Choice of antiretroviral therapy has low impact on weight gain.

OBJECTIVE: Antiretroviral therapy (ART) containing integrase inhibitors (INSTIs) and/or tenofovir alafenamide (TAF) has been associated with greater weight gain. Yet few studies have delineated between exposure to "anchor" drugs (protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI] or INSTIs) and exposure to nucleoside reverse transcriptase inhibitors (NRTIs). DESIGN: In this cohort of antiretroviral (ARV) naïve patients who initiated ART from 2008-2022, we analyzed body mass index (BMI) gain for 8 contemporary "anchor" drugs and 3 contemporary NRTIs during the first 3 years of ART. We censored patients if they stopped, switched, or added another ARV to their regimen. METHODS: We used generalized estimating equations (GEE) to assess the association between BMI gain and choice of ART and a non-linear mixed model for the marginal coefficients of determination. We adjusted for time, baseline demographic and HIV-characteristics, and time-updated HIV and substance use related variables. RESULTS: 4,194 patients contributed 20,528 BMI measurements which were used for multivariable modeling. Most patients were black (55%) and male (77%). Median BMI gain over 3 years was +1.9 kg/m2 (IQR 0.1-4.1). ARV use accounted for only 9% of the predicted BMI change. Only efavirenz (EFV) and tenofovir disoproxil fumarate (TDF) were independently associated with (lower) weight gain while no differences between INSTIs, PIs, or rilpivirine were observed, nor between TAF and abacavir. CONCLUSIONS: The choice of initial ART had little impact on weight gain. INSTIs or TAF were not independently associated with weight change after ART initiation, but EFV and TDF were.

Anal cancer screening among women with HIV: provider experiences and system-level challenges.

Women living with HIV (WLWH) are at increased risk of anal cancer compared to women without HIV, often due to persistent human papillomavirus (HPV) infections. This paper describes current practices and challenges conducting anal cancer screening for WLWH at an urban integrated safety-net system and a non-profit community-based HIV clinic. We conducted 25 semi-structured interviews with clinical and administrative stakeholders to assess knowledge, clinic practices and procedures, and experiences with anal cancer screening. Interview transcripts and fieldnotes were thematically analyzed using an iterative deductive and inductive coding scheme. Findings were organized by the Consolidated Framework for Implementation Research (CFIR) domains and constructs. Provider-level barriers to conducting anal cancer screening included limited knowledge of guidelines. System-level barriers included: structural characteristics such as lack of coordination between clinics to discern provider roles and responsibilities; and limitations in available resources such as configuration of electronic health records and infrastructure to manage referrals of abnormal anal Pap results. We conclude that anal cancer screening and follow-up for WLWH requires organization and coordination between multiple care teams, updated clinical information systems to facilitate communication and support anal Pap ordering and result documentation, and infrastructure that includes policies and protocols for management of abnormal results.Trial registration: ClinicalTrials.gov identifier: NCT02135419.

Extragenital Testing for Neisseria gonorrhoeae and Chlamydia trachomatis in a Large HIV Clinic in the US South: Implementation and Epidemiology.

BACKGROUND: Rectal and oral Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (CT) infections are common among people with HIV, especially men who have sex with men (MSM); however, GC/CT testing rates remain low in many HIV clinics. We evaluated the real-world implementation and results of extragenital nucleic acid amplification testing for GC/CT in an urban HIV clinic. METHODS: Electronic health records were reviewed for all patients 18 years or older with ≥1 outpatient visit to an HIV clinic in Dallas, TX, from February 2016 to May 2019. Extragenital nucleic acid amplification testing became available in February 2017, which was followed by active interventions to increase testing. RESULTS: Overall, 5564 individual patients were included in the preintervention period (February 2016-January 2017), 5067 in the intervention period (February 2017-August 2017), and 7030 in the postintervention period (September 2017-May 2018). Tailored education was provided to patients, and nursing and medical providers, and a self-collection protocol was implemented beginning in spring 2017. A sustained increase in extragenital GC/CT testing among MSM patients, from 70% to 87% (P < 0.01), was observed. Among MSM, overall GC positivity increased from 3.2% to 8.5% and CT positivity increased from 3.9% to 8.3%. N. gonorrhoeae/C. trachomatis infections were highest among young (<35 years) MSM, and approximately 50% of GC/CT infections diagnosed were detected by oral and rectal tests. CONCLUSIONS: Clinic-wide education and self-collection of extragenital specimens were associated with increased GC/CT testing and detection in a large HIV clinic.

