Evaluating the effectiveness and cost-effectiveness of health facility-based and community-based index-linked HIV testing strategies for children: protocol for the B-GAP study in Zimbabwe.

INTRODUCTION: The number of new paediatric infections per year has declined in sub-Saharan Africa due to prevention-of-mother-to-child HIV transmission programmes; many children and adolescents living with HIV remain undiagnosed. In this protocol paper, we describe the methodology for evaluating an index-linked HIV testing approach for children aged 2-18 years in health facility and community settings in Zimbabwe. METHODS AND ANALYSIS: Individuals attending for HIV care at selected primary healthcare clinics (PHCs) will be asked if they have any children aged 2-18 years in their households who have not been tested for HIV. Three options for HIV testing for these children will be offered: testing at the PHC; home-based testing performed by community workers; or an oral mucosal HIV test given to the caregiver to test the children at home. All eligible children will be followed-up to ascertain whether HIV testing occurred. For those who did not test, reasons will be determined, and for those who tested, the HIV test result will be recorded. The primary outcome will be uptake of HIV testing. The secondary outcomes will be preferred HIV testing method, HIV yield, prevalence and proportion of those testing positive linking to care and having an undetectable viral load at 12 months. HIV test results will be stratified by sex and age group, and factors associated with uptake of HIV testing and choice of HIV testing method will be investigated. ETHICS AND DISSEMINATION: Ethical approval for this study was granted by the Medical Research Council of Zimbabwe, the London School of Hygiene and Tropical Medicine and the Institutional Review Board of the Biomedical Research and Training Institute. Study results will be presented at national policy meetings and national and international research conferences. Results will also be published in international peer-reviewed scientific journals and disseminated to study communities at the end of study.

Strengthening provider-initiated testing and counselling in Zimbabwe by deploying supplemental providers: a time series analysis.

BACKGROUND: Expansion of provider-initiated testing and counselling (PITC) is one strategy to increase accessibility of HIV testing services. Insufficient human resources was identified as a primary barrier to increasing PITC coverage in Zimbabwe. We evaluated if deployment of supplemental PITC providers at public facilities in Zimbabwe was associated with increased numbers of individuals tested and diagnosed with HIV. METHODS: From July 2016 to May 2017, International Training and Education Center for Health (I-TECH) deployed 138 PITC providers to supplement existing ministry healthcare workers offering PITC at 249 facilities. These supplemental providers were assigned to facilities on a weekly basis. Each week, I-TECH providers reported the number of HIV tests and positive diagnoses they performed. Using routine reporting systems, we obtained from each facility the number of clients tested and diagnosed with HIV per month. Including data both before and during the intervention period, and utilizing the weekly variability in placement locations of the supplemental PITC providers, we employed generalized estimating equations to assess if the placement of supplemental PITC providers at a facility was associated with a change in facility outputs. RESULTS: Supplemental PITC providers performed an average of 62 (SD = 52) HIV tests per week and diagnosed 4.4 (SD = 4.9) individuals with HIV per week. However, using facility reports from the same period, we found that each person-week of PITC provider deployment at a facility was associated with an additional 16.7 (95% CI, 12.2-21.1) individuals tested and an additional 0.9 (95% CI, 0.5-1.2) individuals diagnosed with HIV. We also found that staff placement at clinics was associated with a larger increase in HIV testing than staff placement at polyclinics or hospitals (24.0 vs. 9.8; p < 0.001). CONCLUSIONS: This program resulted in increased numbers of individuals tested and diagnosed with HIV. The discrepancy between the average weekly HIV tests conducted by supplemental PITC providers (62) and the increase in facility-level HIV tests associated with one week of PITC provider deployment (16.7) suggests that supplemental PITC providers displaced existing staff who may have been reassigned to fulfil other duties at the facility.

The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations.

