Impact of COVID-19 on HIV Adolescent Programming in 16 Countries With USAID-Supported PEPFAR Programs.

INTRODUCTION: The COVID-19 pandemic has disrupted access to critical health services, resulting in diminished gains in HIV epidemic control. This review assesses the magnitude of the impact that the COVID-19 pandemic has had on HIV services for adolescents. METHODS: PEPFAR Monitoring, Evaluation, and Reporting programmatic data were analyzed from across 16 USAID-supported adolescent care and treatment programs for fiscal year 2020 (FY20; October 2019-September 2020). Descriptive statistics were used to calculate absolute number and percent change between the pre-COVID-19 (Quarters 1-2; October 2019-March 2020) and COVID-19 periods (Quarters 3-4; April 2020-September 2020) for clinical cascade indicators. All analyses were conducted in Microsoft Excel. RESULTS: The number of HIV tests conducted during COVID-19 decreased by 21.4% compared with pre-COVID-19, with a subsequent 28% decrease in adolescents identified living with HIV. The rate of proxy linkage to antiretroviral therapy increased between periods, from 86.9% to 90.4%. There was a 25.9% decrease in treatment initiations among adolescents during COVID-19. During FY20, viral load coverage rates for adolescents dropped from 81.6% in FY20Q1 to 76.5% in FY20Q4, whereas the rates of viral load suppression for adolescents increased from 76.1% in FY20Q1 to 80.5% in FY20Q4. CONCLUSION: There was a substantial decrease in case-finding, treatment initiations, and viral load coverage rates for adolescents supported in USAID/PEPFAR programs during the COVID-19 pandemic. Additional health systems adaptations and strategies are required to ensure adolescents have continued access to HIV services during pandemic disruptions.

Increasing Educational Attainment in Adolescents with Sickle Cell Disease.

Adolescents with sickle cell disease (SCD), a chronic condition primarily impacting African Americans, experience challenges graduating high school. Understanding demographic, educational, and community-level correlates of disease is critical to creating effective interventions for these youths. This study aimed to examine 1) educational attainment for adolescents with SCD, 2) neighborhood correlates of their education, and 3) feasibility of a pilot to increase General Education Diploma (GED) class enrollment. Findings suggest demographic characteristics influence educational attainment. Improving educational attainment in adolescents with SCD requires understanding risk beyond disease severity. Identifying risk and protective neighborhood-level factors can inform interventions to improve educational attainment. Feasibility of programming to increase GED enrollment should be further investigated.

Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study.

OBJECTIVES: To describe the content of non-public complete response letters issued by the US Food and Drug Administration (FDA) when they do not approve marketing applications from sponsors (drug companies) and to compare them with the content any subsequent press releases issued by those sponsors DESIGN: Cross sectional study. DATA SOURCES: All applications for which FDA's Center for Drug Evaluation and Research initially issued complete response letters (n=61) from 11 August 2008 to 27 June 2013. Complete response letters and press releases were divided into discrete statements related to seven domains and 64 subdomains and assessed to determine whether they matched. RESULTS: 48% (29) of complete response letters cited deficiencies in both the safety and efficacy domains, and only 13% cited neither safety nor efficacy deficiencies. No press release was issued for 18% (11) of complete response letters, and 21% (13) of press releases did not match any statements from the letters. Press release statements matched 93 of the 687 statements (14%), including 16% (30/191) of efficacy and 15% (22/150) of safety statements. Of 32 complete response letters that called for a new clinical trial for safety or efficacy, 59% (19) had matching press release statements. Seven complete response letters reported higher mortality rates in treated participants; only one associated press release mentioned this fact. CONCLUSIONS: FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters. Press releases are incomplete substitutes for the detailed information contained in complete response letters.