Can a brief peer-led group training intervention improve health literacy in persons living with HIV? Results from a randomized controlled trial.

OBJECTIVE: The goal of this study was to determine if a 6-week, peer-led intervention improves health literacy and numeracy among people living with HIV (PLWH). METHODS: We used a randomized controlled trial with repeated measurements, which included six, 90-minute, group-based training sessions. We recruited PLWH participants (n = 359) from safety-net practices in the New York City Metropolitan area and Rochester, NY. Participants were randomly assigned (1:1) to an intervention group (n = 180) or a control group (n = 179). Outcome measures were collected at baseline, eight weeks post-baseline, and at six months using the Brief Estimate of Health Knowledge and Action-HIV (BEHKA-HIV), the Electronic Health Literacy Scale (eHEALS), the Rapid Estimate of Adult Literacy (REALM), and the Newest Vital Sign (NVS). RESULTS: The intervention group had statistically significant improvements in eHealth literacy and BEHKA-HIV compared to the control group. There were no statistically significant changes in general health literacy or numeracy in either group. The intervention had the greatest impact on participants with the lowest levels of eHealth literacy at baseline. CONCLUSION: The intervention had a positive impact on participants' HIV health literacy and eHealth literacy. PRACTICE IMPLICATIONS: Our findings have implications for broadening the function of peer-workers in the health care continuum.

The risk of depression among racially diverse people living with HIV: the impact of HIV viral suppression.

Understanding the correlates of depression in HIV patients can help identify groups whose members are at increased risk for depression. We conducted a cross-sectional retrospective study among racially diverse, indigent patients living with HIV (PLWH) who were obtaining care in an urban safety-net hospital system and had completed a Patient Health Questionnaire-9 (PHQ-9) in 2014 or 2015. We collected demographics, HIV risk factors, HIV viral loads, CD4 counts, missed visits, and emergency department (ED) visits. Data from the Substance Abuse and Mental Illness Symptoms Screener (SAMISS) were abstracted. Missing data on substance use and CD4 cell counts were imputed to examine the odds of depression (PHQ-9 ≥ 10) by multivariable analysis for a complete case and sensitivity analysis. Stratified analysis by HIV viral suppression (VS) was used to determine the odds of depression among subgroups. Of the 5126 HIV patients (70.8% male,56.3% Black, 44.6% MSM, 6.0% IDU), 1271 (24.8%) experienced depression (PHQ ≥ 10). In a multivariable logistic model female gender, White race, injection drug use (IDU) or men who have sex with men (MSM) as an HIV risk factor, making ≥1 ED visit, having missed any HIV visit, having AIDS, and having a positive drug screen by SAMISS increased the odds for depression. Those who had achieved HIV VS or received efavirenz had lower odds of depression. Even among those with AIDS, those failing to achieve VS were at increased odds for depression, whereas those achieving VS were not. Moderate to severe depression is prevalent among PLWH. Among those with AIDS, HIV VS modifies the odds of depression.

Anal Cancer and Anal Cancer Screening Knowledge, Attitudes, and Perceived Risk Among Women Living With HIV.

OBJECTIVES: The aims of the study were (1) to describe anal cancer knowledge, perceived risk, screening barriers, and acceptability of sample self-collection among women living with HIV (WLWH) at an integrated safety-net system and (2) to describe differences in demographic and psychosocial variables among a subsample of WLWH with a history of abnormal cervical cytology results versus those with normal results. MATERIALS AND METHODS: We conducted telephone surveys with English- and Spanish-speaking WLWH (N = 99) and used electronic health record data to extract insurance type, CD4+ cell count, RNA viral load, and cervical cytology results. We calculated descriptive statistics for participant demographics, HIV laboratory results, and psychosocial variables. Among the subsample of women who completed a recent cervical Pap, we used Fisher exact test to assess differences in demographic variables, CD4+ counts, RNA viral loads, knowledge, awareness, acceptability, and perceived risk by cervical cytology results. RESULTS: Most participants (70%) reported knowing nothing about anal cancer; 28% correctly responded that HIV increases one's chance of getting anal cancer. Most (68%) never heard of an anal Pap test. Forty percent would get an anal Pap if they could self-collect the sample, whereas 59% were neutral or disagreed. The 2 most commonly cited barriers to obtaining an anal Pap were "I do not know enough about it" (n = 15) and "It might hurt" (n = 9). CONCLUSIONS: This study highlights a gap in knowledge and awareness among WLWH regarding their heightened risk for anal cancer. It indicates the need for health education and suggests an opportunity for a self-collection intervention.

