Whilst the availability of HIVST increased HIV testing among both truckers and FSWs, the cost of providing HIVST is higher than that of a routine health facility-based test, driven primarily by the price of the HIV self-test kit. Future research needs to identify strategies which increase demand for HIVST, and determine whether these strategies and the subsequent increased demand for HIVST are cost-effective in relation to the conventional facility based testing currently available.

The cost of offering HIVST was calculated to be double that of routine facility-based testing (USD 10.13 versus USD 5.01 per client tested), primarily due to the high price of the self-test kit. In the two study arms that only offered provider-administered HIV testing in the clinic, only 1% of truckers and 6% of FSWs tested during the study period, while in the intervention arm, which also offered HST, approximately 4% of truckers and 11% of FSWs tested. These lower than expected outcomes resulted in relatively high cost per client estimates for all three study arms. Within the intervention arm, 65% of truckers and 72% of FSWs who tested chose the HIVST option. However, within the intervention arm, the cost per additional client tested was lower for FSWs than for truckers, at USD 0.15 per additional client tested versus USD 0.58 per additional client tested, driven primarily by the higher response rates.

A costing analysis was conducted for a randomized controlled trial (RCT) with male truckers and female sex workers (FSWs) registered in the electronic health record system (EHRS) of the North Star Alliance, which offers healthcare services at major transit hubs in Southern and East Africa. The RCT selected a sample of truckers and FSWs who were irregular HIV testers, according to the EHRS, and evaluated the effect of SMSs promoting the availability of HIV self-testing (HIVST) kits in Kenyan clinics (intervention program) versus a general SMS reminding clients to test for HIV (enhanced and standard program) on HIV testing rates. In this paper, we calculated costs from a provider perspective using a mixed-methods approach to identify, measure, and value the resources utilized within the intervention and standard programs. The results of the analysis reflect the cost per client tested.

HIV testing rates in many sub-Saharan African countries have remained suboptimal, and there is an urgent need to explore strategic yet cost-effective approaches to increase the uptake of HIV testing, especially among high-risk populations.

Funding: This study was supported by a grant from the International Initiative for Impact Evaluation (3IE # TW2.2.06 supplement, Kelvin Principal Investigator) (EK). Elizabeth Kelvin was also supported by the Einstein-Rockefeller-CUNY Center for AIDS Research [P30-AI124414] which is supported by the following National Institutes of Health (NIH) Co-Funding and Participating Institutes and Centers: NIAID, NCI, NICHD, NHBL, NIDA, NIMH, NIA, FIC and OAR. Support for Joanne Mantell also came from a center grant from the National Institute of Mental Health (NIMH) to the HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University [P30-MH43520; Principal Investigator: Robert H. Remien, Ph.D.].

Copyright: © 2018 George et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

In this paper we present a costing analysis conducted on a randomized controlled trial (RCT) evaluating the impact of SMSs announcing the availability of HIVST versus a general SMS reminder to test for HIV on HIV testing rates in the eight North Star Alliance clinics in Kenya. The study population comprised male truckers and FSWs registered as clients in the North Star Alliance electronic health record system (EHRS), and who were listed as irregular HIV testers according to the EHRS.

HIVST is considered a safe and effective strategy for increasing the uptake of HIV testing among high-risk and hard-to-reach populations [ 12 , 16 , 17 ]. HIVST was found to be a highly acceptable testing option among FSWs and truckers [ 15 , 18 ], including in Kenya [ 19 ]. In 2009, Kenya became the first African country to develop guidelines on HIVST, and promote the use of oral self-test kits [ 20 ]. However, interventions are required to promote HIVST with the aim of maximising uptake, especially among high risk populations not testing regularly with the current standard testing options, and ensuring the cost-effectiveness and efficiency of this strategy [ 21 ]. Furthermore, mHealth interventions utilising mobile technology for health promotion have been recommended as a low-cost strategy to increase the uptake of HIV testing, with the potential for broad coverage [ 22 – 24 ].

HIV counselling and testing (HCT) is a key component of the HIV response to achieve the UNAIDS Fast Track goals [ 1 ]. Increasing the availability of HIV self-testing (HIVST) is recommended as a way of increasing coverage, especially among hard-to-reach and high-risk populations [ 1 ], such as long distance truckers and female sex workers (FSWs) in Africa [ 2 – 8 ]. A number of risk factors drive the high prevalence rates amongst truckers, including engagement with FSWs [ 9 ], while both truckers and FSWs have been shown to engage in multiple concurrent sexual partnerships [ 10 – 12 ] and use condoms inconsistently [ 4 ]. Additionally, studies have revealed that truck drivers and FSWs have inadequate access to health services [ 5 , 9 , 13 , 14 ]. Although health clinics are positioned along many major trucking routes in Africa, studies indicate that the uptake of HIV testing amongst these populations remains low [ 5 , 15 ].

