Design and implementation of a global site assessment survey among HIV clinics participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) research consortium.

INTRODUCTION: Timely descriptions of HIV service characteristics and their evolution over time across diverse settings are important for monitoring the scale-up of evidence-based program strategies, understanding the implementation landscape, and examining service delivery factors that influence HIV care outcomes. METHODS: The International epidemiology Databases to Evaluate AIDS (IeDEA) consortium undertakes periodic cross-sectional surveys on service availability and care at participating HIV treatment sites to characterize trends and inform the scientific agenda for HIV care and implementation science communities. IeDEA's 2020 general site assessment survey was developed through a consultative, 18-month process that engaged diverse researchers in identifying content from previous surveys that should be retained for longitudinal analyses and in developing expanded and new content to address gaps in the literature. An iterative review process was undertaken to standardize the format of new survey questions and align them with best practices in survey design and measurement and lessons learned through prior IeDEA site assessment surveys. RESULTS: The survey questionnaire developed through this process included eight content domains covered in prior surveys (patient population, staffing and community linkages, HIV testing and diagnosis, new patient care, treatment monitoring and retention, routine HIV care and screening, pharmacy, record-keeping and patient tracing), along with expanded content related to antiretroviral therapy (differentiated service delivery and roll-out of dolutegravir-based regimens); mental health and substance use disorders; care for pregnant/postpartum women and HIV-exposed infants; tuberculosis preventive therapy; and pediatric/adolescent tuberculosis care; and new content related to Kaposi's sarcoma diagnostics, the impact of COVID-19 on service delivery, and structural barriers to HIV care. The survey was distributed to 238 HIV treatment sites in late 2020, with a 95% response rate. CONCLUSION: IeDEA's approach for site survey development has broad relevance for HIV research networks and other priority health conditions.

Service delivery challenges in HIV care during the first year of the COVID-19 pandemic: results from a site assessment survey across the global IeDEA consortium.

INTRODUCTION: Interruptions in treatment pose risks for people with HIV (PWH) and threaten progress in ending the HIV epidemic; however, the COVID-19 pandemic's impact on HIV service delivery across diverse settings is not broadly documented. METHODS: From September 2020 to March 2021, the International epidemiology Databases to Evaluate AIDS (IeDEA) research consortium surveyed 238 HIV care sites across seven geographic regions to document constraints in HIV service delivery during the first year of the pandemic and strategies for ensuring care continuity for PWH. Descriptive statistics were stratified by national HIV prevalence (<1%, 1-4.9% and ≥5%) and country income levels. RESULTS: Questions about pandemic-related consequences for HIV care were completed by 225 (95%) sites in 42 countries with low (n = 82), medium (n = 86) and high (n = 57) HIV prevalence, including low- (n = 57), lower-middle (n = 79), upper-middle (n = 39) and high- (n = 50) income countries. Most sites reported being subject to pandemic-related restrictions on travel, service provision or other operations (75%), and experiencing negative impacts (76%) on clinic operations, including decreased hours/days, reduced provider availability, clinic reconfiguration for COVID-19 services, record-keeping interruptions and suspension of partner support. Almost all sites in low-prevalence and high-income countries reported increased use of telemedicine (85% and 100%, respectively), compared with less than half of sites in high-prevalence and lower-income settings. Few sites in high-prevalence settings (2%) reported suspending antiretroviral therapy (ART) clinic services, and many reported adopting mitigation strategies to support adherence, including multi-month dispensing of ART (95%) and designating community ART pick-up points (44%). While few sites (5%) reported stockouts of first-line ART regimens, 10-11% reported stockouts of second- and third-line regimens, respectively, primarily in high-prevalence and lower-income settings. Interruptions in HIV viral load (VL) testing included suspension of testing (22%), longer turnaround times (41%) and supply/reagent stockouts (22%), but did not differ across settings. CONCLUSIONS: While many sites in high HIV prevalence settings and lower-income countries reported introducing or expanding measures to support treatment adherence and continuity of care, the COVID-19 pandemic resulted in disruptions to VL testing and ART supply chains that may negatively affect the quality of HIV care in these settings.

Substance use service availability in HIV treatment programs: Data from the global IeDEA consortium, 2014-2015 and 2017.

