Peer-Reviewed Journal Articles

2018

Briones M, Shoptaw S, Cook R, Worley M, Swanson AN, Moody DE, Fang WB, Tsuang J, Furst B, Heinzerling K. Varenicline treatment for methamphetamine dependence: A randomized, double-blind Phase II clinical trial. Drug and alcohol dependence. 2018 May 25.189:30-36. PMID: 29860057.

Abstract
BACKGROUND:
Previous studies have suggested that varenicline, an α4β2 nicotinic receptor partial agonist, and α7 nicotinic receptor full agonist, may be effective for the treatment of methamphetamine (MA) dependence due to dopaminergic effects, relief of glutamatergic and cognitive dysfunction, and activation of nicotinic cholinergic systems. This study aimed to determine if varenicline (1 mg BID) resulted in reduced methamphetamine use compared to placebo among treatment-seeking MA-dependent volunteers.

METHODS:
Treatment-seeking MA-dependent volunteers were randomized to varenicline 1 mg twice daily (n = 27) or placebo (n = 25) and cognitive behavioral therapy for 9 weeks. The primary outcomes were the proportion of participants achieving end-of-treatment-abstinence (EOTA, MA-negative urine specimens during weeks 8 and 9) and the treatment effectiveness score (TES, number of MA-negative urine specimens) for varenicline versus placebo.

RESULTS:
There was no significant difference in EOTA between varenicline (15%, 4/27) and placebo (20%, 5/25; p = 0.9). There was some suggestion that urinary confirmed medication compliance corresponded with EOTA in the varenicline condition, though it did not reach statistical significance, OR = 1.57 for a 100 ng/ml increase in urine varenicline, p = 0.10, 95% CI (0.99, 3.02). There was no significant difference in mean TES in the varenicline condition (8.6) compared to the placebo condition (8.1), and treatment condition was not a statistically significant predictor of TES, IRR = 1.01, p = 0.9, 95% CI (0.39, 2.70).

CONCLUSIONS:
The results of this study indicate that 1 mg varenicline BID was not an effective treatment for MA dependence among treatment-seeking MA-dependent volunteers.

Read the full commentary here.

Zhang SX, Shoptaw S, Reback CJ, Yadav K, Nyamathi AM. Cost-effective way to reduce stimulant-abuse among gay/bisexual men and transgender women: a randomized clinical trial with a cost comparison. Public health. 2018 Jan 1;154:151-60.

Abstract/Summary:

OBJECTIVES:
A randomized controlled study was conducted with 422 homeless, stimulant-using gay/bisexual (G/B) men and 29 transgender women (n = 451) to assess two community-based interventions to reduce substance abuse and improve health: (a) a nurse case-managed program combined with contingency management (NCM + CM) versus (b) standard education plus contingency management (SE + CM).

STUDY DESIGN:
Hypotheses tested included: a) completion of hepatitis A/B vaccination series; b) reduction in stimulant use; and c) reduction in number of sexual partners.

METHODS:
A deconstructive cost analysis approach was utilized to capture direct costs associated with the delivery of both interventions. Based on an analysis of activity logs and staff interviews, specific activities and the time required to complete each were analyzed as follows: a) NCM + CM only; b) SE + CM only; c) time to administer/record vaccines; and d) time to receive and record CM visits. Cost comparison of the interventions included only staffing costs and direct cash expenditures.

RESULTS:
The study outcomes showed significant over time reductions in all measures of drug use and multiple sex partners, compared to baseline, although no significant between-group differences were detected. Cost analysis favored the simpler SE + CM intervention over the more labor-intensive NCM + CM approach. Because of the high levels of staffing required for the NCM relative to SE, costs associated with it were significantly higher.

CONCLUSIONS:
Findings suggest that while both intervention strategies were equally effective in achieving desired health outcomes, the brief SE + CM appeared less expensive to deliver.

Read the full commentary here.

Ladapo JA, Richards AK, DeWitt CM, Harawa NT, Shoptaw S, Cunningham WE, Mafi JN. Disparities in the Quality of Cardiovascular Care Between HIV‐Infected Versus HIV‐Uninfected Adults in the United States: A Cross‐Sectional Study. Journal of the American Heart Association. 2017 Nov 1;6(11):e007107.

Abstract/Summary:
BACKGROUND:
Cardiovascular disease is emerging as a major cause of morbidity and mortality among patients with HIV. We compared use of national guideline-recommended cardiovascular care during office visits among HIV-infected versus HIV-uninfected adults.

