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BACKGROUND Voluntary medical male circumcision (VMMC) has been a recommended HIV prevention strategy in sub-Saharan Africa since 2007, particularly in countries with high HIV prevalence. However, given the scale-up of antiretroviral therapy programmes, it is not clear whether VMMC still represents a cost-effective use of scarce HIV programme resources. METHODS Using five existing well described HIV mathematical models, we compared continuation of VMMC for 5 years in men aged 15 years and older to no further VMMC in South Africa, Malawi, and Zimbabwe and across a range of setting scenarios in sub-Saharan Africa. Outputs were based on a 50-year time horizon, VMMC cost was assumed to be US$90, and a cost-effectiveness threshold of US$500 was used. FINDINGS In South Africa and Malawi, the continuation of VMMC for 5 years resulted in cost savings and health benefits (infections and disability-adjusted life-years averted) according to all models. Of the two models modelling Zimbabwe, the continuation of VMMC for 5 years resulted in cost savings and health benefits by one model but was not as cost-effective according to the other model. Continuation of VMMC was cost-effective in 68% of setting scenarios across sub-Saharan Africa. VMMC was more likely to be cost-effective in modelled settings with higher HIV incidence; VMMC was cost-effective in 62% of settings with HIV incidence of less than 0·1 per 100 person-years in men aged 15-49 years, increasing to 95% with HIV incidence greater than 1·0 per 100 person-years. INTERPRETATION VMMC remains a cost-effective, often cost-saving, prevention intervention in sub-Saharan Africa for at least the next 5 years. FUNDING Bill & Melinda Gates Foundation for the HIV Modelling Consortium.

Summary Background Adolescents living with HIV face challenges to their wellbeing and antiretroviral therapy adherence and have poor treatment outcomes. We aimed to evaluate a peer-led differentiated service delivery intervention on HIV clinical and psychosocial outcomes among adolescents with HIV in Zimbabwe. Methods 16 public primary care facilities (clusters) in two rural districts in Zimbabwe (Bindura and Shamva) were randomly assigned (1:1) to provide enhanced HIV care support (the Zvandiri intervention group) or standard HIV care (the control group) to adolescents (aged 13–19 years) with HIV. Eligible clinics had at least 20 adolescents in pre-ART or ART registers and were geographically separated by at least 10 km to minimise contamination. Adolescents were eligible for inclusion if they were living with HIV, registered for HIV care at one of the trial clinics, and either starting or already on ART. Exclusion criteria were being too physically unwell to attend clinic (bedridden), psychotic, or unable to give informed assent or consent. Adolescents with HIV at all clinics received adherence support through adult counsellors. At intervention clinics, adolescents with HIV were assigned a community adolescent treatment supporter, attended a monthly support group, and received text messages, calls, home visits, and clinic-based counselling. Implementation intensity was differentiated according to each adolescent's HIV vulnerability, which was reassessed every 3 months. Caregivers were invited to a support group. The primary outcome was the proportion of adolescents who had died or had a viral load of at least 1000 copies per μL after 96 weeks. In-depth qualitative data were collected and analysed thematically. The trial is registered with Pan African Clinical Trial Registry, number PACTR201609001767322. Findings Between Aug 15, 2016, and March 31, 2017, 500 adolescents with HIV were enrolled, of whom four were excluded after group assignment owing to testing HIV negative. Of the remaining 496 adolescents, 212 were recruited at Zvandiri intervention sites and 284 at control sites. At enrolment, the median age was 15 years (IQR 14–17), 52% of adolescents were female, 81% were orphans, and 47% had a viral load of at least 1000 copies per μL. 479 (97%) had primary outcome data at endline, including 28 who died. At 96 weeks, 52 (25%) of 209 adolescents in the Zvandiri intervention group and 97 (36%) of 270 adolescents in the control group had an HIV viral load of at least 1000 copies per μL or had died (adjusted prevalence ratio 0·58, 95% CI 0·36–0·94; p=0·03). Qualitative data suggested that the multiple intervention components acted synergistically to improve the relational context in which adolescents with HIV live, supporting their improved adherence. No adverse events were judged to be related to study procedures. Severe adverse events were 28 deaths (17 in the Zvandiri intervention group, 11 in the control group) and 57 admissions to hospital (20 in the Zvandiri intervention group, 37 in the control group). Interpretation Peer-supported community-based differentiated service delivery can substantially improve HIV virological suppression in adolescents with HIV and should be scaled up to reduce their high rates of morbidity and mortality. Funding Positive Action for Adolescents Program, ViiV Healthcare.

