Results of the Sukuma Ndoda ("Stand up, Man") HIV Self-Screening and Assisted Linkage to Care Project in Johannesburg: A Quasi-Experimental Pre-Post Evaluation.

BACKGROUND: HIV testing rates among South African men lag behind rates for women and national targets. Community-based HIV self-screening (HIVSS) distribution and follow-up by community health workers (CHWs) is a scalable option to increase testing coverage, diagnosis, and treatment initiation. We provided HIVSS and assisted linkage to care to men not recently tested (within the past 12 months) residing in high-HIV-burden areas of Johannesburg. METHODS: CHWs distributed HIVSS in 6 clinic catchment areas. Follow-up to encourage confirmatory testing and antiretroviral therapy initiation was conducted through personal support (PS) or an automated short message service (SMS) follow-up and linkage system in 3 clinic areas each. Using a quasi-experimental pre-post design, we compared differences in the proportion of men testing in the clinic catchment areas during the HIVSS campaign (June-August 2019) to the 3 months prior (March-May 2019) and compared treatment initiations by assisted linkage strategy. RESULTS: Among 4793 participants accepting HIVSS, 62% had never tested. Among 3993 participants with follow-up data, 90.6% reported using their HIVSS kit. Testing coverage among men increased by 156%, from under 4% when only clinic-based HIV testing services were available to 9.5% when HIVSS and HIV testing services were available (z = -11.6; P < 0.01). Reported test use was higher for men followed through PS (99% vs. 68% in SMS); however, significantly more men reported reactive self-test results in the SMS group compared with PS (6.4% vs. 2.0%), resulting in more antiretroviral therapy initiations in the SMS group compared with PS (23 vs. 9; P < 0.01). CONCLUSIONS: CHW HIVSS distribution significantly increases testing among men. While PS enabled personalized follow-up, reporting differences indicate SMS is more acceptable and better aligned with expectations of privacy associated with HIVSS.

"We usually see a lot of delay in terms of coming for or seeking care": an expert consultation on COVID testing and care pathways in seven low- and middle-income countries.

BACKGROUND: Rapid diagnostic testing may support improved treatment of COVID patients. Understanding COVID testing and care pathways is important for assessing the impact and cost-effectiveness of testing in the real world, yet there is limited information on these pathways in low-and-middle income countries (LMICs). We therefore undertook an expert consultation to better understand testing policies and practices, clinical screening, the profile of patients seeking testing or care, linkage to care after testing, treatment, lessons learnt and expected changes in 2023. METHODS: We organized a qualitative consultation with ten experts from seven LMICs (India, Indonesia, Malawi, Nigeria, Peru, South Africa, and Zimbabwe) identified through purposive sampling. We conducted structured interviews during six regional consultations, and undertook a thematic analysis of responses. RESULTS: Participants reported that, after initial efforts to scale-up testing, the policy priority given to COVID testing has declined. Comorbidities putting patients at heightened risk (e.g., diabetes) mainly relied on self-identification. The decision to test following clinical screening was highly context-/location-specific, often dictated by local epidemiology and test availability. When rapid diagnostic tests were available, public sector healthcare providers tended to rely on them for diagnosis (alongside PCR for Asian/Latin American participants), while private sector providers predominantly used polymerase chain reaction (PCR) tests. Positive test results were generally taken at 'face value' by clinicians, although negative tests with a high index of suspicion may be confirmed with PCR. However, even with a positive result, patients were not always linked to care in a timely manner because of reluctance to receiving care or delays in returning to care centres upon clinical deterioration. Countries often lacked multiple components of the range of therapeutics advised in WHO guidelines: notably so for oral antivirals designed for high-risk mild patients. Severely ill patients mostly received corticosteroids and, in higher-resourced settings, tocilizumab. CONCLUSIONS: Testing does not always prompt enhanced care, due to reluctance on the part of patients and limited therapeutic availability within clinical settings. Any analysis of the impact or cost-effectiveness of testing policies post pandemic needs to either consider investment in optimal treatment pathways or constrain estimates of benefits based on actual practice.

