Prisoners - "Approximately 60% of participants had an undetectable plasma HIV RNA 24 weeks after release"
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"In this first randomized trial of an intervention to maintain control of viremia among HIV-infected men and women being released from prison, we found higher levels of viral suppression and care engagement than expected based on findings of previous studies of prison and jail releasees.14-17,19,43 Approximately 60% of participants had an undetectable plasma HIV RNA 24 weeks after release and close to 80% attended at least 1 community clinic appointment. By contrast, Baillargeon et al14 reported that just 18% of HIV-infected men and women released from TX state prisons between 2004 and 2007 filled an ART prescription 30 days after release, increasing to only 30% by 60 days. Furthermore, in a subanalysis of 1750 of the releasees returning to the greater Houston area, 28% had a record of attending an HIV clinic by 90 days after release.44
Overall, we observed higher rates of viral suppression and medical care engagement than expected based on previous literature among HIV-infected patients with suppressed viremia released from prison in TX and NC. However, randomization to a comprehensive intervention designed to motivate HIV-infected prison releasees to access HIV care after community re-entry, facilitate linkage to medical care, and support ART adherence increased engagement in medical care after release but did not result in significantly different rates of viral suppression than randomization to standard discharge planning. Additional research is needed to better understand the factors influencing prison releasees' linkage to community care, medication adherence, and maintenance of viral suppression. The characterization of these factors is essential to inform policy and other strategic approaches to HIV prevention and treatment in the United States."
NBC News - Jul 14 2017
For Many Prisoners With HIV, Getting Care Is Harder After Release
New data is bringing to light the unmet needs of ex-prisoners living with HIV.
Researchers at the University of North Carolina and Texas Christian University reviewed the transition of HIV-infected individuals from incarceration back into their communities. They found 40 percent of the individuals interviewed were unable to sustain viral suppression six months after community re-entry.
"There's a connection between the HIV epidemic and the mass incarceration epidemic we have in this country," Dr. David Wohl, co-director of HIV Services at the North Carolina Department of Corrections, told NBC News.
Dr. Wohl, who is also a professor at the UNC School of Medicine, said many people have an upside-down view of HIV among prisoners. He says it is widely believed, for example, that prisoners contract HIV while incarcerated, when the truth is that most are infected before entering prison.
"The reality is that we do a really good job of locking up people who have risk factors for HIV," he said. "That's a byproduct of who we lock up. We lock up people of color and people who have mental health issues."
A 2015 study from the Urban Institute pointed out that more than half of all inmates in jails and state prisons are mentally ill. And black Americans are incarcerated five times more than white Americans, according to the Sentencing Project.
Dr. Wohl said that the biggest challenge facing ex-prisoners with HIV is continuing their care after they are released. In prison, care is regimented.
"By and large, people get great HIV care in prison," Dr. Wohl said. "But when they get out, they come back to a system that isn't taking care of them, and they have to face issues with housing and employment.
"Getting out is something people want to do, but it's stressful, and taking care of your virus might not be the most important thing to do," he added.
Dr. Wohl said he's tackling this dilemma using a "kitchen sink" approach. In tandem with HIV Services in North Carolina's Department of Corrections, counselors are brought in to discuss treatment with prisoners who are slated for release, and actors portray what it's like to get out and find care. A needs assessment is done, and a cell phone is provided for free that is programmed to remind ex-prisoners to take their medicine.
While HIV care in prison is regimented, Dr. Wohl said treatment is not without its challenges. For example, preexisting stigmas against those with HIV are amplified in the prison system, he said, noting many prisoners don't want to stand in a public line to receive their HIV medicine and face being ostracized - or worse.
For vulnerable communities, the structural obstacles are manifold: They are overrepresented in the criminal justice system but do not have adequate access to health care outside of it. Dr. Wohl argues this makes the issue of ex-prisoners struggling with managing their HIV a problem for policymakers.
"Really what's needed is great policy that doesn't lead to people getting incarcerated at the rates we're seeing right now," Dr. Wohl said. "The writing on the wall is that these people aren't given a fair chance."
Randomized Controlled Trial of an Intervention to Maintain Suppression of HIV Viremia After Prison Release: The imPACT Trial
JAIDS May 1 2017 - Wohl, David A. MD*; Golin, Carol E. MD*; Knight, Kevin PhD†; Gould, Michele MPH†; Carda-Auten, Jessica MPH*; Groves, Jennifer S. MBA*; Napravnik, Sonia PhD*; Cole, Stephen R. PhD*; White, Becky L. MD*; Fogel, Cathie PhD*; Rosen, David L. MD, PhD*; Mugavaro, Michael J. MD‡; Pence, Brian W. PhD*; Flynn, Patrick M. PhD*
Background: HIV-infected individuals transitioning from incarceration to the community are at risk for loss of viral suppression. We compared the effects of imPACT, a multidimensional intervention to promote care engagement after release, to standard care on sustaining viral suppression after community re-entry.
