Results From a Pilot Study of an Automated Directly Observed Therapy Intervention Using Artificial Intelligence With Conditional Economic Incentives Among Young Adults With HIV.

BACKGROUND: Despite improvements in antiretroviral therapy (ART) availability, suboptimal adherence is common among youth with HIV (YWH) and can increase drug resistance and poor clinical outcomes. Our study examined an innovative mobile app-based intervention that used automated directly observed therapy (aDOT) using artificial intelligence, along with conditional economic incentives (CEIs) to improve ART adherence and enhance viral suppression among YWH. SETTING: We conducted a pilot study of the aDOT-CEI intervention, informed by the operant framework of Key Principles in Contingency Management Implementation, to improve ART adherence among YWH (18-29) in California and Florida who had an unsuppressed HIV viral load. METHODS: We recruited 28 virally unsuppressed YWH from AIDS Healthcare Foundation clinics, who used the aDOT platform for 3 months. Study outcomes included feasibility and acceptability, self-reported ART adherence, and HIV viral load. RESULTS: Participants reported high satisfaction with the app (91%), and 82% said that it helped them take their medication. Comfort with the security and privacy of the app was moderate (55%), and 59% indicated the incentives helped improve daily adherence. CONCLUSIONS: Acceptability and feasibility of the aDOT-CEI intervention were high with potential to improve viral suppression, although some a priori metrics were not met. Pilot results suggest refinements which may improve intervention outcomes, including increased incentive amounts, provision of additional information, and reassurance about app privacy and security. Additional research is recommended to test the efficacy of the aDOT-CEI intervention to improve viral suppression in a larger sample.

Youth Ending the HIV Epidemic (YEHE): Protocol for a pilot of an automated directly observed therapy intervention with conditional economic incentives among young adults with HIV.

BACKGROUND: Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, and an elevated probability of disease progression and transmission. Tracking and monitoring objective measures of antiretroviral therapy (ART) adherence in real time is critical to bolster the accuracy of research data, support adherence, and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires additional effort from providers to understand individual adherence patterns. In this study, we will monitor medication-taking using a real-time objective measure of adherence that does not rely on self-report or healthcare providers for measurement. METHODS: The Youth Ending the HIV Epidemic (YEHE) study will pilot a novel automated directly observed therapy-conditional economic incentive (aDOT-CEI) intervention to improve ART adherence among youth with HIV (YWH) in California and Florida who have an unsuppressed HIV viral load. The aDOT app uses facial recognition to record adherence each day, and then economic incentives are given based on a participant's confirmed adherence. We will enroll participants in a 3-month pilot study to assess the feasibility and acceptability of the aDOT-CEI intervention using predefined metrics. During and after the trial, a subsample of the pilot participants and staff/providers from participating AIDS Healthcare Foundation (AHF) clinics will participate in individual in-depth interviews to explore intervention and implementation facilitators and barriers. DISCUSSION: YEHE will provide data on the use of an aDOT-CEI intervention to improve adherence among YWH who are not virologically suppressed. The YEHE study will document the feasibility and acceptability and will explore preliminary data to inform a trial to test the efficacy of aDOT-CEI. This intervention has the potential to effectively improve ART adherence and virologic suppression among a key population experiencing health disparities. TRIAL REGISTRATION: The trial registration number is NCT05789875.

Availability of Extragenital Chlamydia and Gonorrhea Testing in 6 High-Incidence States.

BACKGROUND: Extragenital testing (rectal and oropharyngeal) of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) increases the detection of CT/NG infections, compared with genital testing alone. The Centers for Disease Control and Prevention recommends annual extragenital CT/NG screening for men who have sex with men, and additional screenings for women and transgender or gender-diverse individuals if certain sexual behaviors and exposures are reported. METHODS: Prospective computer-assisted telephonic interviews were conducted with 873 clinics between June 2022 and September 2022. The computer-assisted telephonic interview followed a semistructured questionnaire that included closed-ended questions on the availability and accessibility of CT/NG testing. RESULTS: Of the 873 clinics, CT/NG testing was offered in 751 clinics (86.0%), and extragenital testing was offered in only 432 clinics (57.5%). Most clinics (74.5%) with extragenital testing do not offer tests unless patients request them and/or report symptoms. Additional barriers to accessing information on available CT/NG testing include clinics not picking up the telephone, disconnecting the call, and unwillingness or inability to answer questions. CONCLUSIONS: Despite evidence-based recommendations from the Centers for Disease Control and Prevention, the availability of extragenital CT/NG testing is moderate. Patients seeking extragenital testing may encounter barriers such as fulfilling specific criteria or being unable to access information on testing availability.

