False-positive HIV diagnoses: lessons from Ugandan and Russian research cohorts.

BACKGROUND: Research studies rely on accurate assessment of entry criteria in order to maintain study integrity and participant safety, however, challenges can exist with HIV studies in international settings. OBJECTIVE: Examine the unexpectedly high proportion of study participants with an undetectable HIV viral load found in Ugandan and Russian research cohorts meeting antiretroviral therapy (ART)-naïve entry criteria. METHODS: Russian participants with documented HIV and ART-naïve status were recruited between 2012 and 2015 from clinical and non-clinical sites in St. Petersburg. Participants in Uganda were recruited from Mbarara Regional Referral Hospital from 2011 to 2014 with documented HIV infection via rapid diagnostic testing and recorded ART-naïve in the clinic database. HIV viral load testing of baseline samples was performed; the lower limit of detection was 500 copies/mL in Russia and 40 in Uganda. Due to an unexpectedly high proportion of participants with undetectable viremia, additional tests were performed: enzyme-linked immunosorbent assay HIV testing and testing for ART. RESULTS: In Russia, 16% (58/360) had undetectable viremia; 3% (9/360) re-tested HIV-seronegative and 4% (13/360) tested positive for ART. In Uganda 11% (55/482) had undetectable viremia; 5% (26/482) re-tested HIV-seronegative, while <1% (4/482) tested positive for ART. CONCLUSIONS: In both Russia & Uganda, undetectable viremia was much higher than would be expected for an HIV-infected ART-naïve cohort. Misclassification of study participants was due to misdiagnosis of HIV with rapid diagnostic testing and inaccurate accounting of ART use. Confirmatory HIV testing could improve accuracy of participants meeting entry criteria for HIV infection as might increased scrutiny of medication use in an ART-naïve cohort.

Alcohol Use and Food Insecurity Among People Living with HIV in Mbarara, Uganda and St. Petersburg, Russia.

Food insecurity (FI) is a documented problem associated with adverse health outcomes among HIV-infected populations. Little is known about the relationship between alcohol use and FI. We assessed whether heavy alcohol use was associated with FI among HIV-infected, antiretroviral therapy (ART)-naïve cohorts in Uganda and Russia. Inverse probability of treatment weighted logistic regression models were used to evaluate the association using cross-sectional baseline data. FI was experienced by half of the Russia cohort (52 %) and by a large majority of the Uganda cohort (84 %). We did not detect an association between heavy alcohol use and FI in either cohort (Russia: AOR = 0.80, 95 % CI 0.46, 1.40; Uganda: AOR = 1.00, 95 % CI 0.57, 1.74) or based on the overall combined estimate (AOR = 0.89, 95 % CI 0.60, 1.33). Future studies should explore the determinants of FI in HIV-infected populations to inform strategies for its mitigation.

Are decreases in drug use risk associated with reductions in HIV sex risk behaviors among adults in an urban hospital primary care setting?

Drug use is associated with increased sexual risk behaviors. We examined whether decreases in drug use risk are associated with reduction in HIV-related sex risk behaviors among adults. Data was from a cohort of participants (n = 574) identified by drug use screening in a randomized trial of brief intervention for drug use in an urban primary care setting. Inverse probability of treatment weighted (IPTW) logistic regression models were used to examine the relationship between decreases in drug use risk and sex-related HIV risk behavior reduction from study entry to six months. Weights were derived from propensity score modeling of decreases in drug use risk as a function of potential confounders. Thirty seven percent of the study participants (213/574) reported a decrease in drug use risk, and 7% (33/505) reported decreased sex-related HIV risk behavior at the six-month follow-up point. We did not detect a difference in reduction of risky sexual behaviors for those who decreased drug use risk (unadjusted: OR 1.32, 95% CI 0.65-2.70; adjusted OR [AOR] 1.12, 95% CI 0.54-2.36). Adults who screened positive for high drug use risk had greater odds of reducing sex risk behavior in unadjusted analyses OR 3.71, 95% CI 1.81-7.60; but the results were not significant after adjusting for confounding AOR 2.50, 95% CI 0.85-7.30). In this primary care population, reductions in HIV sex risk behaviors have complex etiologies and reductions in drug use risk do not appear to be an independent predictor of them.

Is the quality of brief motivational interventions for drug use in primary care associated with subsequent drug use?

