcing and extending the national laboratory sample transportation network, ensuring adequate infrastructure and supplies, and strengthening laboratory quality management systems across the network. Taken together, these elements are aimed at reducing common failure points in laboratory programs such as stockouts, equipment downtime, training gaps, weak supervision, poor specimen handling, and delayed results delivery.

On the service delivery side, the program intends to optimize testing using both conventional laboratory platforms for viral load and point-of-care (POC) testing where appropriate. The stated target is to raise viral load coverage to more than 700,000 tests per year, which points to a high-throughput national scale-up requiring careful planning around instrument capacity, staffing, commodity forecasting, specimen flow, and quality controls. The NOFO also prioritizes faster turnaround time through an expanded sample transport system and digitalization of specimen accessioning and result return. The targeted turnaround time is 7 to 14 days, which is a critical operational metric because long delays reduce the clinical value of VL and EID testing and make it harder for clinics to follow up with patients, adjust treatment, and confirm that interventions are working.

Administratively, this opportunity is issued by the U.S. Department of Health and Human Services through the Centers for Disease Control and Prevention (CDC), Center for Global Health, under Funding Opportunity Number CDC RFA GH19 1910. It is a discretionary funding opportunity using a cooperative agreement mechanism, which typically means the CDC expects substantial involvement in program direction, monitoring, and technical collaboration during implementation. The CFDA number listed is 93.067, and eligibility is described as unrestricted, meaning a wide range of organizations could apply, subject to any additional eligibility clarifications in the full announcement. The opportunity anticipated two awards, with an award ceiling of $10,000,000. The posting was created on August 29, 2018, and the original application closing date was October 28, 2018, with electronic submissions due by 11:59 p.m. Eastern Time on the deadline date.

Overall, the grant is structured around the idea that reaching and sustaining HIV epidemic control in Malawi depends heavily on laboratory systems that are reliable, timely, and integrated with clinical care. By combining ambitious coverage targets (especially for VL and EID), rigorous quality expectations (including ISO accreditation goals), TB/HIV diagnostic strengthening, expanded attention to co-morbidities, and stronger data and transport systems, the opportunity aims to improve not only the quantity of testing delivered but also the real-world impact of test results on patient outcomes and public health surveillance.

• The Department of Health and Human Services, Centers for Disease Control - CGH in the health sector is offering a public funding opportunity titled "Improving Laboratory Capacity and Quality in the Scale-up of HIV Diagnosis, Care, Treatment, and Monitoring in Malawi under the President's Emergency Plan for AIDS Relief (PEPFAR)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.067.
• This funding opportunity was created on Aug 29, 2018.
• Applicants must submit their applications by Oct 28, 2018 Electronically submitted applications must be submitted no later than 1159 p.m., ET, on the listed application due date.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $10,000,000.00 in funding.
• The number of recipients for this funding is limited to 2 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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