BACKGROUND: Substance use is common among people living with HIV and has been associated with suboptimal HIV treatment outcomes. Integrating substance use services into HIV care is a promising strategy to improve patient outcomes. METHODS: We report on substance use education, screening, and referral practices from two surveys of HIV care and treatment sites participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. HIV care and treatment sites participating in IeDEA are primarily public-sector health facilities and include both academic and community-based hospitals and health facilities. A total of 286 sites in 45 countries participated in the 2014-2015 survey and 237 sites in 44 countries participated in the 2017 survey. We compared changes over time for 147 sites that participated in both surveys. RESULTS: In 2014-2015, most sites (75%) reported providing substance use-related education on-site (i.e., at the HIV clinic or the same health facility). Approximately half reported on-site screening for substance use (52%) or referrals for substance use treatment (51%). In 2017, the proportion of sites providing on-site substance use-related education, screening, or referrals increased by 9%, 16%, and 8%, respectively. In 2017, on-site substance use screening and referral were most commonly reported at sites serving only adults (compared to only children/adolescents or adults and children/adolescents; screening: 86%, 37%, and 59%, respectively; referral: 76%, 47%, and 46%, respectively) and at sites in high-income countries (compared to upper middle income, lower middle income or low-income countries; screening: 89%, 76%, 68%, and 45%, respectively; referral: 82%, 71%, 57%, and 34%, respectively). CONCLUSION: Although there have been increases in the proportion of sites reporting substance use education, screening, and referral services across IeDEA sites, gaps persist in the integration of substance use services into HIV care, particularly in relation to screening and referral practices, with reduced availability for children/adolescents and those receiving care within resource-constrained settings.

Monitoring Pharmacy and Test Kit Stocks in Rural Mozambique: U.S. President's Emergency Plan for AIDS Relief Surveillance to Help Prevent Ministry of Health Shortages.

Support of human immunodeficiency virus (HIV) and tuberculosis (TB) testing and treatment supported by President's Emergency Plan for AIDS Relief (PEPFAR) in Africa requires immense quantities of tests and medications. We sought to use central pharmacy supply data of Mozambique's rural Zambézia Province (2017 population ≈5.11 million persons; ≈12.6% adult HIV prevalence in 2016) to examine shortages, stockouts, and trends in availability. Using stock surveillance for 60 weeks in 2014-2015, we assessed availability of 36 medications [4 classes: adult antiretroviral (ARV) medications, pediatric ARVs, anti-TB medications, and antibiotics] and diagnostic test kits (2 rapid tests for HIV; 1 each for malaria and syphilis). We contrasted these to 2018-2019 data. We modeled pharmacy data using ordinal logistic regression, characterizing weekly product availability in four categories: good, adequate, shortage, or complete stockout. We found 166 (7.7%) stockouts and 150 (6.9%) shortages among 2,160 weekly records. Earlier calendar time was associated with reduced medication supplies (p < .001). Certain medication/test kit classes were associated with reduced supply (p < .001). We found an interaction between time and medication class on the odds of reduced supply (p < .001). Pediatric ARVs had a 17.4 (95% confidence interval: 8.8-34.4) times higher odds of reduced medication supply compared with adult ARVs at study midpoint. Trends comparing the first and last weeks showed adult ARVs having 67% and pediatric having 71% lower odds of reduced supplies. Only adult ARV shortages improved amid growing demand. Data from 2018 to 2019 suggest continuing inventory management challenges. Monitoring of drug (especially pediatric) and test kit shortages is vital to ensure quality improvement to guarantee adequate supplies to enable patients and care providers to achieve sustained viral suppression. A central Mozambican drug repository in the nation's second largest Province continues to experience drug and rapid test kit stockouts.

Implementation of "Treat-all" at adult HIV care and treatment sites in the Global IeDEA Consortium: results from the Site Assessment Survey.