METHODS AND RESULTS:
We analyzed data from a nationally representative sample of HIV-infected and HIV-uninfected patients aged 40 to 79 years in the National Ambulatory Medical Care Survey/National Hospital Ambulatory Medical Care Survey, 2006 to 2013. The outcome was provision of guideline-recommended cardiovascular care. Logistic regressions with propensity score weighting adjusted for clinical and demographic factors. We identified 1631 visits by HIV-infected patients and 226 862 visits by HIV-uninfected patients with cardiovascular risk factors, representing ≈2.2 million and 602 million visits per year in the United States, respectively. The proportion of visits by HIV-infected versus HIV-uninfected adults with aspirin/antiplatelet therapy when patients met guideline-recommended criteria for primary prevention or had cardiovascular disease was 5.1% versus 13.8% (P=0.03); the proportion of visits with statin therapy when patients had diabetes mellitus, cardiovascular disease, or dyslipidemia was 23.6% versus 35.8% (P<0.01). There were no differences in antihypertensive medication therapy (53.4% versus 58.6%), diet/exercise counseling (14.9% versus 16.9%), or smoking cessation advice/pharmacotherapy (18.8% versus 22.4%) between HIV-infected versus HIV-uninfected patients, respectively.

CONCLUSIONS:
Physicians generally underused guideline-recommended cardiovascular care and were less likely to prescribe aspirin and statins to HIV-infected patients at increased risk-findings that may partially explain higher rates of adverse cardiovascular events among patients with HIV. US policymakers and professional societies should focus on improving the quality of cardiovascular care that HIV-infected patients receive.

Read the full commentary here.

Hermanstyne KA, Green Jr HD, Cook R, Tieu HV, Dyer TV, Hucks-Ortiz C, Wilton L, Latkin C, Shoptaw S. Social Network Support and Decreased Risk of Seroconversion in Black MSM: Results of the BROTHERS (HPTN 061) Study. Journal of Acquired Immune Deficiency Syndromes. 2018 Jun 1;78(2):163-8.

Abstract
BACKGROUND AND SETTING:
Black men who have sex with men (BMSM) in the United States have disproportionately high HIV infection rates. Social networks have been shown to influence HIV risk behavior; however, little is known about whether they affect the risk of HIV seroconversion. This study uses data from the BROTHERS (HPTN 061) study to test whether contextual factors related to social networks are associated with HIV seroconversion among BMSM.

METHODS:
We analyzed data from the BROTHERS study (2009-2011), which examined a multicomponent intervention for BMSM in 6 US cities. We ran a series of Cox regression analyses to examine associations between time-dependent measures of network support (personal/emotional, financial, medical, and social participation) and time to HIV seroconversion. We ran unadjusted models followed by models adjusted for participant age at enrollment and study location.

RESULTS:
A total of 1000 BMSM tested HIV negative at baseline and were followed at 6- and 12-month study visits. Twenty-eight men tested HIV positive. In adjusted hazard ratio models, study participants who remained HIV negative had higher proportions of social network members who provided personal/emotional {0.92 [95% confidence interval (CI): 0.85 to 0.99]}, medical [0.92 (95% CI: 0.85 to 0.99)], or social participation [0.91 (95% CI: 0.86 to 0.97)] support.

CONCLUSION:
Findings suggest that the increased presence of social network support can be protective against HIV acquisition. Future research should explore the processes that link social network support with sexual and other transmission risk behaviors as a basis to inform HIV prevention efforts.

Read the full commentary here.

Hermanstyne KA, Shoptaw S, Cunningham WE. Associations of types of substances with condomless sex in vulnerable people living with HIV/AIDS. Journal of HIV/AIDS & Social Services. 2018 Apr 3;17(2):118-26.

Abstract:
For people living with HIV who are not readily retained in medical care, substance use can contribute to risky sexual behavior that may lead to HIV transmission. This cross-sectional study examined the relationship between stimulants versus opioids and condomless sex in a sample of 223 vulnerable people living with HIV/AIDS. We examined the associations of stimulant and opioid use in the past 30 days with condomless sex while controlling for sample characteristics. More than two thirds (69%) reported having condomless sex in the past six months. Results showed a positive association between condomless sex and any illicit substance use (AOR: 2.82; 95% CI: 1.29–6.17; P = 0.009) or stimulant use (AOR: 2.54; 95% CI: 1.04–6.24; P = 0.041) in the past 30 days. These findings suggest the importance of promoting behavioral interventions that increase consistent condom use and reduce stimulant use among people who have difficulties with HIV care retention.

To read the full commentary, click this link.

