Stable HIV Patients Research Articles

Assessing health outcomes of ART Differentiated Care Models in Migori County, Kenya

Background : HIV remains a substantial global health challenge. In Kenya, the prevalence is approximately 6%, with Migori County experiencing notably high rates. Despite this, only a small portion of its population receive antiretroviral therapy (ART). Differentiated care, an individualized approach to HIV treatment, enhances outcomes and eases strain on health systems. This study assesses health outcomes of ART differentiated care in Migori County, Kenya, focusing on retention and viral load results for stable individuals living with HIV.
 Methodology :We employed a pre-post evaluation descriptive mixed methods study design to assess health outcomes following Differentiated Care Model (DCM) implementation. One hundred and ninety-two (192) stable HIV patients from Migori's rural sugar belt, meeting DCM inclusion criteria, were enrolled using single-stage cluster and systematic sampling. DCM outcomes were compared with the standard care model (control). Data sourced from patient records and key informant interviews were analyzed using Chi-square, Fisher's exact tests, logistic regression and thematic analysis.
 Results : We observed notable statistical significance (p < 0.05) in the association between DCM and health outcomes, including patient activity at 6 and 12 months (p < 0.001), transfer-out retention at 6 and 12 months (p = 0.02), loss to follow-up retention at 6 and 12 months (p = 0.006 and p = 0.005, respectively), and deceased patient retention (p = 0.033). However, the viral load suppression post-DCM did not show statistical significance.
 Conclusion : To conclude, Differentiated Care Models positively impact retention outcomes for stable HIV-positive patients, notably reducing lost-to-follow-up and deceased cases. Although not significant at 6 and 12 months, DCM shows promise in early-stage viral load suppression. Gender disparities exist in suppression rates. Patient adherence and viral load awareness are favourable

OP02 The Use Of Discrete Choice Experiments For Measuring Patient Preferences In Health Technology Assessment

IntroductionUnderstanding patient preferences and the demand for healthcare interventions and technology is critical for health technology assessment (HTA). New health technologies have potential for savings and increased efficiency but even the most cost-effective and efficacious interventions can fail if patient preferences are not properly accounted for. Patient preferences in HTA are primarily limited to representation in appraisal committees; however, more robust methods are available and should be incorporated into the assessment of interventions.MethodsUsing data from three discrete choice experiments (DCEs), we reflect on the importance of patient preferences in the design of healthcare interventions. We draw insights from three studies which investigated preferences relating to HIV self-testing amongst long distance truck drivers in Kenya; differentiated antiretroviral therapy services amongst stable HIV patients in Zimbabwe; and tuberculosis preventive therapy for children in Eswatini.ResultsWe highlight three key findings. First, understanding patient preferences is crucial when designing services, and providers sometimes underestimate behavioural barriers and overestimate the extent to which people are motivated simply by health benefits. Optimism is often driven by evidence showing high acceptability, but when preference structures are incorporated in intervention design, there are important insights into how patients plan to utilize services. Second, trade-offs matter in determining which characteristics are perceived to be most important to patients – a key strength of the DCE methodology. Understanding of these trade-offs can help prioritize which characteristics of interventions to target. Finally, disentangling the effect of different characteristics of service delivery models on preferences is important for rethinking how interventions are delivered. If services are designed to better align with preferences, implementers can ensure new interventions have the desired effect on health and economic outcomes.ConclusionsThese findings highlight the value of behavioural economic approaches for investigating preferences for health interventions and providing insights into the demand for services, which must feed into the HTA analyses. Incorporating DCEs into HTA is inexpensive and provides robust data for improving HTA.

A controlled study to assess the effects of a Fast Track (FT) service delivery model among stable HIV patients in Lusaka Zambia.

