Costs and acceptability of simplified monitoring in HIV-suppressed patients switching to dual therapy: the SIMPL'HIV open-label, factorial randomised controlled trial.

BACKGROUND: Clinical and laboratory monitoring of patients on antiretroviral therapy is an integral part of HIV care and determines whether treatment needs enhanced adherence or modification of the drug regimen. However, different monitoring and treatment strategies carry different costs and health consequences. MATERIALS AND METHODS: The SIMPL'HIV study was a randomised trial that assessed the non-inferiority of dual maintenance therapy. The co-primary outcome was a comparison of costs over 48 weeks of dual therapy with standard antiretroviral therapy and the costs associated with a simplified HIV care approach (patient-centred monitoring [PCM]) versus standard, tri-monthly routine monitoring. Costs included outpatient medical consultations (HIV/non-HIV consultations), non-medical consultations, antiretroviral therapy, laboratory tests and hospitalisation costs. PCM participants had restricted immunological and blood safety monitoring at weeks 0 and 48, and they were offered the choice to complete their remaining study visits via a telephone call, have medications delivered to a specified address, and to have blood tests performed at a location of their choice. We analysed the costs of both strategies using invoices for medical consultations issued by the hospital where the patient was followed, as well as those obtained from health insurance companies. Secondary outcomes included differences between monitoring arms for renal function, lipids and glucose values, and weight over 48 weeks. Patient satisfaction with treatment and monitoring was also assessed using visual analogue scales. RESULTS: Of 93 participants randomised to dolutegravir plus emtricitabine and 94 individuals to combination antiretroviral therapy (median nadir CD4 count, 246 cells/mm3; median age, 48 years; female, 17%),patient-centred monitoring generated no substantial reductions or increases in total costs (US$ -421 per year [95% CI -2292 to 1451]; p = 0.658). However, dual therapy was significantly less expensive (US$ -2620.4 [95% CI -2864.3 to -2331.4]) compared to standard triple-drug antiretroviral therapy costs. Approximately 50% of participants selected one monitoring option, one-third chose two, and a few opted for three. The preferred option was telephone calls, followed by drug delivery. The number of additional visits outside the study schedule did not differ by type of monitoring. Patient satisfaction related to treatment and monitoring was high at baseline, with no significant increase at week 48. CONCLUSIONS: Patient-centred monitoring did not reduce costs compared to standard monitoring in individuals switching to dual therapy or those continuing combined antiretroviral therapy. In this representative sample of patients with suppressed HIV, antiretroviral therapy was the primary factor driving costs, which may be reduced by using generic drugs to mitigate the high cost of lifelong HIV treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT03160105.

Patient costs for prevention of mother-to-child HIV transmission and antiretroviral therapy services in public health facilities in Zimbabwe.

Zimbabwe has made large strides in addressing HIV. To ensure a continued robust response, a clear understanding of costs associated with its HIV program is critical. We conducted a cross-sectional evaluation in 2017 to estimate the annual average patient cost for accessing Prevention of Mother-To-Child Transmission (PMTCT) services (through antenatal care) and Antiretroviral Treatment (ART) services in Zimbabwe. Twenty sites representing different types of public health facilities in Zimbabwe were included. Data on patient costs were collected through in-person interviews with 414 ART and 424 PMTCT adult patients and through telephone interviews with 38 ART and 47 PMTCT adult patients who had missed their last appointment. The mean and median annual patient costs were examined overall and by service type for all participants and for those who paid any cost. Potential patient costs related to time lost were calculated by multiplying the total time to access services (travel time, waiting time, and clinic visit duration) by potential earnings (US$75 per month assuming 8 hours per day and 5 days per week). Mean annual patient costs for accessing services for the participants was US$20.00 [standard deviation (SD) = US$80.42, median = US$6.00, range = US$0.00-US$12,18.00] for PMTCT and US$18.73 (SD = US$58.54, median = US$8.00, range = US$0.00-US$ 908.00) for ART patients. The mean annual direct medical costs for PMTCT and ART were US$9.78 (SD = US$78.58, median = US$0.00, range = US$0.00-US$ 90) and US$7.49 (SD = US$60.00, median = US$0.00) while mean annual direct non-medical cost for US$10.23 (SD = US$17.35, median = US$4.00) and US$11.23 (SD = US$25.22, median = US$6.00, range = US$0.00-US$ 360.00). The PMTCT and ART costs per visit based on time lost were US$3.53 (US$1.13 to US$8.69) and US$3.43 (US$1.14 to US$8.53), respectively. The mean annual patient costs per person for PMTCT and ART in this evaluation will impact household income since PMTCT and ART services in Zimbabwe are supposed to be free.

