Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial.

BACKGROUND: Gay, bisexual, and other men who have sex with men (MSM), particularly Black or African American MSM (BMSM) and Hispanic or Latino MSM (HLMSM), continue to be disproportionately affected by the HIV epidemic in the United States. Previous HIV self-testing programs have yielded high testing rates, although these studies predominantly enrolled White, non-Hispanic MSM. Mobile health tools can support HIV prevention, testing, and treatment. This protocol details an implementation study of mailing free HIV self-tests (HIVSTs) nested within a randomized controlled trial designed to assess the benefit of a mobile phone app for increasing the uptake of HIV prevention and other social services. OBJECTIVE: This study was a comparative effectiveness trial of innovative recruitment and testing promotion strategies intended to effectively reach cisgender BMSM and HLMSM. We evaluated the use of a mobile app for increasing access to care. METHODS: Study development began with individual and group consultations that elicited feedback from 3 core groups: HIV care practitioners and researchers, HIV service organization leaders from study states, and BMSM and HLMSM living in the study states. Upon completion of the formative qualitative work, participants from 11 states, based on the observed areas of highest rate of new HIV diagnoses among Black and Hispanic MSM, were recruited through social networking websites and smartphone apps. After eligibility was verified, participants consented and were randomized to the intervention arm (access to the Know@Home mobile app) or the control arm (referral to web resources). We provided all participants with HIVSTs. The evaluation of the efficacy of a mobile phone app to support linkage to posttest prevention services that included sexually transmitted infection testing, pre-exposure prophylaxis initiation, antiretroviral treatment, and acquisition of condoms and compatible lubricants has been planned. Data on these outcomes were obtained from several sources, including HIVST-reporting surveys, the 4-month follow-up survey, laboratory analyses of dried blood spot cards returned by the participant, and data obtained from the state health department surveillance systems. Where possible, relevant subgroup analyses were performed. RESULTS: During the formative development phase, 9 consultations were conducted: 6 in-depth individual discussions and 3 group consultations. From February 2020 through February 2021, we enrolled 2093 MSM in the randomized controlled trial from 11 states, 1149 BMSM and 944 HLMSM. CONCLUSIONS: This study was designed and implemented to evaluate the effectiveness of recruitment strategies to reach BMSM and HMSM and of a mobile app with regard to linkage to HIV prevention or treatment services. Data were also obtained to allow for the analyses of cost and cost-effectiveness related to study enrollment, HIV testing uptake, identification of previously undiagnosed HIV, sexually transmitted infection testing and treatment, and linkage to HIV prevention or treatment services. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04219878); https://clinicaltrials.gov/ct2/show/NCT04219878. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43414.

Modeling the Potential Impact of Missing Race and Ethnicity Data in Infectious Disease Surveillance Systems on Disparity Measures: Scenario Analysis of Different Imputation Strategies.

BACKGROUND: Monitoring progress toward population health equity goals requires developing robust disparity indicators. However, surveillance data gaps that result in undercounting racial and ethnic minority groups might influence the observed disparity measures. OBJECTIVE: This study aimed to assess the impact of missing race and ethnicity data in surveillance systems on disparity measures. METHODS: We explored variations in missing race and ethnicity information in reported annual chlamydia and gonorrhea diagnoses in the United States from 2007 to 2018 by state, year, reported sex, and infection. For diagnoses with incomplete demographic information in 2018, we estimated disparity measures (relative rate ratio and rate difference) with 5 imputation scenarios compared with the base case (no adjustments). The 5 scenarios used the racial and ethnic distribution of chlamydia or gonorrhea diagnoses in the same state, chlamydia or gonorrhea diagnoses in neighboring states, chlamydia or gonorrhea diagnoses within the geographic region, HIV diagnoses, and syphilis diagnoses. RESULTS: In 2018, a total of 31.93% (560,551/1,755,510) of chlamydia and 22.11% (128,790/582,475) of gonorrhea diagnoses had missing race and ethnicity information. Missingness differed by infection type but not by reported sex. Missing race and ethnicity information varied widely across states and times (range across state-years: from 0.0% to 96.2%). The rate ratio remained similar in the imputation scenarios, although the rate difference differed nationally and in some states. CONCLUSIONS: We found that missing race and ethnicity information affects measured disparities, which is important to consider when interpreting disparity metrics. Addressing missing information in surveillance systems requires system-level solutions, such as collecting more complete laboratory data, improving the linkage of data systems, and designing more efficient data collection procedures. As a short-term solution, local public health agencies can adapt these imputation scenarios to their aggregate data to adjust surveillance data for use in population indicators of health equity.