Fast Track models-in which patients coming to facility to pick up medications minimize waiting times through foregoing clinical review and collecting pre-packaged medications-present a potential strategy to reduce the burden of treatment. We examine effects of a Fast Track model (FT) in a real-world clinical HIV treatment program on retention to care comparing two clinics initiating FT care to five similar (in size and health care level), standard of care clinics in Zambia. Within each clinic, we selected a systematic sample of patients meeting FT eligibility to follow prospectively for retention using both electronic medical records as well as targeted chart review. We used a variety of methods including Kaplan Meier (KM) stratified by FT, to compare time to first late pick up, exploring late thresholds at >7, >14 and >28 days, Cox proportional hazards to describe associations between FT and late pick up, and linear mixed effects regression to assess the association of FT with medication possession ratio. A total of 905 participants were enrolled with a median age of 40 years (interquartile range [IQR]: 34-46 years), 67.1% were female, median CD4 count was 499 cells/mm3 (IQR: 354-691), and median time on ART was 5 years (IQR: 3-7). During the one-year follow-up period FT participants had a significantly reduced cumulative incidence of being >7 days late for ART pick-up (0.36, 95% confidence interval [CI]: 0.31-0.41) compared to control participants (0.66; 95% CI: 0.57-0.65). This trend held for >28 days late for ART pick-up appointments, at 23% (95% CI: 18%-28%) among intervention participants and 54% (95% CI: 47%-61%) among control participants. FT models significantly improved timely ART pick up among study participants. The apparent synergistic relationship between refill time and other elements of the FT suggest that FT may enhance the effects of extending visit spacing/multi-month scripting alone. ClinicalTrials.gov Identifier: NCT02776254 https://clinicaltrials.gov/ct2/show/NCT02776254.

Burden of cardiovascular risk factors in stable HIV patients aged 50 years old and above

Background: Advancement in HIV treatment has revolutionized the disease from being an infection with high mortality to a chronic illness. As the PLHIV population ages, we foresee increasing number of patients suffering from dyslipidemia, diabetes mellitus or hypertension that will eventually increase their risk of cardiovascular disease. Methods and materials: The objectives of this study was to stratify the cardiovascular risk factors and determine the prevalence and control of these risk factors. This study was performed at a referral HIV/AIDS clinic in Klang Valley, Malaysia. The cohort studied patients who started follow-up from 2007 till 2015. Patients aged ≥50 years with HIV viral suppression of ≥2 years were included in the study. Definitions of dyslipidemia, hypertension and risk stratification of cardiovascular risk were based on the latest Malaysia clinical practice guidelines. Results: A total of 635 patients were included in the study. Majority of them were male (83.8%), Chinese (56.1%) with heterosexual (60%) as their main modes of transmission. The prevalence of LDL-C dyslipidemia, hypertension and diabetes mellitus were 71%, 38% and 18% respectively. While 52.3% of them belonged to intermediate cardiovascular risk group, almost one third (32.8%) fell under high and very high cardiovascular risk group. Overall, 67.2% of hypertensive patients and 65.9% of patients with LDL-C dyslipidemia did not achieve their target while on treatment. Based on regression analysis, factors associated with poor LDL-C control include younger age, lower CD4 count, higher systolic blood pressure, homosexual, and diabetes mellitus. There are no significant predictors for poor hypertensive control in our cohort of patients. Conclusion: With the high prevalence of these cardiovascular risk factors, emphasis on cardiovascular risk stratification and aggressive control of these risk factors based on respective treatment target is imperative to reduce their cardiovascular morbidity and mortality.

Twenty‐four‐month outcomes from a cluster‐randomized controlled trial of extending antiretroviral therapy refills in ART adherence clubs

