Peer-Reviewed Journal Articles

2018

Brooks RA, Nieto O, Landrian A, Donohoe TJ. Persistent stigmatizing and negative perceptions of pre-exposure prophylaxis (PrEP) users: implications for PrEP adoption among Latino men who have sex with men. AIDS Care. 2018 Jul 18:1-9. [Epub ahead of print.] PMID: 30021456

Abstract
The Centers for Disease Control and Prevention (CDC) estimates the lifetime HIV risk is one in four for Latino men who have sex with men (MSM). Pre-Exposure Prophylaxis (PrEP) is an efficacious biomedical prevention strategy to help prevent the acquisition of HIV. At present, there has been limited uptake of PrEP by Latino MSM. Unfortunately, the negative perceptions and social stigma surrounding PrEP and those who use it may deter uptake of this novel prevention strategy, particularly among high-risk Latino MSM. In this qualitative study, we explore the experiences of using PrEP among Latino MSM. Participants were recruited using gay-oriented social and sexual networking apps to complete an interviewer-administered, semi-structured qualitative interview. Thematic analysis was used to identify emerging themes relating to perceptions of PrEP users and PrEP as an HIV prevention strategy. Major themes included: feelings of protection and sexual freedom; negative and stigmatizing labels associated with PrEP use; assumptions about sexual behaviors and perceptions of sexual risk taking and irresponsibility; and attitudes related to PrEP use in relationships. A striking but not prevalent theme was the perception reported by participants that monolingual Spanish-speaking Latino MSM are skeptical about the effectiveness of PrEP. These findings suggest that efforts are needed to address the stigmatizing and negative perceptions of PrEP that persist in the gay community that may deter adoption among Latino MSM.

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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.

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.

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Davey DJ, Farley E, Towriss C, Gomba Y, Bekker LG, Gorbach P, Shoptaw S, Coates T, Myer L. Risk perception and sex behaviour in pregnancy and breastfeeding in high HIV prevalence settings: Programmatic implications for PrEP delivery. PloS one. 2018 May 14;13(5):e0197143. PMCID: PMC5951545.

Abstract
HIV acquisition during pregnancy and breastfeeding significantly contributes toward paediatric HIV infection; however, little is known about risk behaviours in HIV-uninfected pregnant and postpartum women. We conducted twenty-six in-depth-interviews between July and December 2016 using a semi-structured interview guide among HIV-uninfected pregnant and recently postpartum women at-risk of HIV acquisition (defined as reporting ≥1 of the following: partner’s serostatus unknown or HIV-infected, recent condomless sex in pregnancy, and/or alcohol use during pregnancy) who attended primary healthcare services. Our study contextualizes factors related to risky sexual behaviours during pregnancy and postpartum periods and assesses knowledge and hypothetical acceptability of pre-exposure prophylaxis (PrEP) in pregnancy. Translated and transcribed data were coded and analysed by three researchers using a thematic analysis approach. In interviews with HIV-uninfected pregnant/postpartum women at-risk of HIV acquisition, we identified common themes associated with sexual risk behaviours during pregnancy, including: lack of control over decisions in sex and condom use in pregnancy, low perceived risk (e.g. beliefs that their partner has the same HIV-negative serostatus), and socio-cultural beliefs around condom use during pregnancy (e.g. contact with sperm is essential for baby’s development). PrEP knowledge was low among HIV-uninfected pregnant and breastfeeding women, and potential acceptability was good, though primary concerns were around the potential impact on the infant. While mothers presented a clear desire to protect themselves from HIV acquisition once pregnant, they also reported lack of control, and socio-cultural beliefs, like sex is good for the baby, that increased their risk of seroconversion. Mothers had limited PrEP awareness but reported hypothetical willingness to use PrEP because of concerns over HIV acquisition and onward mother to child transmission.

Read the full article here.

Garcia J, Perez-Brumer AG, Cabello R, Clark JL. “And Then Break the Cliché”: Understanding and Addressing HIV Vulnerability Through Development of an HIV Prevention Telenovela with Men Who Have Sex with Men and Transwomen in Lima, Peru. Archives of sexual behavior. 2018 Feb 20:1-1. PMID: 29464455.

Abstract
HIV and other sexually transmitted infections (STIs) continue to affect men who have sex with men (MSM) and transgender women (TW) in Peru at disproportionately high rates. The ineffectiveness of traditional prevention strategies may be due to the disconnect between health promotion messages and community-level understandings of sexual cultures. We conducted 15 workshops with MSM and TW to develop a community-based sexual health intervention. Intervention development consisted of focus groups and scenic improvisation to identify sexual scripts for an HIV prevention telenovela, or Spanish soap opera. Workshops were stratified by self-reported socioeconomic status, sexual orientation, and gender identity: (1) low-income MSM (n = 9); (2) middle/high-income MSM (n = 6); and (3) TW (n = 8). Employing a conceptual model based on sexual scripts and critical consciousness theories, this paper reports on three themes identified during the telenovela-development process as participants sought to “rescript” social and sexual stereotypes associated with HIV-related vulnerability: (1) management of MSM and TW social identities at the intersection of socioeconomic status, sexuality, and gender performance; (2) social constructions of gender and/or sexual role and perceived and actual HIV/STI risk(s) within sexual partnership interactions; and (3) idealized and actual sexual scripts in the negotiation of safer sex practices between MSM/TW and their partners. These findings are key to reframing existing prevention strategies that fail to effectively engage poorly defined “high-risk populations.” Leveraging community-based expertise, the results provide an alternative to the static transfer of information through expert-patient interactions in didactic sessions commonly used in HIV prevention interventions among MSM and TW.

