scholarly journals Reducing time to differentiated service delivery for newly diagnosed people living with HIV in Kigali, Rwanda: study protocol for a pilot, unblinded, randomised controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e047443
Author(s):  
Jonathan Ross ◽  
Gad Murenzi ◽  
Sarah Hill ◽  
Eric Remera ◽  
Charles Ingabire ◽  
...  

IntroductionCurrent HIV guidelines recommend differentiated service delivery (DSD) models that allow for fewer health centre visits for clinically stable people living with HIV (PLHIV). Newly diagnosed PLHIV may require more intensive care early in their treatment course, yet frequent appointments can be burdensome to patients and health systems. Determining the optimal parameters for defining clinical stability and transitioning to less frequent appointments could decrease patient burden and health system costs. The objectives of this pilot study are to explore the feasibility and acceptability of (1) reducing the time to DSD from 12 to 6 months after antiretroviral therapy (ART) initiation,and (2) reducing the number of suppressed viral loads required to enter DSD from two to one.Methods and analysesThe present study is a pilot, unblinded trial taking place in three health facilities in Kigali, Rwanda. Current Rwandan guidelines require PLHIV to be on ART for ≥12 months with two consecutive suppressed viral loads in order to transition to less frequent appointments. We will randomise 90 participants to one of three arms: entry into DSD at 6 months after one suppressed viral load (n=30), entry into DSD at 6 months after two suppressed viral loads (n=30) or current standard of care (n=30). We will measure feasibility and acceptability of this intervention; clinical outcomes include viral suppression at 12 months (primary outcome) and appointment attendance (secondary outcome).Ethics and disseminationThis clinical trial was approved by the institutional review board of Albert Einstein College of Medicine and by the Rwanda National Ethics Committee. Findings will be disseminated through conferences and peer-reviewed publications, as well as meetings with stakeholders.Trial registration numberNCT04567693.

2021 ◽  
Author(s):  
Lingrui Liu ◽  
Sarah Christie ◽  
Maggie Munsamy ◽  
Phil Roberts ◽  
Merlin Pillay ◽  
...  

Abstract Background: South Africa is home to 7.7 million people living with HIV and supports the largest antiretroviral therapy (ART) program worldwide. Despite global investment in HIV service delivery and the parallel threat of non-communicable diseases (NCDs), there are few examples of integrated programs addressing both HIV and NCDs through differentiated service delivery. In 2014, the National Department of Health (NDoH) launched the Central Chronic Medicines Dispensing and Distribution (CCMDD) program to provide patients with chronic disease, including HIV, with differentiated access to medications via community-based pick-up points. This study describes the expansion of CCMDD to national scale.Methods: Yale monitors CCMDD enrollment as part of its mixed methods evaluation of Project Last Mile (PLM), a national technical support partner for CCMDD since 2016. From March 2016 through October 2019, cumulative weekly data on CCMDD uptake [patients enrolled, facilities registered, pick-up points contracted], type of medication collected [ART only; NCD only; and ART-NCD] and of collection site used [external pick-up points; adherence/outreach clubs; or facility-based fast lanes], were extracted for descriptive, longitudinal analysis.Results: As of October 2019, 3,436 health facilities were registered with CCMDD across 46 health districts (88% national coverage), and 2,037 external pick-up points had been established. A total of 2,069,039 patients were active on CCMDD, a significant increase since 2018 (p<0.001), including 76% collecting ART [64% ART only, 12% ART plus NCD/comorbidities] and 479,120 [24%] collecting for chronic diseases only. Further, 734,005 (35%) of patients were collecting from external pick-up points, a 73% increase in patient volume from 2018.Discussion: This longitudinal description of CCMDD provides an example of a path to national scale for a differentiated service delivery model that integrates management of HIV and noncommunicable diseases. This study demonstrates the success of the program in engaging patients who are not living with HIV, which bodes well for the potential of the program to address the rising burden of NCDs in South Africa.Conclusion: The results signal potential for expansion in resource-limited settings, particularly in the context of private sector strategic support.


Healthcare ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 116
Author(s):  
Martin K. Msukwa ◽  
Munyaradzi P. Mapingure ◽  
Jennifer M. Zech ◽  
Tsitsi B. Masvawure ◽  
Joanne E. Mantell ◽  
...  