Who falls between the cracks? Identifying eligible PrEP users among people with Sub-Saharan African migration background living in Antwerp, Belgium.

INTRODUCTION: This study produces an estimate of the proportion of eligible PrEP users among people of Sub-Saharan African background based on the Belgian PrEP eligibility criteria and examines associations with socio-economic and demographic characteristics. METHODS: We performed logistic regression analysis on data of a representative community-based survey conducted among Sub-Saharan African communities (n = 685) living in Antwerp. RESULTS: Almost a third (30.3%) of the respondents were eligible to use PrEP. Those who were male, single, lower educated, undocumented, and had experienced forced sex were more likely to be eligible for PrEP use. The findings highlight the importance of taking intra-, interpersonal and structural HIV risk factors into account. CONCLUSIONS: The study shows high unmet PrEP needs in this population, especially among those with high vulnerability for HIV acquisition. A better understanding of barriers to PrEP use in this population group is needed to allow for equitable access.

Cost of pre-exposure prophylaxis delivery in family planning clinics to prevent HIV acquisition among adolescent girls and young women in Kisumu, Kenya.

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) is increasingly being implemented in sub-Saharan Africa. Adolescent girls and young women (AGYW) in Kenya contribute more than half of all new infections among young people aged 15-24 years, highlighting the need for evidence on the cost of PrEP in real-world implementation to inform the budget impact, cost-effectiveness, and financial sustainability of PrEP programs. METHODS: We estimated the cost of delivering PrEP to AGYW enrolled in a PrEP implementation study in two family planning clinics in Kisumu county, located in western Kenya. We derived total annual costs and the average cost per client-month of PrEP by input type (variable or fixed) and visit type (initiation or follow-up). We estimated all costs as implemented in the study, and under implementation by the Kenyan Ministry of Health (MoH), both at the program volume observed and if the facilities were delivering PrEP at full capacity (scaled-MoH). RESULTS: For the costing period between March 2018 and March 2019, 615 HIV-negative women contributed 1,128 (502 initiation and 626 follow-up) visits. The average cost per client-month of PrEP dispensed per study protocol and per the MoH scenario was $28.92 and $14.52, respectively. If the MoH scaled the program so that facilities could see PrEP clients at capacity, the average cost per client-month of PrEP was $10.88. Medication costs accounted for the largest proportion of the total annual costs (48% in MoH scenario and 65% in the scaled-MoH scenario). CONCLUSIONS: Using data from a PrEP implementation program, we found that the cost per client-month of PrEP dispensed is reduced by 62% if PrEP delivery at the two clinics is scaled up by the MoH. Our findings are valuable for informing local resource allocation and budgetary cost projections for scale-up of PrEP delivery to AGYW. Additionally, previous cost-effectiveness studies have been limited by the use of fixed assumptions of the cost of PrEP per person-month. Our study provides cost estimates from practical data which will better inform cost-effectiveness and budget impact analyses.

Economic evaluation of differentiated service delivery models for HIV treatment in Lesotho: costs to providers and patients.

INTRODUCTION: Lesotho, the country with the second-highest HIV/AIDS prevalence (23.6%) in the world, has made considerable progress towards achieving the "95-95-95" UNAIDS targets, but recent success in improving treatment access to all known HIV positive individuals has severely strained existing healthcare infrastructure, financial and human resources. Lesotho also faces the challenge of a largely rural population who incur a significant time and financial burden to visit healthcare facilities. Using data from a cluster-randomized non-inferiority trial conducted between August 2017 and July 2019, we evaluated costs to providers and costs to patients of community-based differentiated models of multi-month delivery of antiretroviral therapy (ART) in Lesotho. METHODS: The trial of multi-month dispensing compared 12-month retention in care among three arms: conventional care, which required quarterly facility visits and ART dispensation (3MF); three-month community adherence groups (CAGs) (3MC) and six-month community ART distribution (6MCD). We first estimated the average total annual cost of providing HIV care and treatment followed by the total cost per patient retained 12 months after entry for each arm, using resource utilization data from the trial and local unit costs. We then estimated the average annual cost to patients in each arm with self-reported questionnaire data. RESULTS: The average total annual cost of providing HIV care and treatment per patient was the highest in the 3MF arm ($122.28, standard deviation [SD] $23.91), followed by 3MC ($114.20, SD $23.03) and the 6MCD arm ($112.58, SD $21.44). Per patient retained in care, the average provider cost was $125.99 (SD $24.64) in the 3MF arm and 6% to 8% less for the other two arms ($118.38, SD $23.87 and $118.83, SD $22.63 for the 3MC and 6MCD respectively). There was a large reduction in patient costs for both differentiated service delivery arms: from $44.42 (SD $12.06) annually in the 3MF arm to $16.34 (SD $5.11) annually in the 3MC (63% reduction) and $18.77 (SD $8.31) annually in 6MCD arm (58% reduction). CONCLUSIONS: Community-based, multi-month models of ART in Lesotho are likely to produce small cost savings to treatment providers and large savings to patients in Lesotho. Patient cost savings may support long-term adherence and retention in care.

