Abstract
Background
Urban Black gay, and bisexual men (MSM) bear a disproportionate burden of HIV in the U.S. Mental health is a barrier to adherence to both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP). The objective was to determine the association between psychological distress and ART or PrEP adherence among urban Black MSM.
Methods
Using data from a four-year prospective cohort study, adherence to ART was defined as > 95% and PrEP was defined as > 80% of doses taken in the past 30 days. Psychological distress measures included difficulty sleeping; feeling anxious; suicidality; feeling sad or depressed; feeling sick, ill, or not well in the past 3 months; high (vs. low) overall psychological distress was classified as above the median value. Associations were examined using Chi-square, Fisher’s exact tests, and logistic regression.
Results
Among 165 Black MSM, 44.2% (73) reported high psychological distress. 65.3% (47/72) of participants living with HIV and 39.8% (37/93) of HIV negative participants were ART or PrEP adherent, respectively. Education was significantly associated with PrEP adherence (p = 0.038). Non-injection drug use in the past 3 months (p = 0.008), difficulty sleeping (p = 0.010), feeling anxious (p = 0.003), and feeling sad or depressed (p < 0.001), and overall psychological distress (p < 0.001) were significantly associated with ART adherence. High psychological distress was significantly associated with a reduced odds of ART adherence (aOR 0.23; 95% CI = 0.08–0.70) adjusting for age and non-injection drug use.
Conclusions
Increased psychological distress was significantly associated with ART nonadherence and may represent an important barrier to viral suppression.
Background
Gay and bisexual men (MSM) and specifically, Black MSM under the age of 35, persistently experience higher rates of new HIV infections in the U.S. compared to other subgroups. 1 In 2019, MSM accounted for 69% (25,393) and Black MSM accounted for 26% (9421) of new HIV diagnoses.2,3 In 2019, about three out of four Black MSM with a new HIV diagnosis were aged 13 to 34. 3 In local jurisdictions, the disparity is even greater. In Baltimore City, Maryland in 2020, 83.6% of reported HIV diagnoses among people aged 13+ were among non-Hispanic Black individuals and more than half of new HIV diagnoses (54.1%) were among MSM. 4 Reducing the acquisition and transmission of HIV among MSM and specifically, young Black MSM, is critical to reducing severe and systemic racial/ethnic disparities and overall HIV incidence in the U.S.
Diagnosis and treatment of individuals living with HIV are two key pillars to Ending the HIV Epidemic (EHE). Antiretroviral therapy (ART), usually prescribed as a daily medication to persons with HIV, reduces the HIV viral load thereby reducing the transmissibility of HIV and progression to AIDS. 5 To effectively achieve maximal viral suppression, reach an undetectable viral load, prevent transmission, and prevent ART resistance, adherence levels of 95% of doses taken is required. 6 In Baltimore City among non-Hispanic Black MSM living with HIV (2361), 81% were retained in HIV care with 67% attaining a suppressed viral load as of November 5, 2021. 7 This indicates that there is a large gap between persons diagnosed with HIV and those with suppressed viral loads, suggesting a lack of sufficient adherence (e.g., the extent to which patients take their medication as prescribed) to and persistence (e.g., the consistency of taking medication over time) on ART to suppress potential HIV transmission. 8
Given the challenges to attaining widespread viral suppression among individuals living with HIV, pre-exposure prophylaxis (PrEP) remains an important tool for reducing HIV incidence. PrEP has historically been prescribed as a daily medication for HIV negative persons to reduce their risk of acquisition of HIV, although two newer options include Long-Acting Injectable Cabotegravir (CAB-LA, Apretude) and event-based or on demand regimens using the 2-1-1 dosing strategy. 9 To be an effective tool, PrEP must be prescribed to those at increased risk of HIV acquisition, yet studies suggest prescribing practices are falling short. In 2019, approximately 1.2 million U.S. adults had indications for PrEP (i.e., risk factors for acquiring HIV, such as condomless sex with a partner with HIV whose HIV-RNA level is detectable or unknown, recent sexually transmitted infection, or injection drug use) but only 23.4% were prescribed PrEP.10,11 In a 2017 study in 23 U.S. urban areas among Black MSM eligible for PrEP (N = 962), only 43% (412) reported discussing PrEP with a health care provider in the past year and fewer (26%, 248) reported taking PrEP within the past year. 12 This suggests that there is a substantial gap between the number of PrEP-eligible persons and those taking PrEP.