As Zimbabwe expands tuberculosis preventive treatment (TPT) for people living with HIV (PLHIV), the Ministry of Health and Child Care is considering making TPT more accessible to PLHIV via less-intensive differentiated service delivery models such as Community ART Refill Groups (CARGs). We designed a study to assess the feasibility and acceptability of integrating TPT into CARGs among key stakeholders, including CARG members, in Zimbabwe. We conducted 45 key informant interviews (KII) with policy makers, implementers, and CARG leaders; 16 focus group discussions (FGD) with 136 PLHIV in CARGs; and structured observations of 8 CARG meetings. KII and FGD were conducted in English and Shona. CARG observations were conducted using a structured checklist and time-motion data capture. Ninety six percent of participants supported TPT integration into CARGs and preferred multi-month TPT dispensing aligned with ART dispensing schedules. Participants noted that the existing CARG support systems could be used for TB symptom screening and TPT adherence monitoring/support. Other perceived advantages included convenience for PLHIV and decreased health facility provider workloads. Participants expressed concerns about possible medication stockouts and limited knowledge about TPT among CARG leaders but were confident that CARGs could effectively provide community-based TPT education, adherence monitoring/support, and TB symptom screening provided that CARG leaders received appropriate training and supervision. These results are consistent with findings from pilot projects in other African countries that are scaling up both differentiated service delivery for HIV and TPT and suggest that designing contextually appropriate approaches to integrating TPT into less-intensive HIV treatment models is an effective way to reach people who are established on ART but who may have missed out on access to TPT.


2021 ◽  
pp. 104973232110503
Author(s):  
Ferdinand C. Mukumbang ◽  
Sibusiso Ndlovu ◽  
Brian van Wyk

Differentiated service delivery for HIV treatment seeks to enhance medication adherence while respecting the preferences of people living with HIV. Nevertheless, patients’ experiences of using these differentiated service delivery models or approaches have not been qualitatively compared. Underpinned by the tenets of descriptive phenomenology, we explored and compared the experiences of patients in three differentiated service delivery models using the National Health Services’ Patient Experience Framework. Data were collected from 68 purposively selected people living with HIV receiving care in facility adherence clubs, community adherence clubs, and quick pharmacy pick-up. Using the constant comparative thematic analysis approach, we compared themes identified across the different participant groups. Compared to facility adherence clubs and community adherence clubs, patients in the quick pharmacy pick-up model experienced less information sharing; communication and education; and emotional/psychological support. Patients’ positive experience with a differentiated service delivery model is based on how well the model fits into their HIV disease self-management goals.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lingrui Liu ◽  
Sarah Christie ◽  
Maggie Munsamy ◽  
Phil Roberts ◽  
Merlin Pillay ◽  
...  

Abstract Background South Africa is home to 7.7 million people living with HIV and supports the largest antiretroviral therapy (ART) program worldwide. Despite global investment in HIV service delivery and the parallel challenge of non-communicable diseases (NCDs), there are few examples of integrated programs addressing both HIV and NCDs through differentiated service delivery. In 2014, the National Department of Health (NDoH) of South Africa launched the Central Chronic Medicines Dispensing and Distribution (CCMDD) program to provide patients who have chronic diseases, including HIV, with alternative access to medications via community-based pick-up points. This study describes the expansion of CCMDD toward national scale. Methods Yale monitors CCMDD expansion as part of its mixed methods evaluation of Project Last Mile, a national technical support partner for CCMDD since 2016. From March 2016 through October 2019, cumulative weekly data on CCMDD uptake [patients enrolled, facilities registered, pick-up points contracted], type of medication provided [ART only; NCD only; and ART-NCD] and collection sites preferred by patients [external pick-up points; adherence/outreach clubs; or facility-based fast lanes], were extracted for descriptive, longitudinal analysis. Results As of October 2019, 3,436 health facilities were registered with CCMDD across 46 health districts (88 % of South Africa’s districts), and 2,037 external pick-up points had been contracted by the NDoH. A total of 2,069,039 patients were actively serviced through CCMDD, a significant increase since 2018 (p < 0.001), including 76 % collecting ART [64 % ART only, 12 % ART plus NCD/comorbidities] and 479,120 [24 %] collecting medications for chronic diseases only. Further, 734,005 (35 %) of patients were collecting from contracted, external pick-up points, a 73 % increase in patient volume from 2018. Discussion This longitudinal description of CCMDD provides an example of growth of a national differentiated service delivery model that integrates management of HIV and noncommunicable diseases. This study demonstrates the success of the program in engaging patients irrespective of their chronic condition, which bodes well for the potential of the program to address the rising burden of both HIV and NCDs in South Africa. Conclusions The CCMDD program expansion signals the potential for a differentiated service delivery strategy in resource-limited settings that can be agnostic of the patients chronic disease condition.


CNS Spectrums ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 143-143
Author(s):  
Martin J. Mazzoglio y Nabar ◽  
Santiago Muñoz ◽  
Milagros Muñiz ◽  
Alexis Mejías ◽  
Christian Montivero ◽  
...  