Methods

Study setting The North Star Alliance provides health services to hard-to-reach populations across Africa, including truckers and FSWs. In 2017, the North Star Alliance operated 53 clinics located at major transit hubs in 13 countries in Southern and East Africa, including eight in Kenya where we offered HIVST as an HIV testing option to selected clients. The clinics are open at hours suitable to the target populations and offer a range of prevention and treatment services, including infectious disease (STI, HIV, TB, malaria) screening and treatment, diagnosis and treatment of mobility-related and other non-communicable diseases, health education and, in some clinics, laboratory services.

Sample, eligibility and consent For this study we capitalized on the EHRS used by the North Star clinics and selected all truckers and FSWs registered in the system who met the following eligibility criteria: (a) no indication that they were HIV+; (b) reside in Kenya; (c) had a valid mobile phone number listed; (d) tested for HIV fewer than four times in the past 12 months (indicating that they were not following the recommendation to test every 3 months per year); (e) had not tested for HIV in the past three months; (f) had not participated in our previous study on self-administered HIVST; (g) had an indication of male sex in the system, and were listed as working as truck drivers or trucking assistants (turn boys) or of female sex and were listed as working as a sex worker. For this study, we used a passive consent process due to the large number of participants, making obtaining consent from each individual unfeasible, and the low risk associated with the intervention. The North Star Alliance sent the following consent text message to all eligible clients twice, once in Kiswahili and once in English, a week apart. “North Star Alliance is evaluating our programs for their improvement using client information from our system. The information we use for this evaluation will not be linked to your name and you will not be contacted or have any expenses related to your inclusion. If you have questions about the use of your data, call [phone number of clinic where they had last been seen]. To have your data excluded, reply “NO” to this text”. After each consent message, any clients who contacted us indicating they wanted to opt out of having their data included were removed from the sample prior to randomization. A total of 27 truckers and 138 FSWs contacted us to have their data excluded prior to randomization and 2 truckers contacted us after randomization and were considered study drop-outs and their data were removed before analyses. This left a total of 2262 truckers and 2196 FSWs who tacitly agreed to participate in the study and who were subsequently randomized to one of three study arms.

Description of study arms The study was conducted between December 2016 and April 2017. Truckers were sampled initially, in December 2016, followed by FSWs in February 2017, and sent the consent SMS messages. After the passive consenting process, study SMSs were sent over a three-week period starting in December 2016 for truckers and March 2017 for FSWs. The follow-up period ensued for the two months following the first study SMSs message sent to the standard of care (SOC), Enhanced SOC and Intervention participants, at which point the data was downloaded from the EHRS for analysis. The three study arms of the RCT are described in Table 1. PPT PowerPoint slide

PowerPoint slide PNG larger image

larger image TIFF original image Download: Table 1. Description of study arms. https://doi.org/10.1371/journal.pone.0197305.t001 A clinic receptionist determined which study arm presenting clients belonged to by looking-up the client’s mobile phone number on a spreadsheet listing the numbers of study participants in the intervention arm. The counsellor was then informed when an Intervention client presented so s/he would be given a demonstration of the HIVST kit and then offered the testing choices. Those in the study who visited a North Star Alliance clinic outside of Kenya would be offered the SOC test only as those clinics did not have HIVST kits. In addition, if someone not in the intervention arm came to a Kenyan clinic and specifically requested a HIVST kit, presumably having heard about them from someone in the Intervention arm, they were given a HIVST kit so as not to lose an HIV testing opportunity.