BACKGROUND: Although a number of brief intervention approaches for drug use are based on motivational interviewing (MI), relatively little is known about whether the quality of motivational interviewing skills is associated with intervention outcomes. METHOD: The current study examined whether indices of motivational interviewing skill were associated with subsequent drug use outcomes following two different MI-based brief interventions delivered in primary care; a 15 min Brief Negotiated Interview (BNI) and a 45 min adaptation of motivational interviewing (MOTIV). Audio recordings from 351 participants in a randomized controlled trial for drug use in primary care were coded using the Motivational Interviewing Treatment Integrity Scale, (MITI Version 3.1.1). Separate negative binomial regression analyses, stratified by intervention condition, were used to examine the associations between six MITI skill variables and the number of days that the participant used his/her main drug 6 weeks after study entry. RESULTS: Only one of the MITI variables (% reflections to questions) was significantly associated with the frequency of drug use in the MOTIV condition and this was opposite to the hypothesized direction (global p=0.01, adjusted IRR 1.50, 95%CI: 1.03-2.20 for middle vs. lowest tertile [higher skill, more drug use]. None were significantly associated with drug use in the BNI condition. Secondary analyses similarly failed to find consistent predictors of better drug outcomes. CONCLUSION: Overall, this study provides little evidence to suggest that the level of MI intervention skills are linked with better drug use outcomes among people who use drugs and receive brief interventions in primary care. Findings should be considered in light of the fact that data from the study are from negative trial of SBI and was limited to primary care patients. Future work should consider alternative ways of examining these process variables (i.e., comparing thresholds of proficient versus non-proficient skills) or considering alternative methods of coding intervention skills.

Primary Care Patients with Drug Use Report Chronic Pain and Self-Medicate with Alcohol and Other Drugs.

BACKGROUND: Chronic pain is common among patients with drug use disorders. The prevalence of chronic pain and its consequences in primary care patients who use drugs is unknown. OBJECTIVES: To examine: 1) the prevalence of chronic pain and pain-related dysfunction among primary care patients who screen positive for drug use, and 2) the prevalence of substance use to self-medicate chronic pain in this population. DESIGN: This was a cross-sectional analysis. PARTICIPANTS: This study included 589 adult patients who screened positive for any illicit drug use or prescription drug misuse, recruited from an urban, hospital-based primary care practice. MAIN MEASURES: Both pain and pain-related dysfunction were assessed by numeric rating scales, and grouped as: (0) none, (1-3) mild, (4-6) moderate, (7-10) severe. Questions were asked about the use of substances to treat pain. KEY RESULTS: Among 589 participants, chronic pain was reported by 87% (95% CI: 84-90%), with 13% mild, 24% moderate and 50% severe. Pain-related dysfunction was reported by 74% (95% CI: 70-78%), with 15% mild, 23% moderate, and 36% severe. Of the 576 that used illicit drugs (i.e., marijuana, cocaine, and/or heroin), 51% reported using to treat pain (95% CI: 47-55% ). Of the 121 with prescription drug misuse, 81% (95% CI: 74-88%) used to treat pain. Of the 265 participants who reported any heavy drinking in the past 3 months, 38% (95% CI: 32-44%) did so to treat pain compared to 79% (95% CI: 68-90%) of the 57 high-risk alcohol users. CONCLUSIONS: Chronic pain and pain-related dysfunction were the norm for primary care patients who screened positive for drug use, with nearly one-third reporting both severe pain and severe pain-related dysfunction. Many patients using illicit drugs, misusing prescription drugs and using alcohol reported doing so in order to self-medicate their pain. Pain needs to be addressed when patients are counseled about their substance use.

Changes in health outcomes as a function of abstinence and reduction in illicit psychoactive drug use: a prospective study in primary care.

AIMS: To test (1) whether abstinence and reduction in illicit psychoactive drug use were associated with changes in health outcomes in primary care patients and (2) whether these associations varied by drug type. DESIGN: Secondary analysis of data from a randomized controlled trial that tested a brief intervention for drug use in primary care patients (589 enrolled, 574 completed a 6-month assessment). Analyses were conducted overall and stratified by the most commonly self-identified main drugs (marijuana, cocaine and opioids). SETTING AND PARTICIPANTS: Patients who screened positive for illicit drug use at an urban primary care clinic in Boston, Massachusetts, USA. MEASUREMENTS: Differences in past-month main drug use at baseline and 6-month outcome were categorized as continued or increased use, decreased use without abstinence and abstinence. Primary outcomes were 6-month changes in drug use consequences [Short Inventory of Problems scores (range 0-45)], depressive symptoms and health-related quality of life (HRQol). FINDINGS: Abstinence was associated with a greater decrease in adverse drug use consequences than continued or increased use among the full sample and cocaine and opioids subgroups (adjusted means, full sample: -8.11 versus -0.05, P < 0.001; cocaine: -13.33 versus +1.09, P < 0.001, opioids; -16.84 versus -2.10, P < 0.001). Differences were not significant between those who decreased use compared with those who continued or increased use. There were no significant associations between drug use and depressive symptoms or HRQol. Neither abstinence nor decreased use was associated significantly with consequences in the marijuana subgroup. CONCLUSIONS: Among primary care patients in the United States who use illicit psychoactive drugs, abstinence but not reduction in use without abstinence appears to be associated with decreased adverse drug use consequences.