Additionally, PrEP is only effective with appropriate adherence. 13 To effectively maintain protection from HIV acquisition, at least four out of seven days weekly is required, or 60% adherence. 14 When PrEP is discontinued, protection from HIV acquisition decreases over 7–10 days and, as a result, some have acquired HIV infection soon after discontinuing PrEP. 15 A study among 13,906 individuals linked to PrEP care from July 2012 to March 2019 showed that there was poor PrEP adherence with 52.2% discontinuing PrEP at least once during the study period and only 60.2% of these individuals subsequently reinitiating PrEP. 16
There are many barriers to ART and PrEP uptake and adherence, including mental health conditions.17,18 Depression has been identified as one of the most important mental health related barriers to ART adherence; patients on ART with depression are up to three times more likely to be non-adherent to their medication regimens than their non-depressed counterparts. 19 In addition, severe anxiety is associated with nonadherence to ART which may in part be due to an impaired ability to concentrate on the preparatory tasks associated with taking ART. 19 A scoping review of 51 articles found that both depression and anxiety are barriers to seeking care and to PrEP adherence. 20 One small study (N = 32) found that lower PrEP adherence was associated with generalized anxiety but not major depression. 21 Although there are few published studies examining the association between psychological distress and ART or PrEP adherence, a 2011 study among MSM attending primary health clinics in Australia found that a third of MSM reported psychological distress, but there was no significant difference between psychological distress and HIV diagnostic groups. 22 The objective of this analysis was to determine the association between psychological distress and adherence to ART and PrEP among urban Black MSM. We hypothesize that increased psychological distress would be associated with reduced adherence to ART or PrEP.
Methods
Overview
The data utilized in this study were obtained from the Understanding Sexual Health in Networks (USHINE) study. 23 USHINE is a prospective cohort study conducted by the Johns Hopkins Center for Child and Community Health Research (CCHR) in collaboration with the Baltimore City Health Department and the Centers for Disease Control and Prevention (CDC). This study was approved by the Johns Hopkins School of Medicine Institutional Review Board (IRB).
Study population
Participants were recruited from two public sexual health clinics, a federally qualified health center, a community-based LGBTQ+ organization, community engagement events, and respondent driven sampling. Eligibility criteria included: male sex at birth and male gender identity, aged 18–45 years, residence in a Baltimore City zip code, reporting sex with a man in the past six months, and willingness and ability to give written informed consent for the study. Participants had a baseline visit between July 2018 and February 2020 and followed every three months for up to two years. Visits include an audio-computer self-assisted interview (ACASI) behavioral survey, network interview of recent sex partners, and biologic testing for HIV. This analysis includes participants who completed a nine-month visit between September 2019 and October 2020 which included the mental health measures.
Measures
The behavioral survey assessed age, highest education level, employment status, homelessness, health insurance status, and number of sex partners (past 3 months). Substance use was measured as injection drug use (injection of any illicit substance in prior 3 month) and non-injection substance use (non-injection illicit substance use in prior 3 months).
HIV infection status was assessed at baseline and each three-month visit. HIV positivity was defined as a positive HIV rapid test with ELISA confirmation at any study visit and/or medical record documentation of a prior positive HIV diagnosis and/or a self-reported last test result for those who were missing testing/documented history at that visit. Eligibility for PrEP was based on clinical guidelines and local epidemiology and included all HIV negative MSM participants. 24
Psychological distress (main exposure) was assessed with a scale previously validated among minority MSM across three large U.S. cities which showed strong internal consistency (Cronbach’s α = 0.83) in our study sample. 25 The scale measured prevalence of the following psychological symptoms in the past three months: (1) sleep disturbances, measured by how often the participant had difficulty sleeping, (2) anxiety, measured by how often the participant felt scared or panicky for no apparent reason, (3) suicidality, measured by how often the participant felt like taking their own life, (4) depression, measured by how often the participant felt sad or depressed, and (5) general health, measured by how often the participant felt sick, ill, or not well. The survey was programmed to alert research staff if a participant indicated suicidality, and staff were trained with a site-specific protocol for positive responses, namely offering a referral. All psychological distress measures were assessed with a 4-point Likert-type scale ranging from never, once or twice, a few times, to many times. A psychological distress scale was created by adding the raw item scores and using the median value (4.00) as the cutoff between high and low psychological distress levels. Individual items were coded dichotomously for analyses as never or once or twice compared to more than once or twice. Similar dichotomization has been utilized in a study using the Kessler Psychological Distress Scale (K10), in which scores under 20 (reflecting average answers of “none of the time” or “a little of the time” across all questions) were considered to have no psychological distress and scores over 20 were considered to have psychological distress. 26
The main outcomes, ART and separately, PrEP uptake and adherence, were assessed by two questions for each. The first question assessed any ART or PrEP medication usage in the past three months (Yes/No), and the second question assessed the consistency of medication usage in the past 30 days with item responses that included every day, almost every day, less than almost every day, did not take ART/PrEP within the last 30 days. Those who indicated not taking or taking ART or PrEP at a frequency below the threshold chosen for adherence were coded as non-adherent to ART or PrEP. Individuals categorized as ART adherent were those who reported taking ART every day for the past month to approximate the completion of 95% of doses or greater in the past 30 days, a threshold which has been utilized in previous studies to define ART adherence. 6 Individuals categorized as PrEP adherent were those who reported taking PrEP every day or almost every day to approximate the completion of 80% of doses or greater in the past 30 days, a threshold utilized in previous PrEP studies as a conservative measure of adherence. 14
Statistical Analysis
Summary statistics were generated, and Chi-square and Fisher’s exact tests were used to examine the association between psychological distress, demographic characteristics, substance use and sexual risk behaviors and ART or PrEP adherence. To further explore the relationship between psychological distress and ART adherence, we utilized stepwise logistic regression models including variables significant at p < 0.05 as well as those that we hypothesized might confound the association (such as age).