Methods: This trial randomized 405 HIV-infected inmates being released from prisons in Texas and North Carolina with HIV-1 RNA levels <400 copies/mL to imPACT versus standard care. The imPACT arm received motivational interviewing prerelease and postrelease, referral to care within 5 days of release, and a cellphone for medication text reminders. The standard care arm received routine discharge planning and a cellphone for study staff contact. The primary outcome was the difference between arms in week 24 postrelease viral suppression (HIV-1 RNA <50 copies/mL) using intention-to-treat analysis with multiple imputation of missing data.
Results: The proportion with 24-week HIV-1 RNA <50 copies/mL was 60% and 61% in the imPACT and standard care arms, respectively [odds ratio for suppression 0.95 (95% confidence interval: 0.59 to 1.53)]. By week 6 postrelease, 86% in the imPACT arm versus 75% in the standard care arm attended at least 1 nonemergency clinic visit (P = 0.02). At week 24, 62% in both arms reported not missing any antiretroviral doses in the past 30 days (P > 0.99).
Conclusions: Higher rates of HIV suppression and medical care engagement than expected based on previous literature were observed among HIV-infected patients with suppressed viremia released from prison. Randomization to a comprehensive intervention to motivate and facilitate HIV care access after prison release did not prevent loss of viral suppression. A better understanding of the factors influencing prison releasees' linkage to community care, medication adherence, and maintenance of viral suppression is needed to inform policy and other strategic approaches to HIV prevention and treatment.
In this first randomized trial of an intervention to maintain control of viremia among HIV-infected men and women being released from prison, we found higher levels of viral suppression and care engagement than expected based on findings of previous studies of prison and jail releasees.14-17,19,43 Approximately 60% of participants had an undetectable plasma HIV RNA 24 weeks after release and close to 80% attended at least 1 community clinic appointment. By contrast, Baillargeon et al14 reported that just 18% of HIV-infected men and women released from TX state prisons between 2004 and 2007 filled an ART prescription 30 days after release, increasing to only 30% by 60 days. Furthermore, in a subanalysis of 1750 of the releasees returning to the greater Houston area, 28% had a record of attending an HIV clinic by 90 days after release.44
However, unlike the imPACT trial, the study by Baillargeon et al included those without as well as with viral suppression at the time of release. Individuals unable to achieve control of their HIV infection in prison can be expected to face considerable challenges doing so in the less-structured environment of their community. While in their study less than half of the HIV-infected individuals released from the TX prisonsystem during the period of study had achieved an undetectable viral load during incarceration, those that did had a significantly higher likelihood of filling their ART prescription during the 3-month postrelease observation period. As ART fill rates were greater in this subgroup and increased over time after release, it is conceivable that a substantial proportion of those who left prison with an undetectable viral load filled their HIV medication prescription at 6 months after release.
It is also notable that the rates of viral suppression Springer et al15 reported in their study of prison releasees in New Haven with opioid dependency were comparable with those found in the imPACT trial, with 55% of the control arm having an undetectable HIV RNA level at week 24 after their release. In that study, 73% had a plasma HIV RNA level <400 copies/mL at baseline and, again, undetectable viremia at study entry was strongly associated with viral suppression at 24 weeks.
In the imPACT trial, those randomized to a comprehensive intervention-designed to enhance motivation and self-efficacy to access community HIV care, minimize barriers to such care, and support ART adherence-were no more likely to maintain viral suppression than those receiving standard prerelease discharge planning only. Specifically, analyses including multiple imputation of missing HIV-1 RNA levels found similar rates of viral suppression and failed to detect a significant difference in the primary outcome between the study arms. Participants in both study groups experienced a steady and similar loss of prerelease viral suppression after release. Likewise, viremia copy-years, which quantifies the cumulative HIV-1 RNA exposure over time, was similar between the study groups. Approximately a third of participants in each study arm did not contribute data at the 24-week postrelease time point, and in our primary ITT analysis, we used multiple imputation to impute missing values. Most of these participants were reincarcerated, and it is possible, if not likely, that many of those returning to prison re-established suppression of HIV. In analyses that excluded those who were reincarcerated or lost to follow-up for another reason, no statistically significant difference in 24-week postrelease viral suppression was found.