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Severino AL, Shadfar A, Hakimian JK, Crane O, Singh G, Heinzerling K, Walwyn WM. Pain therapy guided by purpose and perspective in light of the opioid epidemic. Frontiers in psychiatry. 2018;9. PMCID: PMC5925443.

Abstract
Prescription opioid misuse is an ongoing and escalating epidemic. Although these pharmacological agents are highly effective analgesics prescribed for different types of pain, opioids also induce euphoria, leading to increasing diversion and misuse. Opioid use and related mortalities have developed in spite of initial claims that OxyContin, one of the first opioids prescribed in the USA, was not addictive in the presence of pain. These claims allayed the fears of clinicians and contributed to an increase in the number of prescriptions, quantity of drugs manufactured, and the unforeseen diversion of these drugs for non-medical uses. Understanding the history of opioid drug development, the widespread marketing campaign for opioids, the immense financial incentive behind the treatment of pain, and vulnerable socioeconomic and physical demographics for opioid misuse give perspective on the current epidemic as an American-born problem that has expanded to global significance. In light of the current worldwide opioid epidemic, it is imperative that novel opioids are developed to treat pain without inducing the euphoria that fosters physical dependence and addiction. We describe insights from preclinical findings on the properties of opioid drugs that offer insights into improving abuse-deterrent formulations. One finding is that the ability of some agonists to activate one pathway over another, or agonist bias, can predict whether several novel opioid compounds bear promise in treating pain without causing reward among other off-target effects. In addition, we outline how the pharmacokinetic profile of each opioid contributes to their potential for misuse and discuss the emergence of mixed agonists as a promising pipeline of opioid-based analgesics. These insights from preclinical findings can be used to more effectively identify opioids that treat pain without causing physical dependence and subsequent opioid abuse.

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Athanasos P, Ling W, Bochner F, White JM, Somogyi AA. Buprenorphine Maintenance Subjects Are Hyperalgesic and Have No Antinociceptive Response to a Very High Morphine Dose. Pain Medicine. 2018 Mar 5.

Abstract
OBJECTIVE:
Acute pain management in opioid-dependent persons is complicated because of tolerance and opioid-induced hyperalgesia. Very high doses of morphine are ineffective in overcoming opioid-induced hyperalgesia and providing antinociception to methadone-maintained patients in an experimental setting. Whether the same occurs in buprenorphine-maintained subjects is unknown.

DESIGN:
Randomized double-blind placebo-controlled. Subjects were tested on two occasions, at least five days apart, once with intravenous morphine and once with intravenous saline. Subjects were tested at about the time of putative trough plasma buprenorphine concentrations.

SETTING:
Ambulatory.

SUBJECTS:
Twelve buprenorphine-maintained subjects: once daily sublingual dose (range = 2-22 mg); no dose change for 1.5-12 months. Ten healthy controls.

METHODS:
Intravenous morphine bolus and infusions administered over two hours to achieve two separate pseudo-steady-state plasma concentrations one hour apart. Pain tolerance was assessed by application of nociceptive stimuli (cold pressor [seconds] and electrical stimulation [volts]). Ten blood samples were collected for assay of plasma morphine, buprenorphine, and norbuprenorphine concentrations until three hours after the end of the last infusion; pain tolerance and respiration rate were measured to coincide with blood sampling times.

RESULTS:
Cold pressor responses (seconds): baseline: control 34 ± 6 vs buprenorphine 17 ± 2 (P = 0.009); morphine infusion-end: control 52 ± 11(P = 0.04), buprenorphine 17 ± 2 (P > 0.5); electrical stimulation responses (volts): baseline: control 65 ± 6 vs buprenorphine 53 ± 5 (P = 0.13); infusion-end: control 74 ± 5 (P = 0.007), buprenorphine 53 ± 5 (P > 0.98). Respiratory rate (breaths per minute): baseline: control 17 vs buprenorphine 14 (P = 0.03); infusion-end: control 15 (P = 0.09), buprenorphine 12 (P < 0.01). Infusion-end plasma morphine concentrations (ng/mL): control 23 ± 1, buprenorphine 136 ± 10.

CONCLUSIONS:
Buprenorphine subjects, compared with controls, were hyperalgesic (cold pressor test), did not experience antinociception, despite high plasma morphine concentrations, and experienced respiratory depression. Clinical implications are discussed.

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Barbosa-Leiker C, McPherson S, Layton ME, Burduli E, Roll JM, Ling W. Sex differences in opioid use and medical issues during buprenorphine/naloxone treatment. The American journal of drug and alcohol abuse. 2018 Jul 4;44(4):488-96.

Abstract
BACKGROUND:
There are sex differences in buprenorphine/naloxone clinical trials for opioid use. While women have fewer opioid-positive urine samples, relative to men, a significant decrease in opioid-positive samples was found during treatment for men, but not women. In order to inform sex-based approaches to improve treatment outcomes, research is needed to determine if opioid use, and predictors of opioid use, differs between men and women during treatment.