"We usually see a lot of delay in terms of coming for or seeking care": an expert consultation on COVID testing and care pathways in low- and middle-income countries.

Background: Rapid diagnostic testing may support improved treatment of COVID patients. Understanding COVID testing and care pathways is important for assessing the impact and cost-effectiveness of testing in the real world, yet there is limited information on these pathways in low-and-middle income countries (LMICs). We therefore undertook an expert consultation to better understand testing policies and practices, clinical screening, the profile of patients seeking testing or care, linkage to care after testing, treatment, lessons learnt and expected changes in 2023 in LMICs. Methods: We organized a qualitative consultation with ten experts from seven LMICs identified through purposive sampling. We conducted structured interviews during six regional consultations, and undertook a thematic analysis of the responses to our questions. Results: Participants reported that, after initial efforts to scale-up testing (which often encountered delays), the policy priority given to COVID testing has declined. Comorbidities putting patients at heightened risk (e.g., diabetes) mainly relied on self-identification. The decision to test following clinical screening was highly context- and location-specific, often dictated by local epidemiology and test availability. When rapid diagnostic tests were available, public sector healthcare providers tended to rely on them for diagnosis, while private sector providers predominantly used polymerase chain reaction (PCR) tests. Positive test results were generally taken at 'face value' by clinicians, although negative tests with a high index of suspicion may be confirmed with PCR. However, even with a positive result, patients were not always linked to care in a timely manner because of reluctance to receiving care or delays in returning to care centres upon clinical deterioration. Countries often lacked multiple components of the range of therapeutics advised in WHO guidelines: notably so for oral antivirals designed for high-risk mild patients. Severely ill patients mostly received corticosteroids and, in higher-resourced settings, tocilizumab. Conclusions: Testing does not always prompt enhanced care, due to reluctance on the part of patients and limited therapeutic availability within clinical settings. Any analysis of the impact or cost-effectiveness of testing policies post pandemic needs to either consider investment in optimal treatment pathways or constrain estimates of benefits based on actual practice.

Integration of point-of-care screening for type 2 diabetes mellitus and hypertension with COVID-19 rapid antigen screening in Johannesburg, South Africa.

AIMS: We sought to evaluate the yield and linkage-to-care for diabetes and hypertension screening alongside a study assessing the use of rapid antigen tests for COVID-19 in taxi ranks in Johannesburg, South Africa. METHODS: Participants were recruited from Germiston taxi rank. We recorded results of blood glucose (BG), blood pressure (BP), waist circumference, smoking status, height, and weight. Participants who had elevated BG (fasting ≥7.0; random ≥11.1mmol/L) and/or BP (diastolic ≥90 and systolic ≥140mmHg) were referred to their clinic and phoned to confirm linkage. RESULTS: 1169 participants were enrolled and screened for elevated BG and elevated BP. Combining participants with a previous diagnosis of diabetes (n = 23, 2.0%; 95% CI:1.3-2.9%) and those that had an elevated BG measurement (n = 60, 5.2%; 95% CI:4.1-6.6%) at study enrollment, we estimated an overall indicative prevalence of diabetes of 7.1% (95% CI:5.7-8.7%). When combining those with known hypertension at study enrollment (n = 124, 10.6%; 95% CI:8.9-12.5%) and those with elevated BP (n = 202; 17.3%; 95% CI:15.2-19.5%), we get an overall prevalence of hypertension of 27.9% (95% CI:25.4-30.1%). Only 30.0% of those with elevated BG and 16.3% of those with elevated BP linked-to-care. CONCLUSION: By opportunistically leveraging existing COVID-19 screening in South Africa to screen for diabetes and hypertension, 22% of participants received a potential new diagnosis. We had poor linkage-to-care following screening. Future research should evaluate options for improving linkage-to-care, and evaluate the large-scale feasibility of this simple screening tool.

Secondary distribution of HIV self-test kits by HIV index and antenatal care clients: implementation and costing results from the STAR Initiative in South Africa.

