Impact of HIV self-testing for oral pre-exposure prophylaxis scale-up on drug resistance and HIV outcomes in western Kenya: a modelling study.

BACKGROUND: Community-based oral pre-exposure prophylaxis (PrEP) provision has the potential to expand PrEP coverage. HIV self-testing can facilitate PrEP community-based delivery but might have lower sensitivity than facility-based HIV testing, potentially leading to inappropriate PrEP use among people with HIV and subsequent development of drug resistance. We aimed to evaluate the impact of HIV self-testing use for PrEP scale-up. METHODS: We parameterised an agent-based network model, EMOD-HIV, to simulate generic tenofovir disoproxil fumarate and emtricitabine PrEP scale-up in western Kenya using four testing scenarios: provider-administered nucleic acid testing, provider-administered rapid diagnostic tests detecting antibodies, blood-based HIV self-testing, or oral fluid HIV self-testing. Scenarios were compared with a no PrEP counterfactual. Individuals aged 18-49 years with one or more heterosexual partners who screened HIV-negative were eligible for PrEP. We assessed the cost and health impact of rapid PrEP scale-up with high coverage over 20 years, and the budget impact over 5 years, using various HIV testing modalities. FINDINGS: PrEP coverage of 29% was projected to avert approximately 54% of HIV infections and 17% of HIV-related deaths among adults aged 18-49 years over 20 years; health impacts were similar across HIV testing modalities used to deliver PrEP. The percentage of HIV infections with PrEP-associated nucleoside reverse transcriptase inhibitor (NRTI) drug resistance was 0·6% (95% uncertainty intervals 0·4-0·9) in the blood HIV self-testing scenario and 0·8% (0·6-1·0) in the oral HIV self-testing scenario, compared with 0·3% (0·2-0·3) in the antibody rapid diagnostic testing scenario and 0·2% (0·1-0·2) in the nucleic acid testing scenario. Accounting for background NRTI resistance, we found similarly low proportions of drug resistance across scenarios. The budget impact of implementing PrEP using HIV self-testing and provider-administered rapid diagnostic tests were similar, while nucleic acid testing was approximately 50% more costly. INTERPRETATION: Scaling up PrEP using HIV self-testing has similar health impacts, costs, and low risk of drug resistance as provider-administered rapid diagnostic tests. Policy makers should consider leveraging HIV self-testing to expand PrEP access among those at HIV risk. FUNDING: The Bill and Melinda Gates Foundation.

Population health impact, cost-effectiveness, and affordability of community-based HIV treatment and monitoring in South Africa: A health economics modelling study.

Community-based delivery and monitoring of antiretroviral therapy (ART) for HIV has the potential to increase viral suppression for individual- and population-level health benefits. However, the cost-effectiveness and budget impact are needed for public health policy. We used a mathematical model of HIV transmission in KwaZulu-Natal, South Africa, to estimate population prevalence, incidence, mortality, and disability-adjusted life-years (DALYs) from 2020 to 2060 for two scenarios: 1) standard clinic-based HIV care and 2) five-yearly home testing campaigns with community ART for people not reached by clinic-based care. We parameterised model scenarios using observed community-based ART efficacy. Using a health system perspective, we evaluated incremental cost-effectiveness and net health benefits using a threshold of $750/DALY averted. In a sensitivity analysis, we varied the discount rate; time horizon; costs for clinic and community ART, hospitalisation, and testing; and the proportion of the population receiving community ART. Uncertainty ranges (URs) were estimated across 25 best-fitting parameter sets. By 2060, community ART following home testing averted 27.9% (UR: 24.3-31.5) of incident HIV infections, 27.8% (26.8-28.8) of HIV-related deaths, and 18.7% (17.9-19.7) of DALYs compared to standard of care. Adolescent girls and young women aged 15-24 years experienced the greatest reduction in incident HIV (30.7%, 27.1-34.7). In the first five years (2020-2024), community ART required an additional $44.9 million (35.8-50.1) annually, representing 14.3% (11.4-16.0) of the annual HIV budget. The cost per DALY averted was $102 (85-117) for community ART compared with standard of care. Providing six-monthly refills instead of quarterly refills further increased cost-effectiveness to $78.5 per DALY averted (62.9-92.8). Cost-effectiveness was robust to sensitivity analyses. In a high-prevalence setting, scale-up of decentralised ART dispensing and monitoring can provide large population health benefits and is cost-effective in preventing death and disability due to HIV.

Preventing tuberculosis with community-based care in an HIV-endemic setting: a modeling analysis.

