NIH grant: Improving Diagnosis of Reproductive Tract infections in Rwandan Women: Feasibility, Acceptability, and Preliminary Effectiveness of an Evidence-based Diagnostic Algorithm (1R21AI196621-01)

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NIH grant 1R21AI196621-01: Improving Diagnosis of Reproductive Tract infections in Rwandan Women: Feasibility, Acceptability, and Preliminary Effectiveness of an Evidence-based Diagnostic Algorithm
Institute: {'code': 'AI', 'abbreviation': 'NIAID', 'name': 'National Institute of Allergy and Infectious Diseases', 'admin_org_id': '12500003', 'admin_funding_url': ''}. PI: Julien Mutagisha Nyombayire Mutagisha. Award: $131784.
Start: 2026-06-24T00:00:00.
Global resurgence of curable sexually transmitted infections (STI) is a public health concern due to their severe
associated morbidities and increasing antimicrobial resistance. Inadequate diagnosis leads to under- and overtreatment,
fueling HIV/STI risk, antimicrobial resistance, and adverse fertility and pregnancy outcomes. To
address this critical gap, the Center for Family Health Research in Rwanda and Emory colleagues developed
and validated a CT/NG diagnostic algorithm for women informed by local epidemiology as recommended by
WHO. Among symptomatic women seen at our clinic, our algorithm had a sensitivity of 79-91% versus 26%
using the Rwandan National Guidelines. Formative work confirms providers can be trained to use our
algorithm, though microscopy capacity requires development. Our proposal aims to implement and
evaluate our algorithm, including microscopy, in public HC to improve RTI diagnosis in Rwandan
women. Scientific rationale for conducting this work in Rwanda. Rwanda is uniquely suited to answer
these questions faster and at lower cost than the US. STI burden in our Rwandan cohort (NG 26%, CT 16%)
far exceeds US primary care rates, enabling adequate power at a fraction of the domestic sample size.
Rwanda’s universal syndromic management policy provides a clearly defined comparator unavailable in the
heterogeneous US system. Finally, PI Wall’s decade-long CFHR partnership and existing algorithm validation
means work can begin immediately with infrastructure and community trust in place. We will first conduct
stakeholder interviews and needs assessments guided by an implementation science framework in 4 HC to
understand perceptions, barriers, and facilitators to implementing our algorithm with microscopy (Aim 1).
Based on Aim 1 findings, we will co-design training and quality assurance protocols and pilot our algorithm with
microscopy using a self-controlled case series design among 310 women in 4 Rwandan HC (Aim 2). The REAIM
framework will guide evaluation of algorithm with microscopy feasibility, acceptability, and preliminary
effectiveness (Aim 3). Study findings will be shared with high-level stakeholders throughout the study to solicit
feedback to inform future studies and for public health impact. Although conducted in Rwanda, this work
directly advances the health of Americans: STI prevalence in high-burden US communities approaches
Rwandan levels, microscopy for RTI diagnosis is similarly underutilized in US primary care, and the validated
diagnostic algorithm and implementation package developed here can be directly applied and utilized across
the United States to offer expanded and enhanced care to Americans for whom comprehensive STI testing in
pregnancy and primary care remains out of reach, such as in rural communities and for individuals in urban
areas that do not routinely access primary or preventive health care.

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