The role of data and safety monitoring boards in implementation trials: When are they justified?

The National Institutes of Health requires data and safety monitoring boards (DSMBs) for all phase III clinical trials. The National Heart, Lung and Blood Institute requires DSMBs for all clinical trials involving more than one site and those involving cooperative agreements and contracts. These policies have resulted in the establishment of DSMBs for many implementation trials, with little consideration regarding the appropriateness of DSMBs and/or key adaptations needed by DSMBs to monitor data quality and participant safety. In this perspective, we review the unique features of implementation trials and reflect on key questions regarding the justification for DSMBs and their potential role and monitoring targets within implementation trials.

ImPlementation REsearCh to DEvelop Interventions for People Living with HIV (the PRECluDE consortium): Combatting chronic disease comorbidities in HIV populations through implementation research.

Antiretroviral therapy (ART) prevented premature mortality and improved the quality of life among people living with the human immunodeficiency virus (PLWH), such that now more than half of PLWH in the United States are 50 years of age and older. Increased longevity among PLWH has resulted in a significant rise in chronic, comorbid diseases. However, the implementation of guideline-based interventions for preventing, treating, and managing such age-related, chronic conditions among the HIV population is lacking. The PRECluDE consortium supported by the Center for Translation Research and Implementation Science at the National Heart, Lung, and Blood Institute catalyzes implementation research on proven-effective interventions for co-occurring heart, lung, blood, and sleep diseases and conditions among PLWH. These collaborative research studies use novel implementation frameworks with HIV, mental health, cardiovascular, and pulmonary care to advance comprehensive HIV and chronic disease healthcare in a variety of settings and among diverse populations.

Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV.

People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts. The ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation) reduce atherosclerotic (ASCVD) risk in the general population, but little is known regarding strategies for promoting the ABCS among PWH. Guided by the Consolidated Framework for Implementation Research (CFIR), we designed multilevel implementation strategies that target PWH and their clinicians to promote appropriate use of the ABCS based on a 10-year estimated ASCVD risk. Implementation strategies include patient coaching, automated texting, peer phone support, academic detailing and audit and feedback for the patient's clinician. We are evaluating implementation through a stepped wedge cluster randomized trial based on the Reach-Effectiveness-Adoption-Maintenance/Qualitative-Evaluation-for-Systematic-Translation (RE-AIM/QuEST) mixed methods framework that integrates quantitative and qualitative assessments. The primary outcome is change in ASCVD risk. Findings will have important implications regarding strategies for reducing ASCVD risk among PWH.

"Get Ready and Empowered About Treatment" (GREAT) Study: a Pragmatic Randomized Controlled Trial of Activation in Persons Living with HIV.

BACKGROUND: Little is known about strategies to improve patient activation, particularly among persons living with HIV (PLWH). OBJECTIVE: To assess the impact of a group intervention and individual coaching on patient activation for PLWH. DESIGN: Pragmatic randomized controlled trial. SITES: Eight practices in New York and two in New Jersey serving PLWH. PARTICIPANTS: Three hundred sixty PLWH who received care at participating practices and had at least limited English proficiency and basic literacy. INTERVENTION: Six 90-min group training sessions covering use of an ePersonal Health Record loaded onto a handheld mobile device and a single 20-30 min individual pre-visit coaching session. MAIN MEASURES: The primary outcome was change in Patient Activation Measure (PAM). Secondary outcomes were changes in eHealth literacy (eHEALS), Decision Self-efficacy (DSES), Perceived Involvement in Care Scale (PICS), health (SF-12), receipt of HIV-related care, and change in HIV viral load (VL). KEY RESULTS: The intervention group showed significantly greater improvement than the control group in the primary outcome, the PAM (difference 2.82: 95% confidence interval [CI] 0.32-5.32). Effects were largest among participants with lowest quartile PAM at baseline (p < 0.05). The intervention doubled the odds of improving one level on the PAM (odds ratio 1.96; 95% CI 1.16-3.31). The intervention group also had significantly greater improvement in eHEALS (difference 2.67: 95% CI 1.38-3.9) and PICS (1.27: 95% CI 0.41-2.13) than the control group. Intervention effects were similar by race/ethnicity and low education with the exception of eHealth literacy where effects were stronger for minority participants. No statistically significant effects were observed for decision self-efficacy, health status, adherence, receipt of HIV relevant care, or HIV viral load. CONCLUSIONS: The patient activation intervention modestly improved several domains related to patient empowerment; effects on patient activation were largest among those with the lowest levels of baseline patient activation. TRIAL REGISTRATION: This study is registered at Clinical Trials.Gov (NCT02165735).