We conducted two sensitivity analyses. The first explored whether the relationship between adherence and overall and each individual measure of psychological distress remained similar when utilizing a raw score as compared to a dichotomized variable for psychological distress. The second sensitivity analysis explored whether the COVID-19 pandemic affected the main findings by conducting a sub-analysis whereby we restricted the sample to interviews conducted on or prior to March 13, 2020 and re-ran the bivariate and final regression models. All analyses were conducted using Stata 17.0.
Results
Participants eligible for this study were Black MSM whose HIV status and ART or PrEP adherence status were known. Among 567 individuals screened for the cohort study, 74.4% (422) were eligible. Approximately one percent (5) refused to participate, and 98.8% (417) enrolled and completed a baseline visit. Among these, 238 (57.1%) completed a nine-month study visit.
Among the 238 completing the nine-month study visit, 165 (69.3%) met the inclusion criteria; among whom, 93 (56.4%) were HIV negative as of their nine-month visit and 72 (43.6%) were living with HIV. At baseline, those included in the analytic cohort (n = 165) were similar to those who were excluded on the following factors: age, employment status, homelessness, insurance coverage, injection drug use, non-injection drug use, number of sex partners, HIV status, engagement with HIV care among participants with HIV (ART use was not assessed at baseline) and PrEP adherence among HIV negative participants (data not shown). Participants in the analytic cohort were significantly less likely to report greater than high school education at baseline.
Characteristics of Black Gay, Bisexual and Other Men who have Sex with Men (MSM), USHINE study, Baltimore City, Maryland September 2019 – October 2020 (N = 165).
aInjection of any substance in prior 3 months (e.g., methamphetamines, heroin, speedball, crack cocaine).
bUse of any substance by non-injection route (e.g., smoking, snorting) in prior 3 months (e.g., marijuana, cocaine, heroin, psychedelics).
cCreated by adding up the five individual item scores and using the median value (4.00) as the cutoff between high and low psychological distress levels.
dFour-point Likert-type scale: never, once or twice (rarely), a few times, many times.
Almost half (44.2%) of participants had high overall psychological distress in the past three months with 44.9% (74) reporting difficulty sleeping, 24.9% (41) reporting feeling anxious, 3.6% (6) reporting feeling suicidal, 43% (71) reporting feeling sad or depressed, and 20.6% (34) reporting feeling sick, ill, or not well.
Characteristics by Treatment status of HIV Negative Black Gay, Bisexual and Other Men who have Sex with Men (MSM), USHINE study, Baltimore City, Maryland September 2019 – October 2020 (N = 93).
aPrEP adherent defined as taking PrEP every day or almost every day for the past month.
bNon-PrEP adherent defined not taking PrEP or taking PrEP less frequently than every day or almost every day.
cUsing chi-square test to evaluate significance, or Fisher’s exact for cell values <5; bolded items are statistically significant at p < 0.05.
dEmployment defined as not working full time, part time, or self-employed.
eCreated by adding up the five individual item scores and using the median value as the cutoff between high and low psychological distress levels.
fFour-point Likert-type scale: never, once or twice (rarely), a few times, many times.
Characteristics by Treatment status of Black Gay, Bisexual and Other Men who have Sex with Men (MSM) Living with HIV (PLWH), USHINE study, Baltimore City, Maryland September 2019 – October 2020 (N = 72).
aPrEP adherent defined as taking PrEP every day or almost every day for the past month.
bNon-PrEP adherent defined not taking PrEP or taking PrEP less frequently than every day or almost every day.
cUsing chi-square test to evaluate significance, or Fisher’s exact for cell values <5; bolded items are statistically significant at p < 0.05.
dEmployment defined as not working full time, part time, or self-employed.
eCreated by adding up the five individual item scores and using the median value as the cutoff between high and low psychological distress levels.
fFour-point Likert-type scale: never, once or twice (rarely), a few times, many times.