Introduction: Antiretroviral therapy (ART) and TB preventive treatment (TPT) both prevent tuberculosis (TB) disease and deaths among people living with HIV. Differentiated care models, including community-based care, can increase uptake of ART and TPT to prevent TB in settings with a high burden of HIV-associated TB, particularly among men. Methods: We developed a gender-stratified dynamic model of TB and HIV transmission and disease progression among 100,000 adults ages 15-59 in KwaZulu-Natal, South Africa. We drew model parameters from a community-based ART initiation and resupply trial in sub-Saharan Africa (Delivery Optimization for Antiretroviral Therapy, DO ART) and other scientific literature. We simulated the impacts of community-based ART and TPT care programs during 2018-2027, assuming that community-based ART and TPT care were scaled up to similar levels as in the DO ART trial (i.e., ART coverage increasing from 49% to 82% among men and from 69% to 83% among women) and sustained for ten years. We projected the number of TB cases, deaths, and disability-adjusted life years (DALYs) averted relative to standard, clinic-based care. We calculated program costs and incremental cost-effectiveness ratios from the provider perspective. Results: If community-based ART care could be implemented with similar effectiveness to the DO ART trial, increased ART coverage could reduce TB incidence by 27.0% (range 21.3% - 34.1%) and TB mortality by 36.0% (range 26.9% - 43.8%) after ten years. Increasing both ART and TPT uptake through community-based ART with TPT care could reduce TB incidence by 29.7% (range 23.9% - 36.0%) and TB mortality by 36.0% (range 26.9% - 43.8%). Community-based ART with TPT care reduced gender disparities in TB mortality rates by reducing TB mortality among men by a projected 39.8% (range 32.2% - 46.3%) and by 30.9% (range 25.3% - 36.5%) among women. Over ten years, the mean cost per DALY averted by community-based ART with TPT care was $846 USD (range $709 - $1,012). Conclusions: By substantially increasing coverage of ART and TPT, community-based care for people living with HIV could reduce TB incidence and mortality in settings with high burdens of HIV-associated TB and reduce TB gender disparities.

The impact of prevention-effective PrEP use on HIV incidence: a mathematical modelling study.

INTRODUCTION: Models that project the impact and cost-effectiveness of HIV pre-exposure prophylaxis (PrEP) must specify how PrEP use aligns with HIV exposure. We hypothesized that varying PrEP use according to individual-level partnership dynamics rather than prioritization to population subgroups based on average risk will result in larger incidence reductions and greater efficiency. METHODS: We used an individual-based network transmission model calibrated to HIV dynamics in Eswatini to simulate PrEP use among individuals ages 15-34 between 2022 and 2031 under two paradigms of PrEP delivery: "Risk Group" and "Partnership." In the "Risk Group" paradigm, we varied PrEP coverage by risk groups (low, medium and high) defined by average partnership frequency and concurrency. In the "Partnership" paradigm, all individuals are potentially eligible for PrEP, but we assumed use occurs only during partnerships and varied prioritization by partner HIV status (no prioritization to high prioritization with HIV-positive partners). We calculated person-time on PrEP and incidence relative to a no PrEP scenario and estimated efficiency as the person-years of PrEP needed to avert one additional infection (NNT). RESULTS: In the Risk Group paradigm, restricting PrEP to the high-risk group was the most efficient (NNT = 17), but the number of infections averted was limited by the small size of the high-risk group. Expanding PrEP use to all risk groups averted up to three times more infections but with lower efficiency (NNT = 202). PrEP use under the Partnership paradigm was 2-6 times more efficient (NNT = 33-102) than the Risk Group paradigm with all groups eligible for PrEP. A 33% reduction in incidence among 15- to 34-year-olds was achieved at 46% (95% CI: 39-52%) PrEP coverage in the Risk Group paradigm and 6% (95% CI: 5-7%) to 17% (95% CI: 14-20%) in the Partnership paradigm. CONCLUSIONS: Modelling PrEP use based on risk groups resulted in a sharp trade-off between PrEP efficiency and impact, whereas PrEP use predicated on partnerships resulted in much higher efficiency for widespread PrEP availability. Model estimates of PrEP impact and cost-effectiveness in generalized epidemics are strongly influenced by assumptions about how PrEP use aligns with individual-level HIV exposure heterogeneity.

Predicting the Risk of Human Immunodeficiency Virus Type 1 (HIV-1) Acquisition in Rural South Africa Using Geospatial Data.