Variation in Patterns of Racial and Ethnic Disparities in Primary and Secondary Syphilis Diagnosis Rates Among Heterosexually Active Women by Region and Age Group in the United States.

BACKGROUND: Syphilis rates have increased substantially over the past decade. Women are an important population because of negative sequalae and adverse maternal outcomes including congenital syphilis. We assessed whether racial and ethnic disparities in primary and secondary (P&S) syphilis among heterosexually active women differ by region and age group. METHODS: We synthesized 4 national surveys to estimate numbers of heterosexually active women in the United States from 2014 to 2018 by region, race and ethnicity, and age group (18-24, 25-29, 30-44, and ≥45 years). We calculated annual P&S syphilis diagnosis rates, assessing disparities with rate differences and rate ratios comparing White, Hispanic, and Black heterosexually active women. RESULTS: Nationally, annual rates were 6.42 and 2.20 times as high among Black and Hispanic than among White heterosexually active women (10.99, 3.77, and 1.71 per 100,000, respectively). Younger women experienced a disproportionate burden of P&S syphilis and the highest disparities. Regionally, the Northeast had the highest Black-White and Hispanic-White disparities using a relative disparity measure (relative rate), and the West had the highest disparities using an absolute disparity measure (rate difference). CONCLUSIONS: To meet the racial and ethnic disparity goals of the Sexually Transmitted Infections National Strategic Plan, tailored local interventions that address the social and structural factors associated with disparities are needed for different age groups.

Racial and ethnic disparities in HIV diagnoses among heterosexually active persons in the United States nationally and by state, 2018.

BACKGROUND: Despite declining HIV infection rates, persistent racial and ethnic disparities remain. Appropriate calculations of diagnosis rates by HIV transmission category, race and ethnicity, and geography are needed to monitor progress towards reducing systematic disparities in health outcomes. We estimated the number of heterosexually active adults (HAAs) by sex and state to calculate appropriate HIV diagnosis rates and disparity measures within subnational regions. METHODS: The analysis included all HIV diagnoses attributed to heterosexual transmission in 2018 in the United States, in 50 states and the District of Columbia. Logistic regression models estimated the probability of past-year heterosexual activity among adults in three national health surveys, by sex, age group, race and ethnicity, education category, and marital status. Model-based probabilities were applied to estimated counts of HAAs by state, which were synthesized through meta-analysis. HIV diagnoses were overlaid to calculate racial- and ethnic-specific rates, rate differences (RDs), and rate ratios (RRs) among HAAs by sex and state. RESULTS: Nationally, HAA women have a two-fold higher HIV diagnosis rate than HAA men (rate per 100,000 HAAs, women: 6.57; men: 3.09). Compared to White non-Hispanic HAAs, Black HAAs have a 20-fold higher HIV diagnosis rate (RR, men: 21.28, women: 19.55; RD, men: 15.40, women: 31.78) and Hispanic HAAs have a 4-fold higher HIV diagnosis rate (RR, men: 4.68, RD, women: 4.15; RD, men: 2.79, RD, women: 5.39). Disparities were ubiquitous across regions, with >75% of states in each region having Black-to-White RR ≥10. CONCLUSION: The racial and ethnic disparities across regions suggests a system-wide failure particularly with respect to preventing HIV among Black and Hispanic women. Pervasive disparities emphasize the role for coordinated federal responses such as the current Ending the HIV Epidemic (EHE) initiative.

Predicting the impact of sexual behavior change on adolescent STI in the US and New York State: a case study of the teen-SPARC tool.

