Isoniazid preventive therapy completion between July-September 2019: A comparison across HIV differentiated service delivery models in Uganda.

BACKGROUND: Tuberculosis (TB) remains the leading cause of death among people living with HIV (PLHIV). To prevent TB among PLHIV, the Ugandan national guidelines recommend Isoniazid Preventive Therapy (IPT) across differentiated service delivery (DSD) models, an effective way of delivering ART. DSD models include Community Drug Distribution Point (CDDP), Community Client-led ART Delivery (CCLAD), Facility-Based Individual Management (FBIM), Facility-Based Group (FBG), and Fast Track Drug Refill (FTDR). Little is known about the impact of delivering IPT through DSD. METHODS: We reviewed medical records of PLHIV who initiated IPT between June-September 2019 at TASO Soroti (TS), Katakwi Hospital (KH) and Soroti Regional Referral Hospital (SRRH). We defined IPT completion as completing a course of isoniazid within 6-9 months. We utilized a modified Poisson regression to compare IPT completion across DSD models and determine factors associated with IPT completion in each DSD model. RESULTS: Data from 2968 PLHIV were reviewed (SRRH: 50.2%, TS: 25.8%, KH: 24.0%); females: 60.7%; first-line ART: 91.7%; and Integrase Strand Transfer Inhibitor (INSTI)-based regimen: 61.9%. At IPT initiation, the median age and duration on ART were 41.5 (interquartile range [IQR]; 32.3-50.2) and 6.0 (IQR: 3.7-8.6) years, respectively. IPT completion overall was 92.8% (95%CI: 91.8-93.7%); highest in CDDP (98.1%, 95%CI: 95.0-99.3%) and lowest in FBG (85.8%, 95%CI: 79.0-90.7%). Compared to FBIM, IPT completion was significantly higher in CDDP (adjusted rate ratio [aRR] = 1.15, 95%CI: 1.09-1.22) and CCLAD (aRR = 1.09, 95% CI 1.02-1.16). In facility-based models, IPT completion differed between sites (p<0.001). IPT completion increased with age for FBIM and CCLAD and was lower among female participants in the CCLAD (aRR = 0.82, 95%CI 0.67-0.97). CONCLUSION: IPT completion was high overall but highest in community-based models. Our findings provide evidence that supports integration of IPT within DSD models for ART delivery in Uganda and similar settings.

Predicting Lost to Follow-Up Status Using an Adolescent HIV Psychosocial Attrition Risk Assessment Tool: Results From a Mixed Methods Prospective Cohort Study in Uganda.

BACKGROUND: Low retention in care for adolescents living with HIV (ALHIV) has been a key driver of suboptimal viral load suppression rates in Uganda. The objective of this study was to develop a psychosocial risk assessment tool and evaluate its ability to predict the risk of attrition of ALHIV between the ages 15 and 19 years. SETTING: The study was conducted in 20 facilities in Central and Western Uganda from August 2021 through July 2022. METHODS: A mixed methods prospective cohort study was conducted in two phases. In the first phase, the Adolescent Psychosocial Attrition Risk Assessment tool was developed and revised using feedback from focus group discussions and interviews. In the second phase, the ability of the Adolescent Psychosocial Attrition Risk Assessment tool to predict attrition among ALHIV was evaluated using diagnostic accuracy tests. RESULTS: A total of 597 adolescents between the ages 15 and 19 years were enrolled, of which 6% were lost to follow-up at the end of the study period. A 20-question tool was developed, with 12 questions being responded to affirmatively by >50% of all participants. Using a cut-off score of 6 or more affirmative answers translated to an area under the curve of 0.58 (95% CI: 0.49 to 0.66), sensitivity of 55% (95% CI: 36% to 72%), and specificity of 61% (95% CI: 56% to 65%). CONCLUSION: Although the Adolescent Psychosocial Attrition Risk Assessment tool was not effective at predicting lost to follow-up status among ALHIV, the tool was useful for identifying psychosocial issues experienced by ALHIV and may be appropriate to administer during routine care visits to guide action.

A Model for Accelerating Access to Care and Treatment for Children and Adolescents Living with HIV in Nigeria, Tanzania, Uganda, and Zambia: The Faith-Based Action for Scaling-Up Testing and Treatment for the Epidemic Response (FASTER) Initiative.