BACKGROUND: Accurate human immunodeficiency virus (HIV) risk assessment can guide optimal HIV prevention. We evaluated the performance of risk prediction models incorporating geospatial measures. METHODS: We developed and validated HIV risk prediction models in a population-based cohort in South Africa. Individual-level covariates included demographic and sexual behavior measures, and geospatial covariates included community HIV prevalence and viral load estimates. We trained models on 2012-2015 data using LASSO Cox models and validated predictions in 2016-2019 data. We compared full models to simpler models restricted to only individual-level covariates or only age and geospatial covariates. We compared the spatial distribution of predicted risk to that of high incidence areas (≥ 3/100 person-years). RESULTS: Our analysis included 19 556 individuals contributing 44 871 person-years and 1308 seroconversions. Incidence among the highest predicted risk quintile using the full model was 6.6/100 person-years (women) and 2.8/100 person-years (men). Models using only age group and geospatial covariates had similar performance (women: AUROC = 0.65, men: AUROC = 0.71) to the full models (women: AUROC = 0.68, men: AUROC = 0.72). Geospatial models more accurately identified high incidence regions than individual-level models; 20% of the study area with the highest predicted risk accounted for 60% of the high incidence areas when using geospatial models but only 13% using models with only individual-level covariates. CONCLUSIONS: Geospatial models with no individual measures other than age group predicted HIV risk nearly as well as models that included detailed behavioral data. Geospatial models may help guide HIV prevention efforts to individuals and geographic areas at highest risk.

Barriers to accessing preventive health care among African-born individuals in King County, Washington: A qualitative study involving key informants.

Studies of African immigrant health in the U.S. have traditionally focused on infectious diseases. However, the rising burden of non-communicable diseases (NCDs) indicates the increasing importance of general preventive health care. As part of a series of community health events designed for African-born individuals in King County, Washington, we administered key informant interviews (KIIs) with 16 health event participants, medical professionals, and community leaders to identify barriers and facilitators to use of preventive health care among African-born individuals. We used descriptive thematic analysis to organize barriers according to the socio-ecological model. Within the individual domain, KII participants identified lack of knowledge and awareness of preventive health benefits as barriers to engagement in care. Within the interpersonal domain, language and cultural differences frequently complicated relationships with health care providers. Within the societal and policy domains, healthcare costs, lack of insurance, and structural racism were also reported as major barriers. Participants identified community outreach with culturally competent and respectful providers as key elements of interventions to improve uptake. In conclusion, African immigrant communities face several barriers, ranging from individual to policy levels, to accessing health services, resulting in substantial unmet need for chronic disease prevention and treatment. Community-centered and -led care may help facilitate uptake and engagement in care.

Optimizing HIV retesting during pregnancy and postpartum in four countries: a cost-effectiveness analysis.

INTRODUCTION: HIV retesting during late pregnancy and breastfeeding can help detect new maternal infections and prevent mother-to-child HIV transmission (MTCT), but the optimal timing and cost-effectiveness of maternal retesting remain uncertain. METHODS: We constructed deterministic models to assess the health and economic impact of maternal HIV retesting on a hypothetical population of pregnant women, following initial testing in pregnancy, on MTCT in four countries: South Africa and Kenya (high/intermediate HIV prevalence), and Colombia and Ukraine (low HIV prevalence). We evaluated six scenarios with varying retesting frequencies from late in antenatal care (ANC) through nine months postpartum. We compared strategies using incremental cost-effectiveness ratios (ICERs) over a 20-year time horizon using country-specific thresholds. RESULTS: We found maternal retesting once in late ANC with catch-up testing through six weeks postpartum was cost-effective in Kenya (ICER = $166 per DALY averted) and South Africa (ICER=$289 per DALY averted). This strategy prevented 19% (Kenya) and 12% (South Africa) of infant HIV infections. Adding one or two additional retests postpartum provided smaller benefits (1 to 2 percentage point increase in infections averted versus one retest). Adding three retests during the postpartum period averted additional infections (1 to 3 percentage point increase in infections averted versus one retest) but ICERs ($7639 and in Kenya and $11 985 in South Africa) greatly exceeded the cost-effectiveness thresholds. In Colombia and Ukraine, all retesting strategies exceeded the cost-effectiveness threshold and prevented few infant infections (up to 31 and 5 infections, respectively). CONCLUSIONS: In high HIV burden settings with MTCT rates similar to those seen in Kenya and South Africa, HIV retesting once in late ANC, with subsequent intervention, is the most cost-effective strategy for preventing infant HIV infections. In these settings, two HIV retests postpartum marginally reduced MTCT and were less costly than adding three retests. Retesting in low-burden settings with MTCT rates similar to Colombia and Ukraine was not cost-effective at any time point due to very low HIV prevalence and limited breastfeeding.

Assessing HIV Care Outcomes Among African-Born People Living with HIV in Seattle: An Analysis of the University of Washington Electronic Medical Record.

