Depression, ART Adherence, and Receipt of Case Management Services by Adults with HIV in North Carolina, Medical Monitoring Project, 2009-2013.

Depression among persons with HIV is associated with antiretroviral therapy (ART) interruption and discontinuation, virological failure, and poor clinical and survival outcomes. Case management services can address needs for emotional counseling and other supportive services to facilitate HIV care engagement. Using 2009-2013 North Carolina Medical Monitoring Project data from 910 persons engaged in HIV care, we estimated associations of case management utilization with "probable current depression" and with 100% ART dose adherence. After weighting, 53.2% of patients reported receiving case management, 21.7% reported depression, and 87.0% reported ART adherence. Depression prevalence was higher among those reporting case management (24.9%) than among other patients (17.6%) (p < 0.01). Case management was associated with depression among patients living above the poverty level [adjusted prevalence ratio (aPR), 2.05; 95% confidence interval (CI) 1.25-3.36], and not among other patients (aPR, 1.01; 95% CI 0.72-1.43). Receipt of case management was not associated with ART adherence (aPR, 1.00; 95% CI 0.95-1.05). Our analysis indicates a need for more effective depression treatment, even among persons receiving case management services. Self-reported ART adherence was high overall, though lower among persons experiencing depression (unadjusted prevalence ratio, 0.92; 95% CI 0.86-0.99). Optimal HIV clinical and prevention outcomes require addressing psychological wellbeing, monitoring of ART adherence, and effective case management services.

Antiretroviral Adherence Following Prison Release in a Randomized Trial of the imPACT Intervention to Maintain Suppression of HIV Viremia.

Many people living with HIV (PLWH) pass through correctional facilities each year, a large proportion of whom do not maintain viral suppression following release. We examined the effects of imPACT, an intervention designed to promote post-release viral suppression, on antiretroviral therapy (ART) adherence. PLWH awaiting release from prisons in two southern states were randomized to imPACT (consisting of motivational interviewing, care linkage coordination, and text message medication reminders) versus standard care (SC). ART adherence, measured by unannounced monthly telephone pill counts, was compared between study arms over 6 months post-release. Of 381 participants eligible for post-release follow-up, 302 (79%) completed ≥ 1 of 6 possible pill counts (median: 4; IQR 1-6). Average adherence over follow-up was 80.3% (95% CI 77.5, 83.1) and 81.0% (78.3, 83.6) of expected doses taken in the imPACT and SC arms, respectively. There was no difference between arms when accounting for missing data using multiple imputation (mean difference = - 0.2 percentage points [- 3.7, 3.3]), controlling for study site and week of follow-up. Of the 936 (40.9%) pill counts that were missed, 212 (22.7%) were due to re-incarceration. Those who missed pill counts for any reason were more likely to be unsuppressed, suggesting that they had lower adherence. However, missingness was balanced between arms. Among PLWH released from prison, ART adherence averaged > 80% in both study arms over 6 months-a level higher than seen with most other chronic diseases. However, missing data may have led to an overestimate of adherence. Factors independent of the intervention influence ART adherence in this population and should be identified to inform future targeted interventions.

Diagnosis of Concurrent Pulmonary Tuberculosis and Tuberculous Otitis Media Confirmed by Xpert MTB/RIF in the United States.

Tuberculosis (TB) remains an important cause of infectious morbidity in the United States (US), necessitating timely and accurate diagnosis. We report a case of concurrent pulmonary and extrapulmonary TB presenting as tuberculous otitis media in a hospitalized US patient admitted with cough, night sweats, and unilateral purulent otorrhea. Diagnosis was made by smear microscopy and rapidly confirmed by Xpert MTB/RIF-a novel, automated nucleic acid amplification test for the rapid detection of drug-susceptible and drug-resistant TB. This case adds to the growing body of evidence validating Xpert MTB/RIF as an effective tool for the rapid diagnosis of extrapulmonary TB, even in low TB-prevalence settings such as the US, when testing is performed on non-respiratory specimens.

Characteristics of African American Women and Their Partners With Perceived Concurrent Partnerships in 4 Rural Counties in the Southeastern U.S.

