Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia

Chandra, Divya K; Bazazi, Alexander R.; Solim, Muzammil A Nahaboo; Kamarulzaman, Adeeba; Altice, Frederick L.; Culbert, Gabriel J.

doi:10.1080/15284336.2019.1603433

Cited by 8 publications

(9 citation statements)

References 62 publications

(77 reference statements)

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“…It should be noted that methadone could have positively impacted other health and social outcomes in our sample including potentially by reducing injection drug use, but this was not the focus of this analysis. Implementation challenges as well as barriers and facilitators to postrelease retention in this trial have been previously reported [ 44 , 46 ].…”

Section: Discussionmentioning

confidence: 99%

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Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia

et al. 2022

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Introduction Mortality is elevated after prison release and may be higher in people with HIV and opioid use disorder (OUD). Maintenance with opioid agonist therapy (OAT) like methadone or buprenorphine reduces mortality in people with OUD and may confer benefits to people with OUD and HIV leaving prison. Survival benefits of OAT, however, have not been evaluated prospectively in people with OUD and HIV leaving prison. Methods This study prospectively evaluated mortality after prison release and whether methadone initiated before release increased survival after release in a sample of men with HIV and OUD (n = 291). We linked national death records to data from a controlled trial of prerelease methadone initiation conducted from 2010 to 2014 with men with HIV and OUD imprisoned in Malaysia. Vital statistics were collected through 2015. Allocation to prerelease methadone was by randomization (n = 64) and participant choice (n = 246). Cox proportional hazards models were used to estimate treatment effects of prerelease methadone on postrelease survival. Results Overall, 62 deaths occurred over 872.5 person-years (PY) of postrelease follow-up, a crude mortality rate of 71.1 deaths per 1000 PY (95% confidence interval [CI] 54.5–89.4). Most deaths were of infectious etiology, mostly related to HIV. In a modified intention-to-treat analysis, the impact of prerelease methadone on postrelease mortality was consistent with a null effect in unadjusted (hazard ratio [HR] 1.3, 95% CI 0.6–3.1) and covariate-adjusted (HR 1.2, 95% CI 0.5–2.8) models. Predictors of mortality were educational level (HR 1.4, 95% CI 1.0–1.8), pre-incarceration alcohol use (HR 2.0, 95% CI 1.1–3.9), and lower CD4+ T-lymphocyte count (HR 0.8 per 100-cell/mL increase, 95% CI 0.7–1.0). Conclusions Postrelease mortality in this sample of men with HIV and OUD was extraordinarily high, and most deaths were likely of infectious etiology. No effect of prerelease methadone on postrelease mortality was observed, which may be due to study limitations or an epidemiological context in which inadequately treated HIV, and not inadequately treated OUD, is the main cause of death after prison release. Trial registration: NCT02396979. Retrospectively registered 24/03/2015

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Section: Discussionmentioning

confidence: 99%

“…The primary outcome of the trial was sexual and injection-related risk behaviors during the first year postrelease [ 44 , 46 ]. In this paper, we present a secondary analysis of post-release mortality that was developed to more closely examine high rates of study attrition amidst high numbers of participant deaths.…”

Section: Methodsmentioning

confidence: 99%

Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia

et al. 2022

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“…Multivariable Cox regression incorporated time-to-event covariates such as methadone dosage (low, medium, high), previous experience of OAT, type of site, HIV status, and region. Since people released from prison are at increased risk of treatment discontinuation ( Bachireddy et al, 2022 ; Chandra et al, 2019 ), the estimates were controlled for the additional variable reflecting loss-to-follow-up after release. Hazard ratios were adjusted for the year of enrollment to minimize temporal change biases in treatment, political and secular trends.…”

Section: Methodsmentioning

confidence: 99%

Implementation opportunities for scaling up methadone maintenance treatment in Kyrgyzstan: Methadone dosage and retention on treatment over two years

Ivasiy

Madden

Farnum

et al. 2022

Drug and Alcohol Dependence Reports

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“…The primary outcome of the trial was sexual and injection-related risk behaviors during the rst year postrelease [45,47]. In this paper, we present a secondary analysis of post-release mortality that was developed to more closely examine high rates of study attrition amidst high numbers of participant deaths.…”

Section: Methodsmentioning

confidence: 99%

Impact of Prerelease Methadone on Mortality Among People with HIV and Opioid Use Disorder After Prison Release: Results from a Randomized and Participant Choice Open-Label Trial in Malaysia

Bazazi

Culbert

Wegman

et al. 2021

Preprint

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Introduction: Mortality is elevated after prison release and may be higher in people with HIV and opioid use disorder (OUD). Opioid agonist therapy (OAT) with methadone or buprenorphine reduces mortality in people with OUD and may confer benefits to people with OUD and HIV leaving prison. Survival benefits of OAT, however, have not been evaluated prospectively in people with OUD and HIV leaving prison. Methods:This study prospectively evaluated mortality after prison release and whether methadone initiated before release increased survival after release in a sample of men with HIV and OUD (n=291). We linked national death records to data from a controlled trial of prerelease methadone initiation conducted from 2010 to 2014 with men with HIV and OUD imprisoned in Malaysia. Vital statistics were collected through 2015. Allocation to prerelease methadone was by randomization (n=64) and participant choice (n=246). Cox proportional hazards models were used to estimate treatment effects of prerelease methadone on postrelease survival. Results: Overall, 62 deaths occurred over 872.5 person-years (PY) of postrelease follow-up, a crude mortality rate of 71.1 deaths per 1000 PY (95% confidence interval [CI] 54.5–89.4). Most deaths were of infectious etiology. In a modified intention-to-treat analysis, the impact of prerelease methadone on postrelease mortality was consistent with a null effect in unadjusted (hazard ratio [HR] 1.3, 95% CI 0.6–3.1) and covariate-adjusted (HR 1.2, 95% CI 0.5–2.8) models. Predictors of mortality were educational level (HR 1.4, 95% CI 1.0–1.8), pre-incarceration alcohol use (HR 2.0, 95% CI 1.1–3.9), and lower CD4+ T-lymphocyte count (HR 0.8 per 100-cell/mL increase, 95% CI 0.7–1.0). Conclusions: Mortality after prison release in this sample of men with HIV and OUD was extraordinarily high and unaffected by prerelease methadone. Treatment of OUD alone may be insufficient to reduce mortality in settings where inadequately treated HIV is the main cause of death after prison release. Trial registration number: NCT02396979. Retrospectively registered 24/03/2015.

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Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia

Cited by 8 publications

References 62 publications

Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia

Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia

Implementation opportunities for scaling up methadone maintenance treatment in Kyrgyzstan: Methadone dosage and retention on treatment over two years

Impact of Prerelease Methadone on Mortality Among People with HIV and Opioid Use Disorder After Prison Release: Results from a Randomized and Participant Choice Open-Label Trial in Malaysia

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