BACKGROUND: Partner-delivered HIV self-testing kits has previously been highlighted as a safe, acceptable and effective approach to reach men. However, less is known about its real-world implementation in reaching partners of people living with HIV. We evaluated programmatic implementation of partner-delivered self-testing through antenatal care (ANC) attendees and people newly diagnosed with HIV by assessing use, positivity, linkage and cost per kit distributed. METHODS: Between April 2018 and December 2019, antenatal care (ANC) clinic attendees and people or those newly diagnosed with HIV clients across twelve clinics in three cities in South Africa were given HIVST kits (OraQuick Rapid HIV-1/2 Antibody Test, OraSure Technologies) to distribute to their sexual partners. A follow-up telephonic survey was administered to all prior consenting clients who were successfully reached by telephone to assess primary outcomes. Incremental economic costs of the implementation were estimated from the provider's perspective. RESULTS: Fourteen thousand four hundred seventy-three HIVST kits were distributed - 10,319 (71%) to ANC clients for their male partner and 29% to people newly diagnosed with HIV for their partners. Of the 4,235 ANC clients successfully followed-up, 82.1% (3,475) reportedly offered HIVST kits to their male partner with 98.1% (3,409) accepting and 97.6% (3,328) using the kit. Among ANC partners self-testing, 159 (4.8%) reported reactive HIVST results, of which 127 (79.9%) received further testing; 116 (91.3%) were diagnosed with HIV and 114 (98.3%) initiated antiretroviral therapy (ART). Of the 1,649 people newly diagnosed with HIV successfully followed-up; 1,312 (79.6%) reportedly offered HIVST kits to their partners with 95.8% (1,257) of the partners accepting and 95.9% (1,206) reported that their partners used the kit. Among these index partners, 297 (24.6%) reported reactive HIVST results of which 261 (87.9%) received further testing; 260 (99.6%) were diagnosed with HIV and 258 (99.2%) initiated ART. The average cost per HIVST distributed in the three cities was US$7.90, US$11.98, and US$14.81, respectively. CONCLUSIONS: Partner-delivered HIVST in real world implementation was able to affordably reach many male partners of ANC attendees and index partners of people newly diagnosed with HIV in South Africa. Given recent COVID-19 related restrictions, partner-delivered HIVST provides an important strategy to maintain essential testing services.

Painless Capillary Blood Collection: A Rapid Evaluation of the Onflow Device.

Blood-based diagnostics are critical for many medical decisions, but mostly rely on venepuncture, which can be inconvenient and painful. The Onflow Serum Gel (Loop Medical SA, Vaud, Lausanne, Switzerland) is a novel blood collection device that utilises needle-free technology to collect capillary blood. In this pilot study, 100 healthy participants were enrolled and provided two Onflow collected specimens and one venous blood specimen. Five chemistry analytes (AST, ALT, LDH, potassium, creatinine) and haemolysis were measured per specimen, and laboratory analyte results were compared. Onflow was found to be more acceptable than venepuncture with lower pain ratings, and 96.5% of participants would use the Onflow method again. All phlebotomists (100%) found Onflow intuitive and user-friendly, with ~1 mL of Onflow blood successfully collected from 99% of participants in <12 min (mean: 6 min, 40 s) and 91% collected on the first attempt. ALT and AST analytes showed no difference in performance, while creatinine generated a negative bias (-5.6 µmol/L), and increased variability was noted with potassium (3.6%CV) and LDH (6.7%CV), although none were clinically relevant. These differences may be due to 35% of Onflow collected specimens having "mild" haemolysis. Onflow is a promising alternative blood collection device that should now be evaluated in participants with expected abnormal chemistries and as an option for self-collection.

Acceptability, feasibility, and accuracy of blood-based HIV self-testing: A cross-sectional study in Ho Chi Minh City, Vietnam.