The number of children newly infected with HIV dropped by 50%, from 320 000 in 2010 to 160 000 in 2021. Despite progress, ongoing gaps persist in diagnosis, continuity of care, and treatment optimization. In response, the United States President's Emergency Plan for AIDS Relief created the Faith-based Action for Scaling-Up Testing and Treatment for Epidemic Response (FASTER). Faith-based Action for Scaling-Up Testing and Treatment for Epidemic Response addressed gaps in countries with the highest unmet need by working with government to operationalize innovative interventions and ensure alignment with national priorities and with communities living with HIV to ensure the change was community-led. Between 2019 and 2021, FASTER's interventions were incorporated into national policies, absorbed by Ministries of Health, and taken up in subsequent awards and country operating plans. Continued effort is needed to sustain gains made during the FASTER initiative and to continue scaling evidence-based interventions to ensure that children and adolescents are not left behind in the global HIV response.

Understanding Uganda's early adoption of novel differentiated HIV treatment services: a qualitative exploration of drivers of policy uptake.

BACKGROUND: Although differentiated service delivery (DSD) for HIV treatment was endorsed by the WHO in its landmark 2016 guidelines to lessen patients' need to frequently visit clinics and hence to reduce unnecessary burdens on health systems, uptake has been uneven globally. This paper is prompted by the HIV Policy Lab's annual report of 2022 which reveals substantial variations in programmatic uptake of differentiated HIV treatment services across the globe. We use Uganda as a case study of an 'early adopter' to explore the drivers of programmatic uptake of novel differentiated HIV treatment services. METHODS: We conducted a qualitative case-study in Uganda. In-depth interviews were held with national-level HIV program managers (n = 18), district health team members (n = 24), HIV clinic managers (n = 36) and five focus groups with recipients of HIV care (60 participants) supplemented with documentary reviews. Our thematic analysis of the qualitative data was guided by the Consolidated Framework for Implementation Research (CFIR)'s five domains (inner context, outer setting, individuals, process of implementation). RESULTS: Our analysis reveals that drivers of Uganda's 'early adoption' of DSD include: having a decades-old HIV treatment intervention implementation history; receiving substantial external donor support in policy uptake; the imperatives of having a high HIV burden; accelerated uptake of select DSD models owing to Covid-19 'lockdown' restrictions; and Uganda's participation in clinical trials underpinning WHO guidance on DSD. The identified processes of implementation entailed policy adoption of DSD (such as the role of local Technical Working Groups in domesticating global guidelines, disseminating national DSD implementation guidelines) and implementation strategies (high-level health ministry buy-in, protracted patient engagement to enhance model uptake, devising metrics for measuring DSD uptake progress) for promoting programmatic adoption. CONCLUSION: Our analysis suggests early adoption derives from Uganda's decades-old HIV intervention implementation experience, the imperative of having a high HIV burden which prompted innovations in HIV treatment delivery as well as outer context factors such as receiving substantial external assistance in policy uptake. Our case study of Uganda offers implementation research lessons on pragmatic strategies for promoting programmatic uptake of differentiated treatment HIV services in other countries with a high HIV burden.

Scale-Up of HIV Antiretroviral Therapy and Estimation of Averted Infections and HIV-Related Deaths - Uganda, 2004-2022.

On January 28, 2003, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the largest commitment by any nation to address a single disease in history, was announced.* In April 2004, the first person in the world to receive PEPFAR-supported antiretroviral therapy (ART) was a man aged 34 years in Uganda. Effective ART reduces morbidity and mortality among persons with HIV infection (1) and prevents both mother-to-child transmission (MTCT) (2) and sexual transmission once viral load is suppressed to undetectable levels (<200 viral copies/mL) (3). By September 2022, more than 1.3 million persons with HIV infection in Uganda were receiving PEPFAR-supported ART, an increase of approximately 5,000% from September 2004. As indicators of the ART program's effectiveness, a proxy MTCT rate decreased 77%, from 6.4% in 2010 to 1.5% in 2022, and the viral load suppression rate (<1,000 viral copies/mL) increased 3%, from 91% in 2016 to 94% in September 2022. During 2004-2022, ART scale-up helped avert nearly 500,000 HIV infections, including more than 230,000 infections among HIV-exposed infants, and approximately 600,000 HIV-related deaths. Going forward, efforts will focus on identifying all persons with HIV infection and rapidly linking them to effective ART. PEPFAR remains committed to continued strong partnership with the Government of Uganda, civil society, and other development partners toward sustainable solutions aligned with the Joint United Nations Programme on HIV/AIDS (UNAIDS) fast-track strategy to ending the global AIDS epidemic by 2030† and safeguarding impact achieved in the long term.