BACKGROUND Implementation science (IS) occupies a critical place in HIV/AIDS research, reflected by a scientific track ("Track E") at the biannual International AIDS Conference. IS seeks to identify health delivery strategies that cost-effectively translate the efficacy of evidence-based interventions for HIV prevention, testing, and treatment into impact on HIV incidence, quality of life, and mortality. METHOD We reviewed the content of Track E, and other presentations relevant to IS, at the 22nd International AIDS Conference held in Amsterdam in 2018. We identified key findings and themes and made recommendations for areas where the field can be strengthened by the 2020 meeting. RESULTS Trials of "treat all" strategies in Africa showed mixed evidence of effect. Innovations in HIV testing included expanding self-testing and index testing, which are reaching groups, such as men, where previously testing rates have been low. Adherence clubs and other innovations are being trialed to improve retention in care, with mixed findings. The implementation of pre-exposure prophylaxis for HIV prevention continues but with many challenges remaining in identifying implementation strategies that strengthen demand and support continuation. DISCUSSION IS for HIV/AIDS treatment and prevention continues to expand. IS for primary HIV prevention must be prioritized with a dearth of rigorous, intersectoral studies in this area. The weakness of routine data must be addressed. Costing and financing studies should form a stronger component of the conference agenda. Implementation scientists must continue to grapple with the methodological challenges posed by the real-world context for their research.

Although oral PrEP is highly effective at preventing HIV acquisition, optimizing continuation among beneficiaries is challenging in many settings. We estimated the costs of delivering oral PrEP to populations at risk of HIV in seven clinics in Zimbabwe. Full annual economic costs of oral PrEP initiations and continuation visits were estimated from the providers’ perspective for a six-clinic NGO network and one government SGBV clinic in Zimbabwe (January–December 2018). Disaggregating costs of full initiation and incremental follow-up visits enabled modeling of the impact of duration of continuation on the cost per person-year ($pPY) on PrEP. 4677 people initiated oral PrEP, averaging 2.7 follow-up visits per person. Average cost per person initiated was $238 ($183–$302 across the NGO clinics; $86 in the government facility). The full cost per initiation visit, including central and direct costs, was $178, and the incremental cost per follow-up visit, capturing only additional resources used directly in the follow up visits, was $22. The average duration of continuation was 3.0 months, generating an average $pPY of $943, ranging from $839 among adolescent girls and young women to $1219 in men. Oral PrEP delivery costs varied substantially by scale of initiations and by duration of continuation and type of clinic. Extending the average oral PrEP continuation from 2.7 to 5 visits (about 6 months) would greatly improve service efficiency, cutting the $pPY by more than half. Supplementary Information The online version contains supplementary material available at 10.1007/s10461-021-03367-w.

BackgroundSupply and demand-side factors continue to undermine voluntary medical male circumcision (VMMC) uptake. We assessed relative economic costs of four VMMC demand creation/service-delivery modalities as part of a randomised controlled trial in Zimbabwe.MethodsInterpersonal communication agents were trained and incentivised to generate VMMC demand across five districts using four demand creation modalities (standard demand creation (SDC), demand creation plus offer of HIV self-testing (HIVST), human-centred design (HCD)-informed approach, HCD-informed demand creation approach plus offer of HIVST). Annual provider financial expenditure analysis and activity-based-costing including time-and-motion analysis across 15 purposively selected sites accounted for financial expenditures and donated inputs from other programmes and funders. Sites represented three models of VMMC service-delivery: static (fixed) model offering VMMC continuously to walk-in clients at district hospitals and serving as a district hub for integrated mobile and outreach services, (2) integrated (mobile) modelwhere staff move from the district static (fixed) site with their commodities to supplement existing services or to recently capacitated health facilities, intermittently and (3) mobile/outreach model offering VMMC through mobile clinic services in more remote sites.ResultsTotal programme cost was $752 585 including VMMC service-delivery costs and average cost per client reached and cost per circumcision were $58 and $174, respectively. Highest costs per client reached were in the HCD arm—$68 and lowest costs in standard demand creation ($52) and HIVST ($55) arms, respectively. Highest cost per client circumcised was observed in the arm where HIVST and HCD were combined ($226) and the lowest in the HCD alone arm ($160). Across the three VMMC service-delivery models, unit cost was lowest in static (fixed) model ($54) and highest in integrated mobile model ($63). Overall, economies of scale were evident with unit costs lower in sites with higher numbers of clients reached and circumcised.ConclusionsThere was high variability in unit costs across arms and sites suggesting opportunities for cost reductions. Highest costs were observed in the HCD+HIVST arm when combined with an integrated service-delivery setting. Mobilisation programmes that intensively target higher conversion rates as exhibited in the SDC and HCD arms provide greater scope for efficiency by spreading costs.Trial registration numberPACTR201804003064160.