HIV self-testing (HIVST) is an effective approach to increase testing uptake. While oral fluid-based HIVST has been rapidly scaled, use of blood-based HIVST remains limited. We evaluated the acceptability, feasibility, and accuracy of blood-based HIVST among lay users in Ho Chi Minh City (HCMC), Vietnam. We conducted a cross-sectional study among HIV testing clients at the HCMC Pasteur Institute from March 2019 to October 2020. Participants received one HIVST kit and performed the test in front of an observer. The observer used product-specific questionnaires to collect information on the HIVST process, test results, experiences. The participants' interpretations of HIVST results were compared to health staff's interpretations and gold standard laboratory EIA reference tests. Of 2,399 participants who accepted HIVST, 64.7% were men, 62.1% aged 25-49 years, 53.5% had a higher education level, 41.4% were employed, and 35.6% were first-time testers. The vast majority (94.4%) desired to use the test in the future, and 93.9% reported willingness to recommend the test. The majority (90.8%) of participants successfully completed the self-test. One factor associated with successful completion was higher education level (aOR = 1.85; 95% CI: 1.32-2.61); while participants self-testing with SURE CHECK (aOR = 0.21; 95% CI: 0.12-0.37), INSTI (aOR = 0.23; 95% CI: 0.13-0.39), and BioSURE (aOR = 0.29; 95% CI: 0.17-0.51) or being unemployed, retired, or doing housework (aOR = 0.45; 95% CI: 0.25-0.82) were less likely to perform the test successfully. Agreement of positive and negative HIVST results as interpreted by participants and health staff was high (98.1% and 99.9%, respectively). Sensitivity and specificity of the evaluated HIVST were 96.43% (95% CI: 93.62-99.23) and 99.9% (95% CI: 99.75-100), respectively. Our findings confirm that blood-based HIVST is highly acceptable, feasible, and accurate. This evidence informs scale-up of HIVST to increase uptake of essential HIV prevention and treatment services.

HIV self-test reporting using mHealth platforms: A pilot study in Johannesburg, South Africa.

Background: The main impediment to operational scale-up of HIV self-testing (HIVST) and counselling, is a dearth of information on utilisation, reporting, and linkage to care for HIV-positive individuals. To inform solutions to this issue, this study investigated the utility of self-testers reporting their results using a mobile-health (mHealth) platform, and whether seropositive users linked into care. Method: Candidates who met the recruitment criteria across multiple sites within inner-city Johannesburg each received an HIVST kit. Using short message service (SMS) reminders (50% standard and 50% behavioural science), participants were prompted to self-report results on provided platforms. On the seventh day, users who did not make contact, were called, and surveyed via an interactive voice response system (IVRS). Multivariable regression was used in reporting by age and sex. Results: Of the 9,505 participants, 2,467 (25.9%) participants answered any survey question, and of those, 1,933 (78.4%) were willing to self-report their HIV status. Men were more likely than women to make an inbound call (10.2% vs. 9.1%, p = 0.06) however, women were significantly more likely to self-report their test result (AOR = 1.12, 95%CI = 1.01-1.24, p = 0.025). Overall, self-reporting a test result was predicted by being younger and female. In addition, reporting HIV results was associated with age, 25-35 (AOR = 1.58, 95% CI = 1.24-2.02) and above 35 years (AOR = 2.12, 95% CI = 1.61-2.80). Out of 1,933 participants willing to report their HIV status, 314 reported a positive test, indicating a HIV prevalence of 16.2% (95% CI: 14.6%-18.0%) and of those 204 (65.0%) reported inclination to link to care. Conclusion: While self-reporting HIVST results via an IVRS system yielded a higher response rate, behavioural SMSs were ineffective in increasing self-reporting.

Roadmap for Achieving Universal Antiretroviral Treatment.

Modern antiretroviral therapy safely, potently, and durably suppresses human immunodeficiency virus (HIV) that, if left untreated, predictably causes acquired immunodeficiency syndrome (AIDS), which has been responsible for tens of millions of deaths globally since it was described in 1981. In one of the most extraordinary medical success stories in modern times, a combination of pioneering basic science, innovative drug development, and ambitious public health programming resulted in access to lifesaving, safe drugs, taken as an oral tablet daily, for most of the world. However, substantial challenges remain in the fields of prevention, timely access to diagnosis, and treatment, especially in pediatric and adolescent patients. As HIV-positive adults age, treating their comorbidities will require understanding the course of different chronic diseases complicated by HIV-related and antiretroviral toxicities and finding potential treatments. Finally, new long-acting antiretrovirals on the horizon promise exciting new options in both the prevention and treatment fields.