OBJECTIVES:
To test for sex differences in opioid use during a buprenorphine/naloxone clinical trial and determine if sex differences exist in the associations between addiction-related problem areas and opioid use over the course of the trial.

METHOD:
This secondary data analysis of the National Drug Abuse Treatment Clinical Trials Network (CTN) 0003 examined sex differences (men = 347, women = 169) in opioid-positive samples in a randomized clinical trial comparing 7-day vs. 28-day buprenorphine/naloxone tapering strategies. Addiction-related problem areas were defined by Addiction Severity-Lite (ASI-L) domain composite scores.

RESULTS:
Women were more likely than men to use opioids during the course of the buprenorphine/naloxone clinical trial (B = .33, p = .01) and medical issues were positively related to submitting an opioid-positive sample during treatment for women (B = 1.67, p = .01). No ASI-L domain composite score was associated with opioid-positive samples during treatment for men.

CONCLUSION:
Women were more likely than men to use opioids during the course of the buprenorphine/naloxone clinical trial, and medical issues predicted opioid use during treatment for women but not men. Complementary treatment for medical problems during opioid replacement therapy may benefit women.

Read the full commentary here.

Li MJ, Frank HG, Harawa NT, Williams JK, Chou CP, Bluthenthal RN. Racial pride and condom use in post-incarcerated African-American men who have sex with men and women: Test of a conceptual model for the men in life environments intervention. Archives of sexual behavior. 2018 Jan 1;47(1):169-81.

Abstract
African-American men who have sex with men and women (MSMW) are among those most heavily impacted by HIV in the United States, and those who have histories of incarceration are at further risk of infection. The Men in Life Environments (MILE) HIV prevention intervention was developed to provide culturally appropriate skills-based education and support for African-American MSMW with recent histories of incarceration. The MILE’s conceptual framework was informed by three theories: Theory of Reasoned Action and Planned Behavior, Critical Thinking and Cultural Affirmation Model, and Empowerment Theory. The theory-based framework posits that improving racial pride is crucial in building self-efficacy and intentions that in turn promote health-protective behaviors. Therefore, our study aimed to assess whether baseline associations between racial pride and condom use self-efficacy, intentions, and behaviors among African-American MSMW with histories of incarceration align with our conceptual model. We report data on 212 participants recruited from Los Angeles County Sheriff’s Department Men’s Central Jail and the local community. Using structural equation modeling, we tested two separate models: one with female sexual partners and one with male sexual partners, while stratifying by participant’s HIV status. Only among HIV-negative participants was greater racial pride associated with less condomless intercourse with men. In this group, greater self-efficacy and intentions-but not racial pride-predicted less condomless intercourse with women. Our findings suggest that racial pride is an important factor to address in HIV prevention interventions for post-incarcerated African-American MSMW.

The full article may be found here.

Comulada WS, Swendeman D, Koussa MK, Mindry D, Medich M, Estrin D, Mercer N, Ramanathan N. Adherence to self-monitoring healthy lifestyle behaviours through mobile phone-based ecological momentary assessments and photographic food records over 6 months in mostly ethnic minority mothers. Public health nutrition. 2018 Mar;21(4):679-88.

Abstract
OBJECTIVE:
Mobile phones can replace traditional self-monitoring tools through cell phone-based ecological momentary assessment (CEMA) of lifestyle behaviours and camera phone-based images of meals, i.e. photographic food records (PFR). Adherence to mobile self-monitoring needs to be evaluated in real-world treatment settings. Towards this goal, we examine CEMA and PFR adherence to the use of a mobile app designed to help mothers self-monitor lifestyle behaviours and stress. Design/Setting In 2012, forty-two mothers recorded CEMA of diet quality, exercise, sleep, stress and mood four times daily and PFR during meals over 6 months in Los Angeles, California, USA.

SUBJECTS:
A purposive sample of mothers from mixed ethnicities.

RESULTS:
Adherence to recording CEMA at least once daily was higher compared with recording PFR at least once daily over the study period (74 v. 11 %); adherence to both types of reports decreased over time. Participants who recorded PFR for more than a day (n 31) were more likely to be obese v. normal- to overweight and to have higher blood pressure, on average (all P<0·05). Based on random-effects regression, CEMA and PFR adherence was highest during weekdays (both P<0·01). Additionally, PFR adherence was associated with older age (P=0·04). CEMA adherence was highest in the morning (P<0·01). PFR recordings occurred throughout the day.

CONCLUSIONS:
Variations in population and temporal characteristics should be considered for mobile assessment schedules. Neither CEMA nor PFR alone is ideal over extended periods.

Read the full commentary here.

Kelso-Chichetto NE, Okafor CN, Cook RL, Abraham AG, Bolan R, Plankey M. Association between depressive symptom patterns and clinical profiles among persons living with HIV. AIDS and behavior. 2018 May 1;22(5):1411-22. PMCID: PMC5720934.