IntroductionAs countries approach the UNAIDS 95-95-95 targets, there is a need for innovative and cost-saving HIV testing approaches that can increase testing coverage in hard-to-reach populations. The HIV Self-Testing Africa-Initiative distributed HIV self-test (HIVST) kits using unincentivised HIV testing counsellors across 31 public facilities in Malawi, South Africa, Zambia and Zimbabwe. HIVST was distributed either through secondary (partner’s use) distribution alone or primary (own use) and secondary distribution approaches.MethodsWe evaluated the costs of adding HIVST to existing HIV testing from the providers’ perspective in the 31 public health facilities across the four countries between 2018 and 2019. We combined expenditure analysis and bottom-up costing approaches. We also carried out time-and-motion studies on the counsellors to estimate the human resource costs of introducing and demonstrating how to use HIVST for primary and secondary use.ResultsA total of 41 720 kits were distributed during the analysis period, ranging from 1254 in Zimbabwe to 27 678 in Zambia. The cost per kit distributed through the primary distribution approach was $4.27 in Zambia and $9.24 in Zimbabwe. The cost per kit distributed through the secondary distribution approach ranged from $6.46 in Zambia to $13.42 in South Africa, with a wider variation in the average cost at facility-level. From the time-and-motion observations, the counsellors spent between 20% and 44% of the observed workday on HIVST. Overall, personnel and test kit costs were the main cost drivers.ConclusionThe average costs of distributing HIVST kits were comparable across the four countries in our analysis despite wide cost variability within countries. We recommend context-specific exploration of potential efficiency gains from these facility-level cost variations and demand creation activities to ensure continued affordability at scale.

HIV testing is free in Malawi, but users may still incur costs that can deter or delay them accessing these services. We sought to identify and quantify these costs among HIV testing service clients in Malawi. We asked residents of communities participating in a cluster randomised trial investigating the impact of HIV self-testing about their past HIV testing experiences and the direct non-medical and indirect costs incurred to access HIV testing. We recruited 749 participants whose most recent HIV test was within the past 12 months. The mean total cost to access testing was US$2.45 (95%CI: US$2.11–US$2.70). Men incurred higher costs (US$3.81; 95%CI: US$2.91–US$4.50) than women (US$1.83; 95%CI: US$1.61–US$2.00). Results from a two-part multivariable regression analysis suggest that age, testing location, time taken to test, visiting a facility specifically for an HIV test and district of residence significantly affected the odds of incurring costs to testing. In addition, gender, wealth, age, education and district of residence were associated with significant user costs.