BACKGROUND: To the individual with concurrent partners, it is thought that having concurrent partnerships confers no greater risk of acquiring HIV than having multiple consecutive partnerships. However, an individual whose partner has concurrent partnerships (partner's concurrency) is at increased risk for incident HIV infection. We sought to better understand relationships characterized by partner's concurrency among African American women. METHODS: A total of 1013 African American women participated in a cross-sectional survey from 4 rural Southeastern counties. RESULTS: Older age at first sex was associated with lower prevalence of partner's concurrency (prevalence ratio, 0.70; 95% confidence interval, 0.57-0.87), but the participant's age was not associated with partner's concurrency. After adjusting for covariates, ever having experienced intimate partner violence (IPV) and forced sex were most strongly associated with partner's concurrency (prevalence ratios, 1.61 [95% confidence intervals, 1.23-2.11] and 1.65 [1.20-2.26], respectively). Women in mutually monogamous partnerships were the most likely to receive economic support from their partners; women whose partners had concurrent partnerships did not report more economic benefit than did those whose partners were monogamous. CONCLUSIONS: Associations between history of IPV and forced sex with partner's concurrency suggest that women with these experiences may particularly benefit from interventions to reduce partner's concurrency in addition to support for reducing IPV and other sexual risks. To inform these interventions, further research to understand partnerships characterized by partner's concurrency is warranted.

Efficacy of an adapted HIV and sexually transmitted infection prevention intervention for incarcerated women: a randomized controlled trial.

OBJECTIVES: We tested the efficacy of an adapted evidence-based HIV-sexually transmitted infection (STI) behavioral intervention (Providing Opportunities for Women's Empowerment, Risk-Reduction, and Relationships, or POWER) among incarcerated women. METHODS: We conducted a randomized trial with 521 women aged 18 to 60 years in 2 correctional facilities in North Carolina in 2010 and 2011. Intervention participants attended 8 POWER sessions; control participants received a single standard-of-care STI prevention session. We followed up at 3 and 6 months after release. We examined intervention efficacy with mixed-effects models. RESULTS: POWER participants reported fewer male sexual partners than did control participants at 3 months, although this finding did not reach statistical significance; at 6 months they reported significantly less vaginal intercourse without a condom outside of a monogamous relationship and more condom use with a main male partner. POWER participants also reported significantly fewer condom barriers, and greater HIV knowledge, health-protective communication, and tangible social support. The intervention had no significant effects on incident STIs. CONCLUSIONS: POWER is a behavioral intervention with potential to reduce risk of acquiring or transmitting HIV and STIs among incarcerated women returning to their communities.

Effect of directly observed antiretroviral therapy compared to self-administered antiretroviral therapy on adherence and virological outcomes among HIV-infected prisoners: a randomized controlled pilot study.

The effect of directly observed therapy (DOT) versus self-administered therapy (SAT) on antiretroviral (ART) adherence and virological outcomes in prison has never been assessed in a randomized, controlled trial. Prisoners were randomized to receive ART by DOT or SAT. The primary outcome was medication adherence [percent of ART doses measured by the medication event monitoring system (MEMS) and pill counts] at the end of 24 weeks. The changes in the plasma viral loads from baseline and proportion of participants virological suppressed (<400 copies/mL) at the end of 24 weeks were assessed. Sixty-six percent (90/136) of eligible prisoners declined participation. Participants in the DOT arm (n = 20) had higher viral loads than participants in the SAT (n = 23) arm (p = 0.23). Participants, with complete data at 24 weeks, were analyzed as randomized. There were no significant differences in median ART adherence between the DOT (n = 16, 99% MEMS [IQR 93.9, 100], 97.1 % pill count [IQR 95.1, 99.3]) and SAT (n = 21, 98.3 % MEMS [IQR 96.0, 100], 98.5 % pill count [95.8, 100]) arms (p = 0.82 MEMS, p = 0.40 Pill Count) at 24 weeks. Participants in the DOT arm had a greater reduction in viral load of approximately -1 log 10 copies/mL [IQR -1.75, -0.05] compared to -0.05 [IQR -0.45, 0.51] in the SAT arm (p value = 0.02) at 24 weeks. The proportion of participants achieving virological suppression in the DOT vs SAT arms was not statistically different at 24 weeks (53 % vs 32 %, p = 0.21). These findings suggest that DOT ART programs in prison settings may not offer any additional benefit on adherence than SAT programs.

Opt-out HIV testing in prison: informed and voluntary?