Protecting the gains: analysis of HIV treatment and service delivery programme data and interventions implemented in 19 African countries during COVID-19.

INTRODUCTION: The potential disruption in antiretroviral therapy (ART) services in Africa at the start of the COVID-19 pandemic raised concern for increased morbidity and mortality among people living with HIV (PLHIV). We describe HIV treatment trends before and during the pandemic and interventions implemented to mitigate COVID-19 impact among countries supported by the US Centers for Disease Control and Prevention (CDC) through the President's Emergency Plan for AIDS Relief (PEPFAR). METHODS: We analysed quantitative and qualitative data reported by 10,387 PEPFAR-CDC-supported ART sites in 19 African countries between October 2019 and March 2021. Trends in PLHIV on ART, new ART initiations and treatment interruptions were assessed. Viral load coverage (testing of eligible PLHIV) and viral suppression were calculated at select time points. Qualitative data were analysed to summarize facility- and community-based interventions implemented to mitigate COVID-19. RESULTS: The total number of PLHIV on ART increased quarterly from October 2019 (n = 7,540,592) to March 2021 (n = 8,513,572). The adult population (≥15 years) on ART increased by 14.0% (7,005,959-7,983,793), while the paediatric population (<15 years) on ART declined by 2.6% (333,178-324,441). However, the number of new ART initiations dropped between March 2020 and June 2020 by 23.4% for adults and 26.1% for children, with more rapid recovery in adults than children from September 2020 onwards. Viral load coverage increased slightly from April 2020 to March 2021 (75-78%) and viral load suppression increased from October 2019 to March 2021 (91-94%) among adults and children combined. The most reported interventions included multi-month dispensing (MMD) of ART, community service delivery expansion, and technology and virtual platforms use for client engagement and site-level monitoring. MMD of ≥3 months increased from 52% in October 2019 to 78% of PLHIV ≥ age 15 on ART in March 2021. CONCLUSIONS: With an overall increase in the number of people on ART, HIV programmes proved to be resilient, mitigating the impact of COVID-19. However, the decline in the number of children on ART warrants urgent investigation and interventions to prevent further losses experienced during the COVID-19 pandemic and future public health emergencies.

Mobile Phone-based Intervention to promote un-interrupted HIV treatment during the COVID-19 pandemic.

Introduction: Keeping HIV-infected adults away from the health care system during the COVID-19 travel restrictions, presents a challenge to HIV treatment adherence. Methods: This study focused on the initial two phases where Phase 1 designed a Makerere College of Health Sciences (MakCHS) Unstructured Supplementary Service Data (USSD)-based application; and Phase 2 piloted patient enrolment onto the application and determined the feasibility of remote follow-up of patients receiving long-term antiretroviral therapy (ART). Results: A off/online user application, MakCHS Health app, was developed. Overall, 112 patients [(66(59%) female] receiving ART at Mulago ISS clinic, Kampala, were enrolled onto the MakCHS Health app. Up to 89 (80%) utilized the app to access medical help. Patients' medical queries included needs for drug refills, missed taking HIV medication, medical illnesses, access to COVID-19 vaccination and other personal needs that required clinicians' attention. Conclusion: Piloting a MakCHS Health application for patient follow-up was feasible and well-received by HIV treatment providers and patients receiving ART. We recommend scale up of the application to enroll all patients receiving long-term treatment for HIV/AIDS, and subsequently expand to. other HIV treatment programs in similar settings.

Effectiveness of the Med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial.