Abstract
To describe patterns of depressive symptoms across 10-years by HIV status and to determine the associations between depressive symptom patterns, HIV status, and clinical profiles of persons living with HIV from the Multicenter AIDS Cohort Study (N = 980) and Women’s Interagency HIV Study (N = 1744). Group-based trajectory models were used to identify depressive symptoms patterns between 2004 and 2013. Multinomial logistic regressions were conducted to determine associations of depression risk patterns. A 3-group model emerged among HIV-negative women (low: 58%; moderate: 31%; severe: 11%); 5-groups emerged among HIV-positive women (low: 28%; moderate: 31%; high: 25%; decreased: 7%; severe: 9%). A 4-group model emerged among HIV-negative (low: 52%; moderate: 15%; high: 23%; severe: 10%) and HIV-positive men (low: 34%; moderate: 34%; high: 22%; severe: 10%). HIV+ women had higher odds for moderate (adjusted odds ratio [AOR] 2.10, 95% CI 1.63-2.70) and severe (AOR 1.96, 95% CI 1.33-2.91) depression risk groups, compared to low depression risk. HIV+ men had higher odds for moderate depression risk (AOR 3.23, 95% CI 2.22-4.69), compared to low risk. The Framingham Risk Score, ART use, and unsuppressed viral load were associated with depressive symptom patterns. Clinicians should consider the impact that depressive symptoms may have on HIV prognosis and clinical indicators of comorbid illnesses.

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2017

Reisner SL, Perez-Brumer AG, McLean SA, Lama JR, Silva-Santisteban A, Huerta L, Sanchez J, Clark JL, Mimiaga MJ, Mayer KH. Perceived barriers and facilitators to integrating HIV prevention and treatment with cross-sex hormone therapy for transgender women in Lima, Peru. AIDS and Behavior. 2017 Dec 1;21(12):3299-311. PMCID: PMC5647197.

Abstract
Transgender women (TW) represent a vulnerable population at increased risk for HIV infection in Peru. A mixed-methods study with 48 TW and 19 healthcare professionals was conducted between January and February 2015 to explore barriers and facilitators to implementing a model of care that integrates HIV services with gender-affirmative medical care (i.e., hormone therapy) in Lima, Peru. Perceived acceptability of the integrated care model was high among TW and healthcare professionals alike. Barriers included stigma, lack of provider training or Peruvian guidelines regarding optimal TW care, and service delivery obstacles (e.g., legal documents, spatial placement of clinics, hours of operation). The hiring of TW staff was identified as a key facilitator for engagement in health care. Working in partnership with local TW and healthcare provider organizations is critical to overcoming existing barriers to successful implementation of an integrated HIV services and gender-affirmative medical care model for this key population in Peru.

Read the full commentary by clicking here.

Ray LA, Bujarski S, Shoptaw S, Roche DJ, Heinzerling K, Miotto K. Development of the neuroimmune modulator ibudilast for the treatment of alcoholism: a randomized, placebo-controlled, human laboratory trial. Neuropsychopharmacology. 2017 Aug;42(9):1776. PMCID: PMC5520778.

Abstract
Current directions in medication development for alcohol use disorder (AUD) emphasize the need to identify novel molecular targets and efficiently screen new compounds aimed at those targets. Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterase-4 and -10 and macrophage migration inhibitory factor and was recently found to reduce alcohol intake in rats by ∼50%. To advance medication development for AUD, the present study consists of a randomized, crossover, double-blind, placebo-controlled laboratory study of IBUD in nontreatment-seeking individuals with current (ie, past month) mild-to-severe AUD. This study tested the safety, tolerability, and initial human laboratory efficacy of IBUD (50 mg b.i.d.) on primary measures of subjective response to alcohol as well as secondary measures of cue- and stress-induced changes in craving and mood. Participants (N=24) completed two separate 7-day intensive outpatient protocols that included daily visits for medication administration and testing. Upon reaching a stable target dose of IBUD (or matched placebo), participants completed a stress-exposure session (day 5; PM), an alcohol cue-exposure session (day 6; AM), and an i.v. alcohol administration session (day 6; PM). Participants stayed overnight after the alcohol administration, and discharge occurred on day 7 of the protocol. Medication conditions were separated by a washout period that was ⩾7 days. IBUD was well tolerated; however, there were no medication effects on primary measures of subjective response to alcohol. IBUD was associated with mood improvements on the secondary measures of stress exposure and alcohol cue exposure, as well as reductions in tonic levels of craving. Exploratory analyses revealed that among individuals with higher depressive symptomatology, IBUD attenuated the stimulant and mood-altering effects of alcohol as compared with placebo. Together, these findings extend preclinical demonstrations of the potential utility of IBUD for the treatment of AUD and suggest that depressive symptomatology should be considered as a potential moderator of efficacy for pharmacotherapies with neuroimmune effects, such as IBUD.

Read the full article here.

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.

Kitayama K, Segura ER, Lake JE, Perez-Brumer AG, Oldenburg CE, Myers BA, Pourjavaheri P, Okorie CN, Cabello RL, Clark JL. Syphilis in the Americas: a protocol for a systematic review of syphilis prevalence and incidence in four high-risk groups, 1980–2016. Systematic reviews. 2017 Dec;6(1):195.