BackgroundFollowing success demonstrated with the HIV Self-Testing AfRica Initiative, HIV self-testing (HIVST) is being added to national HIV testing strategies in Southern Africa. An analysis of the costs of scaling up HIVST is needed to inform national plans, but there is a dearth of evidence on methods for forecasting costs at scale from pilot projects. Econometric cost functions (ECFs) apply statistical inference to predict costs; however, we often do not have the luxury of collecting large amounts of location-specific data. We fit an ECF to identify key drivers of costs, then use a simpler model to guide cost projections at scale.MethodsWe estimated the full economic costs of community-based HIVST distribution in 92 locales across Malawi, Zambia, Zimbabwe, South Africa and Lesotho between June 2016 and June 2019. We fitted a cost function with determinants related to scale, locales organisational and environmental characteristics, target populations, and per capita Growth Domestic Product (GDP). We used models differing in data intensity to predict costs at scale. We compared predicted estimates with scale-up costs in Lesotho observed over a 2-year period.ResultsThe scale of distribution, type of community-based intervention, percentage of kits distributed to men, distance from implementer’s warehouse and per capita GDP predicted average costs per HIVST kit distributed. Our model simplification approach showed that a parsimonious model could predict costs without losing accuracy. Overall, ECF showed a good predictive capacity, that is, forecast costs were close to observed costs. However, at larger scale, variations of programme efficiency over time (number of kits distributed per agent monthly) could potentially influence cost predictions.DiscussionOur empirical cost function can inform community-based HIVST scale-up in Southern African countries. Our findings suggest that a parsimonious ECF can be used to forecast costs at scale in the context of financial planning and budgeting.

BackgroundWe compared community-led versus an established community-based HIV self-testing (HIVST) model in rural Zimbabwe using a cluster-randomised trial.MethodsForty village groups were randomised 1:1 using restricted randomisation to community-led HIVST, where communities planned and implemented HIVST distribution for 4 weeks, or paid distribution (PD), where distributors were paid US$50 to distribute kits door-to-door over 4 weeks. Individual level primary outcomes compared household survey responses by arm 4 months post-intervention for: (1) newly diagnosed HIV during/within 4 months following HIVST distribution, (2) linkage to confirmatory testing, pre-exposure prophylaxis or voluntary medical male circumcision during/within 4 months following HIVST distribution. Participants were not masked to allocation; analysis used masked data. Trial analysis used random-effects logistic regression.Distribution costs compared: (1) community-led HIVST, (2) PD HIVST and (3) PD costs when first implemented in 2016/2017.ResultsFrom October 2018 to August 2019, 27 812 and 36 699 HIVST kits were distributed in community-led and PD communities, respectively. We surveyed 11 150 participants and 5683 were in community-led arm. New HIV diagnosis was reported by 211 (3.7%) community-led versus 197 (3.6%) PD arm participants, adjusted OR (aOR) 1.1 (95% CI 0.72 to 1.56); 318 (25.9%) community-led arm participants linked to post-test services versus 361 (23.9%) in PD arm, aOR 1.1 (95% CI 0.75 to 1.49.Cost per HIVST kit distributed was US$6.29 and US$10.25 for PD and community-led HIVST, both lower than 2016/2017 costs for newly implemented PD (US$14.52). No social harms were reported.ConclusionsCommunity-led HIVST can perform as well as paid distribution, with lower costs in the first year. These costs may reduce with programme maturity/learning.Trial registration numberPACTR201811849455568.

IntroductionReaching men aged 20–35 years, the group at greatest risk of HIV, with voluntary medical male circumcision (VMMC) remains a challenge. We assessed the impact of two VMMC demand creation approaches targeting this age group in a randomised controlled trial (RCT).MethodsWe conducted a 2×2 factorial RCT comparing arms with and without two interventions: (1) standard demand creation augmented by human-centred design (HCD)-informed approach; (2) standard demand creation plus offer of HIV self-testing (HIVST). Interpersonal communication (IPC) agents were the unit of randomisation. We observed implementation of demand creation over 6 months (1 May to 31 October 2018), with number of men circumcised assessed over 7 months. The primary outcome was the number of men circumcised per IPC agent using the as-treated population of actual number of months each IPC agent worked. We conducted a mixed-methods process evaluation within the RCT.ResultsWe randomised 140 IPC agents, 35 in each arm. 132/140 (94.3%) attended study training and 105/132 (79.5%) reached at least one client during the trial period and were included in final analysis. There was no evidence that the HCD-informed intervention increased VMMC uptake versus no HCD-informed intervention (incident rate ratio (IRR) 0.87, 95% CI 0.38 to 2.02; p=0.75). Nor did offering men a HIVST kit at time of VMMC mobilisation (IRR 0.65, 95% CI 0.28 to 1.50; p=0.31). Among IPC agents that reported reaching at least one man with demand creation, both the HCD-informed intervention and HIVST were deemed useful. There were some challenges with trial implementation; ConclusionThis RCT did not show evidence of an effect of HCD-informed demand intervention or HIVST on VMMC uptake. Findings will inform future design and implementation of demand creation evaluations.Trial registration numberPACTR201804003064160.

