Abstract
The high cost of life-saving antiretroviral (ARV) therapy for HIV represents an expense that impedes accessibility and affordability by patients. This price structure also appears to motivate the diversion of ARVs and the targeting of HIV-positive patients by pill brokers in the illicit market. Our field research with indigent, HIV-positive substance abusers links ARV diversion to high levels of competing needs, including psychiatric disorders, HIV stigma, and homelessness. Interventions to reduce diversion must address the needs of highly vulnerable patients.
Medication adherence is critical in the management of many chronic illnesses, including HIV.1 Antiretroviral (ARV) nonadherence increases the risk of treatment failure, drug resistance, and disease transmission.2 Our recently completed field research among HIV-positive patients in urban south Florida documented modest levels of ARV adherence and a related, yet understudied, phenomenon: the diversion of ARV medications. Diversion—the unlawful channeling of regulated pharmaceuticals from legal sources to illicit markets3—has typically been studied in relation to prescription opioids and other medications with significant abuse potential.4 Nevertheless, the diversion of ARVs by patients is apparent in south Florida5 and has direct implications for nonadherence, making it a critical issue for patient care and public health. We examined factors that affect vulnerability to ARV diversion among highly marginalized HIV-positive individuals.
METHODS
Guided by targeted sampling in geographic areas with high HIV prevalence and poverty indices,6 we used direct outreach to recruit indigent HIV-positive substance abusers in south Florida between 2010 and 2012. Research staff distributed study cards and flyers in street venues and HIV service organizations. We enrolled approximately equal numbers of users diverting their personal ARVs (n = 251) and of those not doing so (n = 252); because diverters had a lower average recruitment rate, recruitment of the full sample of diverters took 24% longer than recruitment of the comparable sample of nondiverters. Eligibility criteria were as follows: age 18 years or older, cocaine or heroin use 12 or more times in the prior 3 months, documented HIV-positive status, and current ARV prescription. In addition, diverters reported that they had diverted ARVs at least once in the prior 3 months. Research staff conducted systematic screening to verify eligibility; 2112 individuals were screened, 599 met study eligibility criteria, and 503 were enrolled. The primary reason for nonenrollment (84%) was repeated failure to present for the interview. Following informed consent, participants completed a single face-to-face interview based on the Global Appraisal of Individual Needs (GAIN)7 instrument, which assessed demographics, substance use, substance dependence as measured by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Revised Edition (DSM-IV-R), and mental health status. Standardized instruments assessed HIV diagnosis and treatment history,8 attitudes toward HIV care providers,9 health literacy,10 HIV-related stigma,11 ARV knowledge and attitudes,12,13 and ARV adherence14; a new instrument assessed ARV diversion. Participants received a $30 stipend upon interview completion. Bivariate logistic regression models examined the factors associated with ARV diversion in this sample; we included significant predictors from the bivariate analyses in the multivariate model.
RESULTS
Median age of participants was 46 years; 59.4% were male. Of the participants, 55.3% met DSM-IV-R criteria for past-year substance dependence, 81.4% reported monthly income below $1000, and 39.2% were homeless in the prior 3 months. Diverters reported a median of 7 lifetime episodes of ARV diversion. Self-reported ARV adherence in the past week was 95% or better among 54.1% of participants; compared with nondiverters, diverters had significantly lower odds of achieving 95% adherence (odds ratio = 0.26; 95% confidence interval = 0.18, 0.37; P ≤ .001). Table 1 displays the bivariate and multivariate predictors of ARV diversion. Male gender, severe depression, severe anxiety, substance dependence, recent homelessness, and high HIV-related stigma were each associated with increased odds of diverting prescribed ARV medications. The odds of diversion were lower among participants reporting higher HIV-related treatment knowledge and higher health literacy, and among those achieving 95% ARV adherence. In the multivariate model, recent homelessness and male gender were associated with increased odds of ARV diversion; higher HIV-related treatment knowledge, better adherence, and higher health literacy remained as significant protective factors.
