Barriers to clinician reporting to the Antiretroviral Pregnancy Registry from within and outside the United States

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Abstract Background Excluding pregnant women with HIV from clinical trials results in inadequate pregnancy safety data for new antiretroviral therapies (ART). More rapid accumulation of ART pregnancy safety data is required. The Antiretroviral Pregnancy Registry (APR) collects teratogenicity data on ART exposures during conception and pregnancy, yet reporting to the registry is suboptimal, impacting ART choices for women with HIV globally. This research assesses awareness of the APR and barriers to reporting among HIV providers in the United States (US) and Australia. Method Anonymous, online surveys were conceived independently by researchers in the US and Australia. The surveys were distributed through national email distribution lists to healthcare providers for pregnant women with HIV, their newborns or women of reproductive potential with HIV, to assess their awareness of the APR and barriers to reporting. Results In total, 146 healthcare providers (66 US, 80 Australia) completed the survey. Respondents from the US had greater awareness of the registry and more reporting experience, describing the process as complex and laborious. Providers from Australia were largely unaware that the APR accepts reports from outside the US. Key barriers to reporting were uncertainty about how to report and incomplete access to all relevant maternal and paediatric data. Conclusions Barriers to reporting to the APR are context specific. There is scope to raise the global profile of the APR to expedite data collection, reducing time between antiretroviral licensure and accumulation of sufficient pregnancy safety data.