Previous studies of HIV-infected releasees highlight the many challenges the formerly incarcerated face in successfully managing their HIV infection.45-47 Although most of the participants were able to maintain viral suppression over the course of postrelease follow-up, the steady decline in viral suppression observed in the imPACT arm, despite its multilevel and evidence-based components, may be due to a profound counter effect from forces that were not addressed adequately by the intervention. There may have been limitations to the support that clinical care centers could provide to these individuals-newly released from prison and saddled with comorbid substance use and mental health disorders, poverty, homelessness, lack of social support, and myriad other challenges. HIV-infected prisoners facing multiple critical life needs that make it difficult for consistent HIV care engagement to be a top priority is a well-described phenomenon.45,46 Our results also imply a need for interventions that directly address the chaotic social environments to which former inmates return and the pervasive and entrenched contextual factors, such as discrimination, inequality, poverty reinforcing policies, and practices-collectively termed, structural violence48-that act as obstacles to desired outcomes such as long-lasting suppression of HIV.
Alternatively, study participation itself could have served as an intervention that promoted care engagement, ART access, and viral suppression-including in the control arm. Participants in both study arms received flip-type cellphones at release. In the case of the control participants, these phones were intended to facilitate study retention. It is unclear to what extent the phones were instrumental to health care access. In addition, regular contact with study data collection staff could have been perceived by participants as being supportive, and this too may have had a positive influence on the study outcomes.
In contrast to the absence of a difference in virologic outcomes when comparing the imPACT and standard-of-care arms, a significantly greater proportion of those in the intervention group accessed nonemergency community medical care within 6 weeks of release than those in the standard-of-care group (86% versus 75%; P = 0.02). The finding of a disconnect between access to community medical care and HIV-1 RNA levels suggests that linkage to care is insufficient when the objective is suppression of HIV viremia. A major assumption of the imPACT intervention was that linkage to community care, when combined with counseling to enhance motivation to engage in care, would lead to ART access and services that would support adherence and address unmet needs. This assumption is logical, as community clinics refill prescribed ART and early linkage to HIV care has been found to improve outcomes, including viral suppression. This model of linkage to community providers of care, rather than ongoing direct provision of such services, is also more sustainable. However, despite higher rates of community care engagement, those in the intervention arm fared no better virologically than those in the standard-of-care arm.
That engagement in HIV care does not ensure virologic success is also evident when considering the HIV Care Cascade, where the drop in the proportion of those having entered HIV care who are subsequently retained in care is the deepest of all the "steps" included in this model.7 However, it is notable that in our study, the mean number of clinic visits in both the intervention and standard-of-care groups was similar and relatively high (almost 3 visits over 24 weeks). Therefore, the progressive loss of virologic suppression observed is not clearly explained by a lack of retention in community care.
Access to clinical care does not necessarily ensure access to ART and barriers to procurement of medications or nonadherence could also explain the observed discordance between care engagement and viral suppression. Most released inmates with HIV infection are eligible for free ART provided by state AIDS Drug Assistance Programs, and at follow-up, the majority of study participants reported having access to ART. The study population consisted largely of those with substance use problems and many with high levels of psychological distress. Such comorbidities are known risks for suboptimal adherence to ART and HIV care and likely also complicated postrelease management of HIV.49,50
As in any research trial, there are limitations to the study that should be considered when interpreting the results. As mentioned above, the rate of participant loss to follow-up, largely driven by reincarceration, was, not unexpectedly, high at 33%. Viral suppression may have been maintained or regained with reincarceration for many participants. However, HIV-1 RNA levels were not available from those who returned to prison, and the balanced rates of reincarceration between the study arms suggests that these results, if available, might raise the overall rates of viral suppression. Clinical care engagement was gauged by attending a community clinic appointment. This is acknowledged to be a minimal degree of engagement, and it is reassuring that participants in both arms tended to enter care early after release and return to clinic over course of the observation period. It should be noted that this trial enrolled individuals incarcerated at state prisons and not jails. Persons leaving jail may face different hurdles to maintaining viral suppression than those re-entering their community from prison and have been reported to have even lower rates of successful linkage.43 Lastly, this trial was conducted in TX and NC, and the same intervention could produce different outcomes in a different location. However, that an interaction between site (ie, state) and the primary outcome was not observed (data not shown) supports the generalizability of the study results.
Overall, we observed higher rates of viral suppression and medical care engagement than expected based on previous literature among HIV-infected patients with suppressed viremia released from prison in TX and NC. However, randomization to a comprehensive intervention designed to motivate HIV-infected prison releasees to access HIV care after community re-entry, facilitate linkage to medical care, and support ART adherence increased engagement in medical care after release but did not result in significantly different rates of viral suppression than randomization to standard discharge planning. Additional research is needed to better understand the factors influencing prison releasees' linkage to community care, medication adherence, and maintenance of viral suppression. The characterization of these factors is essential to inform policy and other strategic approaches to HIV prevention and treatment in the United States.