Clinical Factors Associated With Accurate Presumptive Treatment of Neisseria gonorrhoeae Infections in Men Who Have Sex with Men and Transgender Women.

BACKGROUND: Neisseria gonorrhoeae (N. gonorrhoeae) infections have increased among men who have sex with men and are high among transgender women. Presumptive treatment guidelines may lead to inaccurate treatments and possible antibiotic resistance. Using patient data from AIDS Healthcare Foundation sexually transmitted infection (STI) testing clinics in California and Florida, we identified clinical factors associated with accurate presumptive N. gonorrhoeae treatment. METHODS: Multivariable logistic regression analyses were conducted using patient visit data from 2013 to 2017. A sample of 42 050 patient encounters were analyzed. The primary outcome variable included accurate versus inaccurate presumptive treatment. Risk ratios were generated for particular symptoms, high-risk sexual behavior, and history of N. gonorrhoeae. RESULTS: Twelve percent (5051/42 050) of patients received presumptive N. gonorrhoeae treatment, and 46% (2329/5051) of presumptively treated patients tested positive for N. gonorrhoeae infection. Patients presenting with discharge or patients presenting with dysuria were more likely to receive accurate presumptive treatment. CONCLUSIONS: Providers should continue to follow the Centers for Disease Control and Prevention guidelines and consider presumptive N. gonorrhoeae treatment based on specific symptoms. As the STI epidemic continues to rise in the United States, along with increased antibiotic resistance, it is imperative to accurately test, diagnose, and treat populations at risk for N. gonorrhoeae and other STIs.

Brief Report: Discrepancies Between Self-Reported Adherence and a Biomarker of Adherence in Real-World Settings.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is only effective in preventing new HIV infections when taken consistently. In clinical practice, asking a patient about their adherence (self-report) is the predominant method of assessing adherence to PrEP. Although inexpensive and noninvasive, self-report is subject to social desirability and recall biases. Several clinical trials demonstrate a discrepancy between self-reported adherence and biomarker-based recent adherence. Less is known about the accuracy of self-report in real-world clinical settings. This brief report addresses this knowledge gap and describes the concordance between self-reported adherence and biomarker-based adherence in real-world clinical settings. METHODS: A liquid chromatography-mass spectrometry urine test for tenofovir was developed and used clinically to detect recent nonadherence (no dose in at least 48 hours) for each individual. Two clinics' standard operating procedures recommend utilization of the urine-based adherence test for patients who self-report that they are not struggling with adherence. Those who self-report struggling with adherence receive enhanced adherence support without the need for additional testing. The number of results indicating recent nonadherence from these 2 clinics were analyzed to assess the concordance between self-reported adherence and biomarker-based adherence. RESULTS: Across 2 clinics, 3987 tests were conducted from patients self-reporting as "adherent," and 564 [14.1%; 95% confidence interval (CI): 13.1% to 15.2%] demonstrated recent nonadherence with the liquid chromatography-mass spectrometry test. At clinic #1 in Florida, 3200 tests were conducted, and 465 (14.5%; 95% CI: 13.3% to 15.8%) demonstrated recent nonadherence. At clinic #2 in Texas, 787 tests were conducted, and 99 (12.6%; 95% CI: 10.4% to 14.9%) demonstrated recent nonadherence. CONCLUSIONS: Utilization of biomarker-based adherence monitoring at these 2 clinics resulted in 564 additional patients receiving enhanced adherence support who otherwise would not have been identified as nonadherent to their prescribed PrEP regimen. These findings suggest that objective adherence monitoring can be used clinically to enable providers to identify nonadherent patients and allocate support services accordingly.