INTRODUCTION: Since 2015, the World Health Organization (WHO) has recommended that all people living with HIV (PLHIV) initiate antiretroviral treatment (ART), irrespective of CD4+ count or clinical stage. National adoption of universal treatment has accelerated since WHO's 2015 "Treat All" recommendation; however, little is known about the translation of this guidance into practice. This study aimed to assess the status of Treat All implementation across regions, countries, and levels of the health care delivery system. METHODS: Between June and December 2017, 201/221 (91%) adult HIV treatment sites that participate in the global IeDEA research consortium completed a survey on capacity and practices related to HIV care. Located in 41 countries across seven geographic regions, sites provided information on the status and timing of site-level introduction of Treat All, as well as site-level practices related to ART initiation. RESULTS: Almost all sites (93%) reported that they had begun implementing Treat All, and there were no statistically significant differences in site-level Treat All introduction by health facility type, urban/rural location, sector (public/private) or country income level. The median time between national policy adoption and site-level introduction was one month. In countries where Treat All was not yet adopted in national guidelines, 69% of sites reported initiating all patients on ART, regardless of clinical criteria, and these sites had been implementing Treat All for a median period of seven months at the time of the survey. The majority of sites (77%) reported typically initiating patients on ART within 14 days of confirming diagnosis, with 60% to 62% of sites implementing Treat All in East, Southern and West Africa reporting same-day ART initiation for most patients. CONCLUSIONS: By mid- to late-2017, the Treat All strategy was the standard of care at almost all IeDEA sites, including rural, primary-level health facilities in low-resource settings. While further assessments of site-level capacity to provide high-quality HIV care under Treat All and to support sustained viral suppression after ART initiation are needed, the widespread introduction of Treat All at the service delivery level is a critical step towards global targets for ending the HIV epidemic as a public health threat.

Comprehensiveness of HIV care provided at global HIV treatment sites in the IeDEA consortium: 2009 and 2014.

INTRODUCTION: An important determinant of the effectiveness of HIV treatment programs is the capacity of sites to implement recommended services and identify systematic changes needed to ensure that invested resources translate into improved patient outcomes. We conducted a survey in 2014 of HIV care and treatment sites in the seven regions of the International epidemiologic Database to Evaluate AIDS (IeDEA) Consortium to evaluate facility characteristics, HIV prevention, care and treatment services provided, laboratory capacity, and trends in the comprehensiveness of care compared to data obtained in the 2009 baseline survey. METHODS: Clinical staff from 262 treatment sites in 45 countries in IeDEA completed a site survey from September 2014 to January 2015, including Asia-Pacific with Australia (n = 50), Latin America and the Caribbean (n = 11), North America (n = 45), Central Africa (n = 17), East Africa (n = 36), Southern Africa (n = 87), and West Africa (n = 16). For the 55 sites with complete data from both the 2009 and 2014 survey, we evaluated change in comprehensiveness of care. RESULTS: The majority of the 262 sites (61%) offered seven essential services (ART adherence, nutritional support, PMTCT, CD4+ cell count testing, tuberculosis screening, HIV prevention, and outreach). Sites that were publicly funded (64%), cared for adults and children (68%), low or middle Human Development Index (HDI) rank (68%, 68%), and received PEPFAR support (71%) were most often fully comprehensive. CD4+ cell count testing was universally available (98%) but only 62% of clinics offered it onsite. Approximately two-thirds (69%) of sites reported routine viral load testing (44-100%), with 39% having it onsite. Laboratory capacity to monitor antiretroviral-related toxicity and diagnose opportunistic infections varied widely by testing modality and region. In the subgroup of 55 sites with two surveys, comprehensiveness of services provided significantly increased across all regions from 2009 to 2014 (5.7 to 6.5, p < 0.001). CONCLUSION: The availability of viral load monitoring remains suboptimal and should be a focus for site capacity, particularly in East and Southern Africa, where the majority of those initiating on ART reside. However, the comprehensiveness of care provided increased over the past 5 years and was related to type of funding received (publicly funded and PEPFAR supported).

Implementation of a health management mentoring program: year-1 evaluation of its impact on health system strengthening in Zambézia Province, Mozambique.

BACKGROUND: Avante Zambézia is an initiative of a Non-Governmental Organization (NGO), Friends in Global Health, LLC (FGH) and the Vanderbilt Institute for Global Health (VIGH) to provide technical assistance to the Mozambican Ministry of Health (MoH) in rural Zambézia Province. Avante Zambézia developed a district level Health Management Mentorship (HMM) program to strengthen health systems in ten of Zambézia's 17 districts. Our objective was to preliminarily analyze changes in four domains of health system capacity after the HMM's first year: accounting, Human Resources (HRs), Monitoring and Evaluation (M&E), and transportation management. METHODS: Quantitative metrics were developed in each domain. During district visits for weeklong, on-site mentoring, the health management mentoring teams documented each indicator as a success ratio percentage. We analyzed data using linear regressions of each indicator's mean success ratio across all districts submitting a report over time. RESULTS: Of the four domains, district performance in the accounting domain was the strongest and most sustained. Linear regressions of mean monthly compliance for HR objectives indicated improvement in three of six mean success ratios. The M&E capacity domain showed the least overall improvement. The one indicator analyzed for transportation management suggested progress. CONCLUSION: Our outcome evaluation demonstrates improvement in health system performance during a HMM initiative. Evaluating which elements of our mentoring program are succeeding in strengthening district level health systems is vital in preparing to transition fiscal and managerial responsibility to local authorities.