Telmisartan Therapy Does Not Improve Lymph Node or Adipose Tissue Fibrosis More Than Continued Antiretroviral Therapy Alone.

Background: Fibrosis in lymph nodes may limit CD4+ T-cell recovery, and lymph node and adipose tissue fibrosis may contribute to inflammation and comorbidities despite antiretroviral therapy (ART). We hypothesized that the angiotensin receptor blocker and peroxisome proliferator-activated receptor γ agonist telmisartan would decrease lymph node or adipose tissue fibrosis in treated human immunodeficiency virus type 1 (HIV) infection. Methods: In this 48-week, randomized, controlled trial, adults continued HIV-suppressive ART and received telmisartan or no drug. Collagen I, fibronectin, and phosphorylated SMAD3 (pSMAD3) deposition in lymph nodes, as well as collagen I, collagen VI, and fibronectin deposition in adipose tissue, were quantified by immunohistochemical analysis at weeks 0 and 48. Two-sided rank sum and signed rank tests compared changes over 48 weeks. Results: Forty-four participants enrolled; 35 had paired adipose tissue specimens, and 29 had paired lymph node specimens. The median change overall in the percentage of the area throughout which collagen I was deposited was -2.6 percentage points (P = 0.08) in lymph node specimens and -1.3 percentage points (P = .001) in adipose tissue specimens, with no between-arm differences. In lymph node specimens, pSMAD3 deposition changed by -0.5 percentage points overall (P = .04), with no between-arm differences. Telmisartan attenuated increases in fibronectin deposition (P = .06). In adipose tissue, changes in collagen VI deposition (-1.0 percentage point; P = .001) and fibronectin deposition (-2.4 percentage points; P < .001) were observed, with no between-arm differences. Conclusions: In adults with treated HIV infection, lymph node and adipose tissue fibrosis decreased with continued ART alone, with no additional fibrosis reduction with telmisartan therapy.

Combination antiretroviral therapy improves cognitive performance and functional connectivity in treatment-naïve HIV-infected individuals.

Our study aimed to investigate the short-term effect of combination antiretroviral therapy (cART) on cognitive performance and functional and structural connectivity and their relationship to plasma levels of antiretroviral (ARV) drugs. Seventeen ARV treatment-naïve HIV-infected individuals (baseline mean CD4 cell count, 479 ± 48 cells/mm3) were age matched with 17 HIV-uninfected individuals. All subjects underwent a detailed neurocognitive and functional assessment and magnetic resonance imaging. HIV-infected subjects were scanned before starting cART and 12 weeks after initiation of treatment. Uninfected subjects were assessed once at baseline. Functional connectivity (FC) was assessed within the default mode network while structural connectivity was assessed by voxel-wise analysis using tract-based spatial statistics (TBSS) and probabilistic tractography within the DMN. Tenofovir and emtricitabine blood concentration were measured at week 12 of cART. Prior to cART, HIV-infected individuals had significantly lower cognitive performance than control subjects as measured by the total Z-score from the neuropsychological tests assessing six cognitive domains (p = 0.020). After 12 weeks of cART treatment, there remained only a weak cognitive difference between HIV-infected and HIV-uninfected subjects (p = 0.057). Mean FC was lower in HIV-infected individuals compared with those uninfected (p = 0.008), but FC differences became non-significant after treatment (p = 0.197). There were no differences in DTI metrics between HIV-infected and HIV-uninfected individuals using the TBSS approach and limited evidence of decreased structural connectivity within the DMN in HIV-infected individuals. Tenofovir and emtricitabine plasma concentrations did not correlate with either cognitive performance or imaging metrics. CONCLUSIONS: Twelve weeks of cART improves cognitive performance and functional connectivity in ARV treatment-naïve HIV-infected individuals with relatively preserved immune function. Longer periods of observation are necessary to assess whether this effect is maintained.

Antiretroviral Resistance and Pregnancy Characteristics of Women with Perinatal and Nonperinatal HIV Infection.