Screening and brief intervention for drug use in primary care: the ASPIRE randomized clinical trial.

IMPORTANCE: The United States has invested substantially in screening and brief intervention for illicit drug use and prescription drug misuse, based in part on evidence of efficacy for unhealthy alcohol use. However, it is not a recommended universal preventive service in primary care because of lack of evidence of efficacy. OBJECTIVE: To test the efficacy of 2 brief counseling interventions for unhealthy drug use (any illicit drug use or prescription drug misuse)-a brief negotiated interview (BNI) and an adaptation of motivational interviewing (MOTIV)-compared with no brief intervention. DESIGN, SETTING, AND PARTICIPANTS: This 3-group randomized trial took place at an urban hospital-based primary care internal medicine practice; 528 adult primary care patients with drug use (Alcohol, Smoking, and Substance Involvement Screening Test [ASSIST] substance-specific scores of ≥4) were identified by screening between June 2009 and January 2012 in Boston, Massachusetts. INTERVENTIONS: Two interventions were tested: the BNI is a 10- to 15-minute structured interview conducted by health educators; the MOTIV is a 30- to 45-minute intervention based on motivational interviewing with a 20- to 30-minute booster conducted by master's-level counselors. All study participants received a written list of substance use disorder treatment and mutual help resources. MAIN OUTCOMES AND MEASURES: Primary outcome was number of days of use in the past 30 days of the self-identified main drug as determined by a validated calendar method at 6 months. Secondary outcomes included other self-reported measures of drug use, drug use according to hair testing, ASSIST scores (severity), drug use consequences, unsafe sex, mutual help meeting attendance, and health care utilization. RESULTS: At baseline, 63% of participants reported their main drug was marijuana, 19% cocaine, and 17% opioids. At 6 months, 98% completed follow-up. Mean adjusted number of days using the main drug at 6 months was 12 for no brief intervention vs 11 for the BNI group (incidence rate ratio [IRR], 0.97; 95% CI, 0.77-1.22) and 12 for the MOTIV group (IRR, 1.05; 95% CI, 0.84-1.32; P = .81 for both comparisons vs no brief intervention). There were also no significant effects of BNI or MOTIV on any other outcome or in analyses stratified by main drug or drug use severity. CONCLUSIONS AND RELEVANCE: Brief intervention did not have efficacy for decreasing unhealthy drug use in primary care patients identified by screening. These results do not support widespread implementation of illicit drug use and prescription drug misuse screening and brief intervention. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00876941.

Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial.

IMPORTANCE: People with substance dependence have health consequences, high health care utilization, and frequent comorbidity but often receive poor-quality care. Chronic care management (CCM) has been proposed as an approach to improve care and outcomes. OBJECTIVE: To determine whether CCM for alcohol and other drug dependence improves substance use outcomes compared with usual primary care. DESIGN, SETTING, AND PARTICIPANTS: The AHEAD study, a randomized trial conducted among 563 people with alcohol and other drug dependence at a Boston, Massachusetts, hospital-based primary care practice. Participants were recruited from September 2006 to September 2008 from a freestanding residential detoxification unit and referrals from an urban teaching hospital and advertisements; 95% completed 12-month follow-up. INTERVENTIONS: Participants were randomized to receive CCM (n=282) or no CCM (n=281). Chronic care management included longitudinal care coordinated with a primary care clinician; motivational enhancement therapy; relapse prevention counseling; and on-site medical, addiction, and psychiatric treatment, social work assistance, and referrals (including mutual help). The no CCM (control) group received a primary care appointment and a list of treatment resources including a telephone number to arrange counseling. MAIN OUTCOMES AND MEASURES: The primary outcome was self-reported abstinence from opioids, stimulants, or heavy drinking. Biomarkers were secondary outcomes. RESULTS: There was no significant difference in abstinence from opioids, stimulants, or heavy drinking between the CCM (44%) and control (42%) groups (adjusted odds ratio, 0.84; 95% CI, 0.65-1.10; P=.21). No significant differences were found for secondary outcomes of addiction severity, health-related quality of life, or drug problems. No subgroup effects were found except among those with alcohol dependence, in whom CCM was associated with fewer alcohol problems (mean score, 10 vs 13; incidence rate ratio, 0.85; 95% CI, 0.72-1.00; P=.048). CONCLUSIONS AND RELEVANCE: Among persons with alcohol and other drug dependence, CCM compared with a primary care appointment but no CCM did not increase self-reported abstinence over 12 months. Whether more intensive or longer-duration CCM is effective requires further investigation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00278447.