Overall psychological distress was significantly associated with decreased ART adherence (p = 0.004). Individual psychological distress items significantly associated with decreased ART adherence included difficulty sleeping (p = 0.010), feeling anxious (p = 0.003), and feeling sad or depressed (p < 0.001).
In the unadjusted model, increased overall psychological distress was significantly associated with a reduced odds of ART adherence (OR = 0.22; 95% CI = 0.08–0.63), and this relationship remained significant after adjusting for age (aOR = 0.22; 95% CI = 0.08–0.63) and non-injection drug use (aOR = 0.23; 95% CI = 0.08–0.70).
In sensitivity analyses using the raw score, the results were similar and significant (data not shown). There was no significant relationship between any of the individual items or the combined scale and PrEP adherence. The sensitivity analysis to examine the impact of the COVID-19 pandemic on the findings yielded similar findings (data not shown). We found no statistically significant associations with PrEP adherence, although the power to detect differences was limited at 12%. ART adherence remained significantly associated with overall psychological distress, difficulty sleeping, feeling anxious, and feeling sad or depressed.
Conclusions
These findings from a prospective cohort study of urban Black MSM in Baltimore City may have important implications for other Black MSM populations in similar urban settings. Overall, we found a low number of participants living with HIV who were ART adherent (65.3%), a low number of HIV negative participants who were PrEP adherent (39.8%), and high rates (44.2%) of psychological distress among participants. These results are consistent with previous findings that suggest there is a large gap between the number of individuals at risk of HIV and those who are PrEP adherent as well as those who are living with HIV and are ART adherent.7,12 In addition, the significant association between those who were living with HIV and ART non-adherent experiencing psychological distress is consistent with previous documentation of mental health challenges as a barrier to ART adherence. 20 Our findings of a lack of association between PrEP adherence and psychological distress is not, however, consistent with prior studies showing an association between increased mental health challenges and adherence, although the prior studies measured depression and anxiety which limits direct comparison to these studies.17,18,19,20,21
Many approaches have aimed to address poor mental health as a barrier to medication adherence. A meta-analysis of 22 studies suggested that different psychosocial approaches including counseling, cognitive behavioral therapy, peer support, motivational interviewing, and relaxation may improve ART adherence by addressing the underlying psychological stressors associated with poor adherence. 27 An integrative review of 19 articles focusing on motivational interviewing found that the technique significantly increased ART adherence, reduced substance use and improved mental health. 28 Although psychological distress was not significantly associated with PrEP adherence in these analyses, it is important to continue exploring the barriers to PrEP adherence to reduce the disparity of PrEP uptake and adherence and HIV acquisition among MSM.
This analysis is subject to several limitations. We were constrained by a small sample size that may have limited our ability to detect an association between psychological distress and PrEP or ART adherence. Post-hoc power calculations indicated low (15%) power to detect a difference in psychological distress by PrEP adherence and moderate (85%) power to detect a difference in psychological distress by ART adherence. This suggests additional work is needed to test the hypothesized relationship for PrEP in a larger study population. Additionally, the data are reliant on self-reported measures, which may be subject to recall and reporting bias, although the latter may be minimal in this study because surveys were self-administered using ACASI in a confidential setting. In addition, adherence was measured over a one-month period which may not be representative of long-term adherence.
This analysis addresses some key gaps in the literature. Previous work has looked at the relationship between mental health challenges and ART adherence.17,19 However, few in comparison have focused on the relationship between mental health challenges and PrEP adherence, especially among urban Black MSM. In addition, participants in this sample were recruited from a local community-based organization and from multiple clinical settings, likely improving the generalizability of the findings in this setting and potentially other similar urban settings.
The highly effective regimens of daily oral PrEP and ARTs have not had the impact on HIV incidence among racial and ethnic minority MSM seen in non-Hispanic White MSM.12,29,30,31 The EHE goals, including the prevent and treatment pillars, cannot be achieved without significant reduction in these health disparities, and without improving PrEP and ART uptake and adherence. However, the realities of limited PrEP use, poor PrEP adherence, detectable HIV viremia, mental health issues, and substance use among MSM in many U.S. settings suggest interventions are urgently needed to ensure that prevention tools reach those most in need.32,33
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by Centers for Disease Control and Prevention grants entitled Network Epidemiology of Syphilis Transmission (NEST) (1U01PS005171-01).