AbstractIntroductionHyperammonaemia (HA) is observed in decompensated liver disease. The picture of hyperammonemic encephalopathy in non-cirrhotic patients was reported mostly associated with valproic acid. There are few reports of hyperammonemia in people living with human immunodeficiency virus (PLHIV) and they are associated with other comorbidities and few with antiretrovirals (HAART), but not as adverse drug reactions associated with psychotropic drugs associated with the virus.ObjectiveReport of cases of PLHIV in HARRT with hyperammonemia, its clinical impact and ammonium levels.Materials and MethodsWe report 67 PLHIV in treatment with HAART, negative viral loads, psychopharmacological treatment with valproic acid (n=45) or carbamazepine (n=22). Exclusion criteria were = HCV, HBV and alcohol consumption disorder (current or recent history) and decompensated liver pathology. We apply scales to evaluate side effects (UKU), subjective adherence (DAI), daily life activities (Barthel Index), liver severity (Child-Pugh Classification) and degrees of hepatic encephalopathy (West Haven Scale). The ethical-legal requirements were met. Results: 26.86% presented hyperammonemia, among which 38.88% was symptomatic. The clinical presentation was heterogeneous with a higher prevalence of gastrointestinal and cognitive alterations; the most severe cases presented alterations of the sensorium and 1 case of convulsions. We recorded a greater symptomatic severity with carbamazepine (average ammonia =104.4 pmol/L), but a higher prevalence of non-symptomatic hyperammonemia with valproic acid (62.3 pmol/L). The time of onset of symptoms was lower with carbamazepine, but the time until its decrease was higher with valproic acid.ConclusionsWe observed a higher prevalence of hyperammonemia and associated symptomatology in PLHIV with HAART medicated with carbamazepine. The significant percentage of this adverse drug reaction suggests a biochemical, perhaps preventive, control.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e041734
Author(s):  
Ni Gusti Ayu Nanditha ◽  
Adrianna Paiero ◽  
Hiwot M Tafessu ◽  
Martin St-Jean ◽  
Taylor McLinden ◽  
...  

ObjectivesAs people living with HIV (PLWH) live longer, morbidity and mortality from non-AIDS comorbidities have emerged as major concerns. Our objective was to compare prevalence trends and age at diagnosis of nine chronic age-associated comorbidities between individuals living with and without HIV.Design and settingThis population-based cohort study used longitudinal cohort data from all diagnosed antiretroviral-treated PLWH and 1:4 age-sex-matched HIV-negative individuals in British Columbia, Canada.ParticipantsThe study included 8031 antiretroviral-treated PLWH and 32 124 HIV-negative controls (median age 40 years, 82% men). Eligible participants were ≥19 years old and followed for ≥1 year during 2000 to 2012.Primary and secondary outcome measuresThe presence of non-AIDS-defining cancers, diabetes, osteoarthritis, hypertension, Alzheimer’s and/or non-HIV-related dementia, cardiovascular, kidney, liver and lung diseases were identified from provincial administrative databases. Beta regression assessed annual age-sex-standardised prevalence trends and Kruskal-Wallis tests compared the age at diagnosis of comorbidities stratified by rate of healthcare encounters.ResultsAcross study period, the prevalence of all chronic age-associated comorbidities, except hypertension, were higher among PLWH compared with their community-based HIV-negative counterparts; as much as 10 times higher for liver diseases (25.3% vs 2.1%, p value<0.0001). On stratification by healthcare encounter rates, PLWH experienced most chronic age-associated significantly earlier than HIV-negative controls, as early as 21 years earlier for Alzheimer’s and/or dementia.ConclusionsPLWH experienced higher prevalence and earlier age at diagnosis of non-AIDS comorbidities than their HIV-negative controls. These results stress the need for optimised screening for comorbidities at earlier ages among PLWH, and a comprehensive HIV care model that integrates prevention and treatment of chronic age-associated conditions. Additionally, the robust methodology developed in this study, which addresses concerns on the use of administrative health data to measure prevalence and incidence, is reproducible to other settings.


2021 ◽  
Vol 22 (10) ◽  
pp. 5304
Author(s):  
Ana Santos-Pereira ◽  
Vera Triunfante ◽  
Pedro M. M. Araújo ◽  
Joana Martins ◽  
Helena Soares ◽  
...  

The success of antiretroviral treatment (ART) is threatened by the emergence of drug resistance mutations (DRM). Since Brazil presents the largest number of people living with HIV (PLWH) in South America we aimed at understanding the dynamics of DRM in this country. We analyzed a total of 20,226 HIV-1 sequences collected from PLWH undergoing ART between 2008–2017. Results show a mild decline of DRM over the years but an increase of the K65R reverse transcriptase mutation from 2.23% to 12.11%. This increase gradually occurred following alterations in the ART regimens replacing zidovudine (AZT) with tenofovir (TDF). PLWH harboring the K65R had significantly higher viral loads than those without this mutation (p < 0.001). Among the two most prevalent HIV-1 subtypes (B and C) there was a significant (p < 0.001) association of K65R with subtype C (11.26%) when compared with subtype B (9.27%). Nonetheless, evidence for K65R transmission in Brazil was found both for C and B subtypes. Additionally, artificial neural network-based immunoinformatic predictions suggest that K65R could enhance viral recognition by HLA-B27 that has relatively low prevalence in the Brazilian population. Overall, the results suggest that tenofovir-based regimens need to be carefully monitored particularly in settings with subtype C and specific HLA profiles.


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