Introduction HIV self‐testing (HIVST) is recommended by the World Health Organization in addition to other testing modalities to increase uptake of HIV testing, particularly among harder‐to‐reach populations. This study provides the first empirical evidence of the costs of door‐to‐door community‐based HIVST distribution in Malawi, Zambia and Zimbabwe. Methods HIVST kits were distributed door‐to‐door in 71 sites across Malawi, Zambia and Zimbabwe from June 2016 to May 2017. Programme expenditures, supplemented by on‐site observation and monitoring and evaluation data were used to estimate total economic and unit costs of HIVST distribution, by input and site. Inputs were categorized into start‐up, capital and recurrent costs. Sensitivity and scenario analyses were performed to assess the impact of key parameters on unit costs. Results In total, 152,671, 103,589 and 93,459 HIVST kits were distributed in Malawi, Zambia and Zimbabwe over 12, 11 and 10 months respectively. Across these countries, 43% to 51% of HIVST kits were distributed to men. The average cost per HIVST kit distributed was US$8.15, US$16.42 and US$13.84 in Malawi, Zambia and Zimbabwe, respectively, with pronounced intersite variation within countries driven largely by site‐level fixed costs. Site‐level recurrent costs were 70% to 92% of full costs and 20% to 62% higher than routine HIV testing services (HTS) costs. Personnel costs contributed from 26% to 52% of total costs across countries reflecting differences in remuneration approaches and country GDP. Conclusions These early door‐to‐door community HIVST distribution programmes show large potential, both for reaching untested populations and for substantial economies of scale as HIVST programmes scale‐up and mature. From a societal perspective, the costs of HIVST appear similar to conventional HTS, with the higher providers’ costs substantially offsetting user costs. Future approaches to minimizing cost and/or maximize testing coverage could include unpaid door‐to‐door community‐led distribution to reach end‐users and integrating HIVST into routine clinical services via direct or secondary distribution strategies with lower fixed costs.

Early infant male circumcision (EIMC) conducted by nurse-midwives using the AccuCirc device proved safe, feasible, and acceptable to parents in Zimbabwe. The AccuCirc device has the potential to facilitate widespread scale-up of safe EIMC in sub-Saharan Africa., Background: For prevention of HIV, early infant male circumcision (EIMC) needs to be scaled up in countries with high HIV prevalence. Routine EIMC will maintain the HIV prevention gains anticipated from current adult male circumcision initiatives. We present here the results of a field study of EIMC conducted in Zimbabwe. Methods: The study was observational and based on the World Health Organization (WHO) framework for clinical evaluation of male circumcision devices. We recruited parents of newborn male infants between August 2013 and July 2014 from 2 clinics. Nurse-midwives used the AccuCirc device to circumcise eligible infants. We followed participants for 14 days after EIMC. Outcome measures were EIMC safety, acceptability, and feasibility. Results: We enrolled 500 male infants in the field study (uptake 11%). The infants were circumcised between 6 and 60 days postpartum. The procedure took a median of 17 minutes (interquartile range of 5 to 18 minutes). Mothers’ knowledge of male circumcision was extensive. Of the 498 mothers who completed the study questionnaire, 91% knew that male circumcision decreases the risk of HIV acquisition, and 83% correctly stated that this prevention is partial. Asked about their community’s perception of EIMC, 40% felt that EIMC will likely be viewed positively in their community; 13% said negatively; and 47% said the perception could be both ways. We observed 7 moderate or severe adverse events (1.4%; 95% confidence interval, 0.4% to 2.4%). All resolved without lasting effects. Nearly all mothers (99%) reported great satisfaction with the outcome, would recommend EIMC to other parents, and would circumcise their next sons. Conclusion: This first field study in sub-Saharan Africa of the AccuCirc device for EIMC demonstrated that EIMC conducted by nurse-midwives with this device is safe, feasible, and acceptable to parents.

