Risk of HIV Viral Rebound in the Era of Universal Treatment in a Multicenter Sample of Persons With HIV in Primary Care.

Background: Antiretroviral therapy (ART) is recommended for people with HIV (PWH), irrespective of CD4 cell count, to improve their health and reduce the risk of transmission to sexual partners through long-term viral suppression. We identified risk factors for viral rebound among patients with a period of stable viral suppression to inform counseling and monitoring. Methods: We conducted a multisite, retrospective study of PWH with a 2-year period of sustained viral suppression in the United States using the Centers for AIDS Research Network of Integrated Clinical Systems cohort. We used multivariable logistic regression to identify characteristics independently associated with any viral rebound (viral load [VL] ≥200 copies/mL) and sustained viral rebound (VL ≥200 copies/mL followed by a VL that was also ≥200 copies/mL within 6 months), within 2 years of follow-up. Results: Among 3496 eligible patients with a 2-year period of sustained viral suppression, most (90%) continued to have viral suppression over 2 additional years; 10% experienced viral rebound, and 4% experienced sustained viral rebound. In multivariable analyses, Black race, current smoking, integrase strand transfer inhibitor use, and 5- to 9-year duration of ART were positively associated, and being age ≥50 years was negatively associated, with any viral rebound. Only current smoking and 5- to 9-year (vs 2- to 4-year) duration of ART were positively associated, and being age ≥60 years was negatively associated, with sustained viral rebound. Conclusions: Most people retained in clinical care and with HIV viral suppression on ART will have persistent viral suppression. However, some patients may benefit from additional treatment adherence support.

DirectDetect SARS-CoV-2 Direct Real-Time RT-PCR Study Using Patient Samples.

COVID-19 is an infectious disease that caused a global pandemic affecting people worldwide. As disease detection and vaccine rollout continue to progress, there is still a need for efficient diagnostic tools to satisfy continued testing needs. This preliminary study evaluated a novel SARS-CoV-2 diagnostic test called DirectDetect SARS-CoV-2 Direct Real-time reverse transcriptase polymerase chain reaction (RT-PCR) based on a limited sample size of 24 respiratory samples from 14 SARS-CoV-2-positive patients. The test is advantageous compared to others on the market since it does not require viral transport medium or viral RNA extraction prior to nucleic acid amplification and detection. This capability transforms the hours-long sample preparation time into a minutes-long procedure while also eliminating the need for many costly reagents which may be difficult to obtain during the surge in nucleic acid-based testing during the pandemic. The results show a positive agreement of 94.7, 100, and 94.7% between dry sample swabs, treated samples, and untreated samples tested using the DirectDetect SARS-CoV-2 Direct Real-time RT-PCR compared to tests used in a clinical laboratory, respectively. The findings indicate that DirectDetect can be used for multiple different sample types while reducing the number of reagents and time needed for diagnosis. Although this study shows promising results using the DirectDetect results, further validation of this test using a larger sample set is required to assess the true performance of this test.

Validity of Self-Reported Hepatitis C Virus Status Among Criminal Justice-Involved Persons Living With HIV.

The prevalence of HIV/hepatitis C virus (HCV) coinfection among justice-involved persons is high. The validity of self-reported HCV status in this population has important public health implications, yet has not been studied. Justice-involved persons with HIV from Washington, DC, were enrolled in a study that investigated a mobile health intervention to support HIV treatment. Self-reported and laboratory-confirmed HCV status was compared. Among 103 participants, chronic HCV prevalence was 13%. Positive predictive value of self-reported positive chronic HCV status was low at 55%, and negative predictive value was 98%. Cohen's kappa statistic was 0.60 for agreement. Two women who reported negative HCV status were found to have HCV.

HIV Drug Resistance and Transmission Networks Among a Justice-Involved Population at the Time of Community Reentry in Washington, D.C.

