Cost-effectiveness of easy-access, risk-informed oral pre-exposure prophylaxis in HIV epidemics in sub-Saharan Africa: a modelling study.

BACKGROUND: Approaches that allow easy access to pre-exposure prophylaxis (PrEP), such as over-the-counter provision at pharmacies, could facilitate risk-informed PrEP use and lead to lower HIV incidence, but their cost-effectiveness is unknown. We aimed to evaluate conditions under which risk-informed PrEP use is cost-effective. METHODS: We applied a mathematical model of HIV transmission to simulate 3000 setting-scenarios reflecting a range of epidemiological characteristics of communities in sub-Saharan Africa. The prevalence of HIV viral load greater than 1000 copies per mL among all adults (HIV positive and negative) varied from 1·1% to 7·4% (90% range). We hypothesised that if PrEP was made easily available without restriction and with education regarding its use, women and men would use PrEP, with sufficient daily adherence, during so-called seasons of risk (ie, periods in which individuals are at risk of acquiring infection). We refer to this as risk-informed PrEP. For each setting-scenario, we considered the situation in mid-2021 and performed a pairwise comparison of the outcomes of two policies: immediate PrEP scale-up and then continuation for 50 years, and no PrEP. We estimated the relationship between epidemic and programme characteristics and cost-effectiveness of PrEP availability to all during seasons of risk. For our base-case analysis, we assumed a 3-monthly PrEP cost of US$29 (drug $11, HIV test $4, and $14 for additional costs necessary to facilitate education and access), a cost-effectiveness threshold of $500 per disability-adjusted life-year (DALY) averted, an annual discount rate of 3%, and a time horizon of 50 years. In sensitivity analyses, we considered a cost-effectiveness threshold of $100 per DALY averted, a discount rate of 7% per annum, the use of PrEP outside of seasons of risk, and reduced uptake of risk-informed PrEP. FINDINGS: In the context of PrEP scale-up such that 66% (90% range across setting-scenarios 46-81) of HIV-negative people with at least one non-primary condomless sex partner take PrEP in any given period, resulting in 2·6% (0·9-6·0) of all HIV negative adults taking PrEP at any given time, risk-informed PrEP was predicted to reduce HIV incidence by 49% (23-78) over 50 years compared with no PrEP. PrEP was cost-effective in 71% of all setting-scenarios, and cost-effective in 76% of setting-scenarios with prevalence of HIV viral load greater than 1000 copies per mL among all adults higher than 2%. In sensitivity analyses with a $100 per DALY averted cost-effectiveness threshold, a 7% per year discount rate, or with PrEP use that was less well risk-informed than in our base case, PrEP was less likely to be cost-effective, but generally remained cost-effective if the prevalence of HIV viral load greater than 1000 copies per mL among all adults was higher than 3%. In sensitivity analyses based on additional setting-scenarios in which risk-informed PrEP was less extensively used, the HIV incidence reduction was smaller, but the cost-effectiveness of risk-informed PrEP was undiminished. INTERPRETATION: Under the assumption that making PrEP easily accessible for all adults in sub-Saharan Africa in the context of community education leads to risk-informed use, PrEP is likely to be cost-effective in settings with prevalence of HIV viral load greater than 1000 copies per mL among all adults higher than 2%, suggesting the need for implementation of such approaches, with ongoing evaluation. FUNDING: US Agency for International Development, US President's Emergency Plan for AIDS Relief, and Bill & Melinda Gates Foundation.

Low costs and opportunities for efficiency: a cost analysis of the first year of programmatic PrEP delivery in Kenya's public sector.