Monitored Implementation of COVID-19 Rapid Antigen Screening at Taxi Ranks in Johannesburg, South Africa.

Digital tools can support community-based decentralized testing initiatives to broaden access to COVID-19 diagnosis, especially in high-transmission settings. This operational study investigated the use of antigen-detecting rapid diagnostic tests (Ag-RDTs) for COVID-19 combined with an end-to-end digital health solution, in three taxi ranks in Johannesburg, South Africa. Members of the public were eligible if they were aged ≥18 years, could read, and had a cellphone. Over 15,000 participants, enrolled between June and September 2021, were screened for COVID-19 risk factors. A digital risk questionnaire identified 2061 (13%) participants as moderate risk and 2987 (19%) as high risk, based on symptoms and/or recent exposure to a known case. Of this group referred for testing, 3997 (79%) received Ag-RDTs, with positivity rates of 5.1% in the "high-risk" group and 0.8% in the "moderate-risk" group. A subset of 569 randomly selected participants received additional PCR testing. Sensitivity of the Ag-RDT in this setting was 40% (95% CI: 30.3%, 50.3%); most false negatives had high cycle threshold values (>25), hence low viral loads. Over 80% of participants who tested positive completed a 2-week phone-based follow-up questionnaire. Overall, the digital tool combined with Ag-RDTs enhanced community-based decentralized COVID-19 testing service delivery, reporting and follow-up.

Planning and commitment prompts to encourage reporting of HIV self-test results: A cluster randomized pragmatic trial in Tshwane District, South Africa.

Reporting of HIV self-test results to encourage linkage to HIV care for those who receive a positive test result is a common challenge faced by HIV self-testing programs. The impact of self-testing programs is diminished if individuals who obtain a self-test do not use the test or seek confirmatory testing and initiate HIV treatment following a positive result. We conducted a cluster randomized trial of two interventions designed to increase reporting of HIV self-test results: a "plan and commit" intervention that leveraged insights from behavioral economics, and an enhanced usual care version of the standard HIV self-test community distribution protocol that promoted the importance of reporting results. The trial was conducted at community distribution sites for HIV self-tests in Tshwane Metropolitan Municipality, Gauteng Province, South Africa. The primary outcome was reporting of self-test results via a WhatsApp messaging system. We recruited 1,478 participants at 13 distribution sites over 24 days. In the plan and commit condition, 63/731 participants (8.7%) reported their test results via WhatsApp, compared to 59/747 participants (7.9%) in the enhanced usual care condition (n.s., p = 0.61). During the study period, 101/3,199 individuals (3.1%) who received a self-test under the standard protocol reported test results via WhatsApp, a significant difference across the three arms (p < .00001). Our results suggest that boosting the reporting of self-test results can be done solely through increasing the salience of the importance of reporting and a clear explanation of the procedure for reporting results. Trial Registration: ClinicalTrials.gov: NCT03898557.

Utility of a Machine-Guided Tool for Assessing Risk Behavior Associated With Contracting HIV in Three Sites in South Africa: Protocol for an In-Field Evaluation.

BACKGROUND: Mobile technology has helped to advance health programs, and studies have shown that an automated risk prediction model can successfully be used to identify patients who exhibit a high probable risk of contracting human immunodeficiency virus (HIV). A machine-guided tool is an algorithm that takes a set of subjective and objective answers from a simple questionnaire and computes an HIV risk assessment score. OBJECTIVE: The primary objective of this study is to establish that machine learning can be used to develop machine-guided tools and give us a deeper statistical understanding of the correlation between certain behavioral patterns and HIV. METHODS: In total, 200 HIV-negative adult individuals across three South African study sites each (two semirural and one urban) will be recruited. Study processes will include (1) completing a series of questions (demographic, sexual behavior and history, personal, lifestyle, and symptoms) on an application system, unaided (assistance will only be provided upon user request); (2) two HIV tests (one per study visit) being performed by a nurse/counselor according to South African national guidelines (to evaluate the prediction accuracy of the tool); and (3) communicating test results and completing a user experience survey questionnaire. The output metrics for this study will be computed by using the participants' risk assessment scores as "predictions" and the test results as the "ground truth." Analyses will be completed after visit 1 and then again after visit 2. All risk assessment scores will be used to calculate the reliability of the machine-guided tool. RESULTS: Ethical approval was received from the University of Witwatersrand Human Research Ethics Committee (HREC; ethics reference no. 200312) on August 20, 2020. This study is ongoing. Data collection has commenced and is expected to be completed in the second half of 2021. We will report on the machine-guided tool's performance and usability, together with user satisfaction and recommendations for improvement. CONCLUSIONS: Machine-guided risk assessment tools can provide a cost-effective alternative to large-scale HIV screening and help in providing targeted counseling and testing to prevent the spread of HIV. TRIAL REGISTRATION: South African National Clinical Trial Registry DOH-27-042021-679; https://sanctr.samrc.ac.za/TrialDisplay.aspx?TrialID=5545. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30304.

Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa.

The prevalence of HIV across South Africa places a strain on testing facilities. The use of HIV self-testing (HIVST) devices has been identified as a strategy to ease the burden on these facilities. The usability and performance of the Asante HIV-1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland OR, USA) device by novice users was assessed and reported on, to inform for the implementation of such devices in South Africa and elsewhere. Convenience sampling was used. Participants used the Asante HIVST device and recorded their interpretation of their results. Participants' interpretations were compared with those of trained professionals and, thereafter, verified using the rapid diagnostic testing algorithm. Out of the eligible participants, 410 of the 524 (78.2%) were between the ages of 18-35. The usability assessment indicates that 100% of participants used the HIVST device's information leaflet. However, 19/524 (3.6%) of participants who yielded an invalid result due to critical errors were excluded from the primary efficacy analysis. The average usability score was 98.1%. The sensitivity and specificity results were, 94.7% and 99.8%, respectively. This study shows that the Asante HIV self-test, and similar devices, can be valuable in providing convenient HIV self-testing and immediately available results. To accommodate a greater number of inexperienced users, the instructions may need to be revised.

Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites.

HIV self-testing (HIVST) devices are acknowledged as having the potential to enable the acceleration of HIV diagnosis and linkage to care. How efficiently professional and trained users engaged with the Asante HIV-1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland, OR, USA), and the accuracy of the device in comparison to other HIV rapid diagnostic tests (RDT), was assessed to be able to guide the development and adoption of the device in Senegal and South Africa. Using convenience sampling, potential participants were recruited from catchment areas where HIV was prevalent. Trained users performed an HIV test on participants using an Oral HIVST. The professional user's interpretation of results was then measured against the results of various other RDTs. The South African study had 1652 participants and the Senegalese, 500. Most of the participants in each study were 18-35 years old. Senegal had a higher number of females (346/500, 69.2%) compared to South Africa (699/1662, 42.1%). Asante displayed very high sensitivity and specificity when tested against other devices. In the final enzyme-linked immunosorbent assay (ELISA) comparison, in South Africa, the sensitivity: specificity was 99.1:99.9% and in Senegal, 98.4:100.0%. Senegal further identified 53/63 (84.1%) with HIV-1, 8/63 (12.7) with HIV-2 and 2/63 (3.2%) with HIV-1/2 co-infections. Professional or trained users' interpretations of Asante results correlated strongly to results when using various RDTs, the ELISA assay and Western blot tests, making it a dependable HIV testing instrument.

The cost and intermediary cost-effectiveness of oral HIV self-test kit distribution across 11 distribution models in South Africa.