Justice-involved (JI) populations bear a disproportionate burden of HIV infection and are at risk of poor treatment outcomes. Drug resistance prevalence and emergence, and phylogenetic inference of transmission networks, understudied in vulnerable JI populations, can inform care and prevention interventions, particularly around the critical community reentry period. We analyzed banked blood specimens from CARE+ Corrections study participants in Washington, D.C. (DC) across three time points and conducted HIV drug resistance testing using next-generation sequencing (NGS) at 20% and 5% thresholds to identify prevalent and evolving resistance during community reentry. Phylogenetic analysis was used to identify molecular clusters within participants, and in an extended analysis between participants and publicly available DC sequences. HIV sequence data from 54 participants (99 specimens) were analyzed. The prevalence of transmitted drug resistance was 14% at both thresholds, and acquired drug resistance was 47% at 20%, and 57% at 5% NGS thresholds, respectively. The overall prevalence of drug resistance was 43% at 20%, and 52% at 5% NGS thresholds, respectively. Among 34 participants sampled longitudinally, 21%-35% accumulated 10-17 new resistance mutations during a mean 4.3 months. In phylogenetic analysis within the JI population, 11% were found in three molecular clusters. The extended phylogenetic analysis identified 46% of participants in 22 clusters, of which 21 also included publicly-available DC sequences, and one JI-only unique dyad. This is the first study to identify a high prevalence of HIV drug resistance and its accumulation in a JI population during community reentry and suggests phylogenetic integration of this population into the non-JI DC HIV community. These data support the need for new, effective, and timely interventions to improve HIV treatment during this vulnerable period, and for JI populations to be included in broader surveillance and prevention efforts.

The Implementation of a Text Messaging Intervention to Improve HIV Continuum of Care Outcomes Among Persons Recently Released From Correctional Facilities: Randomized Controlled Trial.

BACKGROUND: Previously incarcerated individuals have suboptimal linkage and engagement in community HIV care. Mobile health (mHealth) interventions have been shown to be effective in addressing these gaps. In Washington, District of Columbia (DC), we conducted a randomized trial of an SMS text messaging-based mHealth intervention (CARE+ Corrections) to increase linkage to community HIV care and antiretroviral treatment adherence among HIV-infected persons involved in the criminal justice system. OBJECTIVE: This study aimed to describe the SMS text messaging-based intervention, participant use of the intervention, and barriers and facilitators of implementation. METHODS: From August 2013 to April 2015, HIV-positive incarcerated individuals were recruited within the DC Department of Corrections, and persons released in the past 6 months were recruited within the community via street-based recruitment, community partnerships, and referrals. Participants were followed for 6 months and received weekly or daily SMS text messages. Formative research resulted in the development of the content of the messages in 4 categories: HIV Appointment Reminders, Medication Adherence, Prevention Reminders, and Barriers to Care following release from jail. Participants could customize the timing, frequency, and message content throughout the study period. RESULTS: Of the 112 participants enrolled, 57 (50.9%) were randomized to the intervention group and 55 (49.1%) to the control group; 2 control participants did not complete the baseline visit, and were dropped from the study, leaving a total of 110 participants who contributed to the analyses. Study retention was similar across both study arms. Median age was 42 years (IQR 30-50), 86% (49/57) were black or African American, 58% (33/57) were male, 25% (14/57) were female, and 18% (10/57) were transgender. Median length of last incarceration was 4 months (IQR 1.7-9.0), and median lifetime number of times incarcerated was 6.5 (IQR 3.5-14.0). Most participants (32/54, 59%) had a baseline viral load of <200 copies/mL. Nearly all participants (52/57, 91%) chose to use a cell phone provided by the study. The most preferred Appointment Reminder message was Hey how you feeling? Don't forget to give a call and make your appointment (19/57, 33%). The most preferred Medication Adherence message was Don't forget your skittles! (31/57, 54%), and 63% (36/57) of participants chose to receive daily (vs weekly) messages from this category at baseline. The most preferred Prevention Reminder message was Stay strong. Stay clean (18/57, 32%). The most preferred Barriers to Care message was Holla at your case manager, they're here to help (12/57, 22%). Minor message preference differences were observed among participants enrolled in the jail versus those from the community. CONCLUSIONS: Participants' ability to customize their SMS text message plan proved helpful. Further large-scale research on mHealth platforms is needed to assess its efficacy among HIV-infected persons with a history of incarceration. TRIAL REGISTRATION: ClinicalTrials.gov NCT01721226; https://clinicaltrials.gov/ct2/show/NCT01721226.

Use of an mHealth Intervention to Improve Engagement in HIV Community-Based Care Among Persons Recently Released from a Correctional Facility in Washington, DC: A Pilot Study.