IntroductionThe antiretroviral therapy (ART) adherence club (AC) model has supported clinically stable HIV patients’ retention with group ART refills and psychosocial support. Reducing visit frequency by increasing ART refills to six months could further benefit patients and unburden health systems. We conducted a pragmatic non‐inferiority cluster randomized trial comparing standard of care (SoC) ACs and six‐month refill intervention ACs in a primary care facility in Khayelitsha, South Africa.MethodsExisting community‐based and facility‐based ACs were randomized to either SoC or intervention ACs. SoC ACs met five times annually, receiving two‐month refills with a four‐month refill over year‐end. Blood was drawn at one AC visit with a clinical assessment at the next. Intervention ACs met twice annually receiving six‐month refills, with an individual blood collection visit before the annual clinical assessment AC visit. The first study visits were in October and November 2017 and participants followed for 27 months. We report retention in care, viral load completion and viral suppression (<400 copies/mL) 24 months after enrolment and calculated intention‐to‐treat risk differences for the primary outcomes using generalized estimating equations specifying for clustering by AC.ResultsOf 2150 participants included in the trial, 977 were assigned to the intervention arm (40 ACs) and 1173 to the SoC (48 ACs). Patient characteristics at enrolment were similar across groups. Retention in care at 24 months was similarly high in both arms: 93.6% (1098/1173) in SoC and 92.6% (905/977) in the intervention arm, with a risk difference of −1.0% (95% CI: −3.2 to 1.3). The intervention arm had higher viral load completion (90.8% (999/1173) versus 85.1% (887/977)) and suppression (87.3% (969 /1173) versus 82.6% (853/977)) at 24 months, with a risk difference for completion of 5.5% (95% CI: 1.5 to 9.5) and suppression of 4.6% (95% CI: 0.2 to 9.0).ConclusionsIntervention AC patients receiving six‐month ART refills showed non‐inferior retention in care, viral load completion and viral load suppression to those in SoC ACs, adding to a growing literature showing good outcomes with extended ART dispensing intervals.

Will differentiated care for stable HIV patients reduce healthcare systems costs?

IntroductionSouth Africa’s National Department of Health launched the National Adherence Guidelines for Chronic Diseases in 2015. These guidelines include adherence clubs (AC) and decentralized medication delivery (DMD) as two differentiated models of care for stable HIV patients on antiretroviral therapy. While the adherence guidelines do not suggest that provider costs (costs to the healthcare system for medications, laboratory tests and visits to clinics or alternative locations) for stable patients in these differentiated models of care will be lower than conventional, clinic‐based care, recent modelling exercises suggest that such differentiated models could substantially reduce provider costs. In the context of continued implementation of the guidelines, we discuss the conditions under which provider costs of care for stable HIV patients could fall, or rise, with AC and DMD models of care in South Africa.DiscussionIn prior studies of HIV care and treatment costs, three main cost categories are antiretroviral medications, laboratory tests and general interaction costs based on encounters with health workers. Stable patients are likely to be on the national first‐line regimen (Tenofovir/Entricitabine/Efavarinz (TDF/FTC/EFV)), so no difference in the costs of medications is expected. Laboratory testing guidelines for stable patients are the same regardless of the model of care, so no difference in laboratory costs is expected as well. Based on existing information regarding the costs of clinic visits, AC visits and DMD drug pickups, we expect that for some clinics, visit costs for DMD or AC models of care could be less, but modestly so, than for conventional, clinic‐based care. For other clinics, however, DMD or AC models could have higher visit costs (see Table 2).ConclusionsThe standard of care for stable patients has already been “differentiated” for years in South Africa, prior to the roll out of the new adherence guidelines. AC and DMD models of care, when implemented as envisioned in the guidelines, are unlikely to generate substantive reductions or increases in provider costs of care.

Outcomes of Three- Versus Six-Monthly Dispensing of Antiretroviral Treatment (ART) for Stable HIV Patients in Community ART Refill Groups: A Cluster-Randomized Trial in Zimbabwe.

Introduction:Multimonth dispensing (MMD) of antiretroviral treatment (ART) aims to reduce patient-related barriers to access long-term treatment and improve health system efficiency. However, randomized evidence of its clinical effectiveness is lacking. We compared MMD within community ART refill groups (CARGs) vs. standard-of-care facility-based ART delivery in Zimbabwe.Methods:A three-arm, cluster-randomized, pragmatic noninferiority trial was performed. Thirty health care facilities and associated CARGs were allocated to either ART collected three-monthly at facility (3MF, control); ART delivered three-monthly in CARGs (3MC); or ART delivered six-monthly in CARGs (6MC). Stable adults receiving ART ≥six months with baseline viral load (VL) <1000 copies/ml were eligible. Retention in ART care (primary outcome) and viral suppression (VS) 12 months after enrollment were compared, using regression models specified for clustering (ClinicalTrials.gov: NCT03238846).Results:4800 participants were recruited, 1919, 1335, and 1546 in arms 3MF, 3MC, and 6MC, respectively. For retention, the prespecified noninferiority limit (-3.25%, risk difference [RD]) was met for comparisons between all arms, 3MC (94.8%) vs. 3MF (93.0%), adjusted RD = 1.1% (95% CI: -0.5% to 2.8%); 6MC (95.5%) vs. 3MF: aRD = 1.2% (95% CI: -1.0% to 3.6%); and 6MC vs. 3MC: aRD = 0.1% (95% CI: -2.4% to 2.6%). VL completion at 12 months was 49%, 45%, and 8% in 3MF, 3MC, and 6MC, respectively. VS in 3MC (99.7%) was high and not different to 3MF (99.1%), relative risk = 1.0 (95% CI: 1.0-1.0). VS was marginally reduced in 6MC (92.9%) vs. 3MF, relative risk = 0.9 (95% CI: 0.9-1.0).Conclusion:Retention in CARGs receiving three- and six-monthly MMD was noninferior versus standard-of-care facility-based ART delivery. VS in 3MC was high. VS in six-monthly CARGs requires further evaluation.

