Community-based HIV self-testing: a cluster-randomised trial of supply-side financial incentives and time-trend analysis of linkage to antiretroviral therapy in Zimbabwe.

BACKGROUND: HIV self-testing (HIVST) requires linkage to post-test services to maximise its benefits. We evaluated effect of supply-side incentivisation on linkage following community-based HIVST and evaluated time-trends in facility-based antiretroviral therapy (ART) initiations. METHODS: From August 2016 to August 2017 community-based distributors (CBDs) in 38 rural Zimbabwean communities distributed HIVST door-to-door in 19-25 day campaigns. Communities were allocated (1:1) using constrained randomisation to either one-off US$50 remuneration per CBD (non-incentive arm), or US$50 plus US$0.20 incentive per client visiting mobile-outreach services (conditional-incentive arm). The primary outcome, assessed by population survey 6 weeks later, was self-reported uptake of any clinic service, analysed with random-effects logistic regression. Separately, non-randomised difference-in-differences in monthly ART initiations were analysed for three time periods (6 months baseline; HIVST campaign; 3 months after) at public clinics with (40 clinics) and without (124 clinics) HIVST distribution in catchment area. FINDINGS: A total of 445 conditional-incentive CBDs distributed 39 205 HIVST kits (mean/CBD: 88; 95% CI: 85 to 92) and 447 non-incentive CBDs distributed 41 173 kits (mean/CBD: 93; 95% CI: 89 to 96). Survey participation was 7146/8566 (83.4%), with 3593 (50.3%) reporting self-testing including 1305 (18.3%) previously untested individuals. Use of clinic services post-HIVST was similar in conditional-incentive (1062/3698, 28.7%) and non-incentive (1075/3448, 31.2%) arms (adjusted risk ratio (aRR) 0.94, 95% CI: 0.86 to 1.03). Confirmatory testing by newly diagnosed/untreated HIVST+clients was, however, higher (conditional-incentive: 25/33, 75.8% vs non-incentive: 20/40, 50.0%: aRR: 1.59, 95% CI: 1.05 to 2.39). In total, 12 808 ART initiations occurred, with no baseline or postcampaign differences between initiation rates in HIVST versus non-HIVST clinics, but initiation rates increased from 7.31 to 9.59 initiations per month in HIVST clinics during distribution, aRR: 1.27, 95% CI 1.17 to 1.39. CONCLUSIONS: Community-based HIVST campaigns achieved high testing uptake, temporally associated with increased demand for ART. Small supply-side incentives did not affect general clinic usage but may have increased confirmatory testing for newly diagnosed HIVST positive participants. TRIAL REGISTRATION NUMBER: PACTR201607001701788.

Urban-rural disparity in sociodemographic characteristics and sexual behaviors of HIV-positive adolescent girls and young women and their perspectives on their male sexual partners: A cross-sectional study in Zimbabwe.

We conducted a cross sectional survey in Zimbabwe to describe urban-rural disparity in socio-demographic characteristics and sexual behaviors of HIV-positive adolescent girls and young women (AGYW) and their male sexual partners. Between September and November 2016, we interviewed 360 sexually active HIV positive AGYW, aged 15--24 years attending ART and PMTCT clinics in urban and rural health facilities in Harare and Mazowe district respectively. HIV positive AGYW in rural areas as compared to those in urban areas were older, less educated, more frequently married or cohabiting, had lower number of male sexual partners in their lifetime and in the last 12 months preceding the survey. They were mostly heterosexually infected, more likely to disclose their status to a family member and to be more adherent to ART (OR = 2.5-95% CI = 1.1-5.5). Most recent male sexual partners of HIV positive AGYW in urban areas as compared to those from rural areas were mainly current or former boyfriends, single, more educated, less likely to have a child with them and to engage in couple voluntary counseling and testing (CVCT). They were more likely to patronize dancing and drinking venues and involved in transactional sex (OR = 2.2-95% CI: 1.2-4). They were also more likely to be circumcised (OR = 2.3-95% CI: 1.3-4.1) and to use condom more consistently in the last 12 months preceding the survey. Our study findings called for the strengthening of HIV prevention interventions in urban areas among HIV positive AGYW who had more than one partner in their lifetime or are patronizing dancing and drinking venues. In Zimbabwe, promotion of CVCT, index testing, male circumcision and condom use should be sustained to engage male sexual partners of both urban and rural HIV positive AGYW in HIV prevention.

The impact and cost-effectiveness of community-based HIV self-testing in sub-Saharan Africa: a health economic and modelling analysis.