Abstract
BACKGROUND:
Syphilis infection has recently resurfaced as a significant public health problem. Although there has been a tremendous amount of research on the epidemiology of syphilis, there has been limited work done to synthesize the extensive body of research and systematically estimate patterns of disease within high-risk groups in the Americas. The purpose of this systematic review and meta-analysis is to (1) summarize recent patterns of syphilis infection in North and South America among four high-risk groups (MSM, transgender women, sex workers, and incarcerated individuals) from 1980 to 2016, (2) identify and differentiate regional geographic epidemiologic characteristics, and (3) compare the epidemics of the economically developed countries of North America from the developing countries and public health systems of Latin America and the Caribbean.

METHODS/DESIGN:
Primary studies reporting syphilis prevalence and/or incidence in at least one of the four high-risk groups will be identified from Medline/PubMed, Embase, Lilacs, SciELO, The Cochrane Library, Web of Science, Scopus, ProQuest, CINAHL, Clase, and Periódica, as well as “gray” literature sources (conference abstracts, country reports, etc.). Studies published from 1980 through 2016 will be included. Data will be extracted from studies meeting inclusion and exclusion criteria and a random effects meta-analysis of prevalence and incidence estimates will be conducted. Heterogeneity, risk of bias, and publication bias will be assessed. Pooled prevalence and incidence estimates will be calculated for comparisons based on geographic region, risk factors, and time period.

DISCUSSION:
Our systematic review and meta-analysis aims to contribute to an improved understanding of global epidemiologic patterns of syphilis infection in most-at-risk populations. Through systematic classification of the existing literature, and comparison of disease patterns across regional, temporal and socio-behavioral differences, we hope to improve public health surveillance and improve efforts to control the spread of disease across the Americas.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016047306.

Read the full review here.

Braun HM, Segura ER, Lake JE, Gandhi M, Rios J, Villaran MV, Sanchez J, Lama JR, Clark JL. Individual and partnership factors associated with anticipated versus actual partner notification following STI diagnosis among men who have sex with men and/or with transgender women in Lima, Peru. Sex Transm Infect. 2017 Nov 30. pii: sextrans-2017-053292. PMCID: PMC5976515.

Abstract
OBJECTIVES:
A detailed understanding of intentions and practices related to partner notification (PN) following STI diagnosis can improve control strategies. We assessed participant-level and partner-level factors guiding notification behaviour among men who have sex with men and/or with transgender women (MSM-TW) in Lima, Peru, including discordances between anticipated and actual notification.

METHODS:
Men newly diagnosed with gonorrhoea, chlamydia and/or syphilis between 2012 and 2014 reported recent partners’ characteristics, anticipated PN practices, and actual PN outcomes following diagnosis. Generalised estimating equation Poisson regression analyses assessed factors guiding PN outcomes.

RESULTS:
Participants (n=150) predominantly identified as homosexual (70%) and moderno (versatile sexual role, 55%); 55% of partners (n=402) were casual. Among all sexual partners, 35% were notified of the STI diagnosis, though only 51% of predicted PN occurred and 26% of actual notifications were unanticipated. 47% of participants notified no partners, while 24% notified all partners. PN was more common with stable versus casual (adjusted prevalence ratio (aPR), 95% CI: 0.53, 0.39 to 0.73) or commercial (aPR, 95% CI: 0.38, 0.12 to 1.21) partners, and among participants who perceived PN as normative among their peers (aPR, 95% CI: 1.96, 1.37 to 2.82). A trend towards greater notification following condom-protected intercourse was observed (aPR, 95% CI: 1.33, 0.98 to 1.81). PN frequency did not differ by type of STI diagnosed.Anticipated notification predicted actual notification (aPR, 95% CI: 1.67, 1.19 to 2.33) only imperfectly: 81 (54%) participants’ PN practices did not match their anticipated behaviour. Successful notification despite anticipated silence (40 participants, 63 partners) was associated with stable partnerships and a normative perception of PN. Non-notification despite intention (43 participants, 73 partners) frequently occurred among participants reporting exclusively oral sex with the partner or with partners identified as activo (insertive role).

CONCLUSIONS:
Anticipated notification imperfectly reflects actual PN behaviour. Future interventions to improve PN among MSM-TW in Peru need to acknowledge partnership contexts.

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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.

Machado IK, Luz PM, Lake JE, Castro R, Velasque L, Clark JL, Veloso VG, Grinsztejn B, De Boni RB. Self-rated health and substance use among individuals in HIV care in Rio de Janeiro, Brazil: a cross-sectional study. International journal of STD & AIDS. 2017 Oct;28(12):1175-83. PMCID: PMC5501998 .

Abstract
Self-rated health (SRH) is associated with morbidity and mortality in HIV-uninfected populations but is understudied in HIV. Substance use may affect SRH in addition to its deleterious effect on HIV disease. This analysis aimed to estimate SRH and substance use prevalence and evaluate factors associated with poor SRH among individuals in HIV care in Rio de Janeiro, Brazil. A convenience sample of HIV-infected adults completed one item of SRH, the Alcohol, Smoking and Substance Involvement Screening Test, and the Patient Health Questionnaire-2 (PHQ-2). Logistic regression models identified factors associated with poor SRH. Participants’ (n = 1029) median age was 42.9 years, 64.2% were male, and 54.5% were nonwhite. Poor SRH was reported by 19.5% and the use of alcohol, tobacco, marijuana, and crack/cocaine by 30.1, 19.5, 3.9, and 3.5%, respectively. Less than high school education (adjusted odds ratio [aOR] 1.54, 95% confidence interval [CI]: 1.08-2.20), lack of sexual activity in previous 12 months (aOR 1.53, 95% CI: 1.01-2.30), crack/cocaine use (aOR 3.82, 95% CI: 1.80-8.09), positive PHQ-2 screen (aOR 3.43, 95% CI: 2.09-5.62), and HIV-1 RNA ≥40 c/ml (aOR 2.51, 95% CI: 1.57-4.02) were significantly associated with poor SRH as identified by logistic regression analyses. Alcohol, marijuana, and sedative use were not significantly associated with poor SRH. These results emphasize the need for substance use and mental health screening and treatment in this population. Further research may elucidate the consequences of poor SRH on treatment adherence, morbidity, and mortality in HIV-infected individuals.