BACKGROUND: In 2017, the Kenyan Ministry of Health integrated provision of pre-exposure prophylaxis (PrEP) into public HIV-1 care clinics as a key component of the national HIV-1 prevention strategy. Estimates of the cost of PrEP provision are needed to inform the affordability and cost-effectiveness of PrEP in Kenya. METHODS: We conducted activity-based micro-costing from the payer perspective to estimate both the financial and economic costs of all resources and activities required to provide PrEP in Kenya's public sector. We estimated total and unit costs in 2019 United States dollars from a combination of project expense reports, Ministry of Health training reports, clinic staff interviews, time-and-motion observations, and routinely collected data from PrEP recipient files from 25 high-volume HIV-1 care clinics. RESULTS: In the first year of programmatic PrEP delivery in 25 HIV-1 care clinics, 2,567 persons initiated PrEP and accrued 8,847 total months of PrEP coverage, accounting for 2 % of total outpatient clinic visits. The total financial cost to the Ministry of Health was $91,175, translating to an average of $10.31 per person per month. The majority (69 %) of financial costs were attributable to PrEP medication, followed by administrative supplies (17 %) and training (9 %). Economic costs were higher ($188,584 total; $21.32 per person per month) due to the inclusion of the opportunity cost of staff time re-allocated to provide PrEP and a proportional fraction of facility overhead. The vast majority (88 %) of the annual $80,811 economic cost of personnel time was incurred during activities to recruit new clients (e.g., discussion of PrEP within HIV-1 testing and counselling services), while the remaining 12 % was for activities related to both initiation and maintenance of PrEP provision (e.g., client consultations, technical advising, support groups). CONCLUSIONS: Integration of PrEP provision into existing public health HIV-1 care service delivery platforms resulted in minimal additional staff burden and low incremental costs. Efforts to improve the efficiency of PrEP provision should focus on reductions in the cost of PrEP medication and extra-clinic demand creation and community sensitization to reduce personnel time dedicated to recruitment-related activities. TRIAL REGISTRATION: ClinicalTrials.gov registration NCT03052010 . Retrospectively registered on February 14, 2017.

Costs of Point-of-Care Viral Load Testing for Adults and Children Living with HIV in Kenya.

BACKGROUND: The number of people living with HIV (PLHIV) in need of treatment monitoring in low-and-middle-income countries is rapidly expanding, straining existing laboratory capacity. Point-of-care viral load (POC VL) testing can alleviate the burden on centralized laboratories and enable faster delivery of results, improving clinical outcomes. However, implementation costs are uncertain and will depend on clinic testing volume. We sought to estimate the costs of decentralized POC VL testing compared to centralized laboratory testing for adults and children receiving HIV care in Kenya. METHODS: We conducted microcosting to estimate the per-patient costs of POC VL testing compared to known costs of centralized laboratory testing. We completed time-and-motion observations and stakeholder interviews to assess personnel structures, staff time, equipment costs, and laboratory processes associated with POC VL administration. Capital costs were estimated using a 5 year lifespan and a 3% annual discount rate. RESULTS: We estimated that POC VL testing cost USD $24.25 per test, assuming a clinic is conducting 100 VL tests per month. Test cartridge and laboratory equipment costs accounted for most of the cost (62% and 28%, respectively). Costs varied by number of VL tests conducted at the clinic, ranging from $54.93 to $18.12 per test assuming 20 to 500 VL tests per month, respectively. A VL test processed at a centralized laboratory was estimated to cost USD $25.65. CONCLUSION: POC VL testing for HIV treatment monitoring can be feasibly implemented in clinics within Kenya and costs declined with higher testing volumes. Our cost estimates are useful to policymakers in planning resource allocation and can inform cost-effectiveness analyses evaluating POC VL testing.

Equity of antiretroviral treatment use in high HIV burden countries: Analyses of data from nationally-representative surveys in Kenya and South Africa.

OBJECTIVE: To assess changes and equity in antiretroviral therapy (ART) use in Kenya and South Africa. METHODS: We analysed national population-based household surveys conducted in Kenya and South Africa between 2007 and 2012 for factors associated with lack of ART use among people living with HIV (PLHIV) aged 15-64 years. We considered ART use to be inequitable if significant differences in use were found between groups of PLHIV (e.g. by sex). FINDINGS: ART use among PLHIV increased from 29.3% (95% confidence interval [CI]: 22.8-35.8) to 42.5% (95%CI: 37.4-47.7) from 2007 to 2012 in Kenya and 17.4% (95%CI: 14.2-20.9) to 30.3% (95%CI: 27.2-33.6) from 2008 to 2012 in South Africa. In 2012, factors independently associated with lack of ART use among adult Kenyan PLHIV were rural residency (adjusted odds ratio [aOR] 1.98, 95%CI: 1.23-3.18), younger age (15-24 years: aOR 4.25, 95%CI: 1.7-10.63, and 25-34 years: aOR 5.16, 95%CI: 2.73-9.74 versus 50-64 years), nondisclosure of HIV status to most recent sex partner (aOR 2.41, 95%CI: 1.27-4.57) and recent recreational drug use (aOR 2.50, 95%CI: 1.09-5.77). Among South African PLHIV in 2012, lack of ART use was significantly associated with younger age (15-24 years: aOR 4.23, 95%CI: 2.56-6.70, and 25-34 years: aOR 2.84, 95%CI: 1.73-4.67, versus 50-64 years), employment status (aOR 1.61, 95%CI: 1.16-2.23 in students versus unemployed), and recent recreational drug use (aOR 4.56, 95%CI: 1.79-11.57). CONCLUSION: Although we found substantial increases in ART use in both countries over time, we identified areas needing improvement including among rural Kenyans, students in South Africa, and among young people and drug users in both countries.