We examined the preliminary effectiveness of a computerized counseling session plus post-incarceration text messaging intervention (CARE + Corrections) to support ART adherence and linkage/engagement in community care among recently incarcerated persons with HIV in Washington, D.C. Recently incarcerated persons with HIV ≥ 18 years old were recruited from the D.C. jail or community outreach and randomized to CARE + Corrections or control arm. Participants completed assessments at baseline, 3-months and 6-months. Multivariable random effects modeling identified predictors of suppressed viral load (≤ 200 copies/mL) and engagement in HIV care at 6 months. Participants (N = 110) were aged 42 (IQR 30-49); 58% male, 24% female, 18% transgender, 85% Black, and lifetime incarceration was a median of 7 years (IQR 2-15). More controls had a regular healthcare provider at baseline. Although not statistically significant, intervention participants had increased odds of viral suppression versus controls at 6 months (AOR 2.04; 95% CI 0.62, 6.70). Those reporting high ART adherence at baseline had higher odds of viral suppression at follow-up (AOR 10.77; 95% CI 1.83, 63.31). HIV care engagement was similar between the two groups, although both groups reported increased engagement at 6 months versus baseline. We observed a positive but non-significant association of viral suppression in the CARE + Corrections group, and care engagement increased in both groups after 6 months. Further attention to increasing viral suppression among CJ-involved persons with HIV upon community reentry is warranted.

Syndemic effect of mental illness and substance use on viral suppression among recently-incarcerated, HIV-infected individuals in the CARE+ Corrections study.

Few studies on HIV-related syndemics of co-occurring and mutually reinforcing psychosocial conditions have assessed clinical outcomes in criminal justice (CJ)-involved populations. Baseline data from the CARE+ Corrections study were used to quantify co-occurring mental illness and substance use and examine syndemic effects on viral suppression among 106 CJ-involved HIV-infected individuals. Ninety-one (86%) reported a mental illness diagnosis, 30 (28%) reported hazardous alcohol use, and 61 (58%) were drug dependent. Eighteen (17%) experienced all three conditions. Drug dependence was clustered with mental illness (prevalence odds ratio [POR] 3.20, 95% CI 1.01-10.14) and hazardous alcohol use (POR 2.61, 95% CI 1.03-6.56). The association between syndemic score, representing the number of conditions reported by each individual, and viral suppression was not statistically significant, although 86% of participants with none of these conditions were virally suppressed, compared to 56% of those with all three (p = 0.56). Mental illness and substance use were concentrated in this sample, indicating a need for integrated care services.

The HIV Care Cascade Among Individuals Under Community Supervision in Baltimore, Maryland.

An estimated one in seven HIV-infected individuals pass through U.S. correctional facilities each year. Transitioning from correctional to community settings may increase HIV treatment interruptions and increase the risk of continued HIV transmission in the community. This study assessed access to HIV providers in the community, antiretroviral treatment, and viral suppression to inform the development of interventions to improve HIV treatment outcomes among individuals involved in community corrections. The sample included 100 individuals under community supervision (probation or parole) in Baltimore, Maryland. While a large proportion of the study sample had undetectable HIV viral loads, 39% did not, and this represents a significant HIV transmission risk. Given the large proportion of individuals involved in the criminal justice system who are under community supervision, community corrections may be an important point of intervention to engage or reengage HIV-positive individuals who are currently out of care.

Gender Differences in HIV Care among Criminal Justice-Involved Persons: Baseline Data from the CARE+ Corrections Study.