Echocardiographic Findings in HIV Positive Children on Anti-retroviral Therapy Attending Routine Outpatient Infectious Disease Clinics in the Niger Delta Region of Nigeria

Background: The aim of this study was to investigate the echocardiographic findings of stable HIV positive children on Highly Active Anti-retroviral Therapy (HAART) attending routine Paediatric Infectious disease clinics in the Niger Delta region of Nigeria.&#x0D; Methods: Over a 3 month period (1st October to 31st December 2019) 71 apparently stable HIV positive children who had been on HAART for at least 3 months had a transthoracic echocardiogram done after written informed consent. A proforma containing their clinical and socioeconomic information and the echocardiographic findings was filled. Data was entered into an Excel spread sheet and analysed using SPSS 22.0.&#x0D; Results: Among the 71 children studied, 34 (47.89%) were aged 6 – 10 years, 42 (59.15%) were females while 15 (26.01%) belonged to social class 3. Of the 71 participants studied, forty-four (61.97%) had abnormal echocardiographic findings on echocardiogram. Mild pulmonary regurgitation was the commonest finding and occurred in 32 (45.07%) of the patients. This was followed by Left Ventricular diastolic dysfunction (LVDD) which occurred in 9 (12.68%) patients, while Left Ventricular systolic dysfunction (LVSD) and Congenital heart defects occurred in 6 (8.45%) subjects each. There was no significant association between occurrence of echocardiographic findings and age, gender, duration of HIV disease, type of HAART and stage of disease at diagnosis and at the time of the study (p&lt;0.05).&#x0D; Conclusion: This study shows that mild pulmonary regurgitation is the commonest echocardiographic finding among stable HIV patients followed by left ventricular dysfunction. Routine baseline and intermittent echocardiography are recommended for initial evaluation and continued care for early detection and quick intervention of cardiac diseases of children with HIV disease.

Therapeutic Monitoring of Antiretroviral Drugs in Immunologically Stable HIV Patients on ART Treatment

Therapeutic Monitoring of Antiretroviral Drugs in Immunologically Stable HIV Patients on ART Treatment

Metabolic and Cardiovascular Comorbidities Among Clinically Stable HIV Patients on Long-Term ARV Therapy in Five Ambulatory Clinics in Lima-Callao, Peru.

Background:There is scarcity of data about the prevalence of non-AIDS defining comorbidities among stable HIV-infected patients in Peru.Objective:We aimed to describe the most frequent cardiometabolic comorbidities found among ambulatory adults on ARV in Peru.Methods:A review of records for patients attending regular visits at 5 clinics in Lima-Callao in January-February 2016 is presented. Patients were adults on ARV for >6 months, with no recent AIDS-defining condition.Results:Three hundred and five medical charts were reviewed. Most patients were male (73.1%, n=223) with a mean age of 46.0 years. Mean time from HIV diagnosis was 9.41 yrs. and mean duration of ARV was 7.78 yrs. Most patients were on an NNRTI-based first line regimen (76.4%, n=233), and 12.1% (n=37) were on rescue regimens. Median CD4 count was 614.2 cells/µL and the proportion of patients with viral load <40 c/mL was 90.8% (n=277). Most frequent metabolic diagnoses were dyslipidemia (51.5%, n=157), obesity (11.1%, n=34), and diabetes mellitus (7.2%, n=22). Hypertension was diagnosed in 8.9% (n=27). Other diagnoses of cardiovascular disease were documented in 3.3% (n=10). Pharmacologic treatment was prescribed in 91.3% of patients with diabetes or hypertension, but in only 29.3% of patients with dyslipidemia.Conclusion:A high proportion of metabolic comorbidities was found, with dyslipidemia being the most frequent, followed by obesity and diabetes. In contrast, cardiovascular disease was documented less frequently. Medical treatment was started for only a third of dyslipidemia patients. HIV care policies need to consider proper management of chronic comorbidities to optimize long-term outcomes.