Rates and Predictors of Non-Adherence to Antiretroviral Therapy among HIV-Positive Individuals in Kenya: Results from the Second Kenya AIDS Indicator Survey, 2012.

INTRODUCTION: Understanding the levels and associated factors of non-adherence to antiretroviral therapy (ART) is crucial in designing interventions to improve adherence and health outcomes of ART. We assessed non-adherence to ART among HIV-infected persons reporting ART use in a nationally representative survey in Kenya. METHODS: The Kenya AIDS Indicator Survey 2012 was a population-based, household survey of persons aged 18 months-64 years conducted in 2012-2013. Self-reported information was collected on demographics, sexual behaviour, HIV status, and ART use. Blood was collected for HIV testing, and if HIV infected, CD4 and viral load testing. HIV-positive specimens were tested for the presence of antiretroviral (ARV) drugs using a qualitative ARV assay using liquid chromatography-tandem mass spectrometry. HIV-positive persons who reported receiving ART but did not have the ARV biomarker present were defined as being non-adherent to their ARV medication. We restricted our analysis to HIV-infected persons aged 15-64 years who reported receiving ART and had laboratory-confirmed results from ARV testing. Multivariate logistic regression was used to identify variables associated with non-adherence. RESULTS: A total of 648 (5.6%; CI 4.9-6.3) tested HIV-positive of whom 559 (86.3%) had sufficient volume of blood to be tested for ARV drugs. Of those, 271 (47.7%; CI 41.8-53.6) self-reported HIV-positive status during the interview and 186 (69.1%; CI 62.2-76.0) of those reported taking ART. The ARV biomarker was absent in 18 of 186 individuals (9.4%; CI 4.9-13.8) who thus were defined as being non-adherent to ART. Non-adherence was associated with being aged 15-29 years (AOR 8.39; CI 2.26-31.22, p = 0.002) compared to aged 30-64 years, rural residence (AOR 5.87; CI 1.39-25.61, p = 0.016) compared with urban residence and taking recreational drugs in the past 30 days (AOR 5.89; CI 1.30-26.70, p = 0.022). CONCLUSION: Overall, less than 10% of Kenyans aged 15-64 years on ART were not adhering to their HIV medication, highlighting the success of the Kenyan national ART program. Our findings, however, point to the need for targeted interventions particularly for young persons, those in rural areas to improve adherence outcomes, as well as delivery of treatment programs that include psychosocial support as a preventative measure to minimize substance abuse and the risk of treatment failure.

Cascade of HIV care and population viral suppression in a high-burden region of Kenya.

INTRODUCTION: Direct measurement of antiretroviral treatment (ART) program indicators essential for evidence-based planning and evaluation - especially HIV incidence, population viral load, and ART eligibility - is rare in sub-Saharan Africa. DESIGN/METHODS: To measure key indicators in rural western Kenya, an area with high HIV burden, we conducted a population survey in September to November 2012 via multistage cluster sampling, recruiting everyone aged 15-59 years living in 3330 randomly selected households. Consenting individuals were interviewed and tested for HIV at home. Participants testing positive were assessed for CD4 cell count and viral load, and their infections classified as either recent or long term based on Limiting Antigen Avidity assays. HIV-negative participants were tested by nucleic acid amplification to detect acute infections. RESULTS: Of 6833 household members eligible for the study, 6076 (94.7% of all women and 81.0% of men) agreed to participate. HIV prevalence and incidence were 24.1% [95% confidence interval [CI] 23.0-25.2] and 1.9 new cases/100 person-years (95% CI 1.1-2.7), respectively. Among HIV-positive participants, 59.4% (95% CI 56.8-61.9) were previously diagnosed, 53.1% (95% CI 50.5-55.7) were receiving care, and 39.7% (95% CI 37.1-42.4) had viral load less than 1000 copies/ml. Applying 2013 WHO recommendations for ART initiation increased the proportion of ART-eligible people from 60.0% (based on national guidelines in place during the survey; 95% CI 57.3-62.7) to 82.0% (95% CI 79.5-84.5). Among HIV-positive people not receiving ART, viral load increased with decreasing CD4 cell count (500-749 vs. ≥750 cells/µl, adjusted mean difference, 0.40 log10 copies/ml, 95% CI 0.20-0.60, P < 0.01). CONCLUSION: This study demonstrates how population-level data can help optimize HIV programs. Based on these results, new regional programs are prioritizing diagnosis and expanding ART eligibility, key steps to reach undetectable viral load.