To examine the relationship between African birth and HIV outcomes and comorbidities among individuals accessing care at the University of Washington. Patients who received a diagnosis of HIV at the University of Washington from 1995 to 2018 were identified. African-born patients were defined as those with recorded birthplace or primary language belonging to an African country. This cohort was compared to all non-African-born patients for initial CD4 count < 200 cells/mL, time from diagnosis to viral suppression, and prevalence of comorbid conditions. We identified 357 African-born and 3710 non-African-born patients. Over the time period, African-born patients were more likely to present with initial CD4 counts < 200 cells/mL (31% vs 19%, p < 0.01), but had shorter time to viral suppression (HR 1.31, [95% CI: 1.14-1.56]). African-born patients had higher rates of hepatitis B and tuberculosis (12% vs. 7% p < 0.01 and 13% vs. 3% p < 0.01). African-born patients living in the Seattle area have better HIV outcomes, but low initial CD4 counts suggest that they are presenting to care late. Increased efforts to engage this population in HIV, hepatitis B, and tuberculosis screening are warranted.

Cost-effectiveness of dual maternal HIV and syphilis testing strategies in high and low HIV prevalence countries: a modelling study.

BACKGROUND: Dual HIV and syphilis testing might help to prevent mother-to-child transmission (MTCT) of HIV and syphilis through increased case detection and treatment. We aimed to model and assess the cost-effectiveness of dual testing during antenatal care in four countries with varying HIV and syphilis prevalence. METHODS: In this modelling study, we developed Markov models of HIV and syphilis in pregnant women to estimate costs and infant health outcomes of maternal testing at the first antenatal care visit with individual HIV and syphilis tests (base case) and at the first antenatal care visit with a dual rapid diagnostic test (scenario one). We additionally evaluated retesting during late antenatal care and at delivery with either individual tests (scenario two) or a dual rapid diagnosis test (scenario three). We modelled four countries: South Africa, Kenya, Colombia, and Ukraine. Strategies with an incremental cost-effectiveness ratio (ICER) less than the country-specific cost-effectiveness threshold (US$500 in Kenya, $750 in South Africa, $3000 in Colombia, and $1000 in Ukraine) per disability-adjusted life-year averted were considered cost-effective. FINDINGS: Routinely offering testing at the first antenatal care visit with a dual rapid diagnosis test was cost-saving compared with the base case in all four countries (ICER: -$26 in Kenya,-$559 in South Africa, -$844 in Colombia, and -$454 in Ukraine). Retesting during late antenatal care with a dual rapid diagnostic test (scenario three) was cost-effective compared with scenario one in all four countries (ICER: $270 in Kenya, $260 in South Africa, $2207 in Colombia, and $205 in Ukraine). INTERPRETATION: Incorporating dual rapid diagnostic tests in antenatal care can be cost-saving across countries with varying HIV prevalence. Countries should consider incorporating dual HIV and syphilis rapid diagnostic tests as the first test in antenatal care to support efforts to eliminate MTCT of HIV and syphilis. FUNDING: WHO, US Agency for International Development, and the Bill & Melinda Gates Foundation.

Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial.

BACKGROUND: Community-based delivery of antiretroviral therapy (ART) for HIV, including ART initiation, clinical and laboratory monitoring, and refills, could reduce barriers to treatment and improve viral suppression, reducing the gap in access to care for individuals who have detectable HIV viral load, including men who are less likely than women to be virally suppressed. We aimed to test the effect of community-based ART delivery on viral suppression among people living with HIV not on ART. METHODS: We did a household-randomised, unblinded trial (DO ART) of delivery of ART in the community compared with the clinic in rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda. After community-based HIV testing, people living with HIV were randomly assigned (1:1:1) with mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills. The primary outcome was HIV viral suppression at 12 months. If the difference in viral suppression was not superior between study groups, an a-priori test for non-inferiority was done to test for a relative risk (RR) of more than 0·95. The cost per person virally suppressed was a co-primary outcome of the study. This study is registered with ClinicalTrials.gov, NCT02929992. FINDINGS: Between May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men. Retention at the month 12 visit was 95% (n=1253). At 12 months, community-based ART increased viral suppression compared with the clinic group (306 [74%] vs 269 [63%], RR 1·18, 95% CI 1·07-1·29; psuperiority=0·0005) and the hybrid approach was non-inferior (282 [68%] vs 269 [63%], RR 1·08, 0·98-1·19; pnon-inferiority=0·0049). Community-based ART increased viral suppression among men (73%, RR 1·34, 95% CI 1·16-1·55; psuperiority<0·0001) as did the hybrid approach (66%, RR 1·19, 1·02-1·40; psuperiority=0·026), compared with clinic-based ART (54%). Viral suppression was similar for men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group. With efficient scale-up, community-based ART could cost US$275-452 per person reaching viral suppression. Community-based ART was considered safe, with few adverse events. INTERPRETATION: In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender. Community-based ART should be implemented and evaluated in different contexts for people with detectable viral load. FUNDING: The Bill & Melinda Gates Foundation; the University of Washington and Fred Hutch Center for AIDS Research; the Wellcome Trust; the University of Washington Royalty Research Fund; and the University of Washington King K Holmes Endowed Professorship in STDs and AIDS.