Outcomes of community-based differentiated models of multi-month dispensing of antiretroviral medication among stable HIV-infected patients in Lesotho: a cluster randomised non-inferiority trial protocol

BackgroundCurrent World Health Organization (WHO) guidelines recommend early initiation of HIV positive patients on antiretroviral therapy (ART) irrespective of their clinical or immunological status known as the test and start approach. Lesotho, like many other countries introduced this approach in 2016 as a strategy to reach epidemic control. There will be rapidly growing number of HIV-infected individuals initiating treatment leading to practical challenges on health systems such as congestion, long waiting time for patients and limited time to provide quality services to patients. Differentiated models of ART delivery is an innovative solution that helps to increase access to care, while reducing the burden on existing health systems. Ultimately this model will help to achieve retention and viral suppression. We describe a demonstration study designed to evaluate a community-based differentiated model of multi-month dispensing (MMD) approaches of ART among stable HIV patients in Lesotho.MethodsThis study will be a three-arm cluster randomised trial, which will enrol approximately 5760 HIV-infected individuals who are stable on ART in 30 selected clusters. The clusters, which are health facilities, will be randomly assigned into the following differentiated model of care arms: (i) 3 monthly ART supply at facilities (Control), (ii) 3 monthly ART supply through community ART groups (CAGs) and (iii) 6 monthly ART supply through community ART distribution points (CAD). Primary outcomes are retention in care and virologic suppression, and secondary outcomes include feasibility and cost effectiveness.DiscussionImportant lessons will be learnt to allow for improved implementation of such demonstration projects, including various needs for reliable supply of medication, access to quality clinical data including access to viral loads (VLs) results, frameworks to support lay worker cadre, involvement of community stakeholders, and reliable data systems including records of key indicators. MMD will have positive implications including improved retention, virologic suppression, convenience and access to medication.Trial registrationClinicalTrials.gov Identifier: NCT03438370. Accepted on 16 February 2018.

Patient and health worker experiences of differentiated models of care for stable HIV patients in Malawi: A qualitative study

IntroductionSeveral models of differentiated care for stable HIV patients on antiretroviral therapy (ART) in Malawi have been introduced to ensure that care is efficient and patient-centered. Three models have been prioritized by the government for a deeper and broader understanding: adjusted appointment spacing through multi-month scripting (MMS); fast-track drug refills (FTRs) on alternating visits; and community ART groups (CAGs) where rotating group members collect medications at the facility for all members. This qualitative study aimed to understand the challenges and successes of implementing these models of care and of the process of patient differentiation.MethodsA qualitative study was conducted as a part of a broader process evaluation in 30 purposefully selected ART facilities between February and May 2016. Semi-structured, in-depth interviews with 32 health workers that managed and coordinated ART clinics and 30 focus groups were held with 216 ART patients. Interviews and focus groups were audio recorded, transcribed, and coded thematically.ResultsParticipants reported that the models of differentiated care have yielded key benefits, including: reduced patients’ travel and visit time, decongestion of facilities, and enhanced social support. Participants suggested that these benefits could lead to improved HIV treatment outcomes for patients. At the same time, some challenges were reported, such as inconsistent stocks of drugs, which can inhibit implementation of MMS. For CAGs, the group-based nature of the model presented some unique problems, such as conflicts within groups or concerns about privacy. Health workers also described some of the reasons why eligible patients may not receive the models or conversely why ineligible patients sometimes get the models.ConclusionsDocumenting patient and health worker perspectives on models of differentiated care is critical to understanding and improving these models. While these models can offer important benefits, the models may not be appropriate for all sites or patients, and patient status and needs may change over time. Key challenges should be recognized and addressed for optimal utilization of the models.