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Satcher MF, Segura ER, Silva-Santisteban A, Sanchez J, Lama JR, Clark JL. Partner-Level Factors Associated with Insertive and Receptive Condomless Anal Intercourse Among Transgender Women in Lima, Peru. AIDS and Behavior. 2017 Aug 1;21(8):2439-51.

Abstract
Condomless anal intercourse among transgender women (TW) in Peru has been shown to vary by the type of partner involved (e.g. primary vs. casual vs. transactional sex partner), but no previous studies have explored variations in partner-level patterns of condom use according to type of anal intercourse. We evaluated the relationship between partnership characteristics and condom use during insertive (IAI) versus receptive anal intercourse (RAI) among TW with recent, non-female partners. Condomless IAI was more common with transactional and casual sex partners and by TW who self-reported HIV-uninfected serostatus (p < 0.05), alcohol use disorders, or substance use before sex. Condomless RAI was more common with primary partners and by TW who described their HIV serostatus as unknown (p < 0.05). Examining partner-level differences between condomless IAI and RAI reveals distinct patterns of HIV/STI risk among TW, suggesting a need for HIV prevention strategies tailored to the specific contexts of partners, practices, and networks.

Read the full article here.

Ober AJ, Watkins KE, Hunter SB, Ewing B, Lamp K, Lind M, Becker K, Heinzerling K, Osilla KC, Diamant AL, Setodji CM. Assessing and improving organizational readiness to implement substance use disorder treatment in primary care: findings from the SUMMIT study. BMC family practice. 2017 Dec;18(1):107. PMCID: PMC5740845.

Abstract
BACKGROUND:
Millions of people with substance use disorders (SUDs) need, but do not receive, treatment. Delivering SUD treatment in primary care settings could increase access to treatment because most people visit their primary care doctors at least once a year, but evidence-based SUD treatments are underutilized in primary care settings. We used an organizational readiness intervention comprised of a cluster of implementation strategies to prepare a federally qualified health center to deliver SUD screening and evidence-based treatments (extended-release injectable naltrexone (XR-NTX) for alcohol use disorders, buprenorphine/naloxone (BUP/NX) for opioid use disorders and a brief motivational interviewing/cognitive behavioral -based psychotherapy for both disorders). This article reports the effects of the intervention on key implementation outcomes.

METHODS:
To assess changes in organizational readiness we conducted pre- and post-intervention surveys with prescribing medical providers, behavioral health providers and general clinic staff (N = 69). We report on changes in implementation outcomes: acceptability, perceptions of appropriateness and feasibility, and intention to adopt the evidence-based treatments. We used Wilcoxon signed rank tests to analyze pre- to post-intervention changes.

RESULTS:
After 18 months, prescribing medical providers agreed more that XR-NTX was easier to use for patients with alcohol use disorders than before the intervention, but their opinions about the effectiveness and ease of use of BUP/NX for patients with opioid use disorders did not improve. Prescribing medical providers also felt more strongly after the intervention that XR-NTX for alcohol use disorders was compatible with current practices. Opinions of general clinic staff about the appropriateness of SUD treatment in primary care improved significantly.

CONCLUSIONS:
Consistent with implementation theory, we found that an organizational readiness implementation intervention enhanced perceptions in some domains of practice acceptability and appropriateness. Further research will assess whether these factors, which focus on individual staff readiness, change over time and ultimately predict adoption of SUD treatments in primary care.

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Brown SE, Vagenas P, Konda KA, Clark JL, Lama JR, Gonzales P, Sanchez J, Duerr AC, Altice FL. Men who have sex with men in Peru: acceptability of medication-assisted therapy for treating alcohol use disorders. American journal of men’s health. 2017 Jul;11(4):1269-78.

Abstract
In Peru, the HIV epidemic is concentrated in men who have sex with men (MSM) and transgender women (TGW). Multiple studies correlate alcohol use disorders (AUDs) with risky sexual behaviors among Peruvian MSM. Qualitative research was used to inform a clinical trial on the acceptability of medication-assisted therapies to assist management of AUDs and improve antiretroviral therapy (ART) adherence among MSM/TGW in Peru. Three focus groups involving HIV-infected or HIV-uninfected MSM/TGW ( n = 26) with AUDs (AUDIT ≥ 8) were transcribed, translated from Spanish into English, and analyzed using thematic content analysis. Despite having an AUD, participants considered themselves “social” drinkers, minimized their drinking behaviors, and differed about whether or not alcohol problems could be treated. Participants expressed skepticism about medication for treating AUDs. Three concepts emerged as necessary components of a treatment program for alcohol problems: cost, family support, and the potential to drink less alcohol without attaining total abstinence. This study reveals important areas of education to increase potential acceptability of a medication for treating AUDs among MSM/TGW. Given the social conditions and knowledge base of the participants, medication-assisted therapies using naltrexone may be a beneficial strategy for MSM with AUDs.