Client and provider preferences for HIV care: Implications for implementing differentiated service delivery in Thailand.

INTRODUCTION: Differentiated service delivery (DSD) for antiretroviral therapy (ART) maintenance embodies the client-centred approach to tailor services to support people living with HIV in adhering to treatment and achieving viral suppression. We aimed to assess the preferences for HIV care and attitudes towards DSD for ART maintenance among ART clients and providers at healthcare facilities in Thailand. METHODS: A cross-sectional study using self-administered questionnaires was conducted in September-November 2018 at five healthcare facilities in four high HIV burden provinces in Thailand. Eligible participants who were ART clients aged ≥18 years and ART providers were recruited by consecutive sampling. Descriptive statistics were used to summarize demographic characteristics, preferences for HIV services and expectations and concerns towards DSD for ART maintenance. RESULTS: Five hundred clients and 52 providers completed the questionnaires. Their median ages (interquartile range; IQR) were 38.6 (29.8 to 45.5) and 37.3 (27.3 to 45.1); 48.5% and 78.9% were females, 16.8% and 1.9% were men who have sex with men, and 2.4% and 7.7% were transgender women, respectively. Most clients and providers agreed that ART maintenance tasks, including ART refill, viral load testing, HIV/sexually transmitted infection monitoring, and psychosocial support should be provided at ART clinics (85.2% to 90.8% vs. 76.9% to 84.6%), by physicians (77.0% to 94.6% vs. 71.2% to 100.0%), every three months (26.7% to 40.8% vs. 17.3% to 55.8%) or six months (33.0% to 56.7% vs. 28.9% to 80.8%). Clients agreed that DSD would encourage their autonomy (84.9%) and empower responsibility for their health (87.7%). Some clients and providers disagreed that DSD would lead to poor ART retention (54.0% vs. 40.4%), increased loss to follow-up (52.5% vs. 42.3%), and delayed detection of treatment failure (48.3% vs. 44.2%), whereas 31.4% to 50.0% of providers were unsure about these expectations and concerns. CONCLUSIONS: Physician-led, facility-based clinical consultation visit spacing in combination with multi-month ART refill was identified as one promising DSD model in Thailand. However, low preference for decentralization and task shifting may prove challenging to implement other models, especially since many providers were unsure about DSD benefits. This calls for local implementation studies to prove feasibility and governmental and social support to legitimize and normalize DSD in order to gain acceptance among clients and providers.

Cost-effectiveness of the long-acting regimen cabotegravir plus rilpivirine for the treatment of HIV-1 and its potential impact on adherence and viral transmission: A modelling study.

INTRODUCTION: Combination antiretroviral therapy (cART) improves outcomes for people living with HIV (PLWH) but requires adherence to daily dosing. Suboptimal adherence results in reduced treatment effectiveness, increased costs, and greater risk of resistance and onwards transmission. Treatment with long-acting (LA), injection-based ART administered by healthcare professionals (directly observed therapy (DOT)) eliminates the need for adherence to daily dosing and may improve clinical outcomes. This study reports the cost-effectiveness of the cabotegravir plus rilpivirine LA regimen (CAB+RPV LA) and models the potential impact of LA DOT therapies. METHODS: Parameterisation was performed using pooled data from recent CAB+RPV LA Phase III trials. The analysis was conducted using a cohort-level hybrid decision-tree and state-transition model, with states defined by viral load and CD4 cell count. The efficacy of oral cART was adjusted to reflect adherence to daily regimens from published data. A Canadian health service perspective was adopted. RESULTS: CAB+RPV LA is predicted to be the dominant intervention when compared to oral cART, generating, per 1,000 patients treated, lifetime cost-savings of $1.5 million, QALY and life-year gains of 107 and 138 respectively with three new HIV cases averted. CONCLUSIONS: Economic evaluations of LA DOTs need to account for the impact of adherence and HIV transmission. This study adds to the existing literature by incorporating transmission and using clinical data from the first LA DOT regimen. Providing PLWH and healthcare providers with novel modes of ART administration, enhancing individualisation of treatment, may facilitate the achievement of UNAIDS 95-95-95 objectives.