Parents who opted for early infant male circumcision (EIMC) and health care workers felt EIMC was a safe and acceptable procedure that would likely become more widely adopted over time. Barriers to EIMC uptake such as parental fears of harm and cultural beliefs are potentially surmountable with adequate education and support., Background: The World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) recommend early infant male circumcision (EIMC) for prevention of HIV. Here, we present findings from a qualitative study in Zimbabwe that assessed parental and health care workers' perspectives of EIMC conducted using devices. Methods: This qualitative study was nested within a trial of EIMC devices. Between January and May 2013, we held 4 focus group discussions (FGDs) and 12 in-depth interviews with parents and 12 in-depth interviews with clinicians (7 trial clinicians and 5 non-trial clinicians). We also conducted 95 short telephone interviews with parents who had arranged to bring their sons for EIMC but then defaulted. Results: Parents who had adopted EIMC spoke of their initial anxieties about the procedure. Additionally, they commented on both the procedure and outcome. Parents who decided against EIMC cited fear of harm, specifically the infant's death, penile injury, and excessive pain. Misperceptions about male circumcision in general and EIMC specifically were a significant barrier to EIMC adoption and were prevalent among health care workers as well as parents. In particular, the findings suggest strong parental concerns about the fate of the discarded foreskin. Parents who chose EIMC for their newborn sons felt that the procedure was safe and expressed satisfaction with the outcome. For their part, health care workers largely thought that EIMC was safe and that the outcome was aesthetically pleasing. They also felt that it would be feasible to offer wide-scale EIMC for HIV prevention in the public sector; they recommended strategies to increase EIMC uptake, in addition to highlighting a few concerns. Conclusions: The qualitative study enables us to better understand parental and health care workers' perspectives of EIMC conducted using devices, especially their perspectives on EIMC safety, feasibility, acceptability, and barriers. These findings will be used to design demand-generation activities that support wider adoption of EIMC.

Background\ud Despite a growing body of literature on HIV service costs in sub-Saharan Africa, only a few studies have estimated the facility-level cost of prevention of Mother-to-Child Transmission (PMTCT) services, and even fewer provide insights into the variation of PMTCT costs across facilities. In this study, we present the first empirical costs estimation of the accelerated program for the prevention of mother-to-child transmission of HIV in Zimbabwe and investigate the determinants of heterogeneity of the facility-level average cost per service. To understand such variation, we explored the association between average costs per service and supply-and demand-side characteristics, and quality of services. One aspect of the supply-side we explore carefully is the scale of production—which we define as the annual number of women tested or the yearly number of HIV-positive women on prophylaxis.\ud \ud Methods\ud We collected rich data on the costs and PMTCT services provided by 157 health facilities out of 699 catchment areas in five provinces in Zimbabwe for 2013. In each health facility, we measured total costs and the number of women covered with PMTCT services and estimated the average cost per woman tested and the average cost per woman on either ARV prophylaxis or ART. We refer to these facility-level average costs per service as unitary costs. We also collected information on potential determinants of the variation of unitary costs. On the supply-side, we gathered data on the scale of production, staff composition and on the types of antenatal and family planning services provided. On the demand side, we measured the total population at the catchment area and surveyed eligible pairs of mothers and infants about previous use of HIV testing and prenatal care, and on the HIV status of both mothers and infants. We explored the determinants of unitary cost variation using a two-stage linear regression strategy.\ud \ud Results\ud The average annual total cost of the PMTCT program per facility was US$16,821 (median US$8,920). The average cost per pregnant woman tested was US$80 (median US$47), and the average cost per HIV-positive pregnant woman initiated on ARV prophylaxis or treatment was US$786 annually (median US$420). We found substantial heterogeneity of unitary costs across facilities regardless of facility type. The scale of production was a strong predictor of unitary costs variation across facilities, with a negative and statistically significant correlation between the two variables (p