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Bachtell RK, Jones JD, Heinzerling KG, Beardsley PM, Comer SD. Glial and neuroinflammatory targets for treating substance use disorders. Drug and alcohol dependence. 2017 Nov 1;180:156-70.  PMCID: PMC5790191.

Abstract
BACKGROUND:
The plenary session at the 2016 Behavior, Biology and Chemistry: Translational Research in Addiction Conference focused on glia as potential players in the development, persistence and treatment of substance use disorders. Glia partake in various functions that are important for healthy brain activity. Drugs of abuse alter glial cell activity producing several perturbations in brain function that are thought to contribute to behavioral changes associated with substance use disorders. Consequently, drug-induced changes in glia-driven processes in the brain represent potential targets for pharmacotherapeutics treating substance use disorders.

METHODS:
Four speakers presented preclinical and clinical research illustrating the effects that glial modulators have on abuse-related behavioral effects of psychostimulants and opioids. This review highlights some of these findings and expands its focus to include other research focused on drug-induced glia abnormalities and glia-focused treatment approaches in substance use disorders.

RESULTS:
Preclinical findings show that drugs of abuse induce neuroinflammatory signals and disrupt glutamate homeostasis through their interaction with microglia and astrocytes. Preclinical and clinical studies testing the effects of glial modulators show general effectiveness in reducing behaviors associated with substance use disorders.

CONCLUSIONS:
The contribution of drug-induced glial activity continues to emerge as an intriguing target for substance use disorder treatments. Clinical investigations of glial modulators have yielded promising results on substance use measures and indicate that they are generally safe and well-tolerated. However, results have not been entirely positive and more questions remain for continued exploration in the development and testing of glial-directed treatments for substance use disorders.

See the full text of this article at this link.

Watkins KE, Ober AJ, Lamp K, Lind M, Setodji C, Osilla KC, Hunter SB, McCullough CM, Becker K, Iyiewuare PO, Diamant A, Heinzerling K, Pincus HA. Collaborative care for opioid and alcohol use disorders in primary care: the SUMMIT randomized clinical trial. JAMA Internal Medicine. 2017 Oct 1;177(10):1480-8. PMCID: PMC5710213.

Abstract
IMPORTANCE:
Primary care offers an important and underutilized setting to deliver treatment for opioid and/or alcohol use disorders (OAUD). Collaborative care (CC) is effective but has not been tested for OAUD.

OBJECTIVE:
To determine whether CC for OAUD improves delivery of evidence-based treatments for OAUD and increases self-reported abstinence compared with usual primary care.

DESIGN, SETTING, AND PARTICIPANTS:
A randomized clinical trial of 377 primary care patients with OAUD was conducted in 2 clinics in a federally qualified health center. Participants were recruited from June 3, 2014, to January 15, 2016, and followed for 6 months.

INTERVENTIONS:
Of the 377 participants, 187 were randomized to CC and 190 were randomized to usual care; 77 (20.4%) of the participants were female, of whom 39 (20.9%) were randomized to CC and 38 (20.0%) were randomized to UC. The mean (SD) age of all respondents at baseline was 42 (12.0) years, 41(11.7) years for the CC group, and 43 (12.2) yearsfor the UC group. Collaborative care was a system-level intervention, designed to increase the delivery of either a 6-session brief psychotherapy treatment and/or medication-assisted treatment with either sublingual buprenorphine/naloxone for opioid use disorders or long-acting injectable naltrexone for alcohol use disorders. Usual care participants were told that the clinic provided OAUD treatment and given a number for appointment scheduling and list of community referrals.

MAIN OUTCOMES AND MEASURES:
The primary outcomes were use of any evidence-based treatment for OAUD and self-reported abstinence from opioids or alcohol at 6 months. The secondary outcomes included the Healthcare Effectiveness Data and Information Set (HEDIS) initiation and engagement measures, abstinence from other substances, heavy drinking, health-related quality of life, and consequences from OAUD.

RESULTS:
At 6 months, the proportion of participants who received any OAUD treatment was higher in the CC group compared with usual care (73 [39.0%] vs 32 [16.8%]; logistic model adjusted OR, 3.97; 95% CI, 2.32-6.79; P < .001). A higher proportion of CC participants reported abstinence from opioids or alcohol at 6 months (32.8% vs 22.3%); after linear probability model adjustment for covariates (β = 0.12; 95% CI, 0.01-0.23; P = .03). In secondary analyses, the proportion meeting the HEDIS initiation and engagement measures was also higher among CC participants (initiation, 31.6% vs 13.7%; adjusted OR, 3.54; 95% CI, 2.02-6.20; P < .001; engagement, 15.5% vs 4.2%; adjusted OR, 5.89; 95% CI, 2.43-14.32; P < .001) as was abstinence from opioids, cocaine, methamphetamines, marijuana, and any alcohol (26.3% vs 15.6%; effect estimate, β = 0.13; 95% CI, 0.03-0.23; P = .01).