Potential Impact and Cost-Effectiveness of Condomless-Sex-Concentrated PrEP in KwaZulu-Natal Accounting for Drug Resistance.

INTRODUCTION: Oral preexposure prophylaxis (PrEP) in the form of tenofovir-disoproxil-fumarate/emtricitabine is being implemented in selected sites in South Africa. Addressing outstanding questions on PrEP cost-effectiveness can inform further implementation. METHODS: We calibrated an individual-based model to KwaZulu-Natal to predict the impact and cost-effectiveness of PrEP, with use concentrated in periods of condomless sex, accounting for effects on drug resistance. We consider (1) PrEP availability for adolescent girls and young women aged 15-24 years and female sex workers, and (2) availability for everyone aged 15-64 years. Our primary analysis represents a level of PrEP use hypothesized to be attainable by future PrEP programs. RESULTS: In the context of PrEP use in adults aged 15-64 years, there was a predicted 33% reduction in incidence and 36% reduction in women aged 15-24 years. PrEP was cost-effective, including in a range of sensitivity analyses, although with substantially reduced (cost) effectiveness under a policy of ART initiation with efavirenz- rather than dolutegravir-based regimens due to PrEP undermining ART effectiveness by increasing HIV drug resistance. CONCLUSIONS: PrEP use concentrated during time periods of condomless sex has the potential to substantively impact HIV incidence and be cost-effective.

Cost-effectiveness of point-of-care testing with task-shifting for HIV care in South Africa: a modelling study.

BACKGROUND: The number of people on antiretroviral therapy (ART) requiring treatment monitoring in low-resource settings is rapidly increasing. Point-of-care (POC) testing for ART monitoring might alleviate burden on centralised laboratories and improve clinical outcomes, but its cost-effectiveness is unknown. METHODS: We used cost and effectiveness data from the STREAM trial in South Africa (February, 2017-October, 2018), which evaluated POC testing for viral load, CD4 count, and creatinine, with task shifting from professional to lower-cadre registered nurses compared with laboratory-based testing without task shifting (standard of care). We parameterised an agent-based network model, EMOD-HIV, to project the impact of implementing this intervention in South Africa over 20 years, simulating approximately 175 000 individuals per run. We assumed POC monitoring increased viral suppression by 9 percentage points, enrolment into community-based ART delivery by 25 percentage points, and switching to second-line ART by 1 percentage point compared with standard of care, as reported in the STREAM trial. We evaluated POC implementation in varying clinic sizes (10-50 patient initiating ART per month). We calculated incremental cost-effectiveness ratios (ICERs) and report the mean and 90% model variability of 250 runs, using a cost-effectiveness threshold of US$500 per disability-adjusted life-year (DALY) averted for our main analysis. FINDINGS: POC testing at 70% coverage of patients on ART was projected to reduce HIV infections by 4·5% (90% model variability 1·6 to 7·6) and HIV-related deaths by 3·9% (2·0 to 6·0). In clinics with 30 ART initiations per month, the intervention had an ICER of $197 (90% model variability -27 to 863) per DALY averted; results remained cost-effective when varying background viral suppression, ART dropout, intervention effectiveness, and reduction in HIV transmissibility. At higher clinic volumes (≥40 ART initiations per month), POC testing was cost-saving and at lower clinic volumes (20 ART initiations per month) the ICER was $734 (93 to 2569). A scenario that assumed POC testing did not increase enrolment into community ART delivery produced ICERs that exceeded the cost-effectiveness threshold for all clinic volumes. INTERPRETATION: POC testing is a promising strategy to cost-effectively improve patient outcomes in moderately sized clinics in South Africa. Results are most sensitive to changes in intervention impact on enrolment into community-based ART delivery. FUNDING: National Institutes of Health.