2017

Briones M, Shoptaw S, Cook R, Worley M, Swanson AN, Moody DE, Fang WB, Tsuang J, Furst B, Heinzerling K. Varenicline treatment for methamphetamine dependence: A randomized, double-blind Phase II clinical trial. Drug and alcohol dependence. 2018 May 25.189:30-36. PMID: 29860057.

Abstract
BACKGROUND:
Previous studies have suggested that varenicline, an α4β2 nicotinic receptor partial agonist, and α7 nicotinic receptor full agonist, may be effective for the treatment of methamphetamine (MA) dependence due to dopaminergic effects, relief of glutamatergic and cognitive dysfunction, and activation of nicotinic cholinergic systems. This study aimed to determine if varenicline (1 mg BID) resulted in reduced methamphetamine use compared to placebo among treatment-seeking MA-dependent volunteers.

METHODS:
Treatment-seeking MA-dependent volunteers were randomized to varenicline 1 mg twice daily (n = 27) or placebo (n = 25) and cognitive behavioral therapy for 9 weeks. The primary outcomes were the proportion of participants achieving end-of-treatment-abstinence (EOTA, MA-negative urine specimens during weeks 8 and 9) and the treatment effectiveness score (TES, number of MA-negative urine specimens) for varenicline versus placebo.

RESULTS:
There was no significant difference in EOTA between varenicline (15%, 4/27) and placebo (20%, 5/25; p = 0.9). There was some suggestion that urinary confirmed medication compliance corresponded with EOTA in the varenicline condition, though it did not reach statistical significance, OR = 1.57 for a 100 ng/ml increase in urine varenicline, p = 0.10, 95% CI (0.99, 3.02). There was no significant difference in mean TES in the varenicline condition (8.6) compared to the placebo condition (8.1), and treatment condition was not a statistically significant predictor of TES, IRR = 1.01, p = 0.9, 95% CI (0.39, 2.70).

CONCLUSIONS:
The results of this study indicate that 1 mg varenicline BID was not an effective treatment for MA dependence among treatment-seeking MA-dependent volunteers.

 

Read the full commentary here.

Chen, I., Zhang, Y., Cummings, V., Cloherty, G.A., Connor, M., Beauchamp, G., Griffith, S., Rose, S., Gallant, J., Scott, H.M. and Shoptaw, S., 2017. Analysis of HIV integrase resistance in Black men who have sex with men in the United States. AIDS Research and Human Retroviruses.

Abstract/Summary:

Resistance to reverse transcriptase and protease inhibitors was frequently detected in HIV from black men who have sex with men (MSM) enrolled in the HIV prevention trials network (HPTN) 061 study. In this study, integrase strand transfer inhibitor (INSTI) resistance was analyzed in black MSM enrolled in HPTN 061 (134 infected at enrollment and 23 seroconverters) and a follow-up study, HPTN 073 (eight seroconverters). The ViroSeq HIV-1 Integrase Genotyping Kit (Abbott Molecular) was used for analysis. Major INSTI resistance mutations were not detected in any of the samples. HIV from 14 (8.4%) of the 165 men, including 4 (12.9%) of 31 seroconverters, had accessory or polymorphic INSTI-associated mutations. The most frequently detected mutation was E157Q. These findings are promising because INSTI-based regimens are now recommended for first-line antiretroviral treatment and because long-acting cabotegravir is being evaluated for pre-exposure prophylaxis.

Read the full commentary here.

Cerrada, C.J., Dzubur, E., Blackman, K.C., Mays, V., Shoptaw, S. and Huh, J., 2017. Development of a Just-in-Time Adaptive Intervention for Smoking Cessation Among Korean American Emerging Adults. International journal of behavioral medicine, pp.1-8.

Abstract/Summary:

Purpose: Cigarette smoking is a preventable risk factor that contributes to unnecessary lung cancer burden among Korean Americans and there is limited research on effective smoking cessation strategies for this population. Smartphone-based smoking cessation apps that leverage just-in-time adaptive interventions (JITAIs) hold promise for smokers attempting to quit. However, little is known about how to develop and tailor a smoking cessation JITAI for Korean American emerging adult (KAEA) smokers.

Method: This paper documents the development process of MyQuit USC according to design guidelines for JITAI. Our development process builds on findings from a prior ecological momentary assessment study by using qualitative research methods. Semi-structured interviews and a focus group were conducted to inform which intervention options to offer and the decision rules that dictate their delivery.