BACKGROUND: Countries around the world seek innovative ways of closing their remaining gaps towards the target of 95% of people living with HIV (PLHIV) knowing their status by 2030. Offering kits allowing HIV self-testing (HIVST) in private might help close these gaps. METHODS: We analysed the cost, use and linkage to onward care of 11 HIVST kit distribution models alongside the Self-Testing AfRica Initiative's distribution of 2.2 million HIVST kits in South Africa in 2018/2019. Outcomes were based on telephonic surveys of 4% of recipients; costs on a combination of micro-costing, time-and-motion and expenditure analysis. Costs were calculated from the provider perspective in 2019 US$, as incremental costs in integrated and full costs in standalone models. RESULTS: HIV positivity among kit recipients was 4%-23%, with most models achieving 5%-6%. Linkage to confirmatory testing and antiretroviral therapy (ART) initiation for those screening positive was 19%-78% and 2%-72% across models. Average costs per HIVST kit distributed varied between $4.87 (sex worker model) and $18.07 (mobile integration model), with differences largely driven by kit volumes. HIVST kit costs (at $2.88 per kit) and personnel costs were the largest cost items throughout. Average costs per outcome increased along the care cascade, with the sex worker network model being the most cost-effective model across metrics used (cost per kit distributed/recipient screening positive/confirmed positive/initiating ART). Cost per person confirmed positive for HIVST was higher than standard HIV testing. CONCLUSION: HIV self-test distribution models in South Africa varied widely along four characteristics: distribution volume, HIV positivity, linkage to care and cost. Volume was highest in models that targeted public spaces with high footfall (flexible community, fixed point and transport hub distribution), followed by workplace models. Transport hub, workplace and sex worker models distributed kits in the least costly way. Distribution via index cases at facility as well as sex worker network distribution identified the highest number of PLHIV at lowest cost.

Costs of integrating HIV self-testing in public health facilities in Malawi, South Africa, Zambia and Zimbabwe.

INTRODUCTION: As 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. METHODS: We 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. RESULTS: A 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. CONCLUSION: The 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.

The cost effectiveness and optimal configuration of HIV self-test distribution in South Africa: a model analysis.

BACKGROUND: HIV self-testing (HIVST) has been shown to be acceptable, feasible and effective in increasing HIV testing uptake. Novel testing strategies are critical to achieving the UNAIDS target of 95% HIV-positive diagnosis by 2025 in South Africa and globally. METHODS: We modelled the impact of six HIVST kit distribution modalities (community fixed-point, taxi ranks, workplace, partners of primary healthcare (PHC) antiretroviral therapy (ART) patients), partners of pregnant women, primary PHC distribution) in South Africa over 20 years (2020-2039), using data collected alongside the Self-Testing AfRica Initiative. We modelled two annual distribution scenarios: (A) 1 million HIVST kits (current) or (B) up to 6.7 million kits. Incremental economic costs (2019 US$) were estimated from the provider perspective; assumptions on uptake and screening positivity were based on surveys of a subset of kit recipients and modelled using the Thembisa model. Cost-effectiveness of each distribution modality compared with the status-quo distribution configuration was estimated as cost per life year saved (estimated from life years lost due to AIDS) and optimised using a fractional factorial design. RESULTS: The largest impact resulted from secondary HIVST distribution to partners of ART patients at PHC (life years saved (LYS): 119 000 (scenario A); 393 000 (scenario B)). However, it was one of the least cost-effective modalities (A: $1394/LYS; B: $4162/LYS). Workplace distribution was cost-saving ($52-$76 million) and predicted to have a moderate epidemic impact (A: 40 000 LYS; B: 156 000 LYS). An optimised scale-up to 6.7 million tests would result in an almost threefold increase in LYS compared with a scale-up of status-quo distribution (216 000 vs 75 000 LYS). CONCLUSION: Optimisation-informed distribution has the potential to vastly improve the impact of HIVST. Using this approach, HIVST can play a key role in improving the long-term health impact of investment in HIVST.

Implementation of different HIV self-testing models with implications for HIV testing services during the COVID-19 pandemic: study protocol for secondary data analysis of the STAR Initiative in South Africa.