Clinic flow for STI, HIV, and TB patients in an urban infectious disease clinic offering point-of-care testing services in Durban, South Africa

BackgroundMany clinics in Southern Africa have long waiting times. The implementation of point-of-care (POC) tests to accelerate diagnosis and improve clinical management in resource-limited settings may improve or worsen clinic flow and waiting times. The objective of this study was to describe clinic flow with special emphasis on the impact of POC testing at a large urban public healthcare clinic in Durban, South Africa.MethodsWe used time and motion methods to directly observe patients and practitioners. We created patient flow maps and recorded individual patient waiting and consultation times for patients seeking STI, TB, or HIV care. We conducted semi-structured interviews with 20 clinic staff to ascertain staff opinions on clinic flow and POC test implementation.ResultsAmong 121 observed patients, the total number of queues ranged from 4 to 7 and total visit times ranged from 0:14 (hours:minutes) to 7:38. Patients waited a mean of 2:05 for standard-of-care STI management, and approximately 4:56 for STI POC diagnostic testing. Stable HIV patients who collected antiretroviral therapy refills waited a mean of 2:42 in the standard queue and 2:26 in the fast-track queue. A rapid TB test on a small sample of patients with the Xpert MTB/RIF assay and treatment initiation took a mean of 6:56, and 40% of patients presenting with TB-related symptoms were asked to return for an additional clinic visit to obtain test results. For all groups, the mean clinical assessment time with a nurse or physician was 7 to 9 min, which accounted for 2 to 6% of total visit time. Staff identified poor clinic flow and personnel shortages as areas of concern that may pose challenges to expanding POC tests in the current clinic environment.ConclusionsThis busy urban clinic had multiple patient queues, long clinical visits, and short clinical encounters. Although POC testing ensured patients received a diagnosis sooner, it more than doubled the time STI patients spent at the clinic and did not result in same-day diagnosis for all patients screened for TB. Further research on implementing POC testing efficiently into care pathways is required to make these promising assays a success.

The effectiveness and cost-effectiveness of 3- vs. 6-monthly dispensing of antiretroviral treatment (ART) for stable HIV patients in community ART-refill groups in Zimbabwe: study protocol for a pragmatic, cluster-randomized trial

BackgroundSub-Saharan Africa is the world region with the greatest number of people eligible to receive antiretroviral treatment (ART). Less frequent dispensing of ART and community-based ART-delivery models are potential strategies to reduce the load on overburdened healthcare facilities and reduce the barriers for patients to access treatment. However, no large-scale trials have been conducted investigating patient outcomes or evaluating the cost-effectiveness of extended ART-dispensing intervals within community ART-delivery models. This trial will assess the clinical effectiveness, cost-effectiveness and acceptability of providing ART refills on a 3 vs. a 6-monthly basis within community ART-refill groups (CARGs) for stable patients in Zimbabwe.MethodsIn this pragmatic, three-arm, parallel, unblinded, cluster-randomized non-inferiority trial, 30 clusters (healthcare facilities and associated CARGs) are allocated using stratified randomization in a 1:1:1 ratio to either (1) ART refills supplied 3-monthly from the health facility (control arm), (2) ART refills supplied 3-monthly within CARGs, or (3) ART refills supplied 6-monthly within CARGs. A CARG consists of 6–12 stable patients who meet in the community to receive ART refills and who provide support to one another. Stable adult ART patients with a baseline viral load < 1000 copies/ml will be invited to participate (1920 participants per arm). The primary outcome is the proportion of participants alive and retained in care 12 months after enrollment. Secondary outcomes (measured at 12 and 24 months) are the proportions achieving virological suppression, average provider cost per participant, provider cost per participant retained, cost per participant retained with virological suppression, and average patient-level costs to access treatment. Qualitative research will assess the acceptability of extended ART-dispensing intervals within CARGs to both providers and patients, and indicators of potential facility-level decongestion due to the interventions will be assessed.DiscussionCost-effective health system models that sustain high levels of patient retention are urgently needed to accommodate the large numbers of stable ART patients in sub-Saharan Africa. This will be the first trial to evaluate extended ART-dispensing intervals within a community-based ART distribution model, and results are intended to inform national and regional policy regarding their potential benefits to both the healthcare system and patients.Trial registrationClinicalTrials.gov, ID: NCT03238846. Registered on 27 July 2017.