BACKGROUND: HIV-infected individuals recently released from incarceration have suboptimal linkage and engagement in community HIV care. We conducted a study to evaluate an information and communication technology intervention to increase linkage to community care among HIV-infected persons recently involved in the criminal justice (CJ) system. Baseline characteristics including risk behaviors and HIV care indicators are reported and stratified by gender. METHODS: We recruited HIV-infected individuals in the District of Columbia jail and persons with a recent history of incarceration through community and street outreach. Participants completed a baseline computer-assisted personal interview regarding HIV care and antiretroviral treatment (ART) adherence, substance use, and sexual behaviors. CD4 and HIV plasma viral load testing were performed at baseline or obtained through medical records. Data were analyzed for the sample overall and stratified by gender. RESULTS: Of 110 individuals, 70% were community-enrolled, mean age was 40 (SD = 10.5), 85% were Black, and 58% were male, 24% female, and 18% transgender women. Nearly half (47%) had condomless sex in the three months prior to incarceration. Although drug dependence and hazardous alcohol use were highly prevalent overall, transgender women were more likely to have participated in drug treatment than men and women (90%, 61%, and 50% respectively; p = 0.01). Prior to their most recent incarceration, 80% had an HIV provider and 91% had ever taken ART. Among those, only 51% reported ≥90% ART adherence. Fewer women (67%) had received HIV medications during their last incarceration compared to men (96%) and transgender women (95%; p = 0.001). Although neither was statistically significant, transgender women and men had higher proportions of baseline HIV viral suppression compared to women (80%, 69%, and 48.0% respectively, p>0.05); a higher proportion of women had a CD4 count ≤200 compared to men and transgender women (17%, 8% and 5% respectively; p>0.05). CONCLUSIONS: In this study, HIV-infected persons with recent incarceration in Washington, DC reported important risk factors and co-morbidities, yet the majority had access to HIV care and ART prior to, during, and after incarceration. Self-reported ART adherence was sub-optimal, and while there were not statistically significant differences, CJ-involved women appeared to be at greatest risk of poor HIV outcomes. TRIAL REGISTRATION: Registered on ClinicalTrials.gov on 10/16/2012. Reference number: NCT01721226.

A Pilot Study of Rapid Hepatitis C Testing in Probation and Parole Populations in Rhode Island.

Hepatitis C virus (HCV) affects between five and seven million individuals in the United States and chronic infection can lead to liver disease, cirrhosis, and hepatocellular carcinoma. Probation/parole offices are a novel setting for rapid HCV testing, providing outreach to populations at increased risk for HCV infection and/or transmitting HCV to others. While some correctional facilities offer HCV testing, many individuals who present to probation/parole offices are never or briefly incarcerated and may not access medical services. We conducted a rapid HCV testing pilot at probation/parole offices in Rhode Island. Overall, 130 people accepted rapid HCV testing, of whom 12 had reactive tests. Only four of these individuals presented to a community-based clinic for confirmatory testing, despite being offered a monetary incentive. Identifying and addressing barriers to HCV confirmatory testing and follow-up care is critical to increasing the uptake of HCV care and treatment in this vulnerable population.

A pilot study of rapid hepatitis C virus testing in the Rhode Island Department of Corrections.

BACKGROUND: The correctional population bears a heavy burden of hepatitis C virus (HCV) infection necessitating expansion of HCV testing and treatment opportunities. Rapid HCV testing provides point-of-care antibody results and may be ideal for correctional facilities, particularly jails, where persons are often incarcerated for short periods of time, yet feasibility has not been established. METHODS: We conducted a pilot study of a rapid HCV testing algorithm among short-term inmates with unknown HCV status. Participants completed a questionnaire, viewed an informational video and underwent rapid HCV testing and confirmatory testing, when indicated. Persons with chronic infection were referred to community care after release. Baseline characteristics, risk behaviors, test results and linkage were examined by descriptive analyses. RESULTS: Two hundred and fifty-two inmates were enrolled and 249 completed all study activities. Twenty-five participants (10%) had reactive rapid tests and 23 (92%) completed confirmatory testing. 15/23 (65%) had detectable HCV RNA, but only 4 linked to care after release. Persons with reactive HCV tests were more likely to be White (P = 0.01) and to have ever injected (P < 0.0001) and/or recently injected (P < 0.0001) drugs. CONCLUSIONS: Rapid HCV testing within jails is feasible, identifies previously unrecognized cases of HCV infection, and implementation should be considered. Low rates of linkage to care after release remain a barrier to care.

Survey of US Correctional Institutions for Routine HCV Testing.

To ascertain HCV testing practices among US prisons and jails, we conducted a survey study in 2012, consisting of medical directors of all US state prisons and 40 of the largest US jails, that demonstrated a minority of US prisons and jails conduct routine HCV testing. Routine voluntary HCV testing in correctional facilities is urgently needed to increase diagnosis, enable risk-reduction counseling and preventive health care, and facilitate evaluation for antiviral treatment.