COVID-19 pandemic and antiretrovirals (ARV) availability in Nigeria: recommendations to prevent shortages.

HIV/AIDS is an infectious disease that has claimed the lives of millions of people worldwide. Currently, there is no vaccine that has been developed in a bid to fight this deadly infection, however, antiretrovirals (ARVs), which are drugs used in the treatment of HIV infection are routinely prescribed to infected persons. They act via several mechanisms of action to reduce the severity of infection and rate of infectivity of the virus by decreasing the viral load while increasing CD4 counts. COVID-19 pandemic has resulted in unprecedented events affecting almost all areas of humans' life including availability of medicines and other consumables. This paper analyses the availability of ARVs during COVID-19 era and offered recommendations to be adopted in order to prevent shortages.

Economic Burden Among Gay, Bisexual, and Other Men Who Have Sex With Men Living With HIV or Living Without HIV in the Multicenter AIDS Cohort Study.

BACKGROUND: With HIV now considered a chronic disease, economic burden for people living with HIV (LWH) may threaten long-term disease outcomes. We studied associations between economic burden (employment, income, insurance, and financial difficulty) and HIV status for gay, bisexual, and other men who have sex with men (GBMSM) and how economic burden relates to disease progression. SETTING: We analyzed data collected every 6 months through 2015 from GBMSM LWH and GBMSM living without HIV from 2 waves (2001-2003 cohort and 2010+ new recruit cohort) of the Multicenter AIDS Cohort Study. METHODS: Using generalized estimating equations, we first assessed the association between HIV status (exposure) and economic burden indicators since the last study visit (outcomes) of employment (working/student/retired versus not currently working), personal annual income of ≥$10,000, insurance (public/private versus none), and financial difficulty meeting basic expenses. Then among people LWH, we assessed the relationships between economic burden indicators (exposures), risk of progressive immune suppression (CD4 ≤500 cells/uL), and progression to AIDS (CD4 ≤200; outcomes). RESULTS: Of 1721 participants, 59.5% were LWH (n = 1024). GBMSM LWH were 12% less likely to be employed, 16% more likely to have health insurance, and 9% more likely to experience financial difficulty than GBMSM living without HIV. Among GBMSM LWH, employment was associated with a 6% and 32% lower likelihood of immune suppression or progression to AIDS, respectively, and the income was associated with a 15% lower likelihood of progression to AIDS. CONCLUSIONS: Interventions that stabilize employment, income, and offer insurance support may enrich GBMSM LWH's ability to prevent disease progression.

Costs of providing HIV care and optimal allocation of HIV resources in Guyana.

INTRODUCTION: Great strides in responding to the HIV epidemic have led to improved access to and uptake of HIV services in Guyana, a lower-middle-income country with a generalized HIV epidemic. Despite efforts to scale up HIV treatment and adopt the test and start strategy, little is known about costs of HIV services across the care cascade. METHODS: We collected cost data from the national laboratory and nine selected treatment facilities in five of the country's ten Regions, and estimated the costs associated with HIV testing and services (HTS) and antiretroviral therapy (ART) from a provider perspective from January 1, 2016 to December 31, 2016. We then used the unit costs to construct four resource allocation scenarios. In the first two scenarios, we calculated how close Guyana would currently be to its 2020 targets if the allocation of funding across programs and regions over 2017-2020 had (a) remained unchanged from latest-reported levels, or (b) been optimally distributed to minimize incidence and deaths. In the next two, we estimated the resources that would have been required to meet the 2020 targets if those resources had been distributed (a) according to latest-reported patterns, or (b) optimally to minimize incidence and deaths. RESULTS: The mean cost per test was US$15 and the mean cost per person tested positive was US$796. The mean annual cost per of maintaining established adult and pediatric patients on ART were US$428 and US$410, respectively. The mean annual cost of maintaining virally suppressed patients was US$648. Cost variation across sites may suggest opportunities for improvements in efficiency, or may reflect variation in facility type and patient volume. There may also be scope for improvements in allocative efficiency; we estimated a 28% reduction in the total resources required to meet Guyana's 2020 targets if funds had been optimally distributed to minimize infections and deaths. CONCLUSIONS: We provide the first estimates of costs along the HIV cascade in the Caribbean and assessed efficiencies using novel context-specific data on the costs associated with diagnostic, treatment, and viral suppression. The findings call for better targeting of services, and efficient service delivery models and resource allocation, while scaling up HIV services to maximize investment impact.