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The US HIV epidemic is driven by infections in men who have sex with men and characterized by profound disparities in HIV prevalence and outcomes for Black Americans. Black men who have sex with men living with HIV are reported to have worse care outcomes than other men who have sex with men, but the reasons for these health inequities are not clear. We planned a prospective observational cohort study to help understand the reasons for worse HIV care outcomes for Black versus White men who have sex with men in Atlanta.
The aim of this study is to identify individual, dyadic, network, neighborhood, and structural factors that explain disparities in HIV viral suppression between Black and White men who have sex with men living with HIV in Atlanta.
Black and White men who have sex with men living with HIV were enrolled in a prospective cohort study with in-person visits and viral suppression assessments at baseline, 12 months, and 24 months; additional surveys of care and risk behaviors at 3, 6, and 18 months; analysis of care received outside the study through public health reporting; and qualitative interviews for participants who experienced sentinel health events (eg, loss of viral suppression) during the study. The study is based on the Bronfenbrenner socioecological theoretical model.
Men who have sex with men (n=400) were enrolled between June 2016 and June 2017 in Atlanta. Follow-up was completed in June 2019; final study retention was 80% at 24 months.
Health disparities for Black men who have sex with men are hypothesized to be driven by structural racism and barriers to care. Observational studies are important to document and quantify the specific factors within the socioecological framework that account for disparities in viral suppression. In the meantime, it is also critical to push for steps to improve access to care, including Medicaid expansion in Southern states, such as Georgia, which have not yet moved to expand Medicaid.
DERR1-10.2196/21985
For men who have sex with men in the United States, each step of the HIV care continuum [
Despite increases in the number of Black men who have sex with men taking antiretroviral therapy and developing viral suppression, they are still less likely than White men who have sex with men to be prescribed and adhere to antiretroviral therapy and sustain viral suppression [
The southern US census region has the highest concentration of people living with HIV among men who have sex with men in the country [
The National HIV/AIDS Strategy goals for 2016 to 2020 prioritize reducing racial disparities in HIV care and treatment [
Furthering our understanding of disparities in HIV treatment, care, and prevention between Black and White individuals requires new types of data collection. Although data on the HIV care continuum by race are available through surveillance data sources and in some clinical settings, the traditional means of depicting care continuum data are limited in that they use cross-sectional data to describe a longitudinal process [
The limited longitudinal data we have suggest a widening of the racial disparity in retention in care and viral suppression over time. Colasanti et al [
This protocol describes Engage[men]t, a prospective cohort study of 400 Black and White men who have sex with men living with HIV in Atlanta, Georgia. The study aims to longitudinally examine factors associated with disparities in key HIV care and prevention indicators between Black and White populations. Key care indicators include lack of or delays in linkage to or retention in care, antiretroviral therapy nonadherence, and detectable viral load. Key prevention indicators include disclosure of HIV status to sex partners and condom use with susceptible sex partners. Advancing our understanding of the modifiable factors associated with these care and prevention indicators has the potential to inform the development of interventions that may improve care and prevention outcomes. We hypothesize a priori that there is no direct causal effect of race on care outcomes; rather, we postulate that the apparent associations between race and care outcomes are explained by indirect effects through intermediate individual- and community-level factors that may manifest because of systemic and structural racism. As such, our study is grounded in the Bronfenbrenner [
Socioecological model of factors potentially associated with worse HIV care outcomes for Black men who have sex with men living with HIV, adapted from Bronfenbrenner [
The study design is a prospective, observational cohort of 400 men who have sex with men living with HIV in Atlanta, Georgia with 2 groups: Black men who have sex with men and White men who have sex with men. Recruitment of the cohort took place from June 2016 to July 2017. Participants were followed for 2 years with study assessments at baseline, 3, 6, 12, 18, and 24 months. In our mixed methods design, we sought to use multiple types of data and modes of inquiry to address concepts of triangulation and expansion [
Self-report positive HIV status, confirmed by HIV antibody screening at baseline
Assigned male sex at birth
Currently identifies as male
Age ≥16 years
Self-report single race to be Black or White
Able to complete survey instruments in English
Lives in the Atlanta metropolitan statistical area
Had at least one male sex partner in the 12 months before the baseline interview
Participant is determined to not be living with HIV per study testing at baseline
Participant is currently enrolled in another HIV prevention or treatment clinical trial
Self-report Hispanic ethnicity
Participant recruitment involved use of venue-based, web-based, or virtual and print recruitment methods. All 3 methods linked potential recruits to a web-based survey portal with a short description of the study and the opportunity to consent and complete a brief eligibility survey on a study tablet or personal electronic device. The eligibility surveys were hosted on a secure, Health Information Portability and Accountability Act–compliant server (administered by Survey Gizmo). Men were asked to leave their contact information at the end of the surveys so that study staff could follow up and schedule an enrollment (baseline) visit.