Technology use in linking criminal justice reentrants to HIV care in the community: a qualitative formative research study.

Innovative interventions increasing linkage, adherence, and retention in care among HIV-infected persons in the criminal justice system are needed. The authors conducted a qualitative study to investigate technology-based tools to facilitate linkage to community-based care and viral suppression for HIV-infected jail detainees on antiretroviral medications being released to the community. The authors conducted 24 qualitative interview-12 in Rhode Island and 12 in Washington, DC-among recently incarcerated HIV-infected persons to elicit their perceptions on the use of technology tools to support linkage to HIV care among criminal justice populations. This article discusses participants' perceptions of the acceptability of technological tools such as (a) a computer-based counseling and (b) text messaging interventions. The participants reported positive experiences when previewing the technology-based tools to facilitate linkage to HIV care and adherence to HIV medications. Successful linkage to care has been shown to improve HIV-associated and non-HIV-associated health outcomes, as well as prevent criminal recidivism and facilitate reentrants' successful and meaningful transition. These findings can be used to inform the implementation of interventions aimed at promoting adherence to antiretroviral medications and linkage to care for HIV-infected persons being released from the correctional setting.

The feasibility of implementing the HIV seek, test, and treat strategy in jails.

To successfully implement the Seek, Test, and Treat (STT) strategy to curb the HIV epidemic, the criminal justice system must be a key partner. Increasing HIV testing and treatment among incarcerated persons has the potential to decrease HIV transmission in the broader community, but whether it is feasible to consider the implementation of the STT within jail facilities is not known. We conducted a retrospective review of Rhode Island Department of Corrections (RIDOC) medical records to assess whether persons newly diagnosed in the jail were able to start ART and be linked to community HIV care after release. From 2001 to 2007, 64 RIDOC detainees were newly diagnosed with HIV. During their index incarcerations, 64% were informed of positive confirmatory HIV test results, 50% completed baseline evaluations, and 9% began ART. Linkage to community care was confirmed for 58% of subjects. Subjects incarcerated for >14 days were significantly more likely to receive HIV test results and complete baseline evaluation (p<0.001). A similar association was not observed for ART initiation until incarceration length reached 60 days (p<0.001). There was no association between incarceration length and linkage to care. This comprehensive analysis demonstrates that length of incarceration impacts HIV test result delivery, baseline evaluation, and ART initiation in the RIDOC. Jails are an important venue to "Seek" and "Test"; however, completing the "Treat" part of the STT strategy is hindered by the transient nature of this criminal justice population and may require new strategies to improve linkage to care.

Information and Communication Technology to Link Criminal Justice Reentrants to HIV Care in the Community.

The United States has the world's highest prison population, and an estimated one in seven HIV-positive persons in the USA passes through a correctional facility annually. Given this, it is critical to develop innovative and effective approaches to support HIV treatment and retention in care among HIV-positive individuals involved in the criminal justice (CJ) system. Information and communication technologies (ICTs), including mobile health (mHealth) interventions, may offer one component of a successful strategy for linkage/retention in care. We describe CARE+ Corrections, a randomized controlled trial (RCT) study now underway in Washington, that will evaluate the combined effect of computerized motivational interview counseling and postrelease short message service (SMS) text message reminders to increase antiretroviral therapy (ART) adherence and linkage and retention in care among HIV-infected persons involved in the criminal justice system. In this report, we describe the development of this ICT/mHealth intervention, outline the study procedures used to evaluate this intervention, and summarize the implications for the mHealth knowledge base.

Linkage to HIV care for jail detainees: findings from detention to the first 30 days after release.

Of people living with HIV in the US, ~16 % or over 150,000 individuals passed through a correctional facility in 2006. Given the enormous impact of HIV within incarcerated populations, facilitating continuity of care from jails to the community is particularly important in reducing morbidity and mortality for releasees. Grantees participating in the Enhancing Linkages to HIV Primary Care in Jail Settings Initiative developed models for identifying HIV-positive detainees during incarceration and linking them to care following release. In this sample of 1,021 HIV-infected releasees, 79 % received clinical services and 74 % received additional community services within 30 days post-release. Our analysis found several significant factors associated with linkage including: receipt of HIV or medication education in jail, having a completed discharge plan at release, staff awareness of clients' release date, and stable housing on the 30th day post-release. In addition, a subset of participants who had both jail and community viral load assessments showed a statistically significant increase in suppressed viral load. EnhanceLink data suggest that jails may be effective settings to engage individuals in care.