BACKGROUND: Knowledge of HIV status remains below target in sub-Saharan Africa, especially among men and adolescents. HIV self-testing (HIVST) is a novel approach that enables unique distribution strategies, with potential to be highly decentralised and to provide complementary coverage to facility-based testing approaches. However, substantial gaps in evidence remain on the effectiveness and cost-effectiveness of HIVST, particularly in rural settings, and on approaches to facilitate linkage to confirmatory HIV testing, prevention, and treatment services. This protocol describes two cluster-randomized trials (CRT) included within the UNITAID/PSI HIV Self-Testing Africa (STAR) project. METHODS: Two independent CRTs were designed around existing reproductive health programmes in rural Malawi and rural/peri-urban Zambia. Common features include use of constrained randomisation to allocate health clinic catchment areas to either standard HIV testing (SOC) or SOC plus community-based distribution of OraQuick HIV Self Tests (Bethlehem, PA USA, assembled in Thailand) by trained lay distributors selected by the community. Community-based distribution agents will be trained (3-day curriculum) to provide brief demonstration of kit use and interpretation, information and encouragement to access follow up services, and management of social harm. The primary outcome of both CRTs is the proportion of the population aged 16 years and older who tested for HIV within the 12-month intervention period. Secondary outcomes in both trials include lifetime HIV testing, antiretroviral therapy (ART) initiation and ART use. Circumcision status among males will be a secondary outcome in Zambia and clinic-level demand for ART will be a secondary outcome in Malawi. Outcomes will be measured using cross-sectional household surveys, and routine data extraction from participating clinics. Costing studies will be used to evaluate the cost-effectiveness of the intervention arm. Qualitative research will be used to guide distribution and explore reasons for testing and linkage to onward care. DISCUSSION: The STAR-Malawi and STAR-Zambia trials will provide rigorous evidence of whether community-based lay HIVST distribution is an effective and cost-effective approach to increasing coverage of HIV testing and demand for follow-on HIV services in rural and peri-urban communities in sub-Saharan Africa. TRIAL REGISTRATION: Clinicaltrials.gov, Malawi: NCT02718274 , 18 March 2016; Zambia: NCT02793804 , 3 June 2016. Protocol date: 21 February 2018.

Costs of facility-based HIV testing in Malawi, Zambia and Zimbabwe.

BACKGROUND: Providing HIV testing at health facilities remains the most common approach to ensuring access to HIV treatment and prevention services for the millions of undiagnosed HIV-infected individuals in sub-Saharan Africa. We sought to explore the costs of providing these services across three southern African countries with high HIV burden. METHODS: Primary costing studies were undertaken in 54 health facilities providing HIV testing services (HTS) in Malawi, Zambia and Zimbabwe. Routinely collected monitoring and evaluation data for the health facilities were extracted to estimate the costs per individual tested and costs per HIV-positive individual identified. Costs are presented in 2016 US dollars. Sensitivity analysis explored key drivers of costs. RESULTS: Health facilities were testing on average 2290 individuals annually, albeit with wide variations. The mean cost per individual tested was US$5.03.9 in Malawi, US$4.24 in Zambia and US$8.79 in Zimbabwe. The mean cost per HIV-positive individual identified was US$79.58, US$73.63 and US$178.92 in Malawi, Zambia and Zimbabwe respectively. Both cost estimates were sensitive to scale of testing, facility staffing levels and the costs of HIV test kits. CONCLUSIONS: Health facility based HIV testing remains an essential service to meet HIV universal access goals. The low costs and potential for economies of scale suggests an opportunity for further scale-up. However low uptake in many settings suggests that demand creation or alternative testing models may be needed to achieve economies of scale and reach populations less willing to attend facility based services.

Modeling Impact and Cost-Effectiveness of Increased Efforts to Attract Voluntary Medical Male Circumcision Clients Ages 20-29 in Zimbabwe.

BACKGROUND: Zimbabwe aims to increase circumcision coverage to 80% among 13- to 29-year-olds. However, implementation data suggest that high coverage among men ages 20 and older may not be achievable without efforts specifically targeted to these men, incurring additional costs per circumcision. Scale-up scenarios were created based on trends in implementation data in Zimbabwe, and the cost-effectiveness of increasing efforts to recruit clients ages 20-29 was examined. METHODS: Zimbabwe voluntary medical male circumcision (VMMC) program data were used to project trends in male circumcision coverage by age into the future. The projection informed a base scenario in which, by 2018, the country achieves 80% circumcision coverage among males ages 10-19 and lower levels of coverage among men above age 20. The Zimbabwe DMPPT 2.0 model was used to project costs and impacts, assuming a US$109 VMMC unit cost in the base scenario and a 3% discount rate. Two other scenarios assumed that the program could increase coverage among clients ages 20-29 with a corresponding increase in unit cost for these age groups. RESULTS: When circumcision coverage among men ages 20-29 is increased compared with a base scenario reflecting current implementation trends, fewer VMMCs are required to avert one infection. If more than 50% additional effort (reflected as multiplying the unit cost by >1.5) is required to double the increase in coverage among this age group compared with the base scenario, the cost per HIV infection averted is higher than in the base scenario. CONCLUSIONS: Although increased investment in recruiting VMMC clients ages 20-29 may lead to greater overall impact if recruitment efforts are successful, it may also lead to lower cost-effectiveness, depending on the cost of increasing recruitment. Programs should measure the relationship between increased effort and increased ability to attract this age group.

Modeling Costs and Impacts of Introducing Early Infant Male Circumcision for Long-Term Sustainability of the Voluntary Medical Male Circumcision Program.