Participants and Sites
Eligible participants were HIV-infected men and women, age 18 years and older incarcerated within the Texas Department of Criminal Justice (TDCJ) or North Carolina Department of Public Safety (NCDPS) prison, treated with ART with a recorded plasma HIV RNA level of <400 copies/mL within the past 90 days, and expected to be released to the community within approximately 12 weeks. In addition, participants were required to be English speaking and, to minimize risk to study staff, to have not been convicted of violent offenses, such as those related to sexual assault, serious injury, or death. All had to be willing and able to provide written informed consent.
Study screening and recruitment occurred at prison medical clinics during routine visits or in a secured room within the prison unit. Interested patients met in a secure but private area with a research associate, who, as part of the informed consent process, explained the study and answered questions regarding participation.
The efficacy of antiretroviral therapy (ART) in preventing secondary HIV transmission coupled with the recognition that many HIV-infected persons in the United States are undiagnosed or not in care have led to a strategy to expand HIV testing, and strengthen the uptake and continued use of HIV therapy for those infected.1-9 This multifaceted seek, test, treat, and retain approach to HIV prevention is readily applied to correctional settings, such as prisons, where the prevalence of HIV infection is several times that of the general population, and routine HIV screening provides opportunities for detection and treatment during incarceration.10-13
Although HIV testing is commonplace in US prisons and ART is freely accessible to inmates,13 retention in HIV care after prison release has been reported to be less successful. In an analysis of ART prescription fill records for 2115 individuals released from state prison in Texas from 2004 to 2007, 55% with a plasma HIV RNA level below the limits of assay detection just before release, only 30% of releasees had filled their ART prescription by 60 days after community re-entry.14 Postrelease HIV RNA level data were not collected. Achievement of an undetectable plasma HIV RNA level was the primary outcome of a substudy of 94 HIV-infected patients with a history of opioid dependence participating in a larger randomized trial of directly observed administration of ART after prison release in Connecticut.15 At baseline, 54% had an undetectable viral load, and this was largely unchanged by 24 weeks after release when 58% had viral suppression. The highest rate of controlled viremia was among those who were maintained on buprenorphine (82%) and lowest rate was observed in the control arm that did not receive substitution therapy (55%). There was no significant effect of directly observed administration of ART on viral suppression in this or the larger parent trial. Studies of HIV-infected prisoners who were released and then reincarcerated provide additional virologic outcome data after prison release, and in these, viral suppression at reincarceration has been found to be the exception rather than the rule.16,17
Interventions to support HIV care, ART adherence, and viral suppression after prison release also have been explored. Zaller et al18described the successful implementation of a comprehensive case management program linking over 95% of incarcerated HIV-infected prison releasees to community care and services in Rhode Island. However, a controlled trial of a similar intervention that enrolled 104 HIV-infected prisoners released in North Carolina found no significant difference in 24-week rates of community medical care access between those randomized to the intervention (92%) and to standard discharge planning conducted by prison staff (89%).19 Virologic outcomes were not assessed.
Almost all the previous research that has examined HIV-related clinical outcomes after prison release in the United States was conducted a decade ago, when ART tended to be more cumbersome and less forgiving of all but high-level adherence. Furthermore, individuals with suppressed and detectable viremia at the time of prison release were typically enrolled-mixing the maintenance of viral suppression with the achievement of viral suppression after community re-entry.
Given the limitations of the research published to date and the importance to successful HIV prevention of developing interventions that effectively support the continuity of HIV care and maintenance of ART through the transition from imprisonment to community re-entry, we developed a multidimensional intervention rooted in the seek, test, treat, and retain approach, called imPACT (Individuals Motivated to Participate in Adherence, Care and Treatment).20 Designed to promote engagement in HIV care after release for HIV-infected prisoners, imPACT consisted of 3 main components: motivational interviewing before and after release, prerelease needs assessment and community medical care link coordination, and cellphone provision with texted reminders before each antiretroviral medication dose. By design, the focus of the imPACT intervention was linkage to community clinics, where assessments of need could be conducted and supportive services provided.
In a randomized controlled trial conducted in Texas and North Carolina-states that combined incarcerate approximately 1 in 7 of all prison inmates in the United States-the imPACT intervention was compared with the standard discharge planning for maintaining viral suppression in HIV-infected individuals released from state prison in both states.