HIV testing in prison settings has been identified as an important mechanism to detect cases among high-risk, underserved populations. Several public health organizations recommend that testing across health-care settings, including prisons, be delivered in an opt-out manner. However, implementation of opt-out testing within prisons may pose challenges in delivering testing that is informed and understood to be voluntary. In a large state prison system with a policy of voluntary opt-out HIV testing, we randomly sampled adult prisoners in each of seven intake prisons within two weeks after their opportunity to be HIV tested. We surveyed prisoners' perception of HIV testing as voluntary or mandatory and used multivariable statistical models to identify factors associated with their perception. We also linked survey responses to lab records to determine if prisoners' test status (tested or not) matched their desired and perceived test status. Thirty-eight percent (359/936) perceived testing as voluntary. The perception that testing was mandatory was positively associated with age less than 25 years (adjusted relative risk [aRR]: 1.45, 95% confidence interval [CI]: 1.24, 1.71) and preference that testing be mandatory (aRR: 1.81, 95% CI: 1.41, 2.31) but negatively associated with entry into one of the intake prisons (aRR: 0.41 95% CI: 0.27, 0.63). Eighty-nine percent of prisoners wanted to be tested, 85% were tested according to their wishes, and 82% correctly understood whether or not they were tested. Most prisoners wanted to be HIV tested and were aware that they had been tested, but less than 40% understood testing to be voluntary. Prisoners' understanding of the voluntary nature of testing varied by intake prison and by a few individual-level factors. Testing procedures should ensure that opt-out testing is informed and understood to be voluntary by prisoners and other vulnerable populations.

Routine HIV screening in North Carolina in the era of the Affordable Care Act: update on laws, reimbursement, and tests.

Eighteen percent of the 1.2 million human immunodeficiency virus (HIV)-infected individuals in the United States are undiagnosed, with North Carolina accounting for the eighth largest number of new HIV diagnoses in 2011. In an effort to identify more HIV-infected individuals by reducing physician barriers to HIV testing, the Centers for Disease Control and Prevention have expanded their HIV screening recommendations to adolescents and adults without HIV risk factors or behaviors, eliminated federal requirements for pretest counseling, and modified the informed consent process. In 2010, the Office of National AIDS (acquired immunodeficiency syndrome) Policy released the first-ever national HIV/AIDS strategy, with the goal of reducing new infections, increasing access to care, improving HIV outcomes, and reducing HIV racial/ethnic disparities. In 2013, the US Preventive Services Task Force released A-level recommendations recommending nonrisk-based HIV screening for adults and adolescents that are consistent with the recommendations of the Centers for Disease Control and Prevention. In concert with these federal recommendations, the majority of states have modified their consent and counseling requirements. The implementation of the Patient Protection and Affordable Care Act will add requirements and incentives for federal (Medicare), state (Medicaid), and private (insurance) payers to reimburse physicians and patients for nonrisk-based HIV screening.

Another case of cryptococcal meningitis in a person without HIV who injects drugs: A possible risk factor in need of further investigation.

Cryptococcal meningitis is a fungal central nervous infection typically occurring in patients with severe immunocompromise. We present a case of cryptococcal meningitis occurring in a patient with active injection drug use (IDU) but no immunocompromising condition. This is the seventh case in the recent literature of cryptococcal central nervous involvement in an otherwise healthy young person with IDU, suggesting a possible association in need of further exploration.

Dissolution of primary intimate relationships during incarceration and implications for post-release HIV transmission.

Incarceration is associated with sexually transmitted infections (STIs) including human immunodeficiency virus (HIV). Incarceration may contribute to STI/HIV by disrupting primary intimate relationships that protect against high-risk relationships. Research on sexual network disruption during incarceration and implications for post-release sexual risk behavior is limited. We interviewed a sample of HIV-positive men incarcerated in North Carolina to assess how commonly inmates leave partners behind in the community; characteristics of the relationships; and the prevalence of relationship dissolution during incarceration. Among prison inmates, 52% reported having a primary intimate partner at the time of incarceration. In the period prior to incarceration, 85% of men in relationships lived with and 52% shared finances with their partners. In adjusted analyses, men who did not have a primary cohabiting partner at the time of incarceration, versus those did, appeared to have higher levels of multiple partnerships (adjusted prevalence ratio (PR), 1.5; 95% confidence interval (CI) 0.9-2.6; p = 0.11) and sex trade, defined as giving or receiving sex for money, goods, or services (adjusted PR, 2.1; 95% CI 0.9-4.8; p = 0.08) in the 6 months prior to incarceration. Involvement in financially interdependent partnerships appeared to be associated with further reductions in risk behaviors. Of men in primary partnerships at the time of prison entry, 55% reported their relationship had ended during the incarceration. The findings suggest that involvement in primary partnerships may contribute to reductions in sexual risk-taking among men involved in the criminal justice system but that many partnerships end during incarceration. These findings point to the need for longitudinal research into the effects of incarceration-related sexual network disruption on post-release HIV transmission risk.

Novel Treponema pallidum serologic tests: a paradigm shift in syphilis screening for the 21st century.

