Rationale, design, and sample characteristics of a randomized controlled trial of directly observed antiretroviral therapy delivered in methadone clinics

Berg, Karina M.; Mouriz, Jennifer; Li, Xuan; Duggan, Elise; Goldberg, Uri; Arnsten, Julia H.

doi:10.1016/j.cct.2009.05.003

Cited by 25 publications

(33 citation statements)

References 27 publications

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“…19 Briefly, methadone-maintained patients were randomly assigned to one of two ART groups for 24 weeks: DOT intervention or treatment as usual (TAU) control. The trial was conducted on-site in a network of methadone clinics at the Albert Einstein College of Medicine and Montefiore Medical Center in the Bronx, New York.…”

Section: Design and Settingmentioning

confidence: 99%

Directly Observed Antiretroviral Therapy in Substance Abusers Receiving Methadone Maintenance Therapy Does Not Cause Increased Drug Resistance

Brust

Litwin

Berg

et al. 2011

AIDS Research and Human Retroviruses

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Direct observation of antiretroviral therapy (DOT) can increase adherence rates in HIV-infected substance users, but whether this affects the development of antiretroviral drug resistance has not been fully explored. We conducted a 24-week randomized controlled trial of methadone clinic-based antiretroviral DOT compared with treatment as usual (TAU) among antiretroviral-experienced substance users. To examine the development of new resistance mutations, we identified all participants with an amplifiable resistance test at both baseline and either week 8 or week 24. We compared the development of new drug resistance mutations between participants in the two arms of the trial. Among the 77 participants enrolled in the parent trial, antiretroviral DOT was efficacious for improving adherence and decreasing HIV viral load. Twenty-one participants had a detectable HIV viral load at both baseline and a second time point. Of these, nine developed new drug resistance mutations not seen at baseline (three in the DOT arm and six in the TAU arm; p ¼ 0.27). Overall, five subjects in the TAU arm developed major mutations correlating with their current antiretroviral regimen, while no subjects in the DOT arm developed such mutations. Direct observation of antiretroviral therapy was associated with improved adherence and viral suppression among methadone maintained HIV-infected substance users, but was not associated with an increase in the development of antiretroviral drug resistance. DOT should be considered for substance users attending methadone maintenance clinics who are at high risk of nonadherence.

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Section: Design and Settingmentioning

confidence: 99%

Directly Observed Antiretroviral Therapy in Substance Abusers Receiving Methadone Maintenance Therapy Does Not Cause Increased Drug Resistance

Brust

Litwin

Berg

et al. 2011

AIDS Research and Human Retroviruses

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“…12 Regular, often daily, interactions with health-care providers in the MMT programme: (i) promote the cessation of injecting drug use; (ii) increase adherence to the ART regimen; (iii) ensure regular monitoring of the CD4+ cell count; and (iv) increase opportunities for discussing treatment options, for managing medication side-effects and comorbid conditions and for psychosocial counselling. 20,34,36,37 Thus, the higher CD4+ cell counts we found at ART baseline in patients receiving ART and MMT were not unexpected.…”

Section: Discussionmentioning

confidence: 54%

Methadone maintenance treatment and mortality in HIV-positive people who inject opioids in China

Zhao¹,

Shi²,

McGoogan³

et al. 2013

Bull. World Health Organ.

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“…It is possible that adequate levels of adherence can be maintained through participation in MMT due to being engaged with the health care system where close monitoring through follow-up visits as well additional care to address potential barriers to ART adherence (i.e., co-occurring mental illness) are provided (Spire, Lucas, & Carrieri, 2007). Further, addiction treatment including MMT can improve access to ART, where co-administration of ART with daily dispensed MMT is possible (Berg, Mouriz, Li, Goldberg, & Arnsten, 2009). There are numerous health and social benefits derived from addressing opioid addiction through MMT, including increased employment, physical and mental health, and social functioning (Corsi, Kwiatkowski, & Booth, 2002; Fiellin, O'Connor, Chawarski, Pakes, Pantalon, &Schottenfeld, 2001; Zweben, &Payte, 1990).…”

Section: Discussionmentioning

confidence: 99%

Psychosocial factors in adherence to antiretroviral therapy among HIV-positive people who use drugs.

Lee¹,

Milloy²,

Walsh³

et al. 2016

Health Psychology

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Objectives Sub-optimal adherence to antiretroviral therapy (ART) among HIV-infected people who use illicit drugs (PWUD) remains a significant concern, and there is a lack of effective adherence interventions for this population. Therefore, we sought to identify psychosocial determinants of optimal adherence, including adherence self-efficacy and outcome expectancies, with the aim of informing interventions designed to improve adherence among PWUD. Methods From December 2005 to November 2013, data were derived from the AIDS Care Cohort to evaluate Exposure to Survival Services (ACCESS), a prospective cohort of PWUD in Vancouver, Canada. Multivariable generalized estimating equations (GEE) analysis was used to identify longitudinal factors independently associated with ≥95% adherence to ART. Results Among 667 participants, including 220 (33%) women, 391 (59%) had ≥95% ART adherence at baseline. In multivariable GEE analysis, adherence self-efficacy (Adjusted Odds Ratio [AOR] = 1.16, 95% Confidence Interval [CI]: 1.11 - 1.21 per 10-point increase) was independently and positively associated with adherence, while negative outcome expectancy (AOR = 0.95, 95% CI: 0.93 - 0.98) was negatively associated. Conclusions In light of the ongoing challenges associated with ART adherence among HIV-positive PWUD, and our findings of associations between adherence, self-efficacy and outcomes expectancies, tailored intervention strategies based on constructs of social learning theory should be implemented and evaluated in an effort to improve adherence among HIV-infected PWUD.

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Rationale, design, and sample characteristics of a randomized controlled trial of directly observed antiretroviral therapy delivered in methadone clinics

Cited by 25 publications

References 27 publications

Directly Observed Antiretroviral Therapy in Substance Abusers Receiving Methadone Maintenance Therapy Does Not Cause Increased Drug Resistance

Directly Observed Antiretroviral Therapy in Substance Abusers Receiving Methadone Maintenance Therapy Does Not Cause Increased Drug Resistance

Methadone maintenance treatment and mortality in HIV-positive people who inject opioids in China

Psychosocial factors in adherence to antiretroviral therapy among HIV-positive people who use drugs.

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