Results: Qualitative findings highlighted that (1) smoking episodes are highly context-driven and that (2) KAEA smokers believe they need personalized cessation strategies tailored to different contexts. Thus, MyQuit USC operates via decision rules that guide the delivery of personalized implementation intentions, which are contingent on dynamic factors, to be delivered “just in time” at user-scheduled, high-risk smoking situations.

Conclusion: Through an iterative design process, informed by quantitative and qualitative formative research, we developed a smoking cessation JITAI tailored specifically for KAEA smokers. Further testing is under way to optimize future versions of the app with the most effective intervention strategies and decision rules. MyQuit USC has the potential to provide cessation support in real-world settings, when KAEAs need them the most.

Read the full commentary here.

2016

Iris Chen, Gordon Chau, Jing Wang, William Clarke, Mark A. Marzinke, Vanessa Cummings, Autumn Breaud, Oliver Laeyendecker, Sheldon D. Fields, Sam Griffith, Hyman M. Scott, Steven Shoptaw, Carlos del Rio, Manya Magnus, Sharon Mannheimer, Hong-Van Tieu, Darrell P. Wheeler, Kenneth H. Mayer, Beryl A. Koblin, Susan H. Eshleman. (2016). Analysis of HIV Diversity in HIV-Infected Black Men Who Have Sex with Men (HPTN 061). PLOS ONE 11(12): e0167629. https://doi.org/10.1371/journal.pone.0167629

Abstract/Summary: Background: HIV populations often diversify in response to selective pressures, such as the immune response and antiretroviral drug use. We analyzed HIV diversity in Black men who have sex with men who were enrolled in the HIV Prevention Trials Network 061 study.

Methods: A high resolution melting (HRM) diversity assay was used to measure diversity in six regions of the HIV genome: two in gag, one in pol, and three in env. HIV diversity was analyzed for 146 men who were HIV infected at study enrollment, including three with acute infection and 13 with recent infection (identified using a multi-assay algorithm), and for 21 men who seroconverted during the study. HIV diversification was analyzed in a paired analysis for 62 HIV-infected men using plasma samples from the enrollment and 12-month (end of study) visits.

Results: Men with acute or recent infection at enrollment and seroconverters had lower median HRM scores (lower HIV diversity) than men with non-recent infection in all six regions analyzed. In univariate analyses, younger age, higher CD4 cell count, and HIV drug resistance were associated with lower median HRM scores in multiple regions; ARV drug detection was marginally associated with lower diversity in the pol region. In multivariate analysis, acute or recent infection (all six regions) and HIV drug resistance (both gag regions) were associated with lower median HRM scores. Diversification in the pol region over 12 months was greater for men with acute or recent infection, higher CD4 cell count, and lower HIV viral load at study enrollment.

Conclusions: HIV diversity was significantly associated with duration of HIV infection, and lower gag diversity was observed in men who had HIV drug resistance. HIV pol diversification was more pronounced in men with acute or recent infection, higher CD4 cell count, and lower HIV viral load.

Read the full commentary here.

Fletcher, J. B., Landovitz, R. J., Shoptaw, S., & Reback, C. J. (2016). Contingent vs. Non-Contingent Rewards: Time-based Intervention Response Patterns among Stimulant-using Men who have Sex with Men. Journal of Substance Abuse Treatment.

Abstract/Summary: Stimulant use rates are higher among men who have sex with men (MSM) than the general population. Contingency management (CM) may be an effective intervention for reducing stimulant use in this population. To specify both the mechanism and temporal effects of contingent reward on behavior change, logistic growth trajectory modeling (LGTM) was used to contrast a non-contingent matched rewards condition (i.e., non-contingent yoked controls; NCYC) to a voucher-based CM intervention (maximum = $430) to reduce stimulant use among MSM. Stimulant-using MSM were randomized to either a CM intervention (n = 70) or a NCYC condition (n = 70). Results from a LGTM (analytical sample n = 119; nCM = 61; nNCYC = 58) indicated four distinct intervention response patterns: responders (i.e., predicted >90% stimulant metabolite-free urinalyses; 64.7% of sample); worsening intervention response (14.3%); non-responders (12.6%); and, single-positive (8.4%); all estimated trajectory coefficients were significant at p < 0.03 (2-tailed). Participants receiving CM were significantly overrepresented in the responder (64%) and single-positive (80%) categories (χ2(3) = 29.04; p < 0.001); all non-responders and 76.5% of the worsening intervention response category were in the NCYC condition. Results demonstrate the utility of trajectory modeling and further support the contingent application of reward as the operative mechanism associated with patterns of stimulant abstinence with CM applied to a sample of stimulant-using MSM outside the context of formal drug treatment.

Read the full commentary here.

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