Modeling the health impact and cost threshold of long-acting ART for adolescents and young adults in Kenya.

BACKGROUND: Despite high efficacy of oral antiretroviral therapy (ART), viral suppression among adolescents and young adults (AYA) living with HIV in sub-Saharan Africa (SSA) remains low. Compared to daily oral ART, bimonthly long-acting injectable ART (LA-ART) may simplify adherence, improve clinical outcomes, and decrease HIV transmission in this priority population. However, LA-ART will likely cost more than oral ART and the cost threshold at which LA-ART will be cost effective in SSA has not been evaluated. METHODS: We adapted a mathematical model of HIV transmission and progression in Kenya to include HIV acquisition and viral suppression among AYA (age 10-24). We projected the population-level health and economic impact of providing LA-ART to AYA over a 10-year time horizon assuming oral ART costs of US$233 annually and a two-month duration of viral suppression per LA-ART injection. We calculated the maximum cost at which switching from oral to LA-ART would be considered cost-effective, using thresholds of $500 and $1,508 per disability-adjusted life year averted (WHO's threshold of HIV treatment interventions and Kenya's gross domestic product per capita). FINDINGS: Assuming 85% of AYA switch from oral to injectable formulations, LA-ART is estimated to prevent 40,540 infections and 20,480 deaths over 10 years. The maximum increase in the annual per-person cost of receiving LA-ART is estimated to be $89 and $236 for LA-ART to be cost-effective under the thresholds of $500 and $1,508 per DALY averted, respectively. The cost threshold was lower when non-adherent oral ART AYA users were assumed to be less likely to switch to LA-ART. INTERPRETATION: Providing LA-ART to AYA can be cost-effective in Kenya if it is less than twice the cost of oral ART. Long-acting injectable ART for priority populations with low viral suppression has the potential to cost-effectively avert disability and death. FUNDING: National Institutes of Health (R01 HD085807; PI: Kohler).

Trends in Reported Sexual Behavior and Y-Chromosomal DNA Detection Among Female Sex Workers in the Senegal Preexposure Prophylaxis Demonstration Project.

BACKGROUND: Preexposure prophylaxis (PrEP) can reduce HIV acquisition among female sex workers (FSWs). However, changes in condomless sex frequency after PrEP initiation could reduce PrEP effectiveness when PrEP adherence is suboptimal as well as increase the risk of acquiring other sexually transmitted infections. Objective measures of condomless sex may be more accurate for determining changes in sexual behavior than self-reported measures. METHODS: We longitudinally measured self-reported condom use, number of clients, and presence of Y-chromosomal DNA (Yc-DNA) in vaginal swabs among 267 FSWs accessing PrEP at 4 clinics in Senegal between 2015 and 2016. We assessed trends in sexual behavior over time since PrEP initiation using generalized estimating equations and evaluated predictors of Yc-DNA detection. RESULTS: We found no increase in self-reported condomless sex with clients (odds ratio [OR], 0.94; 95% confidence interval [CI], 0.89-1.00), main partners (OR, 0.99; 95% CI, 0.96-1.02), or Yc-DNA detection (OR, 0.99; 95% CI, 0.90-1.08) over time since initiation. Y-chromosomal DNA was detected in 34 (22%) of 154 swabs tested and in 15 (26%) of 58 swabs from FSW reporting consistent condom use among both clients and main partners. Self-reported condom use with clients or main partners did not predict Yc-DNA detection. CONCLUSIONS: In a FSW PrEP demonstration project in Senegal, we found no evidence of risk compensation among FSWs on PrEP as measured by self-reported behavior or through Yc-DNA detection. Y-chromosomal DNA detection was frequently detected among FSWs reporting consistent condom use, highlighting limitations of self-reported sexual behavioral measures.

Cost of Differentiated HIV Antiretroviral Therapy Delivery Strategies in Sub-Saharan Africa: A Systematic Review.