Characteristics and comprehensiveness of adult HIV care and treatment programmes in Asia-Pacific, sub-Saharan Africa and the Americas: results of a site assessment conducted by the International epidemiologic Databases to Evaluate AIDS (IeDEA) Collaboration.

INTRODUCTION: HIV care and treatment programmes worldwide are transforming as they push to deliver universal access to essential prevention, care and treatment services to persons living with HIV and their communities. The characteristics and capacity of these HIV programmes affect patient outcomes and quality of care. Despite the importance of ensuring optimal outcomes, few studies have addressed the capacity of HIV programmes to deliver comprehensive care. We sought to describe such capacity in HIV programmes in seven regions worldwide. METHODS: Staff from 128 sites in 41 countries participating in the International epidemiologic Databases to Evaluate AIDS completed a site survey from 2009 to 2010, including sites in the Asia-Pacific region (n=20), Latin America and the Caribbean (n=7), North America (n=7), Central Africa (n=12), East Africa (n=51), Southern Africa (n=16) and West Africa (n=15). We computed a measure of the comprehensiveness of care based on seven World Health Organization-recommended essential HIV services. RESULTS: Most sites reported serving urban (61%; region range (rr): 33-100%) and both adult and paediatric populations (77%; rr: 29-96%). Only 45% of HIV clinics that reported treating children had paediatricians on staff. As for the seven essential services, survey respondents reported that CD4+ cell count testing was available to all but one site, while tuberculosis (TB) screening and community outreach services were available in 80 and 72%, respectively. The remaining four essential services - nutritional support (82%), combination antiretroviral therapy adherence support (88%), prevention of mother-to-child transmission (PMTCT) (94%) and other prevention and clinical management services (97%) - were uniformly available. Approximately half (46%) of sites reported offering all seven services. Newer sites and sites in settings with low rankings on the UN Human Development Index (HDI), especially those in the President's Emergency Plan for AIDS Relief focus countries, tended to offer a more comprehensive array of essential services. HIV care programme characteristics and comprehensiveness varied according to the number of years the site had been in operation and the HDI of the site setting, with more recently established clinics in low-HDI settings reporting a more comprehensive array of available services. Survey respondents frequently identified contact tracing of patients, patient outreach, nutritional counselling, onsite viral load testing, universal TB screening and the provision of isoniazid preventive therapy as unavailable services. CONCLUSIONS: This study serves as a baseline for on-going monitoring of the evolution of care delivery over time and lays the groundwork for evaluating HIV treatment outcomes in relation to site capacity for comprehensive care.

Optimizing PMTCT service delivery in rural North-Central Nigeria: protocol and design for a cluster randomized study.

Nigeria has more HIV-infected women who do not receive needed services for the prevention of mother-to-child transmission of HIV (PMTCT) than any other nation in the world. To meet the UNAIDS/WHO goal of eliminating mother-to-child HIV transmission by 2015, multiple interventions will be required to scale up PMTCT services, especially to lower-level, rural health facilities. To address this, we are conducting a cluster-randomized controlled study to evaluate the impact and cost-effectiveness of a novel, family-focused integrated package of PMTCT services. A systematic re-assignment of patient care responsibilities coupled with the adoption of point-of-care CD4 + cell count testing could facilitate the ability of lower-cadre health providers to manage PMTCT care, including the provision and scale-up of antiretroviral therapy (ART) to pregnant women in rural settings. Additionally, as influential community members, male partners could support their partners' uptake of and adherence to PMTCT care. We describe an innovative approach to scaling up PMTCT service provision that incorporates considerations of where and from whom women can access services (task-shifting), ease of obtaining a CD4 + cell count result (point-of-care testing), the degree of HIV service integration for HIV-infected women and their infants, and the level of family and community involvement (specifically male partner involvement). This systematic approach, if proven feasible and effective, could be scaled up in Nigeria and similar resource-limited settings as a means to accelerate progress toward eliminating mother-to-child transmission of HIV and help women with HIV infection take ART and live long, healthy lives (Trial registration: NCT01805752).

Non-AIDS-defining events among HIV-1-infected adults receiving combination antiretroviral therapy in resource-replete versus resource-limited urban setting.

