421. Return of Results in Sexually Transmitted Infection Research: The Ethics of Notification and Treatment

BACKGROUND: In prevalence studies of sexually transmitted infections (STI), investigators often provide syndromic management for symptomatic participants, but may provide no specific treatment for asymptomatic individuals with positive test results due to the delays between sample collection and processing. It is unknown how frequently positive test results are returned to participants so that they know to seek treatment. The potential outcome, untreated study participants with documented infection, is concerning given the history of ethical lapses in STI research and the vulnerability of many STI study populations. METHODS: To characterize the extent of this issue, 82 prevalence studies from the World Health Organization’s (WHO) Report on global sexually transmitted infection surveillance, 2018, were reviewed to determine whether return of test results were reported. Studies were classified as either results returned, unspecified, or other. Publications were coded by country income in accordance with World Bank designations based on the study population’s location(s). RESULTS: Nearly half (45%) of the cited studies did not specify if participants were notified of their STI test results. Most study populations (78%) were in lower- and middle-income countries (LMIC) while 20% were in high-income countries (HIC). The remaining 2% of studies screened populations in both LMIC and HIC. Return of results was similar across income groups. Half of papers (50%) in HIC clearly indicated the return of results, whereas 44% were unspecified and one publication (6%) indicated results were not returned due to an unlinked-anonymized testing protocol (other). Results were returned in 53% of studies conducted in LMIC and not specified in 47%. CONCLUSION: A substantial proportion of STI prevalence studies cited in a 2018 WHO report did not specify if participants received their test results. Institutional approval and informed consent are critical, but insufficient for ethical research. Clinically relevant results should be returned to study participants and treating clinicians to ensure appropriate management of identified infections, if not treated during research. This is especially important in STI research in vulnerable populations. DISCLOSURES: All authors: No reported disclosures.