BACKGROUND: Efficient and scalable models for HIV treatment are needed to maximize health outcomes with available resources. By adapting services to client needs, differentiated antiretroviral therapy (DART) has the potential to use resources more efficiently. We conducted a systematic review assessing the cost of DART in sub-Saharan Africa compared with the standard of care. METHODS: We searched PubMed, Embase, Global Health, EconLit, and the grey literature for studies published between 2005 and 2019 that assessed the cost of DART. Models were classified as facility-vs. community-based and individual- vs group-based. We extracted the annual per-patient service delivery cost and incremental cost of DART compared with standard of care in 2018 USD. RESULTS: We identified 12 articles that reported costs for 16 DART models in 7 countries. The majority of models were facility-based (n = 12) and located in Uganda (n = 7). The annual cost per patient within DART models (excluding drugs) ranged from $27 to $889 (2018 USD). Of the 11 models reporting incremental costs, 7 found DART to be cost saving. The median incremental saving per patient per year among cost-saving models was $67. Personnel was the most common driver of reduced costs, but savings were sometimes offset by higher overheads or utilization. CONCLUSIONS: DART models can save personnel costs by task shifting and reducing visit frequency. Additional economic evidence from community-based and group models is needed to better understand the scalability of DART. To decrease costs, programs will need to match DART models to client needs without incurring substantial overheads.

The role of costing in the introduction and scale-up of HIV pre-exposure prophylaxis: evidence from integrating PrEP into routine maternal and child health and family planning clinics in western Kenya.

INTRODUCTION: Understanding the cost of strategies to reach and deliver pre-exposure prophylaxis (PrEP) to priority populations is essential to assess the cost-effectiveness and budget impact of HIV prevention programmes. Providing PrEP through maternal and child health and family planning clinics offers a promising strategy to reach women in high HIV burden settings. We estimated incremental costs and explored the cost drivers of integrating PrEP delivery into routine maternal and child health and family planning services in Kenya. METHODS: We conducted a costing study from the provider perspective within the PrEP Implementation for Young Women and Adolescents programme in western Kenya. We identified all within- and above-facility activities supporting PrEP delivery and measured clinical service time using time-and-motion studies. We obtained input costs from programme budgets, expenditure records and staff interviews. We estimated changes in costs if creatinine testing were postponed from initiation to first follow-up visit and if PrEP were prioritized to clients at high HIV risk using a behavioural risk assessment tool. We also projected costs under Ministry of Health (MOH) implementation assuming MOH salaries and programme supervision. We estimated annual numbers of PrEP visits from programme data abstracted from 16 facilities between November 2017 and June 2018. We report the cost per client-month of PrEP dispensed in 2017 USD. RESULTS: For an annual programme output of 24,005 screenings, 4198 PrEP initiations and 4427 follow-up visits, the average cost per client-month of PrEP dispensed in the study was $26.52. Personnel, drugs and laboratory tests comprised 43%, 25% and 14% of programme costs respectively. Postponing creatinine testing and prioritizing PrEP delivery to clients at high HIV risk reduced total programme costs by 8% and 14% respectively. In the MOH scenario assuming no changes in outputs, the projected cost per client-month of PrEP dispensed decreased to $16.54 and total programme costs decreased by 38%. CONCLUSIONS: Incremental PrEP costs are sensitive to the service delivery strategy used to engage priority populations. Postponing creatinine testing and prioritizing PrEP delivery to clients at high HIV risk may reduce costs. Context-specific cost data are crucial to assess the cost-effectiveness and affordability of PrEP delivery models.

Harambee!: A pilot mixed methods study of integrated residential HIV testing among African-born individuals in the Seattle area.

BACKGROUND: African-born individuals in the U.S. are disproportionately affected by HIV yet have low HIV testing rates. We conducted a mixed methods study to assess the uptake and feasibility of a novel strategy for integrating HIV testing into residential health fairs among African-born individuals in Seattle, WA. METHODS: From April to May 2018, we held six health fairs at three apartment complexes with high numbers of African-born residents. Fairs included free point-of-care screening for glucose, cholesterol, body mass index, blood pressure, and HIV, as well as social services and health education. The health fairs were hosted in apartment complex common areas with HIV testing conducted in private rooms. Health fair participants completed a series of questionnaires to evaluate demographics, access to health services, and HIV testing history. We conducted 18 key informant interviews (KIIs) with health fair participants and community leaders to identify barriers to HIV testing among African-born individuals. RESULTS: Of the 111 adults who accessed at least one service at a health fair, 92 completed questionnaires. Fifty-five (61%) were female, 48 (52%) were born in Africa, and 55 (63%) had health insurance. Half of African-born participants accepted HIV testing; all tested negative. The most common reasons for declining testing were lack of perceived risk for HIV and knowledge of HIV status. We identified a high prevalence of non-communicable diseases (NCDs) among health fair participants; among those tested, 77% (55/71) were overweight/obese, 39% (31/79) had blood pressure > 140/90 mmHg, and 30% (22/73) had total cholesterol > 200 mg/dL. KIIs identified community stigma and misinformation as major barriers to HIV testing among African-born individuals. CONCLUSIONS: Residential health fairs are a feasible method to increase HIV testing among African-born individuals in Seattle. The high prevalence of NCDs highlights the importance of integrating general preventive services within HIV testing programs in this population.