The mainstay of diagnosis for Treponema pallidum infections is based on nontreponemal and treponemal serologic tests. Many new diagnostic methods for syphilis have been developed, using specific treponemal antigens and novel formats, including rapid point-of-care tests, enzyme immunoassays, and chemiluminescence assays. Although most of these newer tests are not yet cleared for use in the United States by the Food and Drug Administration, their performance and ease of automation have promoted their application for syphilis screening. Both sensitive and specific, new screening tests detect antitreponemal IgM and IgG antibodies by use of wild-type or recombinant T. pallidum antigens. However, these tests cannot distinguish between recent and remote or treated versus untreated infections. In addition, the screening tests require confirmation with nontreponemal tests. This use of treponemal tests for screening and nontreponemal serologic tests as confirmatory tests is a reversal of long-held practice. Clinicians need to understand the science behind these tests to use them properly in syphilis management.

Characteristics and behaviors associated with HIV infection among inmates in the North Carolina prison system.

OBJECTIVES: We identified factors associated with testing HIV positive in a prison system performing voluntary HIV testing on inmates and estimated the number of undetected HIV cases to evaluate the efficacy of risk-factor-based HIV testing. METHODS: We used logistic regression to estimate associations between HIV serostatus and HIV risk behaviors, mental health, coinfection status, and sociodemographic characteristics for prisoners entering the North Carolina Department of Correction from January 2004 through May 2006. We estimated the number of undetected HIV cases on the basis of age-, gender-, and race-specific HIV prevalences among prisoners and in the state. RESULTS: Nearly 3.4% (718/21 419) of tested prisoners were HIV positive. The strongest risk factors for infection among men were having sex with men (odds ratio [OR] = 8.0), Black race (OR = 6.2), other non-White race (OR = 7.4), and being aged 35 to 44 years (OR = 4.1). The strongest risk factor among women was Black race (OR = 3.8). Among HIV-positive prisoners, 65% were coinfected with HCV. We estimated that between 24% (223) and 61% (1101) of HIV cases remained undetected. CONCLUSIONS: The associations between HIV serostatus and a variety of factors highlight the potential limitations of risk-factor-based HIV testing in prisons, as do the high number of potential undetected HIV cases.

An evaluation of HIV testing among inmates in the North Carolina prison system.

OBJECTIVES: We examined the use of voluntary HIV testing among state prisoners in the North Carolina prison system. METHODS: We calculated system-wide and facility-specific proportions and rates of adult inmates tested for HIV and estimated associations between testing status and inmate characteristics for prisoners in North Carolina. RESULTS: Of the 54 016 inmates who entered prison between January 2004 and May 2006, 20 820 (38%) were tested for HIV; of those tested, 18 574 (89%) were tested at admission. Across the 8 intake prisons, more than 80% of inmates in both female facilities but less than 15% of inmates in 4 of 6 male facilities were tested. Prisoners with a documented history of heroin use, crack or cocaine use, conventional HIV risk behavior, or tuberculosis were at least 10% more likely to be tested than were inmates without these characteristics. However, more than 60% of men reporting conventional risk behaviors were not tested. Before covariate adjustment, Black men were 30% less likely than White men to be tested; in the multivariable regression model, this difference was attenuated to 13%. CONCLUSIONS: Rates of HIV testing varied widely across intake prisons, and many male inmates with documented risk of infection were never tested.

The virologic, immunologic, and clinical effects of interleukin 2 with potent antiretroviral therapy in patients with moderately advanced human immunodeficiency virus infection: a randomized controlled clinical trial--AIDS Clinical Trials Group 328.

BACKGROUND: Interleukin 2 (IL-2) administration increases CD4 counts in persons with higher counts. This study investigated persons with moderately advanced human immunodeficiency virus infection receiving highly active antiretroviral therapy (HAART). METHODS: Two hundred four patients with CD4 T-cell counts from 50/microL to 350/microL who were treatment naive or had been treated only with reverse transcriptase inhibitors began a specified protease inhibitor HAART regimen. Virologic responders (< or =5000 copies/mL) at 12 weeks were randomized to open-label continuous-infusion IL-2 (IV IL-2), subcutaneous IL-2 (SC IL-2), or HAART alone. Thirty were not randomized and 15 enrolled in a substudy, leaving 159 for analysis. Subjects continued HAART alone for 72 weeks (n = 52) or with IV IL-2 (n = 53) or SC IL-2 (n = 54) for 5 days every 8 weeks. The IV IL-2 subjects could switch to SC IL-2 if their CD4 T-cell count increased by 100/microL or by 25%. RESULTS: Patients receiving IV or SC IL-2 had greater increases in CD4 cell counts. At week 84, median increases were 459/microL, 312/microL, and 102/microL. Increases of greater than 50% at week 60 (primary end point) were achieved in 39 patients (81%) and 32 (67%) in the IV and SC IL-2 arms, respectively, compared with 13 (29%) in the HAART arm (P<.001 for both). Treatment with IL-2 did not increase plasma human immunodeficiency virus RNA levels. There were fewer new AIDS-defining events in the IV (P = .006) and SC (P = .03) IL-2 groups than in the HAART group (0, 1, and 7, respectively). Drug-related adverse events were more frequent with IL-2 treatment. CONCLUSION: Addition of IL-2 to HAART can significantly expand CD4 T-cell counts in moderately advanced human immunodeficiency virus infection, without loss of virologic control.