Conflicting effects of atazanavir therapy on atherosclerotic risk factors in stable HIV patients: A randomized trial of regimen switch to atazanavir.

Bilirubin acts as a potent endogenous antioxidant, with higher concentrations associated with lower rates of CVD; the antiretroviral drug atazanavir (ATV) increases bilirubin levels but may also increase von Willebrand factor levels. We tested the hypothesis that increasing endogenous bilirubin using ATV would improve cardiometabolic risk factors and vascular function in older patients with HIV. Ninety participants were enrolled in two study protocols. In protocol 1, we evaluated markers of inflammation, thrombosis, and conduit artery endothelial function in subjects on non-ATV containing regimens. Participants were randomly assigned to continue baseline treatment or switch to an ATV-based regimen. Measurements were made at baseline and 28 days. In the protocol 2, we enrolled 30 subjects who received atazanavir for more than one year and were compared to the aim 1 protocol subjects at baseline. 60 subjects were enrolled in the first protocol (mean age 53, +/- 6 years), with 31 randomized to ATV and 29 continuing baseline treatment. Atazanavir significantly increased serum total bilirubin levels (p<0.001) and acutely but not chronically plasma total antioxidant capacity (p<0.001). An increase in von Willebrand Factor (p<0.001) and reduction in hs-CRP (p = 0.034) were noted. No changes were seen in either flow-mediated endothelium-dependent or vasodilation. In cross-sectional analysis (second protocol), similar findings were seen in the baseline attributes of non-atazanavir-based and long-term atazanavir users. Increasing serum bilirubin levels with atazanavir in subjects with HIV reduces hs-CRP, temporarily reduces oxidative stress, but increases von Willebrand Factor. Atazanavir does not improve endothelial function of conduit arteries.Trial registration: ClinicalTrials.gov NCT03019783.

Cognitive Problems in Stable HIV Patients May Indicate Virus in CSF

Cognitive Problems in Stable HIV Patients May Indicate Virus in CSF

Brief Report: Decentralizing ART Supply for Stable HIV Patients to Community-Based Distribution Centers: Program Outcomes From an Urban Context in Kinshasa, DRC.

Facility-based antiretroviral therapy (ART) provision for stable patients with HIV congests health services in resource-limited countries. We assessed outcomes and risk factors for attrition after decentralization to community-based ART refill centers among 2603 patients with HIV in Kinshasa, Democratic Republic of Congo, using a multilevel Poisson regression model. Death, loss to follow-up, and transfer out were 0.3%, 9.0%, and 0.7%, respectively, at 24 months. Overall attrition was 5.66/100 person-years. Patients with >3 years on ART, >500 cluster of differentiation type-4 count, body mass index >18.5, and receiving nevirapine but not stavudine showed reduced attrition. ART refill centers are a promising task-shifting model in low-prevalence urban settings with high levels of stigma and poor ART coverage.

"They just come, pick and go." The Acceptability of Integrated Medication Adherence Clubs for HIV and Non Communicable Disease (NCD) Patients in Kibera, Kenya.