Objective. To compare HIV drug resistance in pregnant women with perinatal HIV (PHIV) and those with nonperinatal HIV (NPHIV) infection. Methods. We conducted a multisite cohort study of PHIV and NPHIV women from 2000 to 2014. Sample size was calculated to identify a fourfold increase in antiretroviral (ARV) drug resistance in PHIV women. Continuous variables were compared using Student's t-test and Wilcoxon rank-sum tests. Categorical variables were compared using χ (2) and Fisher's exact tests. Univariate analysis was used to determine factors associated with antiretroviral drug resistance. Results. Forty-one PHIV and 41 NPHIV participants were included. Women with PHIV were more likely to have drug resistance than those with NPHIV ((55% versus 17%, p = 0.03), OR 6.0 (95% CI 1.0-34.8), p = 0.05), including multiclass resistance (15% versus 0, p = 0.03), and they were more likely to receive nonstandard ARVs during pregnancy (27% versus 5%, p = 0.01). PHIV and NPHIV women had similar rates of preterm birth (11% versus 28%, p = 0.08) and cesarean delivery (47% versus 46%, p = 0.9). Two infants born to a single NPHIV woman acquired HIV infection. Conclusions. PHIV women have a high frequency of HIV drug resistance mutations, leading to nonstandard ARVs use during pregnancy. Despite nonstandard ARV use during pregnancy, PHIV women did not experience increased rates of adverse pregnancy outcomes.

Evaluation of a Statewide HIV-HCV-STD Online Clinical Education Program by Healthcare Providers - A Comparison of Nursing and Other Disciplines.

The New York State HIV-HCV-STD Clinical Education Initiative (CEI) has developed a large repository of online resources and disseminated them to a wide range of healthcare providers. To evaluate the CEI online education program and in particular to compare the self-reported measures by clinicians from different disciplines, we analyzed the data from 1,558 course completions in a study period of three months. The results have shown that the overall evaluations by the clinicians were very positive. Meanwhile, there were significant differences across the clinical disciplines. In particular, physicians and nurse practitioners were the most satisfied. In contrast, pharmacists and case/care managers recorded lower than average responses. Nurses and counselors had mixed results. Nurse practitioners' responses were very similar to physicians on most measures, but significantly different from nurses in many aspects. For more effective knowledge dissemination, online education programs should consider the unique needs by clinicians from specific disciplines.

Enhancing physical function in HIV-infected older adults: A randomized controlled clinical trial.

OBJECTIVE: HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. METHOD: In total, 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to 1 of 2 groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. RESULTS: The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p < .05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared with the control group (p < .05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p < .05). CONCLUSION: Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. (PsycINFO Database Record

Lipid-Lowering Therapy in HIV-Infected Patients: Relationship with Antiretroviral Agents and Impact of Substance-Related Disorders.

BACKGROUND: The use of combination antiretroviral therapy (cART) has significantly decreased the morbidity and mortality associated with human immunodeficiency virus (HIV) infection. Lipid disorders, including lipodystrophy, hypertriglyceridemia, and hypercholesterolemia, remain the most commonly reported metabolic disorders among those treated with long-term cART. Mounting evidence suggests an association between drug abuse and poor glycemic control and diabetes complications. Substance related disorders (SRD) may increase the risk of metabolic syndrome. MATERIALS AND METHODS: The aim of this retrospective cohort study was to examine the relationship between SRD, cART, and lipid-lowering agent use in an HIV infected population. Patients received efavirenz or protease inhibitor-based cART for at least 6 months. Prescription information was retrieved from the medical records. The primary outcome was the use of lipid-lowering agents including statins, fibrates and fish oil. The impact of SRD and cART was assessed on the lipid-lowering agent use. RESULTS: A total of 276 subjects with HIV infection were included, 90 (33%) received lipid-lowering agents, and 31 (34%) had SRD. Smoking was prevalent among subjects with SRD (84 vs 15%, p<0.001). Statins were the mainstay for the management of dyslipidemia (66%), followed by the fibrates (24%), omega-3 fatty acids (5%), nicotinic acid (3%) and the cholesterol absorption inhibitors (3%). Use of statins or fibrates was significantly higher among subjects without SRD than those with (40 vs 23%, p=0.005). The type of cART, including efavirenz and protease inhibitors, appeared to have no significant impact on the use pattern of lipid-lowering agents. Lopinavir/ritonavir (lopinavir/r) was mostly prescribed for subjects with SRD (25 vs 8%, p=0.02). CONCLUSION: Among HIV-infected patients, statins remain the mainstay for the management of dyslipidemia in routine clinical care, followed by fibrates. A significant high risk of metabolic disorders among patients with SRD is implicated by heavy tobacco use and prevalent lopinavir/r-based treatment. Significantly low rate of lipid-lowering agent use in this population underscores the importance of lipid disorder scrutiny and cART treatment optimization for HIV-infected patients with SRD.