PURPOSE: Adolescents aged 13-18 years bear a large burden of sexually transmitted infections (STIs) and changing adolescent sexual risk behavior is a key component of reducing this burden. We demonstrate a novel publicly available modeling tool (teen-SPARC) to help state and local health departments predict the impact of behavioral change on gonorrhea, chlamydia, and HIV burden among adolescents. METHODS: Teen-SPARC is built in Excel for familiarity and ease and parameterized using data from CDC's Youth Risk Behavior Surveillance System. We present teen-SPARC's methods, including derivation of national parameters and instructions to obtain local parameters. We model multiple scenarios of increasing condom use and estimate the impact on gonorrhea, chlamydia, and HIV incidence, comparing national and New York State (NYS) results. RESULTS: A 1% annual increase in condom use (consistent with Healthy People 2020 goals) could prevent nearly 10,000 cases of STIs nationwide. Increases in condom use of 17.1%, 2.2%, and 25.5% in NYS would be necessary to avert 1000 cases of gonorrhea, 1000 cases of chlamydia, and 10 cases of HIV infection, respectively. Additional results disaggregate outcomes by age, sex, partner sex, jurisdiction, and pathogen. CONCLUSION: Teen-SPARC may be able to assist health departments aiming to tailor behavioral interventions for STI prevention among adolescents.

Cost Analysis of Single-Dose Hepatitis B Revaccination Among Infants Born to Hepatitis B Surface Antigen-Positive Mothers and Not Responding to the Initial Vaccine Series.

OBJECTIVES: Infants born to mothers who are hepatitis B surface antigen (HBsAg) positive are at risk for perinatal hepatitis B infection. As prevention, these infants receive a series of 3 or 4 doses of hepatitis B vaccine starting at birth and postvaccination serologic testing. Infants with antibody levels <10 mIU/mL are considered vaccine nonresponders and should be revaccinated. The objective of this cost analysis was to assess a single-dose revaccination strategy among infant nonresponders. METHODS: We used a decision analytic tree to compare the costs of a single-dose revaccination strategy with the costs of a 3-dose revaccination strategy. The analysis consisted of 3 epidemiologic scenarios that varied levels of previous protection among infants indicated for revaccination. We assumed health outcomes in each strategy were the same, and we evaluated costs from the societal perspective using 2016 US dollars. We conducted sensitivity analyses on key variables, including the minimum required efficacy of a single revaccination dose. RESULTS: In all analyses, the single-dose revaccination strategy was a lower-cost option than the 3-dose revaccination strategy. Under the assumption that all revaccination visits were previously unscheduled, single-dose revaccination reduced the cost per infant by $119.81 to $155.72 (depending on the scenario). Across all scenarios, the most conservative estimate for the threshold efficacy (the minimum efficacy required to result in a lower-cost option) value of single-dose revaccination was 67%. CONCLUSIONS: For infants who were born to HBsAg-positive mothers and who were not responding to the initial vaccine series, a single-dose revaccination strategy, compared with a 3-dose revaccination strategy, reduced costs across several scenarios. These results helped inform the Advisory Committee on Immunization Practices' vote in February 2017 to recommend single-dose revaccination.

Cost-effectiveness analysis of catch-up hepatitis A vaccination among unvaccinated/partially-vaccinated children.

BACKGROUND: Since 2006, the US Centers for Disease Control and Prevention has recommended hepatitis A (HepA) vaccination routinely for children aged 12-23months to prevent hepatitis A virus (HAV) infection. However, a substantial proportion of US children are unvaccinated and susceptible to infection. We present results of economic modeling to assess whether a one-time catch-up HepA vaccination recommendation would be cost-effective. METHODS: We developed a Markov model of HAV infection that followed a single cohort from birth through death (birth to age 95years). The model compared the health and economic outcomes from catch-up vaccination interventions for children at target ages from two through 17years vs. outcomes resulting from maintaining the current recommendation of routine vaccination at age one year with no catch-up intervention. RESULTS: Over the lifetime of the cohort, catch-up vaccination would reduce the total number of infections relative to the baseline by 741 while increasing doses of vaccine by 556,989. Catch-up vaccination would increase net costs by $10.2million, or $2.38 per person. The incremental cost of HepA vaccine catch-up intervention at age 10years, the midpoint of the ages modeled, was $452,239 per QALY gained. Across age-cohorts, the cost-effectiveness of catch-up vaccination is most favorable at age 12years, resulting in an Incremental Cost-Effectiveness Ratio of $189,000 per QALY gained. CONCLUSIONS: Given the low baseline of HAV disease incidence achieved by current vaccination recommendations, our economic model suggests that a catch-up vaccination recommendation would be less cost-effective than many other vaccine interventions, and that HepA catch-up vaccination would become cost effective at a threshold of $50,000 per QALY only when incidence of HAV rises about 5.0 cases per 100,000 population.