INTRODUCTION: Combination antiretroviral therapy (cART) has massively reduced HIV mortality. However, long-term cART increases the risk of adverse drug reactions (ADRs), which can lead to higher morbidity, mortality and healthcare costs for people living with HIV (PLHIV).Pharmacovigilance-monitoring the effects of medicines-is essential for understanding real-world drug safety. In Uganda, pharmacovigilance systems have only recently been developed, and rates of ADR reporting for cART are very low. Thus, the safety profile of medicines currently used to treat HIV and tuberculosis in our population is poorly understood.The Med Safety mobile application has been developed through the European Union's Innovative Medicines Initiative WEB-Recognising Adverse Drug Reactions project to promote digital pharmacovigilance. This mobile application has been approved for ADR-reporting by Uganda's National Drug Authority. However, the barriers and facilitators to Med Safety uptake, and its effectiveness in improving pharmacovigilance, are as yet unknown. METHODS AND ANALYSIS: A pragmatic cluster-randomised controlled trial will be implemented over 30 months at 191 intervention and 191 comparison cART sites to evaluate Med Safety. Using a randomisation sequence generated by the sealed envelope software, we shall randomly assign the 382 prescreened cART sites to the intervention and comparison arms. Each cART site is a cluster that consists of healthcare professionals and PLHIV receiving dolutegravir-based cART and/or isoniazid preventive therapy. Healthcare professionals enrolled in the intervention arm will be trained in the use of mobile-based, paper-based and web-based reporting, while those in the comparison arm will be trained in paper-based and web-based reporting only. ETHICS AND DISSEMINATION: Ethical approval was given by the School of Biomedical Sciences Research and Ethics Committee at Makerere University (SBS-REC-720), and administrative clearance was obtained from Uganda National Council for Science and Technology (HS1366ES). Study results will be shared with healthcare professionals, policymakers, the public and academia. TRIAL REGISTRATION NUMBER: PACTR202009822379650.

Implementation of a peer support intervention to promote the detection, reporting and management of adverse drug reactions in people living with HIV in Uganda: a protocol for a quasi-experimental study.

INTRODUCTION: Patients have contributed <1% of spontaneous adverse drug reaction (ADR) reports in Uganda's pharmacovigilance database. Peer support combined with mobile technologies could empower people living with HIV (PLHIV) to report ADRs and improve ADR management through linkage to care. We seek to test the feasibility and effect of a peer support intervention on ADR reporting by PLHIV receiving combination antiretroviral therapy (cART) in Uganda; identify barriers and facilitators to the intervention; and characterise ADR reporting and management. METHODS AND ANALYSIS: This is a quasi-experimental study to be implemented over 4 months at 12 intervention and 12 comparison cART sites from four geographical regions of Uganda. Per region, two blocks each with a tertiary, secondary and primary care cART site will be selected by simple random sampling. Blocks per region will be randomly assigned to intervention and comparison arms.Study units will include cART sites and PLHIV receiving cART. PLHIV at intervention sites will be assigned to peer supporters to empower them to report ADRs directly to the National Pharmacovigilance Centre (NPC). Peer supporters will be expert clients from among PLHIV and/or recognised community health workers.Direct patient reporting of ADRs to NPC will leverage the Med Safety App and toll-free unstructured supplementary service data interface to augment traditional pharmacovigilance methods.The primary outcomes are attrition rate measured by number of study participants who remain in the study until the end of follow-up at 4 months; and number of ADR reports submitted to NPC by PLHIV as measured by questionnaire and data abstraction from the national pharmacovigilance database at baseline and 4 months. ETHICS AND DISSEMINATION: The study received ethical approval from: School of Health Sciences Research and Ethics Committee at Makerere University (MAKSHSREC-2020-64) and Uganda National Council for Science and Technology (HS1206ES). Results will be shared with PLHIV, policy-makers, the public and academia. TRIAL REGISTRATION NUMBER: ISRCTN75989485.