Brief Report: Integration of PrEP Services Into Routine Antenatal and Postnatal Care: Experiences From an Implementation Program in Western Kenya.

BACKGROUND: Programmatic approaches for delivering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women in settings with high HIV burden are undefined. The PrEP Implementation for Young Women and Adolescents (PrIYA) Program developed approaches for delivering PrEP in maternal child health (MCH) clinics. METHODS: Under the PrIYA Program, nurse-led teams worked with MCH staff at 16 public, faith-based, and private facilities in Kisumu, Kenya, to determine optimal clinic flow for PrEP integration into antenatal care (ANC) and postnatal care (PNC). A program-dedicated nurse facilitated integration. HIV-uninfected women were screened for behavioral risk factors; same-day PrEP was provided to interested and medically eligible women. PrEP and MCH services were evaluated using standardized flow mapping and time-and-motion surveys. RESULTS: Clinics developed 2 approaches for integrating PrEP delivery within ANC/PNC: (1) co-delivery: ANC/PNC and PrEP services delivered by same MCH nurse or (2) sequential services: PrEP services after ANC/PNC by a PrEP-specialized nurse. Three clinics selected co-delivery and 13 sequential services, based on patient volume and space availability. Overall, 86 ANC/PNC visits were observed. Clients who initiated PrEP took a median of 18 minutes (interquartile range 15-26) for PrEP-related activities (risk assessment, PrEP counseling, creatinine testing, dispensation, and documentation) in addition to other routine ANC/PNC activities. For clients who declined PrEP, an additional 13 minutes (interquartile range 7-15) was spent on PrEP-related risk assessment and counseling. CONCLUSIONS: PrEP delivery within MCH used co-delivery or sequential approaches. The moderate additional time burden for PrEP initiation in MCH would likely decline with community awareness and innovations such as group/peer counseling or expedited dispensing.

Costs and cost-effectiveness of HIV/noncommunicable disease integration in Africa: from theory to practice.

: The current article reviews economic aspects of selected HIV/noncommunicable disease (NCD) service delivery integration programs to assess the efficiency of integration in limited capacity settings. We define economies of scope and scale and their relevance to HIV/NCD integration. We summarize the results of a systematic review of cost and cost-effectiveness studies of integrated care, which identified 12 datasets (nine studies) with a wide range of findings driven by differences in research questions, study methods, and health conditions measured. All studies were done in Africa and examined screening interventions only. No studies assessed the cost of integrated, long-term disease management. Few studies estimated the cost-effectiveness of integrated screening programs. The additional cost of integrating NCD screening with HIV care platforms represented a 6-30% increase in the total costs of the programs for noncancer NCDs, with cervical cancer screening costs dependent on screening strategy. We conducted 11 key informant interviews to uncover perceptions of the economics of HIV/NCD integration. None of the informants had hard information about the economic efficiency of integration. Most expected integrated care to be more cost-effective than current practice, though a minority thought that greater specialization could be more cost-effective. In the final section of this article, we summarize research needs and propose a 'minimum economic dataset' for future studies. We conclude that, although integrated HIV/NCD care has many benefits, the economic justification is unproven. Better information on the cost, cost-effectiveness, and fiscal sustainability of integrated programs is needed to justify this approach in limited-resource countries.

Expanding HIV testing and linkage to care in southwestern Uganda with community health extension workers.

INTRODUCTION: Achieving the UNAIDS goals of 90-90-90 will require more than doubling the number of people accessing HIV care in Uganda. Community-based programmes for entry into HIV care are effective strategies to expand access to HIV care, but few programmes have been evaluated with a particular focus on scale-up. METHODS: Integrated Community Based Initiatives, a Uganda-based non-governmental organization, designed and implemented a programme of community-based HIV counselling and testing and facilitated linkage to care utilizing community health extension workers (CHEWs) in rural Sheema District, Uganda. CHEWs performed programme activities during 1 October 2015 through 31 March 2016. Outcomes for this evaluation were (1) the number of people tested for HIV, and (2) the proportion of those testing positive who were seen at an ART clinic within three months of their positive test, and (3) the cost of the programme per person newly diagnosed with HIV. Microcosting methods were used to calculate the programme costs. Program scalability factors were evaluated using a published framework. RESULTS: Sixty-two CHEWs attended a five-day training that introduced the biology of HIV, the conduct of confidential HIV testing, HIV prevention messages, and linkage, referral, and reporting requirements. CHEWs received a $30 monthly stipend and a field testing kit that included a bicycle, field bag, umbrella, gumboots, reporting booklet, pens, and HIV testing materials. Trained CHEWs tested 43,696 persons for HIV infection during the six-month programme period. Nine-hundred seventy-four participants (2.2%) were identified as HIV positive, and 623 participants (64%) were linked to HIV care. An estimated 69% of adult residents received testing as part of this campaign. The programme cost $3.02 per person test, $135.70 per positive person identified, and $212.15 per HIV-positive person linked to care. CONCLUSIONS: Lay community health extension workers (CHEWs) can be rapidly trained to scale-up home-based HIV testing and counselling (HTC) and linkage to care in a high-quality and low-cost manner to large numbers of people in a rural, high burden setting. A combination HIV testing approach, such as adding partner testing to community-based testing, could increase the proportion of HIV-positive persons identified.