In-person recruitment occurred at gay bars and at community events with a large men who have sex with men or HIV focus such as gay pride. Events were selected for attendance based on venue-space time sampling [
Before completing the study’s eligibility survey, men provided informed consent by clicking on a box affirming their decision to continue and consent to be screened for the study. At the conclusion of the survey, men were informed if they were preliminarily eligible for the study. Preliminarily eligible men were given the opportunity to leave their contact information for follow-up. Men who were not eligible were also provided an opportunity to leave their contact information for possible enrollment in other current and future studies within the research group.
Potential recruits were rescreened by study staff and eligible men were scheduled for an initial baseline visit at one of 4 sites where study enrollment occurred. These sites included an HIV-focused community-based organization, a public HIV medical clinic, an office location in Decatur, Georgia and Emory University’s Rollins School of Public Health.
Eligible men attended a baseline visit that lasted approximately 3 hours and included the following activities: (1) meeting with a study counselor to confirm study eligibility; (2) completion of intake forms and assessment of HIV care experience in the preceding 12 months; (3) completion of the study questionnaire using computer-assisted self-interview software; (4) collection of biological specimens; and (5) discussion with the study counselor about HIV care and treatment and prevention strategies with sexual partners, and referrals to HIV linkage and care services and other social services. The types of data collected and their relationship to the conceptual framework are shown in
Assessment methods and outcomes for study indicators of effective HIV care and prevention.
Indicators of | Assessment methods | Baseline and cohort outcomes | Sentinel event qualitative data | |
|
||||
Linkage |
Survey responses Medical record abstractions |
First care visit within 3 months, if unlinked | Failure to have first visit in 3 months | |
Engagement and |
Survey responses Medical record abstractions Public health surveillance data |
≥1 visit in 6-month window, if linked to care | Failure to have ≥1 visit in 6 months | |
Adherence |
Survey responses Laboratory assessment of antiretroviral medication concentrations in blood Medical record abstractions |
No missed doses within previous week | Missed ≥1 doses within previous week | |
Suppression |
Survey responses Medical record abstractions Public health surveillance data |
No detectable viral load in previous 6 months | Loss of suppression among previously suppressed | |
|
||||
Disclosure of HIV status to sexual partners |
Survey responses |
Aim 1: Disclosure to all new partners in previous 6 months |
Previously diagnosed: Failing to disclose HIV status to a new partner before first anal intercourse |
|
Condom use with susceptible sexual partners |
Survey responses |
Consistent and complete condom use with all HIV-negative or unknown anal intercourse partners in the previous 6 months, in light of preexposure prophylaxis use by partners and viral suppression status [ |
Unprotected anal intercourse with a susceptible (HIV-negative or HIV-unknown status) partner |
The baseline questionnaire collected demographics as well as information about HIV care and treatment, hepatitis and other STIs, drug and alcohol use, HIV disclosure and condom use with anal sex partners, health care access and utilization (including use of Ryan White Care Act–supported services), mental health and other psychosocial influencers, housing, and transportation. Sexual health questionnaire elements built on a previously described questionnaire design to elicit partner-specific data [
The 12-month in-person visit was very similar to the baseline visit with the exception that participants had the option to complete the 12-month survey from home in advance of their visit, and there was a limited laboratory specimen collection. At the visit, if the participant had not completed the survey at home, they were asked to complete a short computer-assisted self-interview survey on their HIV care and treatment experiences since their baseline visit, they had a quick check in with the study counselor about any referrals they need for HIV and other supportive services, and they provided a urine specimen and had blood drawn to test for CD4 count, HIV viral load, heavy alcohol use (using a carbohydrate-deficient transferrin test) [
The 24-month in-person visit mirrored the 12-month in-person visit, with the exception that the laboratory specimen collection was expanded to include all tests from baseline except for testing for HIV infection status. Participants were compensated US $60 for their baseline and 12-month visits and US $75 for their 24-month visit.
At months 3, 6, and 18, we emailed participants with a URL to complete a web-based survey remotely. These surveys were similar to the ones completed at baseline, 12 months, and 24 months and collected updated demographics and longitudinal data on HIV care and treatment experiences, sexual behaviors, and drug or alcohol use. For each completed web-based survey, participants received a US $40 electronic gift card of their choice to either Amazon, Target, CVS, or Starbucks.