TABLE 1—
Bivariate and Multivariate Logistic Regression Models Predicting Past-90-Day Antiretroviral (ARV) Diversion Among HIV-Positive Substance Abusers: South Florida, 2010–2012
| Diverters (n = 251), Mean ±SD or No. % | Nondiverters (n = 252), Mean ±SD or No. % | OR (95% CI) | |
| Bivariate models | |||
| Demographics | |||
| Age, y | 45.9 ±7.9 | 46.2 ±7.6 | 1.00 (0.97, 1.02) |
| Male gendera | 166 (66.1) | 133 (52.8) | 1.75** (1.22, 2.50) |
| Years since HIV diagnosis | 13.0 ±7.4 | 13.5 ±7.2 | 0.99 (0.97, 1.02) |
| High school educationa | 132 (52.6) | 152 (60.3) | 1.37 (0.96, 1.95) |
| Health status | |||
| Good self-reported healthb | 124 (49.4) | 125 (49.6) | 1.01 (0.71, 1.43) |
| 95% ARV adherencea | 95 (37.8) | 177 (70.2) | 0.26*** (0.18, 0.37) |
| Risk factors | |||
| Homeless in past 90 da | 120 (47.8) | 77 (30.6) | 2.08*** (1.45, 3.00) |
| Substance dependencea | 155 (61.8) | 123 (48.8) | 1.69** (1.19, 2.41) |
| Severe depressiona | 155 (61.8) | 120 (47.6) | 1.78** (1.25, 2.53) |
| Severe anxietya | 93 (37.1) | 65 (25.8) | 1.69** (1.16, 2.48) |
| HIV-related stigma scorec | 24.6 ±7.7 | 23.1 ±7.5 | 1.03* (1.00, 1.05) |
| Protective factors | |||
| HIV treatment knowledged | 5.6 ±1.5 | 6.0 ±1.0 | 0.76*** (0.66, 0.88) |
| ARV medication attitudese | 8.3 ±2.3 | 8.6 ±1.4 | 0.94 (0.85, 1.03) |
| Health literacyf | 8.5 ±3.6 | 9.6 ±2.9 | 0.91*** (0.86, 0.96) |
| Attitudes toward HIV providersg | 43.4 ±5.7 | 44.2 ±4.9 | 0.97 (0.94, 1.00) |
| Multivariate model | |||
| Male gendera | 1.99*** (1.34, 2.96) | ||
| 95% ARV adherencea | 0.29*** (0.20, 0.43) | ||
| Homeless in past 90 da | 1.64* (1.09, 2.47) | ||
| Substance dependencea | 1.30 (0.85, 1.98) | ||
| Severe depressiona | 1.23 (0.76, 1.99) | ||
| Severe anxietya | 1.08 (0.65, 1.79) | ||
| HIV-related stigma score | 0.99 (0.96, 1.02) | ||
| HIV treatment knowledge | 0.85* (0.72, 0.99) | ||
| Health literacy | 0.92** (0.86, 0.98) | ||
Note. CI = confidence interval; OR = odds ratio. The total sample size was n = 503. The multivariate model includes significant predictors from the bivariate analyses.
Reference category is “no.”
Reference category is poor or fair.
For HIV-related stigma, scale range = 11–44; higher scores represent higher stigma.
For HIV treatment knowledge, scale range = 0–7; higher scores represent higher knowledge.
For ARV medication attitudes, scale range = 0–10; higher scores represent more positive attitudes.
For health literacy, scale range = 0–12; higher scores represent better health literacy.
For attitudes toward HIV providers, scale range = 12–48; higher scores represent more positive attitudes.
*P ≤ .05; ** P ≤ .01; ***P ≤ .001.
DISCUSSION
The diversion of noncontrolled prescription drugs garners less attention and resources from law enforcement, the health practitioner and scientific communities, policymakers, educators, and industry than the diversion of controlled substances. Nevertheless, diversion of noncontrolled substances, such as ARVs, has clear implications for the integrity of the medication supply chain, for patient safety, and for public health.15 Our data show that indigent substance-abusing patients face challenges with ARV adherence and, moreover, that nonadherence is linked to the diversion of ARVs. The targeting of indigent, street-based, HIV-positive patients by pill brokers or “collectors” who offer small sums for patients’ monthly supplies of ARV medications appears to be common in south Florida5,16; even 37.4% of nondiverters reported being approached for this purpose (H. L. S., unpublished data, 2011). The pricing structure of ARV medications makes them highly profitable in the illicit market,17 in effect incentivizing diversion and the targeting of HIV-positive individuals with high levels of competing needs. In our sample, men appeared to be especially vulnerable to ARV diversion. Although the reason is unclear, males were more likely to report recent homelessness, which may increase their exposure to street-level pill brokers and dealers. Interventions to enhance medication adherence and reduce diversion should be tailored for the most vulnerable, homeless HIV-positive individuals. Individual-level, practitioner-based interventions should aim at instilling knowledge of ARV treatment regimens and health literacy factors; HIV treatment specialists and other health practitioners should be aware of the potential for ARV diversion to better support their patients. Housing insecurity requires increased attention at a structural level to reduce the exploitation of vulnerable HIV-positive individuals.
Acknowledgments
This research was supported by the National Institute on Drug Abuse (grant R01DA023157).
Note. The contents of this brief are solely the responsibility of the authors and do not necessarily represent the official views of the National Institute on Drug Abuse or the National Institutes of Health.
Human Participant Protection
The study was approved by the institutional review boards of the University of Delaware and Nova Southeastern University.
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