INTRODUCTION: HIV self-testing (HIVST) presents a convenient, private approach that removes barriers to providing HIV testing services. The Self-Testing Africa (STAR) Initiative aims to scale up HIVST among priority and undertested populations. HIVST has the potential to help maintain testing services during the social distancing restrictions implemented to prevent the spread of COVID-19. This project evaluates linkage to confirmatory testing and treatment for HIV-positive clients for the STAR South Africa site. METHODS AND ANALYSIS: This secondary data analysis protocol aims to evaluate different HIVST distribution models from a prospective study implemented during November 2017 and December 2020 by Ezintsha, a subdivision of Wits Reproductive Health and HIV Institute. Routinely collected distribution and self-reported HIVST outcomes data will be deidentified and analysed. The main outcomes of interest are linkage to care and treatment among HIVST users who report a reactive HIVST result. Additionally, we plan to determine sociodemographic factors associated with linkage to care and treatment among HIVST users. Descriptive statistics will be used to describe the variables of interest, and modified Poisson regression with robust variance estimation will be performed to identify factors associated with linkage to care and treatment among HIVST users who report a reactive HIVST result. Risk ratios and 95% CIs for the risk ratios will be reported. ETHICS AND DISSEMINATION: The study protocol has been approved by the University of Witwatersrand Human Research Ethics Committee. The dissemination plan for the study findings will include presentations to local and international health authorities, international conferences and publications in open access journals.

A Lay-User Assessment of Hepatitis C Virus Self-Testing Device Usability and Interpretation in Johannesburg, South Africa.

Only 20% of people with hepatitis C virus (HCV) know their status. In low-income countries diagnosis is under 10%. Self-testing for HCV antibodies (HCVST) could expand the coverage of HCV testing services. Currently, there are no stringent regulatory authority (SRA) approved HCVSTs, therefore lay-user usability of three prototype kits was assessed. This was a cross-sectional observational study conducted with 171 (CareStart n = 60, Bioline n = 52, First Response n = 59) participants. Participants were given one of the three HCVST kits with only instructions for use (IFU) and asked to perform the test in front of a professional trained in rapid diagnostic tests (RDT). Usability indices were calculated based on the correctness of performing each step of the product-specific process followed by contrived results interpretation and a post-test interview. The usability index was 93.9% for CareStart, 90.7% for Bioline and 94.9% for First Response. Most errors were on incorrect handwashing, sample collection and transfer to the test device. An average of 93.1% of contrived results were correctly interpreted, with most errors related to interpreting invalid results. Most participants (n = 167) stated they would visit a clinic after a positive result. With negative results, nearly half (28/60 (46.7%)) stated they should condomize, while just over two-thirds of participants that used Bioline (35/52 (67.3%)) and First Response (38/59 (64.4%)) said they should re-test. Most participants (n = 162) found the devices easy to use. Participants liked that self-testing was fast, private and convenient, however there were some confusion with IFU steps and pictures, finger-pricking with the lancet, collecting blood after the finger-prick, and transferring the sample/buffer. Prototype HCVST kits exhibit high usability and result interpretation by lay-users, and should be considered for SRA approval.

Uptake of the Ithaka mobile application in Johannesburg, South Africa, for human immunodeficiency virus self-testing result reporting.

BACKGROUND: Human immunodeficiency virus self-testing (HIVST) can reduce facility-based HIV testing barriers; however, no proven applications exist with widespread uptake for self-reporting or linkage to care. Mobile health (mHealth) applications (apps) have shown high usability and feasibility scores, so Ithaka was developed for South Africans to self-report HIVST results outside clinical settings. OBJECTIVES: This study investigated the use of Ithaka as a support tool for HIVST users, specifically the ability to self-report results. METHOD: This cross-sectional study was conducted from November 2018 to June 2019. At existing HIVST distribution sites, individuals were given HIVST kits and then invited to use Ithaka. Participants could test at home and report their results through the app anytime. Ithaka tracked when people logged-on, registered, received counselling and reported results. Post-study surveys on user experience were also conducted. RESULTS: Of 751 participants, 531 (70.7%) logged onto the app, 412 (54.9%) registered, 295 (39.3%) received counselling and 168 (22.4%) self-reported results. Participants strongly agreed that Ithaka was useful and that it was easy to upload results. Forty-one participants completed a post-test survey, and 39/41 (95.1%) completed the app journey. Most participants (36/41;87.8%) had no challenges, although 2/41 (4.9%) cited perceived data costs, 2/41 (4.9%) difficulty uploading results and 1/41 (2.4%) language, as challenges. CONCLUSION: Despite the small sample size, this study has shown that HIVST participants under pragmatic conditions were willing and able to self-report results via the app, whilst also identifying areas of improvement for scaling up.