OBJECTIVE: To compare incidence and distribution of non-AIDS-defining events (NADEs) among HIV-1-infected adults receiving combination antiretroviral therapy (cART) in urban sub-Saharan African versus United States settings. DESIGN: Retrospective cohort analysis of clinical trial and observational data. METHODS: Compared crude and standardized (to US cohort by age and sex) NADE rates from two urban adult HIV-infected cART-initiating populations: a clinical trial cohort in Gaborone, Botswana (Botswana) and an observational cohort in Nashville, Tennessee (USA). RESULTS: Crude NADE incidence rates were similar: 10.0 [95% confidence interval 6.3-15.9] per 1000 person-years in Botswana versus 12.4 [8.4-18.4] per 1000 person-years in the United States. However, after standardizing to an older, predominantly male US population, the overall NADE incidence rates were higher in Botswana [18.7 (8.3-33.1) per 1000 person-years]. Standardized rates differed most for cardiovascular events (8.4 versus 5.0 per 1000 person-years) and non-AIDS-defining malignancies (8.0 versus 0.5 per 1000 person-years) - both higher in Botswana. Conversely, hepatic NADE rates were higher in the United States (4.0 versus 0.0 per 1000 person-years), whereas renal NADE rates [3.0 per 1000 person-years (United States) versus 2.4 per 1000 person-years (Botswana)] were comparable. CONCLUSION: Crude NADE incidence rates were similar between cART-treated patients in a US observational cohort and a sub-Saharan African clinical trial. However, when standardized to the US cohort, overall NADE rates were higher in Botswana. NADEs appear to be a significant problem in our sub-Saharan African setting, and the monitoring, prevention, and treatment of NADEs should be a critical component of care in resource-limited settings.

Initial response to highly active antiretroviral therapy in HIV-1C-infected adults in a public sector treatment program in Botswana.

OBJECTIVE: To describe the response to highly active antiretroviral treatment (HAART) in a public sector pilot antiretroviral (ARV) treatment program in Botswana. METHODS: The response to HAART is described in adult HIV-infected ARV-naive patients initiating treatment from April 2001 to January 2002 at Princess Marina Hospital in Gaborone, Botswana. Patients had medical and laboratory evaluations before initiating ARV treatment and were followed longitudinally. For analysis, data were collected from charts and patient management records. RESULTS: One hundred fifty-three ARV-naive patients initiated HAART. Most received didanosine plus stavudine (ddI + d4T) with efavirenz or nevirapine. The mean CD4 cell count increase was 149 cells/mm at 24 weeks and 204 cells/mm at 48 weeks. The percentage of patients with an HIV-1 RNA level < or =400 copies/mL was 87.0% at 24 weeks and 78.8% at 48 weeks. The Kaplan-Meier 1-year survival estimate was 84.7% (79.0%, 90.8%), with a 3.2-fold increased risk (P = 0.004) of mortality among patients with a CD4 cell count <50 cells/mm. The 1-year Kaplan-Meier estimate of toxicity-related drug switches was 32.2% (20.3%, 40.4%). The most common toxicity was peripheral neuropathy, occurring more frequently in patients with a preexisting diagnosis of peripheral neuropathy and among those placed on ddI + d4T-containing regimens. CONCLUSIONS: An excellent response to HAART was observed among HIV-1C-infected patients, paralleling those seen elsewhere. Despite excellent responses, high rates of toxicity were observed for ddI + d4T-containing regimens.

Antibiotic resistance: a survey of physician perceptions.

BACKGROUND: Antibiotic resistance is caused partly by excessive antibiotic prescribing, yet little is known about prescribers' views on this problem. METHODS: We surveyed 490 internal medicine physicians at 4 Chicago-area hospitals to assess their attitudes about the importance of antibiotic resistance, knowledge of its prevalence, self-reported experience with antibiotic resistance, beliefs about its causes, and attitudes about interventions designed to address the problem. RESULTS: The response rate was 87% (424 of 490 physicians). Antibiotic resistance was perceived as a very important national problem by 87% of the respondents, but only 55% rated the problem as very important at their own hospitals. Nearly all physicians (97%) believed that widespread and inappropriate antibiotic use were important causes of resistance. Yet, only 60% favored restricting use of broad-spectrum antibiotics, although this percentage varied by hospital and physician group. CONCLUSIONS: Although most physicians view antibiotic resistance as a serious national problem, perceptions about its local importance, its causes, and possible solutions vary more widely. Disparities in physician knowledge, beliefs, and attitudes may compromise efforts to improve antibiotic prescribing and infection control practices.