Mobile Phone-based intervention to promote un-interrupted HIV treatment during the COVID-19 pandemic

Introduction: Keeping HIV-infected adults away from the health care system during the COVID-19 travel restrictions, presents a challenge to HIV treatment adherence. Methods: This study focused on the initial two phases where Phase 1 designed a Makerere College of Health Sciences (MakCHS) Unstructured Supplementary Service Data (USSD)-based application; and Phase 2 piloted patient enrolment onto the application and determined the feasibility of remote follow-up of patients receiving long-term antiretroviral therapy (ART). Results: A off/online user application, MakCHS Health app, was developed. Overall, 112 patients [(66(59%) female] receiving ART at Mulago ISS clinic, Kampala, were enrolled onto the MakCHS Health app. Up to 89 (80%) utilized the app to access medical help. Patients' medical queries included needs for drug refills, missed taking HIV medication, medical illnesses, access to COVID-19 vaccination and other personal needs that required clinicians' attention. Conclusion: Piloting a MakCHS Health application for patient follow-up was feasible and well-received by HIV treatment providers and patients receiving ART. We recommend scale up of the application to enroll all patients receiving long-term treatment for HIV/AIDS, and subsequently expand to. other HIV treatment programs in similar settings

Developing and Validating an Effective Pediatric and Adolescent HIV Testing Eligibility Screening Tool for High-Volume Entry Points in Uganda.

INTRODUCTION: Because of low pediatric HIV prevalence, more tests are needed to find 1 HIV-positive child compared with adults. In Uganda, the number needed to test (NNT) to find 1 new HIV-positive child was 64 in outpatient departments (OPDs) and 31 through index testing. We aimed to develop and validate a pediatric (1.5-14 years) screening tool to optimize testing approaches. METHODS: Phase 1 evaluated the performance of 10 screening questions in 14 OPDs using a variable selection algorithm to evaluate combinations of screening questions. Using logistic regression, we identified the number of screening questions with the best predictive accuracy using the receiver operation characteristic curve. Phase 2 validated the proposed tool in 15 OPDs and 7 orphan and vulnerable children programs. We estimated sensitivity, specificity, and NNT accounting for intercluster correlations. RESULTS: A total of 3482 children were enrolled. The optimal model included reported HIV-positive maternal status or 2/5 symptoms (sickly in the last 3 months, recurring skin problems, weight loss, not growing well, and history of tuberculosis). The proposed tool had sensitivity of 83.6% [95% confidence interval (CI): 68.1 to 92.4] and specificity of 62.5% (95% CI: 55.0 to 69.4). The tool was validated in a sample of 11,342 children; sensitivity was 87.8% (95% CI: 80.9 to 92.5) and specificity 62.6% (95% CI: 54.8 to 69.7) across OPDs and community sites. In OPDs, sensitivity was 88.1% (95% CI: 80.8 to 92.8) and specificity 69.0% (95% CI: 61.9 to 75.3). The NNT was 43 (95% CI: 28 to 67) across settings and 28 (95% CI: 20 to 38) for OPD. CONCLUSIONS: This HIV screening tool has high sensitivity and reasonable specificity, increasing testing efficiency and yield for children and adolescents.

Establishing targets for advanced HIV disease: A call to action.

The World Health Organization (WHO) has published a guideline for the management of individuals with advanced HIV disease (AHD) to reduce HIV-related deaths. The guideline consists of a package of recommendations including interventions to prevent, diagnose and treat common opportunistic infections, including tuberculosis (TB), cryptococcosis and severe bacterial infections, along with rapid initiation of antiretroviral treatment and enhanced adherence support. Currently no clear targets exist for these key interventions. Emerging programmatic data from Uganda, Tanzania and Nigeria suggest that an estimated 80% of eligible people continue to miss the recommended cryptococcal or TB testing, highlighting the remaining challenges to the effective implementation of WHO-recommended AHD packages of care in real-world resource-limited settings. The absence of mortality indicators for the leading causes of HIV-related deaths, because of the lack of mechanisms to ascertain cause of death, has had a negative impact on establishing interventions to reduce mortality. We suggest that setting 95-95-95 targets for CD4 testing, cryptococcal antigen and TB testing, and treatment that are aligned to the WHO AHD package of care would be a step in the right direction to achieving the greater goal of the WHO End TB strategy and the proposed new strategy to end cryptococcal meningitis deaths. However, these targets will only be achieved if there is healthcare worker training, expanded access to bedside point-of-care diagnostics for hospitalised patients and those in outpatient care who meet the criteria for AHD, and health systems strengthening to minimise delays in initiating the WHO-recommended therapies for TB and cryptococcal disease.