INTRODUCTION: The prevalence of undiagnosed HIV is declining in Africa, and various HIV testing approaches are finding lower positivity rates. In this context, the epidemiological impact and cost-effectiveness of community-based HIV self-testing (CB-HIVST) is unclear. We aimed to assess this in different sub-populations and across scenarios characterized by different adult HIV prevalence and antiretroviral treatment programmes in sub-Saharan Africa. METHODS: The synthesis model was used to address this aim. Three sub-populations were considered for CB-HIVST: (i) women having transactional sex (WTS); (ii) young people (15 to 24 years); and (iii) adult men (25 to 49 years). We assumed uptake of CB-HIVST similar to that reported in epidemiological studies (base case), or assumed people use CB-HIVST only if exposed to risk (condomless sex) since last HIV test. We also considered a five-year time-limited CB-HIVST programme. Cost-effectiveness was defined by an incremental cost-effectiveness ratio (ICER; cost-per-disability-adjusted life-year (DALY) averted) below US$500 over a time horizon of 50 years. The efficiency of targeted CB-HIVST was evaluated using the number of additional tests per infection or death averted. RESULTS: In the base case, targeting adult men with CB-HIVST offered the greatest impact, averting 1500 HIV infections and 520 deaths per year in the context of a simulated country with nine million adults, and impact could be enhanced by linkage to voluntary medical male circumcision (VMMC). However, the approach was only cost-effective if the programme was limited to five years or the undiagnosed prevalence was above 3%. CB-HIVST to WTS was the most cost-effective. The main drivers of cost-effectiveness were the cost of CB-HIVST and the prevalence of undiagnosed HIV. All other CB-HIVST scenarios had an ICER above US$500 per DALY averted. CONCLUSIONS: CB-HIVST showed an important epidemiological impact. To maximize population health within a fixed budget, CB-HIVST needs to be targeted on the basis of the prevalence of undiagnosed HIV, sub-population and the overall costs of delivering this testing modality. Linkage to VMMC enhances its cost-effectiveness.

Economic cost analysis of door-to-door community-based distribution of HIV self-test kits in Malawi, Zambia and Zimbabwe.

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.

The Self-Testing AfRica (STAR) Initiative: accelerating global access and scale-up of HIV self-testing.

INTRODUCTION: HIV self-testing (HIVST) was first proposed as an additional option to standard HIV testing services in the 1980s. By 2015, two years after the first HIVST kit was approved for the American market and the year in which Unitaid invested in the "HIV Self-Testing AfRica (STAR) Initiative," HIVST remained unexplored with negligible access in low- and middle-income countries (LMIC). However, rapid progress had been made. This commentary outlines the interlinked market, regulatory and policy barriers that had inhibited product development and kept HIVST out of LMIC policy. We detail the components of STAR that enabled rapid HIVST scale-up, including critical investments in implementation, research, market forecasting, and engagement with manufacturers and regulators. DISCUSSION: The STAR Initiative has generated crucial information about how to distribute HIVST products effectively, ethically and efficiently. Service delivery models range from clinic-based distribution to workplace and partner-delivered approaches to reach first-time male testers, to community outreach to sex workers and general population "hotspots." These data directly informed supportive policy, notably the 2016 WHO guidelines strongly recommending HIVST as an additional testing approach, and regulatory change through support for WHO prequalification of the first HIVST kit in 2017. In July 2015, only two countries had national HIVST policies and were implementing HIVST. Three years later, 59 countries have policies, actively implemented in 28, with an additional 53 countries reporting policies under development. By end-November 2018 several quality-assured HIVST products had been registered, including two WHO prequalified tests. STAR Initiative countries have drafted regulations governing in vitro diagnostics, including HIVST products. With enabling policies, pre-qualification and regulations in place, donor procurement of kits has increased rapidly, to a forecasted estimate of 16 million HIVST kits procured by 2020. CONCLUSIONS: The STAR Initiative provided a strong foundation to introduce HIVST in LMICs and allow for rapid scale-up based on the wealth of multi-country evidence gathered. Together with sustained coordination and acceleration of market development work, HIVST can help address the testing gap and provide a focused and cost-effective means to expand access to treatment and prevention services.

Barriers to HIV service utilisation by people living with HIV in two provinces of Zimbabwe: Results from 2016 baseline assessment.