Background World Health Organization (WHO) adolescent HIV-testing and treatment guidelines recommend community-based interventions to support antiretroviral therapy (ART) adherence and retention in care, while acknowledging that the evidence to support this recommendation is weak. This cluster randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of a psychosocial, community-based intervention on HIV-related and psychosocial outcomes. Methods/design We are conducting the trial in two districts. Sixteen clinics were randomized to either enhanced ART-adherence support or standard of care. Eligible individuals (HIV-positive adolescents aged 13–19 years and eligible for ART) in both arms receive ART and adherence support provided by adult counselors and nursing staff. Adolescents in the intervention arm additionally attend a monthly support group, are allocated to a designated community adolescent treatment supporter, and followed up through a short message service (SMS) and calls plus home visits. The type and frequency of contact is determined by whether the adolescent is “stable” or in need of enhanced support. Stable adolescents receive a monthly home visit plus a weekly, individualized SMS. An additional home visit is conducted if participants miss a scheduled clinic appointment or support-group meeting. Participants in need of further, enhanced, support receive bi-weekly home visits, weekly phone calls and daily SMS. Caregivers of adolescents in the intervention arm attend a caregiver support group. Trial outcomes are assessed through a clinical, behavioral and psychological assessment conducted at baseline and after 48 and 96 weeks. The primary outcome is the proportion who have died or have virological failure (viral load ≥1000 copies/ml) at 96 weeks. Secondary outcomes include virological failure at 48 weeks, retention in care (proportion of missed visits) and psychosocial outcomes at both time points. Statistical analyses will be conducted and reported in line with CONSORT guidelines for cluster randomized trials, including a flowchart. Discussion This study provides a unique opportunity to generate evidence of the impact of the on-going Zvandiri program, for adolescents living with HIV, on virological failure and psychosocial outcomes as delivered in a real-world setting. If found to reduce rates of treatment failure, this would strengthen support for further scale-up across Zimbabwe and likely the region more widely. Trial registration Pan African Clinical Trial Registry database, registration number PACTR201609001767322 (the Zvandiri trial). Retrospectively registered on 5 September 2016.

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.

Early infant male circumcision (EIMC) conducted by nurse-midwives using the AccuCirc device was safe and less costly per procedure than when conducted by doctors: for nurse-midwives, US$38.87 in vertical programs and US$33.72 in integrated programs; for doctors, US$49.77 in vertical programs., Background: The 14 countries that are scaling up voluntary male medical circumcision (VMMC) for HIV prevention are also considering early infant male circumcision (EIMC) to ensure longer-term reductions in HIV incidence. The cost of implementing EIMC is an important factor in scale-up decisions. We conducted a comparative cost analysis of EIMC performed by nurse-midwives and doctors using the AccuCirc device in Zimbabwe. Methods: Between August 2013 and July 2014, nurse-midwives performed EIMC on 500 male infants using AccuCirc in a field trial. We analyzed the overall unit cost and identified key cost drivers of EIMC performed by nurse-midwives and compared these with costing data previously collected during a randomized noninferiority comparison trial of 2 devices (AccuCirc and the Mogen clamp) in which doctors performed EIMC. We assessed direct costs (consumable and nonconsumable supplies, device, personnel, associated staff training, and waste management costs) and indirect costs (capital and support personnel costs). We performed one-way sensitivity analyses to assess cost changes when we varied key component costs. Results: The unit costs of EIMC performed by nurse-midwives and doctors in vertical programs were US$38.87 and US$49.77, respectively. Key cost drivers of EIMC were consumable supplies, personnel costs, and the device price. In this cost analysis, major cost drivers that explained the differences between EIMC performed by nurse-midwives and doctors were personnel and training costs, both of which were lower for nurse-midwives. Conclusions: EIMC unit costs were lower when performed by nurse-midwives compared with doctors. To minimize costs, countries planning to scale up EIMC should consider using nurse-midwives, who are in greater supply than doctors and are the main providers at the primary health care level, where most infants are born.