A prospective cohort study of outcomes for isoniazid prevention therapy: a nested study from a national QI collaborative in Uganda.

BACKGROUND: Tuberculosis (TB) and human immunodeficiency virus (HIV) co-infection constitute a deadly infectious disease synergy disease and major public health problem throughout the world. The risk of developing active TB in people living with HIV (PLHIV) is 21 times higher than the rest of the world population. The overlap of latent TB infection and HIV infection has resulted in marked increases in TB incidence in countries with dual epidemics. Although antiretroviral therapy (ART) is the single most significant way to reduce incident TB in PLHIV, besides early ART initiation, isoniazid preventive therapy (IPT) is the key intervention to prevent TB among PLHIV. This prospective cohort and longitudinal study aimed to document; retention, adherence, development of active TB disease, possible adverse drug reactions and completion among patients initiated on IPT in Jan 2019. METHODS: This was both a prospective cohort and longitudinal study nested within a national quality improvement collaborative in which multiple quality improvement teams tested changes in care delivery to improve the delivery of IPT. The prospective cohort were HIV patients without TB disease initiated on a dosage of Isoniazid 300 mg/day for adults and 150 mg/day for children for a period of 6 months. Association statistics were used to describe patient characteristics and outcomes. Variables with p-value < 0.05 were used to determine linear by linear associations between patient characteristics assumed to influence both primary and secondary outcomes. Variables with a p-value < 0.05 were included in the logistical regression model. The final model included those factors that retained statistical significance. The odds ratios (OR) and adjusted OR (AOR) along with its 95% confidence interval were used to determine the power of relationship in determining the outcomes of interest. The model was tested for fitness using goodness-of-fit Hosmer-Lemeshow tests. RESULTS: The completion of IPT was at 89%. A significant proportion of patients adhered to treatment (89%) and kept their appointment schedules-retention (89%). All patients (100%) received IPT at each appointment visit. Only 4% of patients experienced side effects of isoniazid (INH) but none of them developed active TB at the end of the 6 month INH dose. Multivariate logistic regression analysis of covariates of IPT completion revealed a strong and statistical association between IPT completion and age, gender, retention and side effects of INH. Our multivariate model found that children below 15 years were less likely to complete INH than patients ≥ 15 years (AOR = 0.416, p = 0.230, df = 1). Female patients were 2 times more likely to complete INH dose than male patients (AOR = 1.598, p = 0.018). Patients who kept all their appointment schedules were 10 times more likely to complete IPT than those who missed one or more schedules (AOR = 10.726, p = 0.000, df = 1). We also found that patients who did not report any side effects associated with INH were 2 times more likely to complete INH (AOR = 1.958, p = 0.016, df = 1) than patients who reported one or more side effects. CONCLUSION: Treatment completion is the end-point of the IPT initiation strategy in Uganda. With a completion rate of 89%, our results seem re-assuring and suggest that improvement collaborative is an effective approach to achieving results through combined efforts. The high rates of completion are encouraging indicators of progress in the implementation of collaborative activities in the study setting. However, such collaboratives would require periodic evaluation to prevent possible relapses in progress attained.

High acceptability and viral suppression of patients on Dolutegravir-based first-line regimens in pilot sites in Uganda: A mixed-methods prospective cohort study.

Uganda adopted the integrase inhibitor dolutegravir (DTG) as part its preferred first-line HIV treatment regimen in 2018. Prior to the national rollout, the Uganda Ministry of Health and Clinton Health Access Initiative (CHAI) launched a pilot study in July 2017 aimed at better understanding patients' and prescribers' experience and acceptability of DTG. Patients were enrolled in the study if they were newly initiating treatment or switched from an NNRTI regimen due to intolerance. Patients were followed up for 6 months after initiation onto DTG and acceptability and experiences were assessed through questionnaires at one-month and six-month follow-up visits. In addition to acceptability side effects of patients on DTG regimens were assessed. Analysis was conducted using MS Excel and SAS 9.4 and confidence intervals were adjusted for facility level clustering. A total of 365 patients from 6 study sites were enrolled in the study, of whom 50% were treatment-experienced and 50% treatment naïve. 325 patients completed the 6 months of follow-up. Survey results showed a high level of acceptability (more than 90%) of DTG-containing regimens for both categories of patients during the from one-month and six-months interviews. The rate of self-reported side effects amongst patients was 33% overall and higher for experienced (37%) than naïve (29%) patients at 6 months. Although frequencies declined between month-1 and month-6, the changes were not statistically significant. Almost all patients (94%) were virally suppressed at 6 months. Overall, the study findings showed a very high level of acceptability of Dolutegravir-based regimens across both experienced and naïve patients. The overall viral suppression rate in this cohort was 94% at six months of taking DTG-based regimen.