BACKGROUND: The emergence of antiretroviral therapy (ART) transformed HIV from a terminal illness to a chronic disease. However, limited access to health services remains one of many barriers to HIV service utilisation by people living with HIV (PLHIV) in low-resource settings. The goal of this study was to describe the barriers to HIV service utilisation in two provinces of Zimbabwe. METHODS: A qualitative descriptive study was conducted with PLHIV and village health workers (VHW) in eight districts within the two provinces. Convenience sampling was used to select the participants. This sampling was limited to communities supported by health facilities with more than 500 PLHIV enrolled into HIV care and treatment. Interviews were audio-recorded and transcripts were subjected to thematic content analysis. RESULTS: A total of 22 community focus group discussions (FGDs) were conducted. Barriers to using HIV services cited in PLHIV and VHW FGDs were similar. These were categorised as health system-related barriers, which include user fees, long waiting times, lack of confidentiality and negative attitudes by healthcare providers, and lack of consistent community-based HIV services. Community-related barriers cited were stigma and discrimination, food insecurity, distance to facilities and counterproductive messaging from religious sectors. Client-related factors reported were inadequate male involvement in HIV-related activities and defaulting after symptoms improved. CONCLUSION: Our assessment has indicated that there are several barriers to the utilisation of HIV services by PLHIV in the two provinces of Zimbabwe. As new strategies and programmes are being introduced in the current resource-constrained era, efforts should be made to understand the needs of the clients. If programmes are designed with an effort to address some of these challenges, there is a possibility that countries will quickly achieve the 90-90-90 targets set by The Joint United Nations Programme on HIV/AIDS.

The emerging health impact of voluntary medical male circumcision in Zimbabwe: An evaluation using three epidemiological models.

BACKGROUND: Zimbabwe adopted voluntary medical male circumcision (VMMC) as a priority HIV prevention strategy in 2007 and began implementation in 2009. We evaluated the costs and impact of this VMMC program to date and in future. METHODS: Three mathematical models describing Zimbabwe's HIV epidemic and program evolution were calibrated to household survey data on prevalence and risk behaviors, with circumcision coverage calibrated to program-reported VMMCs. We compared trends in new infections and costs to a counterfactual without VMMC. Input assumptions were agreed in workshops with national stakeholders in 2015 and 2017. RESULTS: The VMMC program averted 2,600-12,200 infections (among men and women combined) by the end of 2016. This impact will grow as circumcised men are protected lifelong, and onward dynamic transmission effects, which protect women via reduced incidence and prevalence in their male partners, increase over time. If other prevention interventions remain at 2016 coverages, the VMMCs already performed will avert 24,400-69,800 infections (2.3-5% of all new infections) through 2030. If coverage targets are achieved by 2021 and maintained, the program will avert 108,000-171,000 infections (10-13% of all new infections) by 2030, costing $2,100-3,250 per infection averted relative to no VMMC. Annual savings from averted treatment needs will outweigh VMMC maintenance costs once coverage targets are reached. If Zimbabwe also achieves ambitious UNAIDS targets for scaling up treatment and prevention efforts, VMMC will reduce the HIV incidence remaining at 2030 by one-third, critically contributing to the UNAIDS goal of 90% incidence reduction. CONCLUSIONS: VMMC can substantially impact Zimbabwe's HIV epidemic in the coming years; this investment will save costs in the longer term.

Providers' Perceptions and Training Needs for Counseling Adolescents Undergoing Voluntary Medical Male Circumcision.

Background: The majority of individuals who seek voluntary medical male circumcision (VMMC) services in sub-Saharan Africa are adolescents (ages 10-19 years). However, adolescents who obtain VMMC services report receiving little information on human immunodeficiency virus (HIV) prevention and care. In this study, we assessed the perceptions of VMMC facility managers and providers about current training content and their perspectives on age-appropriate adolescent counseling. Methods: Semistructured in-depth interviews were conducted with 33 VMMC providers in Tanzania (n = 12), South Africa (n = 9), and Zimbabwe (n = 12) and with 4 key informant facility managers in each country (total 12). Two coders independently coded the data thematically using a 2-step process and Atlas.ti qualitative coding software. Results: Providers and facility managers discussed limitations with current VMMC training, noting the need for adolescent-specific guidelines and counseling skills. Providers expressed hesitation in communicating complete sexual health information-including HIV testing, HIV prevention, proper condom usage, the importance of knowing a partner's HIV status, and abstinence from sex or masturbation during wound healing-with younger males (aged <15 years) and/or those assumed to be sexually inexperienced. Many providers revealed that they did not assess adolescent clients' sexual experience and deemed sexual topics to be irrelevant or inappropriate. Providers preferred counseling younger adolescents with their parents or guardians present, typically focusing primarily on wound care and procedural information. Conclusions: Lack of training for working with adolescents influences the type of information communicated. Preconceptions hinder counseling that supports comprehensive HIV preventive behaviors and complete wound care information, particularly for younger adolescents.

Adolescent Wound-Care Self-Efficacy and Practices After Voluntary Medical Male Circumcision-A Multicountry Assessment.