Voluntary medical male circumcision (VMMC) has been shown to be an effective prevention strategy against HIV infection in males [1-3]. Since 2007, the President's Emergency Plan for AIDS Relief (PEPFAR) has supported VMMC programs in 14 priority countries in Africa. Today several of these countries are preparing to transition their VMMC programs from a scale-up and expansion phase to a maintenance phase. As they do so, they must consider the best approaches to sustain high levels of male circumcision in the population. The two alternatives under consideration are circumcising adolescents 10-14 years old over the long term or integrating early infant male circumcision (EIMC) into maternal and child health programs. The paper presents an analysis, using the Decision Makers Program Planning Tool, Version 2.0 (DMPPT 2.0), of the estimated cost and impact of introducing EIMC into existing VMMC programs in several countries in eastern and southern Africa. Limited cost data exist for the implementation of EIMC, but preliminary studies, such as the one detailed in Mangenah, et al. [4-5], suggest that the cost of EIMC may be less than that of adolescent and adult male circumcision. If this is the case, then adding EIMC to the VMMC program will increase the number of circumcisions that need to be performed but will not increase the total cost of the program over the long term. In addition, we found that a delayed or slow start-up of EIMC would not substantially reduce the impact of adding it to the program or increase cumulative long-term costs, which should make introduction of EIMC more feasible and attractive to countries contemplating such a program innovation.

Evaluating Opportunities for Achieving Cost Efficiencies Through the Introduction of PrePex Device Male Circumcision in Adult VMMC Programs in Zambia and Zimbabwe.

BACKGROUND: Results from recent costing studies have put into question potential Voluntary Medical Male Circumcision (VMMC) cost savings with the introduction of the PrePex device. METHODS: We evaluated the cost drivers and the overall unit cost of VMMC for a variety of service delivery models providing either surgical VMMC or both PrePex and surgery using current program data in Zimbabwe and Zambia. In Zimbabwe, 3 hypothetical PrePex only models were also included. For all models, clients aged 18 years and older were assumed to be medically eligible for PrePex and uptake was based on current program data from sites providing both methods. Direct costs included costs for consumables, including surgical VMMC kits for the forceps-guided method, device (US $12), human resources, demand creation, supply chain, waste management, training, and transport. RESULTS: Results for both countries suggest limited potential for PrePex to generate cost savings when adding the device to current surgical service delivery models. However, results for the hypothetical rural Integrated PrePex model in Zimbabwe suggest the potential for material unit cost savings (US $35 per VMMC vs. US $65-69 for existing surgical models). CONCLUSIONS: This analysis illustrates that models designed to leverage PrePex's advantages, namely the potential for integrating services in rural clinics and less stringent infrastructure requirements, may present opportunities for improved cost efficiency and service integration. Countries seeking to scale up VMMC in rural settings might consider integrating PrePex only MC services at the primary health care level to reduce costs while also increasing VMMC access and coverage.

A Reevaluation of the Voluntary Medical Male Circumcision Scale-Up Plan in Zimbabwe.

BACKGROUND: The voluntary medical male circumcision (VMMC) program in Zimbabwe aims to circumcise 80% of males aged 13-29 by 2017. We assessed the impact of actual VMMC scale-up to date and evaluated the impact of potential alterations to the program to enhance program efficiency, through prioritization of subpopulations. METHODS AND FINDINGS: We implemented a recently developed analytical approach: the age-structured mathematical (ASM) model and accompanying three-level conceptual framework to assess the impact of VMMC as an intervention. By September 2014, 364,185 males were circumcised, an initiative that is estimated to avert 40,301 HIV infections by 2025. Through age-group prioritization, the number of VMMCs needed to avert one infection (effectiveness) ranged between ten (20-24 age-group) and 53 (45-49 age-group). The cost per infection averted ranged between $811 (20-24 age-group) and $5,518 (45-49 age-group). By 2025, the largest reductions in HIV incidence rate (up to 27%) were achieved by prioritizing 10-14, 15-19, or 20-24 year old. The greatest program efficiency was achieved by prioritizing 15-24, 15-29, or 15-34 year old. Prioritizing males 13-29 year old was programmatically efficient, but slightly inferior to the 15-24, 15-29, or 15-34 age groups. Through geographic prioritization, effectiveness varied from 9-12 VMMCs per infection averted across provinces. Through risk-group prioritization, effectiveness ranged from one (highest sexual risk-group) to 60 (lowest sexual risk-group) VMMCs per infection averted. CONCLUSION: The current VMMC program plan in Zimbabwe is targeting an efficient and impactful age bracket (13-29 year old), but program efficiency can be improved by prioritizing a subset of males for demand creation and service availability. The greatest program efficiency can be attained by prioritizing young sexually active males and males whose sexual behavior puts them at higher risk for acquiring HIV.