IntroductionThe number of people on antiretroviral therapy (ART) for the long-term management of HIV in low- and middle-income countries (LMICs) is continuing to increase, along with the prevalence of Non-Communicable Diseases (NCDs). The need to provide large volumes of HIV patients with ART has led to significant adaptations in how medication is delivered, but access to NCD care remains limited in many contexts. Medication Adherence Clubs (MACs) were established in Kibera, Kenya to address the large numbers of patients requiring chronic HIV and/or NCD care. Stable NCD and HIV patients can now collect their chronic medication every three months through a club, rather than through individual clinic appointments.MethodologyWe conducted a qualitative research study to assess patient and health-care worker perceptions and experiences of MACs in the urban informal settlement of Kibera, Kenya. A total of 106 patients (with HIV and/or other NCDs) and health-care workers were purposively sampled and included in the study. Ten focus groups and 19 in-depth interviews were conducted and 15 sessions of participant observation were carried out at the clinic where the MACs took place. Thematic data analysis was conducted using NVivo software, and coding focussed on people’s experiences of MACs, the challenges they faced and their perceptions about models of care for chronic conditions.ResultsMACs were considered acceptable to patients and health-care workers because they saved time, prevented unnecessary queues in the clinic and provided people with health education and group support whilst they collected their medication. Some patients and health-care workers felt that MACs reduced stigma for HIV positive patients by treating HIV as any other chronic condition. Staff and patients reported challenges recruiting patients into MACs, including patients not fully understanding the eligibility criteria for the clubs. There were also some practical challenges during the implementation of the clubs, but MACs have shown that it is possible to learn from ART provision and enable stable HIV and NCD patients to collect chronic medication together in a group.ConclusionsExtending models of care previously only offered to HIV-positive cohorts to NCD patients can help to de-stigmatise HIV, allow for the efficient clinical management of co-morbidities and enable patients to benefit from peer support. Through MACs, we have demonstrated that an integrated approach to providing medication for chronic diseases including HIV can be implemented in resource-poor settings and could thus be rolled out in other similar contexts.

Medication Adherence Clubs: a potential solution to managing large numbers of stable patients with multiple chronic diseases in informal settlements.

ObjectivesTo assess the care of hypertension, diabetes mellitus and/or HIV patients enrolled into Medication Adherence Clubs (MACs).MethodsRetrospective descriptive study was carried out using routinely collected programme data from a primary healthcare clinic at informal settlement in Nairobi, Kenya. All patients enrolled into MACs were selected for the study. MACs are nurse‐facilitated mixed groups of 25–35 stable hypertension, diabetes mellitus and/or HIV patients who met quarterly to confirm their clinical stability, have brief health discussions and receive medication. Clinical officer reviewed MACs yearly, when a patient developed complications or no longer met stable criteria.ResultsA total of 1432 patients were enrolled into 47 clubs with 109 sessions conducted between August 2013 and August 2014. There were 1020 (71%) HIV and 412 (29%) non‐communicable disease patients. Among those with NCD, 352 (85%) had hypertension and 60 (15%) had DM, while 12 had HIV concurrent with hypertension. A total of 2208 consultations were offloaded from regular clinic. During MAC attendance, blood pressure, weight and laboratory testing were completed correctly in 98–99% of consultations. Only 43 (2%) consultations required referral for clinical officer review before their routine yearly appointment. Loss to follow‐up from the MACs was 3.5%.ConclusionsThis study demonstrates the feasibility and early efficacy of MACs for mixed chronic disease in a resource‐limited setting. It supports burden reduction and flexibility of regular clinical review for stable patients. Further assessment regarding long‐term outcomes of this model should be completed to increase confidence for deployment in similar contexts.

Impaired Urine Dilution Capability in HIV Stable Patients.

Renal disease is a well-recognized complication among patients with HIV infection. Viral infection itself and the use of some antiretroviral drugs contribute to this condition. The thick ascending limb of Henle's loop (TALH) is the tubule segment where free water clearance is generated, determining along with glomerular filtration rate the kidney's ability to dilute urine. Objective. We analyzed the function of the proximal tubule and TALH in patients with HIV infection receiving or not tenofovir-containing antiretroviral treatment in comparison with healthy seronegative controls, by applying a tubular physiological test, hyposaline infusion test (Chaimowitz' test). Material & Methods. Chaimowitz' test was performed on 20 HIV positive volunteers who had normal renal functional parameters. The control group included 10 healthy volunteers. Results. After the test, both HIV groups had a significant reduction of serum sodium and osmolarity compared with the control group. Free water clearance was lower and urine osmolarity was higher in both HIV+ groups. Proximal tubular function was normal in both studied groups. Conclusion. The present study documented that proximal tubule sodium reabsorption was preserved while free water clearance and maximal urine dilution capability were reduced in stable HIV patients treated or not with tenofovir.