Understanding implementation barriers in the national scale-up of differentiated ART delivery in Uganda.

BACKGROUND: Although Differentiated Service Delivery (DSD) for anti-retroviral therapy (ART) has been rolled-out nationally in several countries since World Health Organization (WHO)'s landmark 2016 guidelines, there is little research evaluating post-implementation outcomes. The objective of this study was to explore patients' and HIV service managers' perspectives on barriers to implementation of Differentiated ART service delivery in Uganda. METHODS: We employed a qualitative descriptive design involving 124 participants. Between April and June 2019 we conducted 76 qualitative interviews with national-level HIV program managers (n = 18), District Health Team leaders (n = 24), representatives of PEPFAR implementing organizations (11), ART clinic in-charges (23) in six purposively selected Uganda districts with a high HIV burden (Kampala, Luwero, Wakiso, Mbale, Budadiri, Bulambuli). Six focus group discussions (48 participants) were held with patients enrolled in DSD models in case-study districts. Data were analyzed by thematic approach as guided by a multi-level analytical framework: Individual-level factors; Health-system factors; Community factors; and Context. RESULTS: Our data shows that multiple barriers have been encountered in DSD implementation. Individual-level: Individualized stigma and a fear of detachment from health facilities by stable patients enrolled in community-based models were reported as bottlenecks. Socio-economic status was reported to have an influence on patient selection of DSD models. Health-system: Insufficient training of health workers in DSD delivery and supply chain barriers to multi-month ART dispensing were identified as constraints. Patients perceived current selection of DSD models to be provider-intensive and not sufficiently patient-centred. Community: Community-level stigma and insufficient funding to providers to fully operationalize community drug pick-up points were identified as limitations. CONTEXT: Frequent changes in physical addresses among urban clients were reported to impede the running of patient groups of rotating ART refill pick-ups. CONCLUSION: This is one of the first multi-stakeholder evaluations of national DSD implementation in Uganda since initial roll-out in 2017. Multi-level interventions are needed to accelerate further DSD implementation in Uganda from demand-side (addressing HIV-related stigma, community engagement) and supply-side dimensions (strengthening ART supply chain capacities, increasing funding for community models and further DSD program design to improve patient-centeredness).

Results from a proactive follow-up intervention to improve linkage and retention among people living with HIV in Uganda: a pre-/post- study.

BACKGROUND: Despite gains in HIV testing and treatment access in sub-Saharan Africa, patient attrition from care remains a problem. Evidence is needed of real-world implementation of low-cost, scalable, and sustainable solutions to reduce attrition. We hypothesized that more proactive patient follow-up and enhanced counseling by health facilities would improve patient linkage and retention. METHODS: At 20 health facilities in Central Uganda, we implemented a quality of care improvement intervention package that included training lay health workers in best practices for patient follow-up and counseling, including improved appointment recordkeeping, phone calls and home visits to lost patients, and enhanced adherence counseling strategies; and strengthening oversight of these processes. We compared patient linkage to and retention in HIV care in the 9 months before implementation of the intervention to the 9 months after implementation. Data were obtained from facility-based registers and files and analysed using multivariable logistic regression. RESULTS: Among 1900 patients testing HIV-positive during the study period, there was not a statistically significant increase in linkage to care after implementing the intervention (52.9% versus 54.9%, p = 0.63). However, among 1356 patients initiating antiretroviral therapy during the follow-up period, there were statistically significant increases in patient adherence to appointment schedules (44.5% versus 55.2%, p = 0.01) after the intervention. There was a small increase in Ministry of Health-defined retention in care (71.7% versus 75.7%, p = 0.12); when data from the period of intervention ramp-up was dropped, this increase became statistically significant (71.7% versus 77.6%, p = 0.01). The increase in retention was more dramatic for patients under age 19 years (N = 84; 64.0% versus 83.9%, p = 0.01). The cost per additional patient retained in care was $47. CONCLUSIONS: Improving patient tracking and counseling practices was relatively low cost and enhanced patient retention in care, particularly for pediatric and adolescent patients. This approach should be considered for scale-up in Uganda and elsewhere. However, no impact was seen in improved patient linkage to care with this proactive follow-up intervention. TRIAL REGISTRATION: Pan African Clinical Trial Registry #PACTR201611001756166 . Registered August 31, 2016.