Background: Adolescent boys (aged 10-19 years) constitute the majority of voluntary medical male circumcision (VMMC) clients in sub-Saharan Africa. They are at higher risk of postoperative infections compared to adults. We explored adolescents' wound-care knowledge, self-efficacy, and practices after VMMC to inform strategies for reducing the risks of infectious complications postoperatively. Methods: Quantitative and qualitative data were collected in South Africa, Tanzania, and Zimbabwe between June 2015 to September 2016. A postprocedure survey was conducted approximately 7-10 days after VMMC among male adolescents (n = 1293) who had completed a preprocedure survey; the postprocedure survey assessed knowledge of proper wound care and wound-care self-efficacy. We also conducted in-depth interviews (n = 92) with male adolescents 6-10 weeks after the VMMC procedure to further explore comprehension of providers' wound-care instructions as well as wound-care practices, and we held 24 focus group discussions with randomly selected parents/guardians of the adolescents. Results: Adolescent VMMC clients face multiple challenges with postcircumcision wound care owing to factors such as forgetting, misinterpreting, and disregarding provider instructions. Although younger adolescents stated that parental intervention helped them overcome potential hindrances to wound care, parents and guardians lacked crucial information on wound care because most had not attended counseling sessions. Some older adolescents reported ignoring symptoms of infection and not returning to the clinic for review when an adverse event had occurred. Conclusions: Increased involvement of parents/guardians in wound-care counseling for younger adolescents and in wound-care supervision, alongside the development of age-appropriate materials on wound care, are needed to minimize postoperative complications after VMMC.

Comparative Cost of Early Infant Male Circumcision by Nurse-Midwives and Doctors in Zimbabwe.

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.

Employing Demand-Based Volumetric Forecasting to Identify Potential for and Roles of Devices in Scale-Up of Medical Male Circumcision in Zambia and Zimbabwe.

INTRODUCTION: Devices for male circumcision (MC) are becoming available in 14 priority countries where MC is being implemented for HIV prevention. Understanding potential impact on demand for services is one important programmatic consideration because countries determine whether to scale up devices within MC programs. METHODS: A population-based survey measuring willingness to undergo MC, assuming availability of surgical MC and 3 devices, was conducted among 1250 uncircumcised men, ages 10-49 years in Zambia and 1000 uncircumcised men, ages 13-49 years in Zimbabwe. Simulated Test Market methodology was used to estimate incremental MC demand and the extent to which devices might be preferred over surgery, assuming availability of: surgical MC in both countries; the devices PrePex, ShangRing, and Unicirc in Zambia; and PrePex in Zimbabwe. RESULTS: Modeled estimates indicate PrePex has the potential to provide an overall increase in MC demand ranging from an estimated 13%-50%, depending on country and WHO prequalification ages, replacing 11%-41% of surgical procedures. In Zambia, ShangRing could provide 8% overall increase, replacing 45% of surgical procedures, and Unicirc could provide 30% overall increase, replacing 85% of surgical procedures. CONCLUSIONS: In both countries, devices have potential to increase overall demand for MC, assuming wide scale awareness and availability of circumcision by the devices. With consideration for age and country, PrePex may provide the greatest potential increase in demand, followed by Unicirc (measured in Zambia only) and ShangRing (also Zambia only). These results inform one program dimension for decision making on potential device introduction strategies; however, they must be considered within the broader programmatic context.

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.

An assessment of the Zimbabwe ministry of health and child welfare provider initiated HIV testing and counselling programme.

BACKGROUND: Provider-initiated HIV testing and counselling (PITC) is widely recommended to ensure timely treatment of HIV. The Zimbabwe Ministry of Health introduced PITC in 2007. We aimed to evaluate institutional capacity to implement PITC and investigate patient and health care worker (HCW) perceptions of the PITC programme. METHODS: Purposive selection of health care institutions was conducted among those providing PITC. Study procedures included 1) assessment of implementation procedures and institutional capacity using a semi-structured questionnaire; 2) in-depth interviews with patients who had been offered HIV testing to explore perceptions of PITC, 3) Focus group discussions with HCW to explore views on PITC. Qualitative data was analysed according to Framework Analysis. RESULTS: Sixteen health care institutions were selected (two central, two provincial, six district hospitals; and six primary care clinics). All institutions at least offered PITC in part. The main challenges which prevented optimum implementation were shortages of staff trained in PITC, HIV rapid testing and counselling; shortages of appropriate counselling space, and, at the time of assessment, shortages of HIV test kits. Both health care workers and patients embraced PITC because they had noticed that it had saved lives through early detection and treatment of HIV. Although health care workers reported an increase in workload as a result of PITC, they felt this was offset by the reduced number of HIV-related admissions and satisfaction of working with healthier clients. CONCLUSION: PITC has been embraced by patients and health care workers as a life-saving intervention. There is need to address shortages in material, human and structural resources to ensure optimum implementation.