Assessing the impact of the COVID-19 restrictions on HIV testing services in Malawi: an interrupted time series analysis.

Background: Restrictions on public gatherings and movement to mitigate the spread of COVID-19 may have disrupted access and availability of HIV services in Malawi. We quantified the impact of these restrictions on HIV testing services in Malawi.Methods: We conducted an interrupted time series analysis of routine aggregated programme data from 808 public and private, adult and paediatric health facilities across rural and urban communities in Malawi between January 2018 and March 2020 (pre-restrictions) and April to December 2020 (post restrictions), with April 2020 as the month restrictions took effect. Positivity rates were expressed as the proportion of new diagnoses per 100 persons tested. Data were summarised using counts and median monthly tests stratified by sex, age, type of health facility and service delivery points at health facilities. The immediate effect of restriction and post-lockdown outcomes trends were quantified using negative binomial segmented regression models adjusted for seasonality and autocorrelation.Results: The median monthly number of HIV tests and diagnosed people living with HIV (PLHIV) declined from 261 979 (interquartile range [IQR] 235 654-283 293) and 7 929 (IQR 6 590-9 316) before the restrictions, to 167 307 (IQR 161 122-185 094) and 4 658 (IQR 4 535-5 393) respectively, post restriction. Immediately after restriction, HIV tests declined by 31.9% (incidence rate ratio [IRR] 0.681; 95% CI 0.619-0.750), the number of PLHIV diagnosed declined by 22.8% (IRR 0.772; 95% CI 0.695-0.857), while positivity increased by 13.4% (IRR 1.134; 95% CI 1.031-1.247). As restrictions eased, total HIV testing outputs and the number of new diagnoses increased by an average of 2.3% each month (slope change: 1.023; 95% CI 1.010-1.037) and 2.5% (slope change:1.025; 95% CI 1.012-1.038) respectively. Positivity remained similar (slope change: 1.001; 95% CI 0.987-1.015). Unlike general trends noted, while HIV testing services among children aged <12 months declined 38.8% (IRR 0.351; 95% CI 0.351-1.006) with restrictions, recovery has been minimal (slope change: 1.008; 95% CI 0.946-1.073).Conclusion: COVID-19 restrictions were associated with significant but short-term declines in HIV testing services in Malawi, with differential recovery in these services among population subgroups, especially infants. While efforts to restore HIV testing services are commendable, more nuanced strategies that promote equitable recovery of HIV testing services can ensure no subpopulations are left behind.

Efficiency in PrEP Delivery: Estimating the Annual Costs of Oral PrEP in Zimbabwe.

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.

Relative efficiency of demand creation strategies to increase voluntary medical male circumcision uptake: a study conducted as part of a randomised controlled trial in Zimbabwe.

BACKGROUND: Supply 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. METHODS: Interpersonal 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. RESULTS: Total 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. CONCLUSIONS: There 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 NUMBER: PACTR201804003064160.

Innovative demand creation strategies to increase voluntary medical male circumcision uptake: a pragmatic randomised controlled trial in Zimbabwe.

INTRODUCTION: Reaching 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). METHODS: We 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. RESULTS: We 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; <50% of IPC agents converted any men to VMMC, which undermined our ability to show an effect of demand creation and may reflect acceptability and feasibility of the interventions. CONCLUSION: This 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 NUMBER: PACTR201804003064160.

Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13-17 years? Findings from routine service delivery during active surveillance in Zimbabwe.

BACKGROUND: Male circumcision devices have the potential to accelerate adolescent voluntary medical male circumcision roll-out. Here, we present findings on safety, acceptability and satisfaction from active surveillance of PrePex implementation among 618 adolescent males (13-17 years) circumcised in Zimbabwe. METHODS: The first 618 adolescents consecutively circumcised from October 2015 to October 2016 using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for post-circumcision visits and adverse events (AEs). A survey was conducted amongst 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex. RESULTS: A total of 1,811 adolescent males were circumcised across the three PrePex active surveillance sites. Of these, 870 (48%) opted for PrePex but only 618/870 (71%) were eligible. Among the 618, two (0.3%) self-removals requiring surgery (severe AEs), were observed. Four (0.6%) removals by providers (moderate AEs) did not require surgery. Another 6 (1%) mild AEs were due to: bleeding (n = 2), swelling (n = 2), and infection (n = 2). All AEs resolved without sequelae. Adherence to follow-up appointments was high (97.7% attended 7 day visit). A high proportion (71.6%) of survey respondents said they heard about PrePex from a mobilizer; 49.8% said they chose PrePex because they wanted to avoid the pain associated with the surgical procedure/surgery on their penis. Acceptability and satisfaction with PrePex was high; 95.4% indicated willingness to recommend PrePex to peers. A majority (92%) reported experiencing pain when PrePex was being removed. CONCLUSIONS: Active surveillance of the first 618 adolescent males circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery among 13-17 year-olds. There is need to intensify specific demand generation activities for PrePex male circumcision among this group of males.