The prospective cohort study was supplemented by the collection of rich qualitative data on participants’ HIV care and treatment experiences, and the factors underlying racial disparities. We selected a subset of participants (n=21) to participate in a series of in-depth interviews at 6-month intervals over the course of the cohort study. Participant selection was based on a combination of survey data (from baseline and 3 months) and laboratory data. The survey and laboratory data were used to identify participants who had experienced sentinel events. Sentinel care events included incident lapse in care visits, antiretroviral therapy adherence problems, detectable viral load in a previously suppressed participant, lack of first care visit within 3 months of diagnosis, and lack of initial viral suppression within 6 months of diagnosis. Sentinel prevention events included a lack of discussion of seropositive status with a new or ongoing anal intercourse partner and lack of condom use with a susceptible partner. The goal was to sample participants for the individual in-depth interviews who had experienced a range of lapses in the continuum of care. Interviews utilized a timeline approach to capture clinical, social, and sexual life events over the course of a 6-month period before the interview [
Audio data from the in-depth interviews were recorded, transcribed, and deidentified. Timelines were scanned and turned into diagrams. Data were analyzed and coded in MAXQDA (version 18.2.5, Verbi GmbH). First, deductive codes were added to the transcripts to highlight key themes and guide comparisons, followed by inductive codes. Two staff members independently coded each transcript, with discrepancies in coding discussed and resolved at team meetings. Timeline diagrams were coded to develop phenotypes of patterns: analysis of phenotypes involved grouping timelines into similar sets or patterns, with a particular focus on identifying linkages across phenotypes. This allowed us to build concepts grounded in the data to explain phenomena observed and to identify phenotypes that may be specific to Black men who have sex with men or White men who have sex with men.
We obtained permission for the release of medical records and abstracted the clinical records of a sample of our participants to augment the survey and laboratory data we collected and to gain a better understanding of the degree to which medical record data can be used to validate self-report survey data. Participants signed medical releases for all HIV clinicians they reported to us, and the releases were used by study staff to request copies of medical records. Clinical visits for the 1 year preceding and 2 years during study enrollment were abstracted.
In an attempt to validate the quality of HIV care and treatment-related data from self-reported surveys and from medical record abstractions, and to obtain a fuller picture of HIV care outcomes, participants consented to the release of their reportable laboratory data to the study, and we requested individual-level HIV surveillance data from the Georgia Department of Public Health. By law, Georgia Department of Public Health receives all reports of HIV western blot tests, CD4 counts and viral load tests performed on patients in Georgia. On a biannual basis, we provided Georgia Department of Public Health with a list of names for all consenting participants, for whom we requested specific HIV surveillance data (eg, first HIV-positive test, CD4 count, or viral load in a date range). These data will allow us to assess the quality of our self-report, laboratory, and medical record data and provide a less biased data set for examining viral load outcomes.
Using the baseline visit interview and laboratory data from participants, we will initially identify factors associated with key care and prevention outcomes. Factors in the theoretical model will be considered as exposures; these factors are summarized by level of the socioecological model (eg, individual, microsystem, exosystem) in
For each HIV care and prevention outcome
where
Proposed measures in the theoretical model.
Type | Measures |
Individual |
Age, education, employment Health insurance coverage Incarceration history Stable housing Access to transportation Health literacy Health care perceptions and self-efficacy HIV treatment self-efficacy and optimism Depression, mental illness Experienced, perceived, internalized HIV stigma Experienced, perceived, internalized homophobia Experienced, perceived, internalized racism Drug use Condom efficacy, skills, errors Time since diagnosis HIV disease stage Social support |
Microsystem |
Dyadic Partner demographics, type, relationship strength Substance use Locations for meeting and sex Power and dynamics Network Peer norms for HIV care |
Exosystem |
Service environment Distribution of providers by service type Colocation of provider services Transportation options Community Poverty, insurance coverage, crime rates, Percentage same-sex households Community HIV stigma, gay stigma, racism |
Study power was estimated for the key outcome of HIV viral suppression, at the final analytic step of assessing the relationship of mediators with the outcome, among racial groups. We assumed n=160 per racial group, α=.05, power 80%, and race-specific suppression levels constrained to national estimates for HIV-diagnosed men who have sex with men by race [
Among those who had a suppressed viral load at the baseline visit, we will use the viral load data from each follow-up survey and study visit to identify time of loss of viral load suppression. For participants who experience a loss of viral load suppression, time of loss of viral load suppression will be defined as the midpoint between the first study visit at which their viral load was >40 copies/mL and the most recent study visit at which their viral load was suppressed. We will fit Cox proportional hazards models of the form:
where
Audio data from in-depth interviews will be recorded, transcribed and deidentified. Timelines will be scanned and turned into diagrams of sentinel events and their perceived influencers. Both the audio recordings and diagrams will be loaded into MAXQDA for coding and analysis. All interviewing and coding is team-based. We will implement a data handling and analysis plan based around principles of data reduction. We will use conduct grounded theory–based thematic analysis of the in-depth interview. Analysis of transcripts and diagrams began early in the data collection phase to identify emergent themes and we will continue iterative revision of the interview questions and probes. At weekly meetings, interviewers reviewed recent timelines and transcripts to identify codes and areas of questioning for future interviews. Through this process codebooks were developed that include a detailed description of each code, inclusion and exclusion criteria, and examples of the code in use. Deductive codes will be applied to the transcripts to highlight key themes and guide comparisons [
Using this codebook, 2 researchers will independently code each transcript, and transcripts will be assessed for intercoder reliability using Cohen α [
Data analysis will involve generating frequencies of the codes and comparing the frequency of code occurrence across age and race, across phenotypes of sentinel event experiences, and across new or prevalent HIV-positive status. A particular focus of the analysis will be on identifying linkages across codes (eg, the extent to which those with major network influences also report service environment influences) and comparisons in patterns of these linkages by age and race and new versus prevalent positive HIV status within age and race. We will also compare code frequency between interviews with providers and cohort participants to examine whether there are differences in the perceptions of domains of influence on HIV care. This will allow us to build concepts grounded in the data to explain phenomena observed. The result will be the generation of a unique data set that illustrates racial variations in dynamic and multilevel influences on successful HIV treatment and care.