Effect of Depot Medoxyprogesterone Acetate on Immune Functions and Inflammatory Markers of HIV-Infected Women.

OBJECTIVES: Depot medroxyprogesterone acetate (DMPA) was associated with increased HIV transmission and accelerated disease progression in untreated women. The potential underlying mechanisms include immune modulation. We evaluated the effect of a single DMPA injection on cell-mediated immunity (CMI), T-cell activation, T-cell regulation (Treg), and inflammation in HIV-infected women on combination antiretroviral regimen (cART). METHODS: Women with HIV plasma RNA ≤ 400 copies per milliliter on stable cART received DMPA and had immunologic and medroxyprogesterone acetate (MPA) measurements at baseline, 4 weeks [peak MPA concentration (Cmax)], and 12 weeks [highest MPA area under the concentration curve]. RESULTS: At baseline, among 24 women with median age of 32 years and 622 CD4(+) cells per microliter, ≥ 68% had HIV, varicella-zoster virus, phytohemagglutinin A and CD3/CD28 CMI measured by lymphocyte proliferation, and/or IFNγ/IL2 dual-color fluorospot. CMI did not significantly change after DMPA administration except for a 1.4-fold increase in IL2/IFNγ varicella-zoster virus fluorospot at week 12. T-cell activation decreased after DMPA administration, reaching statistical significance at week 12 for CD4(+)CD25+%. Treg behaved heterogeneously with an increase in CD8+FOXP3+% at week 4 and a decrease in CD4+IL35+% at week 12. There was a decrease in TGFß at week 12 and no other changes in plasma biomarkers. Correlation analyses showed that high MPA Cmax and/or area under the concentration curve were significantly associated with increases of IFNγ HIV enzyme-linked ImmunoSpot, CD4+IL35+%, and CD4+TGFß+% Treg and decreases of plasma IL10 from baseline to weeks 4 and/or 12. CONCLUSIONS: A single dose of DMPA did not have immune-suppressive or pro-inflammatory effects in HIV-infected women on cART. Additional studies need to assess the effect of multiple doses.

Activation of persons living with HIV for treatment, the great study.

BACKGROUND: Patient empowerment represents a potent tool for addressing racial, ethnic and socioeconomic disparities in health care, particularly for chronic conditions such as HIV infection that require active patient engagement. This multimodal intervention, developed in concert with HIV patients and clinicians, aims to provide HIV patients with the knowledge, skills, attitudes and tools to become more activated patients. METHODS/DESIGN: Randomized controlled trial of a multimodal intervention designed to activate persons living with HIV. The intervention includes four components: 1) use of a web-enabled hand-held device (Apple iPod Touch) loaded with a Personal Health Record (ePHR) customized for HIV patients; 2) six 90-minute group-based training sessions in use of the device, internet and the ePHR; 3) a pre-visit coaching session; and 4) clinician education regarding how they can support activated patients. Outcome measures include pre- post changes in patient activation measure score (primary outcome), eHealth literacy, patient involvement in decision-making and care, medication adherence, preventive care, and HIV Viral Load. DISCUSSION: We hypothesize that participants receiving the intervention will show greater improvement in empowerment and the intervention will reduce disparities in study outcomes. Disparities in these measures will be smaller than those in the usual care group. Findings have implications for activating persons living with HIV and for other marginalized groups living with chronic illness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02165735, 6/13/2014.

Identifying Effective Approaches for Dissemination of Clinical Evidence--Correlation Analyses on Promotional Activities and Usage of a Guideline-Driven Interactive Case Simulation Tool in a Statewide HIV-HCV-STD Clinical Education Program.

Dissemination of the latest clinical evidence to community-based healthcare providers is a critical step to translate biomedical knowledge into clinical practice. We performed a study to analyze the correlations between the promotional activities and the usage of a guideline-driven interactive case simulation tool (ICST) for insomnia screening and treatment in a statewide HIV-HCV-STD clinical education program. For this purpose, we tracked users' interactions with the ICST and the sending of promotional email newsletters during a study period of 44 weeks. Results showed that promotional activities were strongly correlated with the number of audience as well as the intensity of use of the target resource. The strength of correlation varied in specific use contexts. Strong correlations were found between the sending of email newsletters and the intensity of resource use by promotion recipients, by new users, and through the most convenient access channel associated with the promotion. Selection of approaches for resource dissemination should consider the potentials and limitations of use contexts to make them more effective.