HIV self-testing: breaking the barriers to uptake of testing among men and adolescents in sub-Saharan Africa, experiences from STAR demonstration projects in Malawi, Zambia and Zimbabwe.

INTRODUCTION: Social, structural and systems barriers inhibit uptake of HIV testing. HIV self-testing (HIVST) has shown promising uptake by otherwise underserved priority groups including men, young people and first-time testers. Here, we use characteristics of HIVST kit recipients to investigate delivery to these priority groups during HIVST scale-up in three African countries. METHODS: Kit distributors collected individual-level age, sex and testing history from all clients. These data were aggregated and analysed by country (Malawi, Zambia and Zimbabwe) for five distribution models: local community-based distributor (CBD: door-to-door, street and local venues), workplace distribution (WD), integration into HIV testing services (IHTS), or public health facilities (IPHF) and during demand creation for voluntary male medical circumcision (VMMC). Used kits were collected and re-read from CBD and IHTS recipients. RESULTS: Between May 2015 and July 2017, 628,705 HIVST kits were distributed in Malawi (172,830), Zambia (190,787) and Zimbabwe (265,091). Community-based models, the first to be established, accounted for 519,658 (82.7%) of kits distributed, with 275,419 (53.0%) used kits returned. Subsequent model diversification delivered 54,453 (8.7%) test-kits through IHTS, 23,561 (3.7%) through VMMC, 21,183 (3.4%) through IPHF and 9850 (1.7%) through WD. Men took 294,508 (48.2%) kits, and 263,073 (43.1%) went to young people (16 to 24 years). A higher proportion of male self-testers (65,577; 22.3%) were first-time testers than women (54,096; 17.1%) with this apparent in Zimbabwe (16.2% vs. 11.4%), Zambia (25.4% vs. 17.7%) and Malawi (27.9% vs. 25.9%). The highest proportions of first-time testers were in young (16 to 24 years) and older (>50 years) men (country-ranges: 18.7% to 35.9% and 13.8% to 26.8% respectively). Most IHTS clients opted for HIVST in preference to standard HTS in each of 12 delivery sites, with those selecting HIVST having lower HIV prevalence, potentially due to self-selection. CONCLUSIONS: HIVST delivered at scale using several different models reached a high proportion of men, young people and first-time testers in Malawi, Zambia and Zimbabwe, some of whom may not have tested otherwise. As men and young people have limited uptake under standard facility-and community-based HIV testing, innovative male- and youth-sensitive approaches like HIVST may be essential to reaching UNAIDS fast-track targets for 2020.

Safety and Acceptability of the PrePex Device When Used in Routine Male Circumcision Service Delivery During Active Surveillance in Zimbabwe.

BACKGROUND: Male circumcision devices have the potential to accelerate voluntary medical male circumcision roll-out, with PrePex being one promising device. Here, we present findings on safety and acceptability from active surveillance of the implementation of PrePex among 1000 males circumcised in Zimbabwe. METHODS: The first 1000 men consecutively circumcised using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for postcircumcision visits, and adverse events (AEs). A survey was conducted among 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex. RESULTS: A total of 2156 men aged 18 years or older were circumcised across the 6 PrePex active surveillance sites. Of these, 1000 (46.4%) were circumcised using PrePex. Among them, 4 (0.4%) self-removals that required surgery (severe AEs) were observed. Six (0.6%) removals by providers (moderate AEs) did not require surgery. A further 280 (28%) AEs were mild or moderate pain during device removal. There were also 12 (1.2%) moderate AEs unrelated to pain. All AEs resolved without sequelae. There was high adherence to follow-up appointments, with 97.7% of clients attending the scheduled day 7 visit. Acceptability of PrePex was high among survey participants, 93% indicated willingness to recommend the device to peers. Of note, 95.8% of respondents reported experiencing pain when the device was being removed. Additionally, 85.2% reported experiencing odor while wearing the device or during removal. CONCLUSIONS: Active surveillance of the first 1000 men circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery.

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.

Estimating the Cost of Early Infant Male Circumcision in Zimbabwe: Results From a Randomized Noninferiority Trial of AccuCirc Device Versus Mogen Clamp.

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.