The potential to expand antiretroviral therapy by improving health facility efficiency: evidence from Kenya, Uganda, and Zambia.

BACKGROUND: Since 2000, international funding for HIV has supported scaling up antiretroviral therapy (ART) in sub-Saharan Africa. However, such funding has stagnated for years, threatening the sustainability and reach of ART programs amid efforts to achieve universal treatment. Improving health system efficiencies, particularly at the facility level, is an increasingly critical avenue for extending limited resources for ART; nevertheless, the potential impact of increased facility efficiency on ART capacity remains largely unknown. Through the present study, we sought to quantify facility-level technical efficiency across countries, assess potential determinants of efficiency, and predict the potential for additional ART expansion. METHODS: Using nationally-representative facility datasets from Kenya, Uganda and Zambia, and measures adjusting for structural quality, we estimated facility-level technical efficiency using an ensemble approach that combined restricted versions of Data Envelopment Analysis and Stochastic Distance Function. We then conducted a series of bivariate and multivariate regression analyses to evaluate possible determinants of higher or lower technical efficiency. Finally, we predicted the potential for ART expansion across efficiency improvement scenarios, estimating how many additional ART visits could be accommodated if facilities with low efficiency thresholds reached those levels of efficiency. RESULTS: In each country, national averages of efficiency fell below 50 % and facility-level efficiency markedly varied. Among facilities providing ART, average efficiency scores spanned from 50 % (95 % uncertainty interval (UI), 48-62 %) in Uganda to 59 % (95 % UI, 53-67 %) in Zambia. Of the facility determinants analyzed, few were consistently associated with higher or lower technical efficiency scores, suggesting that other factors may be more strongly related to facility-level efficiency. Based on observed facility resources and an efficiency improvement scenario where all facilities providing ART reached 80 % efficiency, we predicted a 33 % potential increase in ART visits in Kenya, 62 % in Uganda, and 33 % in Zambia. Given observed resources in facilities offering ART, we estimated that 459,000 new ART patients could be seen if facilities in these countries reached 80 % efficiency, equating to a 40 % increase in new patients. CONCLUSIONS: Health facilities in Kenya, Uganda, and Zambia could notably expand ART services if the efficiency with which they operate increased. Improving how facility resources are used, and not simply increasing their quantity, has the potential to substantially elevate the impact of global health investments and reduce treatment gaps for people living with HIV.

Evaluating facility-based antiretroviral therapy programme effectiveness: a pilot study comparing viral load suppression and retention rates.

OBJECTIVES: Increased demand for antiretroviral therapy (ART) services combined with plateaued levels of development assistance for HIV/AIDS requires that national ART programmes monitor programme effectiveness. In this pilot study, we compared commonly utilised performance metrics of 12- and 24-month retention with rates of viral load (VL) suppression at 15 health facilities in Uganda. METHODS: Retrospective chart review from which 12- and 24-month retention rates were estimated, and parallel HIV RNA VL testing on consecutive adult patients who presented to clinics and had been on ART for a minimum of six months. Rates of VL suppression were then calculated at each facility and compared to retention rates to assess the correlation between performance metrics. Multilevel logistic regression models predicting VL suppression and 12- and 24-month retention were constructed to estimate facility effects. RESULTS: We collected VL samples from 2961 patients and found that 88% had a VL ≤1000 copies/ml. Facility rates of VL suppression varied between 77% and 96%. When controlling for patient mix, a significant variation in facility performance persisted. Retention rates at 12 and 24 months were 91% and 79%, respectively, with a comparable facility-level variation. However, neither 12-month (ρ = 0.16) nor 24-month (ρ = -0.19) retention rates were correlated with facility rates of VL suppression. CONCLUSIONS: Retaining patients in care and suppressing VL are both critical outcomes. Given the lack of correlation noted in this study, the utilisation of VL monitoring may be necessary to truly assess the effectiveness of health facilities delivering ART services.