Background: Safe and cost-effective programs for implementing early infant male circumcision (EIMC) in Africa need to be piloted. We present results on a relative cost analysis within a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe. Methods: Between January and June 2013 male infants who met inclusion criteria were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor using a 2:1 allocation ratio. We evaluated the overall unit cost plus the key cost drivers of EIMC using both AccuCirc and Mogen clamp. Direct costs included consumable and nonconsumable supplies device personnel associated staff training and environmental costs. Indirect costs comprised capital and support personnel costs. In 1-way sensitivity analyses we assessed potential changes in unit costs due to variations in main parameters one at a time holding all other values constant. Results: The unit costs of EIMC using AccuCirc and Mogen clamp were $49.53 and $55.93 respectively. Key cost drivers were consumable supplies capacity utilization personnel costs and device price. Unit prices are likely to be lowest at full capacity utilization and increase as capacity utilization decreases. Unit prices also fall with lower personnel salaries and increase with higher device prices. Conclusions: EIMC has a lower unit cost when using AccuCirc compared with Mogen clamp. To minimize unit costs countries planning to scale-up EIMC using AccuCirc need to control costs of consumables and personnel. There is also need to negotiate a reasonable device price and maximize capacity utilization. Copyright © 2015 Wolters Kluwer Health Inc.

Background Early infant male circumcision (EIMC) is simpler, safer and more cost-effective than adult circumcision. In sub-Saharan Africa, there are concerns about acceptability of EIMC which could affect uptake. In 2009 a quantitative survey of 2,746 rural Zimbabweans (aged 18–44) indicated that 60% of women and 58% of men would be willing to have their newborn son circumcised. Willingness was associated with knowledge of HIV and male circumcision. This qualitative study was conducted to better understand this issue. Methods In 2010, 24 group discussions were held across Zimbabwe with participants from seven ethnic groups. Additionally, key informant interviews were held with private paediatricians who offer EIMC (n = 2) plus one traditional leader. Discussions were audio-recorded, transcribed, translated into English (where necessary), coded using NVivo 8 and analysed using grounded theory principles. Results Knowledge of the procedure was poor. Despite this, acceptability of EIMC was high among parents from most ethnic groups. Discussions suggested that fathers would make the ultimate decision regarding EIMC although mothers and extended family can have (often covert) influence. Participants' concerns centred on: safety, motive behind free service provision plus handling and disposal of the discarded foreskin. Older men from the dominant traditionally circumcising population strongly opposed EIMC, arguing that it separates circumcision from adolescent initiation, as well as allowing women (mothers) to nurse the wound, considered taboo. Conclusions EIMC is likely to be an acceptable HIV prevention intervention for most populations in Zimbabwe, if barriers to uptake are appropriately addressed and fathers are specifically targeted by the programme.

BACKGROUND\ud \ud Early infant male circumcision (EIMC) has been identified as a key HIV prevention intervention. Exploring the decision-making process for adoption of EIMC for HIV prevention among parents and other key stakeholders is critical for designing effective demand creation interventions to maximize uptake, roll out and impact in preventing HIV. This paper describes key players, decisions and actions involved in the EIMC decision-making process.\ud \ud METHODS\ud \ud Two complementary qualitative studies explored hypothetical and actual acceptability of EIMC in Zimbabwe. The first study (conducted 2010) explored hypothetical acceptability of EIMC among parents and wider family through focus group discussions (FGDs, n = 24). The follow-up study (conducted 2013) explored actual acceptability of EIMC among parents through twelve in-depth interviews (IDIs), four FGDs and short telephone interviews with additional parents (n = 95). Short statements from the telephone interviews were handwritten. FGDs and IDIs were audio-recorded, transcribed and translated into English. All data were thematically coded.\ud \ud RESULTS\ud \ud Study findings suggested that EIMC decision-making involved a discussion between the infant's parents. Male and female participants of all age groups acknowledged that the father had the final say. However, discussions around EIMC uptake suggested that the infant's mother could sometimes covertly influence the father's decision in the direction she favoured. Discussions also suggested that fathers who had undergone voluntary medical male circumcision were more likely to adopt EIMC for their sons, compared to their uncircumcised counterparts. Mothers-in-law/grandparents were reported to have considerable influence. Based on study findings, we describe key EIMC decision makers and attempt to illustrate alternative outcomes of their key actions and decisions around EIMC within the Zimbabwean context.\ud \ud CONCLUSIONS\ud \ud These complementary studies identified critical players, decisions and actions involved in the EIMC decision-making process. Findings on who influences decisions regarding EIMC in the Zimbabwean context highlighted the need for EIMC demand generation interventions to target fathers, mothers, grandmothers, other family members and the wider community.