An evaluation of a routine opt-out rapid HIV testing program in a Rhode Island jail.

There is an increased prevalence of HIV among incarcerated populations. We conducted a rapid HIV testing pilot program using oral specimens at the Rhode Island Department of Corrections (RIDOC) jail. Detainees (N = 1,364) were offered rapid testing upon jail entrance and 98% completed testing. Twelve detainees had reactive rapid tests, one of which was a new HIV diagnosis. To evaluate the program qualitatively, we conducted key informant interviews and focus groups with key stakeholders. There was overwhelming support for the oral fluid rapid HIV test. Correctional staff reported improved inmate processing due to the elimination of phlebotomy required with conventional HIV testing. Delivering negative rapid HIV test results in real-time during the jail intake process remained a challenge but completion of confirmatory testing among those with reactive rapid tests was possible. Rapid HIV testing using oral specimens in the RIDOC jail was feasible and preferred by correctional staff.

Drug treatment outcomes among HIV-infected opioid-dependent patients receiving buprenorphine/naloxone.

BACKGROUND: Buprenorphine/naloxone allows the integration of opioid dependence and HIV treatment. METHODS: We conducted a prospective study in HIV-infected opioid-dependent patients to investigate the impact of buprenorphine/naloxone treatment on drug use. Self-report and chart review assessments were conducted every 3 months (quarters 1-4) for 1 year. Outcomes were buprenorphine/naloxone treatment retention, drug use, and addiction treatment processes. RESULTS: Among 303 patients enrolled between July 2005 and December 2007, retention in buprenorphine/naloxone treatment was 74%, 67%, 59%, and 49% during Quarters 1, 2, 3, and 4, respectively. Past 30-day illicit opioid use decreased from 84% of patients at baseline to 42% in retained patients over the year. Patients were 52% less likely to use illicit opioids for each quarter in treatment (Odds ratio = 0.66; 95% CI: 0.61 to 0.72). Buprenorphine/naloxone doses and office visits approximated guidelines published by the United States Department of Health and Human Services. Urine toxicology monitoring was less frequent than recommended. CONCLUSIONS: Buprenorphine/naloxone provided in HIV treatment settings can decrease opioid use. Strategies are needed to improve retention and address ongoing drug use in this treatment population.

Linking HIV-positive jail inmates to treatment, care, and social services after release: results from a qualitative assessment of the COMPASS Program.

Approximately 17% of individuals living with HIV/AIDS pass through the correctional system each year. Jails provide a unique opportunity to diagnose and treat HIV infection among high-risk, transient populations with limited access to medical services. In 2007, the US Health Resources and Services Administration funded a multi-site demonstration project entitled Enhancing Linkages to HIV Primary Care in Jail Settings that aims to improve diagnosis and treatment services for HIV-positive jail detainees and link them to community-based medical care and social services upon release. We performed an evaluation of the Rhode Island demonstration site entitled Community Partnerships and Supportive Services for HIV-Infected People Leaving Jail (COMPASS). Through in-depth qualitative interviews among 20 HIV-positive COMPASS participants in Rhode Island, we assessed how COMPASS impacted access to health care and social services utilization. Most individuals were receiving HIV treatment and care services upon enrollment, but COMPASS enhanced linkage to medical care and follow-up visits for HIV and other co-morbidities for most participants. Several participants were successfully linked to new medical services as a result of COMPASS, including one individual newly diagnosed with HIV and another who had been living with HIV for many years and was able to commence highly active antiretroviral therapy (HAART). While many individuals reported that COMPASS support prevented substance abuse relapse, ongoing substance abuse nevertheless remained a challenge for several participants. Most participants enrolled in one or more new social services as a result of COMPASS, including Medicaid, Supplemental Security Income, food assistance, and housing programs. The primary unmet needs of COMPASS participants were access to mental health services and stable housing. Intensive case management of HIV-positive jail detainees enhances access to medical and social support services and helps prevent relapse to substance abuse. Expanding intensive case management programs, public housing, and mental health services for recently released HIV-positive detainees should be public health priorities.