CONCLUSIONS AND RELEVANCE:
Among adults with OAUD in primary care, the SUMMIT collaborative care intervention resulted in significantly more access to treatment and abstinence from alcohol and drugs at 6 months, than usual care.

TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01810159.

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Wu Z, Tang Z, Mao Y, Van Veldhuisen P, Ling W, Liu D, Shen Z, Detels R, Lan G, Erinoff L, Lindblad R. Testing and linkage to HIV care in China: a cluster-randomised trial. The Lancet HIV. 2017 Dec 1;4(12):e555-65.

Abstract
BACKGROUND:
Multistage, stepwise HIV testing and treatment procedures can result in lost opportunities to provide timely antiretroviral therapy (ART). Incomplete engagement of patients along the care cascade translates into high preventable mortality. We aimed to identify whether a structural intervention to streamline testing and linkage to HIV health care would improve testing completeness, ART initiation, and viral suppression and reduce mortality.

METHODS:
We did a cluster-randomised, controlled trial in 12 hospitals in Guangxi, China. All hospitals were required to be level 2A county general hospitals and ART delivery sites. We selected the 12 most similar hospitals in terms of structural characteristics, past patient caseloads, and testing procedures. Hospitals were randomly assigned (1:1) to either the One4All intervention or standard of care. Hospitals were randomised in a block design and stratified by the historical rate of testing completeness of the individual hospital during the first 6 months of 2013. We enrolled patients aged 18 years or older who were identified as HIV-reactive during screening in study hospitals, who sought inpatient or outpatient care in a study hospital, and who resided in the study catchment area. The One4All strategy incorporated rapid, point-of-care HIV screening and CD4 counts, and in-parallel viral load testing, to promote fast and complete diagnosis and staging and provide immediate ART to eligible patients. Participants in control hospitals received standard care services. All enrolled patients were assessed for the primary outcome, which was testing completeness within 30 days, defined as completion of three required tests and their post-test counselling. Safety assessments were hospital admissions for the first 90 days and deaths up to 12 months after enrolment. This trial is registered with ClinicalTrials.gov, number NCT02084316.

FINDINGS:
Between Feb 24 and Nov 25, 2014, we enrolled 478 patients (232 in One4All, 246 in standard of care). In the One4All group, 177 (76%) of 232 achieved testing completeness within 30 days versus 63 (26%) of 246 in the standard-of-care group (odds ratio 19·94, 95% CI 3·86-103·04, p=0·0004). Although no difference was observed between study groups in the number of hospital admissions at 90 days, by 12 months there were 65 deaths (28%) in the in the One4All group compared with 115 (47%) in the standard-of-care group (Cox proportional hazard ratio 0·44, 0·19-1·01, p=0·0531).

INTERPRETATION:
Our study provides strong evidence for the benefits of a patient-centred approach to streamlined HIV testing and treatment that could help China change the trajectory of its HIV epidemic, and help to achieve the goal of an end to AIDS.

FUNDING:
US National Institute on Drug Abuse Clinical Trials Network and China’s National Health and Family Planning Commission.

Read the full commentary here.

Warren CE, Ndwiga C, Sripad P, Medich M, Njeru A, Maranga A, Odhiambo G, Abuya T. Sowing the seeds of transformative practice to actualize women’s rights to respectful maternity care: reflections from Kenya using the consolidated framework for implementation research. BMC women’s health. 2017 Dec;17(1):69.

Abstract
BACKGROUND:
Despite years of growing concern about poor provider attitudes and women experiencing mistreatment during facility based childbirth, there are limited interventions that specifically focus on addressing these issues. The Heshima project is an evidence-based participatory implementation research study conducted in 13 facilities in Kenya. It engaged a range of community, facility, and policy stakeholders to address the causes of mistreatment during childbirth and promote respectful maternity care.

METHODS:
We used the consolidated framework for implementation research (CFIR) as an analytical lens to describe a complex, multifaceted set of interventions through a reflexive and iterative process for triangulating qualitative data. Data from a broad range of project documents, reports, and interviews were collected at different time points during the implementation of Heshima. Assessment of in-depth interview data used NVivo (Version 10) and Atlas.ti software to inductively derive codes for themes at baseline, supplemental, and endline. Our purpose was to generate categories of themes for analysis found across the intervention design and implementation stages.

RESULTS:
The implementation process, intervention characteristics, individual champions, and inner and outer settings influenced both Heshima’s successes and challenges at policy, facility, and community levels. Implementation success stemmed from readiness for change at multiple levels, constant communication between stakeholders, and perceived importance to communities. The relative advantage and adequacy of implementation of the Respectful Maternity Care (RMC) resource package was meaningful within Kenyan politics and health policy, given the timing and national promise to improve the quality of maternity care.

CONCLUSION:
We found the CFIR lens a promising and flexible one for understanding the complex interventions. Despite the relatively nascent stage of RMC implementation research, we feel this study is an important start to understanding a range of interventions that can begin to address issues of mistreatment in maternity care; replication of these activities is needed globally to better understand if the Heshima implementation process can be successful in different countries and regions.

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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.

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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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