HIV testing procedures Those who tested in the clinic (the SOC test or HIVST with supervision) underwent the standard pre- and post-testing counselling process. Additionally, those who chose HIVST for supervised use in the clinic were given the OraQuick HIVST kit (OraSure Technologies, 2017) with written (English and Kiswahili) and pictorial instructions in a private room. An HCT counsellor sat in the room with the study participant while s/he used the HIV test kit (supervised self-administration) in order to answer any questions that arose during the test administration and to provide guidance if required. Upon the availability of the HIV test result 20 minutes later, the client was given the option to view the results in private or with the counsellor. After viewing the HIV test results, the client received the standard post-test counselling and any referrals if appropriate. If the client chose to view the test results in private, s/he was encouraged to disclose the test results during post-test counselling, but the final decision whether or not to disclose was the clients’. If s/he did not disclose the results, the counsellor proceeded with post-test counselling regardless of whether the HIV test result was positive or negative, including information about accessing HIV care, in the event the test result was positive. Those who chose to take a HIVST kit for use outside of the clinic were pre-test counselled in the clinic, instructed to use their test within three days, and call or send a SMS after using the test to receive a call-back for post-test counselling and any referrals if appropriate. Participants who failed to contact the clinic staff within the three days after taking a test kit were called to inquire about the use of the test and provide counselling and referrals if appropriate. Clients were informed that they could call or send a SMS at any time while self-testing if they had any questions or concerns. As with in-clinic self-testing, clients were encouraged to disclose their test result during post-test counselling, but this remained the client’s choice, and if s/he did not disclose, the counsellor provided the information for both HIV test outcome scenarios.

Costing perspective and approach Costs were estimated from the provider perspective using 2016 prices. Costs incurred prior to this period were adjusted for price year differences using the Campbell and Cochrane Economics Methods Group (CCEMG) and the Evidence for Policy and Practice Information and Coordinating Centre (EPPI-Centre) Cost Converter [25]. Costs were estimated in Kenyan Shillings (KES), and in cases where costs were obtained in other international currencies, they were converted into the local currency [26]. Once the analysis was complete, the results were converted to US dollars (USD) for international comparative purposes. The study used an average annual exchange rate for the base year (2016) of 101.51 KES/ 1 USD [27]. The unit of analysis identified by this study is the HCT client; hence, this costing analysis quantified the cost per client tested. A mixed-methods approach was used to identify, measure and value costs [28]. Costs were identified and valued using a bottom-up micro-costing approach where data were available, with the remainder estimated using a top-down gross-costing approach [28]. Resources were allocated in line with an activity-based approach [26, 29] according to their economic classification, as per the activities identified: Sending SMSs Pre-counselling HIV Testing Post-test counselling Call-back counselling A secondary classification between direct and indirect costs was then established [28]. In the context of this study, direct costs arose solely from the provision of the HCT service and were allocated as such. Direct costs emanating from this study included staff directly involved in HCT, as well as consumables used during the HCT process. All costs related to the provision of the SMS service were assigned to that particular activity. All indirect costs identified (those not specifically borne by the HCT service) were allocated proportionally. All resources with a lifespan greater than a year were treated as capital items and costed as such [26]. In addition to infrastructure and equipment, this included non-recurrent training and recruitment costs.