The study was approved in March 2016 and launched in June 2016. We enrolled 400 Black (n=206) and White (n=194) men in Atlanta, Georgia over the course of 1 year. Retention rates at 3, 6, 12, and 24 months were 95%, 95%, 87%, and 80%, respectively. A total of 53 qualitative interviews were conducted. The final study visit occurred in February 2019.
Disparities are a stubbornly persistent feature of the US HIV epidemic, and we have an increased understanding of the confluence of factors that drive these disparities. Race is a marker for a myriad of barriers to effective care, and observational cohort data offer the opportunity to understand which factors related to race mediate the relationship between Black race and worse HIV-related outcomes. That understanding can suggest priorities to reduce disparities. In other words, we know that associations with race and poor clinical outcomes are not causal, and our study sought to identify the patterns of associations that explain observed racial inequities. For example, our previous cohort of Black and White men who have sex with men in Atlanta [
We acknowledge that our study is subject to limitations. First, we are susceptible to selection bias if we recruit men whose patterns of exposures and viral suppression are not reflective of the underlying community of men who have sex with men in Atlanta. We attempted to mitigate this risk by using systematic methods to select venues, by not recruiting men who have sex with men living with HIV from care settings, and by screening high risk populations to identify newly diagnosed men who have sex with men to include a heterogeneous group of participants. We also anticipated the risk of selection bias if we had differential loss of men to follow up by important baseline characteristics. By conducting active follow-up, having shorter check in visits between annual visits, and maintaining multiple modes of contact, we were able to maintain high retention in the cohort. We attempted to minimize the risk of information bias in several ways. To reduce misclassification, we validated key outcomes (eg, HIV infection status, viral suppression, recreational drug use, problematic alcohol use) with biological measurements. We also supplemented our self-reported and annual viral load measurements by including all viral load measurements during the study period through public health surveillance data. We recognize that the social determinants of health we are considering as possible mediating factors in the association between Black race and lower levels of viral suppression are likely highly correlated with one another; in our analytic approach, we will assess mediation with a single factor at a time, and then use multivariable logistic regression to control for potential confounding.
Disparities in viral suppression for Black men who have sex with men are an inequitable health outcome that impacts the health of Black men who have sex with men living with HIV, and increases the risks of transmission for their partners. Identifying and addressing reasons for excess unsuppressed viral load in Black men who have sex with men is thus critical to improve the health and longevity of Black men who have sex with men living with HIV and to reduce levels of HIV incidence among men who have sex with men in the United States [
National Institute of Health summary statement/peer reviews.
acquired immunodeficiency syndrome
human immunodeficiency virus
ribonucleic acid
sexually transmitted infection
This study was funded by the National Institute for Allergy and Infectious Diseases (National Institutes of Health R01AI112723). This work was supported by the Center for AIDS Research at Emory University (P30AI050409). We acknowledge the contributions of Mark Padilla, Susan Wirtz, Maryam Ahmad, Neena Smith-Bankhead, Jordan Helms, Natalie Rivadeneira, Margaret Forshag, Audrey Copeland, Michelle Brown, Larisa Niles-Carnes, Vasti Shuler, John Stanton, Jeffery Roman, Natasha Ross, Abilash Pulicken, Carissa Vyhonsky, Amelia Remiarz, Susanna Trost, Dina Pimenova, Jordan Chappell, Shelby Mullin, Ruth Dana, Jessica Swiniarski, Emily Pingel, Caroline Goodroe, and Amy Elder.
CK acknowledges research grants to their institution from the National Institutes of Health, the Centers for Disease Control and Prevention, Gilead, and ViiV. Other authors have no conflicts to declare.