Assessing linkage to and retention in care among HIV patients in Uganda and identifying opportunities for health systems strengthening: a descriptive study.

BACKGROUND: While antiretroviral therapy (ART) availability for HIV patients has increased dramatically in Uganda, patient linkage to and retention in care remains a challenge. We assessed patterns of engagement in care in 20 Ugandan health facilities with low retention based on national reporting. METHODS: We assessed patient linkage to care (defined as registering for pre-ART or ART care at the facility within 1 month of HIV diagnosis) and 6-month retention in care (having a visit 3-6 months after ART initiation) and associations with patient-/facility-level factors using multivariate logistic regression. RESULTS: Among 928 newly HIV-diagnosed patients, only 53.0% linked to care within 1 month. Of these, 83.7% linked within 1 week. Among 678 newly initiated ART patients, 14.5% never returned for a follow-up visit at the facility. Retention was 71.7% according to our primary definition but much lower if stricter definitions were used. Most patients were already falling behind appointment schedules at their first ART follow-up (median: 28 days post-initiation vs. recommended 14 days). 27.3% of newly-initiated patients had follow-up appointments scheduled 45+ days apart rather than monthly per national guidelines. Linkage and retention were not strongly correlated with each other within facilities (rs = 0.06; p = 0.82). Females, adolescents, and patients in rural settings tended to have lower linkage and retention in multivariable-adjusted models. CONCLUSIONS: Linkage support may be most critical immediately after testing positive, as patients are less likely to link over time. More information is needed on reasons for appointment schedules by clinicians and implications on retention. TRIAL REGISTRATION: This study was registered in the Pan African Clinical Trial Registry database (#PACTR201611001756166).

Adherence to antiretroviral therapy and retention in care for adolescents living with HIV from 10 districts in Uganda.

BACKGROUND: Adolescents have gained increased attention because they are the only age group where HIV related mortality is going up. We set out to describe the level and factors associated with adherence to antiretroviral therapy (ART) as well as the 1 year retention in care among adolescents in 10 representative districts in Uganda. In addition, we explored the barriers and facilitators of adherence to ART among adolescents. METHODS: The study involved 30 health facilities from 10 representative districts in Uganda. We employed both qualitative and quantitative data collection methods in convergent design. The former involved Focus group discussions with adolescents living with HIV, Key informant interviews with various stakeholders and in depth interviews with adolescents. The quantitative involved using retrospective records review to extract the last recorded adherence level from all adolescents who were active in HIV care. Factors associated with adherence were extracted from the ART cards. For the 1 year retention in care, we searched the hospital records of all adolescents in the 30 facilities who had started ART 1 year before the study to find out how many were still in care. RESULTS: Out of 1824 adolescents who were active on ART, 90.4 % (N = 1588) had ≥95 % adherence recorded on their ART cards at their last clinic visit. Only location in rural health facilities was independently associated with poor adherence to ART (P = 0.008, OR 2.64 [1.28 5.43]). Of the 156 adolescents who started ART, 90 % (N = 141) were still active in care 1 year later. Stigma, discrimination and disclosure issues were the most outstanding of all barriers to adherence. Other barriers included poverty, fatigue, side effects, pill burden, depression among others. Facilitators of adherence mainly included peer support groups, counseling, supportive health care workers, short waiting time and provision of food and transport. CONCLUSION: Adherence to ART was good among adolescents. Being in rural areas was associated with poor adherence to ART and 1 year retention in care was very good among adolescents who were newly started on ART. Stigma and disclosure issues continue to be the main barriers to adherence among adolescents.