Data collection and analysis The cost of providing HIV testing to clients in the different study arms depended on a number of key economic inputs, including staff, consumables and medical supplies, equipment and infrastructure, training, and facility management and supervision. The approach to the collection and analysis of the data is described in the following sections: Measurement and valuation of cost items Cost allocation Cost and outcomes comparison Sensitivity analysis 1. Measurement and valuation of cost items Per client costs were estimated by activity for each resource identified. For certain resources, unit costs were available at the client level, which were multiplied by the patient utilization of that resource to obtain a cost per client estimate [28]. In the absence of client-level data, average monthly costs per clinic were divided by the average number of HCT clients per month utilizing the clinic, in order to arrive at a cost per client estimate [28]. Patient utilization data were collected using questionnaires designed to first identify the exhaustive list of resources used within each of the activities, and second, to estimate the patient utilization of each resource–the cost-identification process for each activity [26, 28]. Patient utilization questionnaires were distributed to clinic staff involved in HCT-related functions, as well as relevant head office staff directly involved with the management of the facilities. All data were verified in interviews held with relevant head office staff or facility managers. The questionnaires became more specific and detailed with each round of data collection until the integrity and level of detail of the patient utilization data was satisfactory [26]. To value each resource used, interviews were held with relevant head office staff as well as facility managers to obtain cost information [26, 28]. As with the patient utilization data collection process, questionnaires became more specific and detailed with each round of data collection until the integrity and detail of unit cost data was satisfactory. Where costs and costing information could not be ascertained, assumptions were made and rationalized. Capital costs, such as infrastructure, furniture and equipment, incurred in all three study arms were annuitized and apportioned according to testing uptake [26, 28]. The annuity calculation was performed in Microsoft Excel 2016 using the PMT function and required inputs such as discount rate, lifespan of the item, and purchase price. These inputs were converted to monthly values in order to estimate the replacement value for each of the capital items. This study used a discount rate of 3%, as employed in other costing studies reviewed [17, 30, 31]. Where possible, estimates of useful life were used that were specific to the resource [26, 28], instead of annuitizing all capital inputs over a three- to five-year period like other costing studies [17, 30, 31]. This was considered to be a more contextually-relevant approach [28]. 2. Cost allocation Indirect costs and those shared across all North Star Alliance facilities were allocated to the HCT function according to the proportion of clients utilizing HCT services at the facilities, estimated to be 44.41% [17, 28, 30]. This was verified by the facility managers who estimated that the HCT function accounts for almost half of the clinic’s resources and staff time. The counsellors reported spending 30 minutes per client on average, for HCT. More specifically, for the average HCT client (in the SOC or Enhanced SOC arms), the 30-minute period was utilized as follows: 5 minutes was spent on pre-counselling (Activity B), 20 minutes conducting the HIV test (Activity C), and 5 minutes on post-test counselling (Activity D). Thus, the HCT share of indirect or shared costs was apportioned to each activity within the HCT function [29] accordingly: Activities B (5/30), C (20/30) and D (5/30), based on the fraction of time spent by the counsellors on each activity [28]. For the HIVST function (offered to participants in the Intervention arm), the cost allocation followed the same rationale used for HCT, but with different proportions. The HCT counsellors were trained to provide a five-minute demonstration on how to use the self-testing kit. Thus, for those who self-tested in the clinic with provider supervision, the total time spent by the counsellor was 35 minutes: (Activities B (5/35), C (25/35) which included the self-test demonstration, and D (5/35). For those who self-tested at home, the total time was 15 minutes, but the activities comprising the self-test at home were still costed out at 35 minutes for methodological consistency: (Activities B (5/35) for the pre-test counselling, C (5/35) for the self-test demonstration, and E (5/35) for the call-back counselling [28]. 3. Cost-and outcomes comparison The costs per client tested were compared across the three RCT arms. In order to calculate the cost per additional client tested in each arm, we divided the number of additional clients tested by the additional cost. This gives an indication of the value for money of offering HIVST to both FSWs and truckers. The lower the additional cost per client, the greater the value for money, with negative values indicating a cost saving. 4. Sensitivity Analysis The study performed a series of univariate sensitivity analyses on the major cost drivers and key parameters identified. This determined the robustness of the cost analysis and the impact on the resulting average cost per client and cost per additional client tested. These parameters are discussed below: Counsellor salaries: The study used an average of KES 39 322.50 within the cost analysis. The questionnaire indicated that Counsellors’ salaries varied from KES 22 030 to KES 55 080 so the sensitivity analysis varied the parameter accordingly.

HCT Timeframe: This study used the average of 30 minutes per client in the cost analysis, which, according to the questionnaire could take up to 75 minutes per client (although very rarely and highly unlikely). The range of possible values accounted for within the sensitivity analysis allowed for an HCT timeframe of 45 and 60 minutes. The extreme value of 75 minutes was excluded from the sensitivity analysis as this would not have provided an accurate reflection of costs.

HIVST cost drivers: The cost of the HIVST kit and the supporting costs were subjected to a sensitivity analysis to explore assumptions made by other costing studies as listed below. ○. HIVST test kit: The price of the HIVST kit was USD 9.22, however, the price dropped to USD 2.00 as per the Gates foundation agreement which took place post the RCT [32]. ○. HIVST support component: The staff and all other resource-related costs were eliminated as part of a sensitivity analysis to determine the cost of HIVST based solely on the provision of the kit, without the five-minute demonstration (unsupervised HIVST), as explored by other HIVST costing studies reviewed. This illustrated the difference in cost between a supervised (as costed by this study) and unsupervised HIVST strategy.

Activity A cost: The supporting costs of Activity A are eliminated in the sensitivity analysis and only the direct costs (service provider and data charges) are included to evaluate the effect on the cost per additional person tested. This assumption is made on two costing studies which used an automated system and software to send text message reminders to clients [23, 33]. Finally, a scenario analysis was conducted that estimated optimal response rates for the SMS and HIVST interventions, and a reduced cost for HIVST kits of USD 5.00 and USD 2.00 (the latter a 2017 negotiated price agreement) [34]. The number of participants who returned for testing was increased according to the literature which suggested a 55% response to the receipt of three informational text messages [23]. The proportion of self-testers was increased to 80% of the participants who returned for testing within the Intervention arm. This assumption was based on average results of two studies that showed 72.97%, 82.7% and 84.2% of study participants preferred HIVST over facility-based testing [16, 35].