Randomized Controlled Trial of an Intervention to Maintain Suppression of HIV Viremia After Prison Release: The imPACT Trial.

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.

A pilot study of health beliefs and attitudes concerning measures of antiretroviral adherence among prisoners receiving directly observed antiretroviral therapy.

High level adherence to antiretroviral therapy (ART) is required to achieve and maintain suppression of HIV replication. Although directly observed therapy (DOT) has been suggested as an intervention to improve adherence, there is a paucity of data describing the attitudes and beliefs regarding DOT for ART among HIV-infected individuals. This study was designed to evaluate the acceptability and psychometric properties of a survey instrument for use in assessing barriers and facilitators of adherence to ART DOT in prison. From July 1, 1999 to April 1, 2000, we piloted an interviewer-administered questionnaire to assess health beliefs and attitudes regarding HIV treatment among 65 HIV-infected prison inmates receiving one or more of their antiretrovirals via directly observed therapy (DOT). The first 24 participants were administered the questionnaire to determine the feasibility of surveying prisoners in a correctional setting. There were no adherence data collected on these participants. The remaining 41 participants had their adherence measured in addition to receiving the questionnaire. Thirty-one were included in the final analysis because 10 did not complete the study. Multiple antiretroviral adherence measures (electronic device medication monitoring [eDEM] caps, medication administration records [MARs], and pill counts) were assessed among a subset of the participants (n = 31) and correlated to the instrument response items. The median internal consistency reliability coefficient for the multi-item scales was 0.79. The strongest correlation between inmates' beliefs and their adherence was between "positive beliefs about protease inhibitors" and the MAR adherence measure (r = 0.72; p < 0.001). This study provides preliminary support for the psychometric properties of the survey in this correctional setting.

"Inside These Fences Is Our Own Little World": Prison-Based HIV Testing and HIV-Related Stigma Among Incarcerated Men and Women.

Correctional facilities offer opportunities to provide comprehensive HIV services including education, testing, treatment, and coordination of post- release care. However, these services may be undermined by unaddressed HIV stigma. As part of a prison-based HIV testing study, we interviewed 76 incarcerated men and women from the North Carolina State prison system. The sample was 72% men, median age 31.5 years (range: 19 to 60). Thematic analysis revealed high levels of HIV-related fear and stigma, homophobia, incomplete HIV transmission knowledge, beliefs that HIV is highly contagious within prisons ("HIV miasma"), and the View of HIV testing as protective. Interviewees described social distancing behaviors and coping mechanisms they perceived to be protective, including knowing their HIV status and avoiding contact with others and shared objects. Interviewees endorsed universal testing, public HIV status disclosure, and segregation of HIV-positive inmates. Intensified education and counseling efforts are needed to ameliorate entrenched HIV-transmission fears and stigmatizing beliefs.

Clinician Perspectives on Delaying Initiation of Antiretroviral Therapy for Clinically Eligible HIV-Infected Patients.

OBJECTIVES: Guidelines for antiretroviral therapy (ART) initiation have evolved, but consistently note that adherence problems should be considered and addressed. Little is known regarding the reasons providers delay ART initiation in clinically eligible patients. METHODS: In 2009, we surveyed a probability sample of HIV care providers in 582 outpatient facilities in the United States and Puerto Rico with an open-ended question about nonclinical reasons for delaying ART initiation in otherwise clinically eligible patients. RESULTS: Very few providers (2%) reported never delaying ART. Reasons for delaying ART were concerns about patient adherence (68%), patient acceptance (60%), and structural barriers (33%). Provider and practice characteristics were associated with reasons for delaying ART. CONCLUSION: Reasons for delaying ART were consistent with clinical guidelines and were both patient level and structural. Providers may benefit from training and access to referrals for ancillary services to enhance their ability to monitor and address these issues with their patients.