Is manufacturer’s Instructions-For-Use sufficient in a multilingual and low literacy context? The example of HIV self-testing in West Africa

Background: The ATLAS project aims to promote the use of HIV self-testing (HIVST) in Côte d'Ivoire, Mali and Senegal. In order to ensure accurate HIVST use, it was necessary to evaluate if the manufacturer’s Instructions-For-Use (IFUs), standardized at the international level, provides complete, accessible and adapted information in the 3 countries’ contexts.Materials & Methods: In December 2018, cognitive interviews were conducted with 64 participants, mostly Men who have Sex with Men (40,6%) and Female Sex Workers (43,8%) in Côte d'Ivoire, Mali and Senegal. Among them, 17,2 % never performed HIV test before and 38% of participants cannot read. They were invited to perform an oral HIVST (OraQuick®) and were requested, at each step of the procedure to share their understanding of the IFU for HIVST use, of the result interpretation and of related actions to be taken. All participants had in hands the manufacturer's IFUs in French, including the free national hotline number. Half of them additionally received manufacturer's demonstration video translated into local languages. Directive interviews guide included 50 questions to collect participants’ perception of what was missing or unclear in the supporting tools. The methodology was validated with all national AIDS programmes and ministries of health.Results: Out of 64 HIVST performed, 5 results were positive (7,8%) and confirmed with additional tests. Overall, the IFU was well understood: 58 participants (92%) were able to interpret their HIVST result correctly without assistance. However, some misuses were observed at various stages, particularly for people who cannot read, with some instructions misunderstood or perceived as not adapted. Only participants who can read have access to information as “do not eat” or “do not use the test if you are on ART” as it is not illustrated in the IFUs. Most of the participants did not spontaneously identify the promotion of the free hotline number and/or the link to the demonstration video. Some procedure’s steps were misinterpreted: 7 participants (11%) did not swab correctly the flat pad along the gum, 3 participants (5%) have read the result at inaccurate time (at 20 seconds, at 5 minutes or after 40 minutes), 13 participants (20%) did not put the stand (for the tube including the liquid) in the right way and 8 other participants struggled to slide tube into the stand. Among 42 participants who can not read and/or who had not seen the video beforehand, 14 of them (33%) had at least one difficulty to interpret the result or to understand what to do after the test/result. On the other hand, the results of the cognitive interviews showed that demonstration video provides a real added value to the user’s understanding and accurate HIVST use (31 participants out of 32 found it very easy to understand with 9 of them who felt they do not need the IFUs if they previously watched the demonstration video). The video translation into local languages, produced by the ATLAS project, was very much appreciated by the participants.Conclusion: The manufacturer's IFUs alone appear not to be sufficient in a multilingual, low-literacy context to ensure accurate HIVST use. Access to additional supporting tools (complementary leaflet, demonstration video or free hotline) is essential in the 3 countries’ contexts

Coûts unitaires de l’autodépistage et du dépistage classique du VIH dans les centres de santé publics et communautaires en Côte d’Ivoire, au Mali et au Sénégal

ObjectifsL’atteinte des « trois 95 » de l’ONUSIDA a induit l’adoption de stratégies de dépistage VIH innovantes en Afrique de l’Ouest. Le projet ATLAS déploie l’autodépistage du VIH (ADVIH) en Côte d'Ivoire (CI), au Mali (ML) et au Sénégal (SN) en stratégie avancée et fixe (Figure 1). Les stratégies fixes sont mises en oeuvre dans (i) des structures de santé fixes pour le dépistage des partenaires de personnes vivant avec le VIH (Index), et pour celui des patients ayant une Infection Sexuellement Transmissible (IST) et leurs partenaires, et (ii) dans des cliniques communautaires à destination des hommes ayant des rapports sexuels avec des hommes (HSH), des travailleuses du sexe (TS) et des personnes usagères de drogues (UD). Cette étude a pour objectif d’estimer les coûts unitaires des stratégies fixes ADVIH et celui des tests de diagnostic rapide (TDR).Matériels et MéthodesL’évaluation des coûts de dispensation des ADVIH a porté sur 37 (CI=16 ; ML=11 ; SN=10) centres de santé publics et communautaires entre 2019 et 2021 suivant la perspective du fournisseur. Nous avons combiné une analyse de rapports financiers avec celle d’une collecte de coûts dans les centres complétés par des observations de sessions de dispensation ADVIH et de dépistage VIH, en excluant les coûts centraux.RésultatsAu total, 16001 kits d’ADVIH (CI=9306 ; ML=3973 ; SN=2722) ont été dispensés pour 32194 TDR réalisés (CI=8213; ML=3612; SN=20369). Les coûts unitaires moyens de l’ADVIH étaient compris entre 4$et$8 pour la Côte d’Ivoire et le Sénégal (Tableau 1). Ces coûts étaient plus élevés au Mali, entre 7$et 26$, liés à des coûts de personnels élevés (management/administration et agents dispensateurs HSH), ainsi que de faibles volumes de kits ADVIH dispensés pour certains canaux. En Côte d'Ivoire et au Sénégal, les coûts moyens du dépistage avec TDR ont été estimés dans l’ensemble des canaux à environ 4$ par personne testée (coûts non estimés au Mali).ConclusionDans les trois pays, les coûts moyens d’introduction des ADVIH en stratégies fixes à faible volume étaient légèrement plus élevés que ceux des TDR. L’ADVIH peut diversifier l’offre de service de dépistage au niveau des structures fixes, améliorant ainsi l’accès au dépistage des populations cibles non-atteintes par les services TDR

Can task shifting improve efficiency of HIV self-testing kits distribution? A case study in Mali

International audienceBackground: The ATLAS project introduced HIV self-testing (HIVST) in consultations of people living with HIV (PLHIV) at public health facilities in Côte d'Ivoire, Mali and Senegal for secondary distribution to their partners. Preliminary data from a qualitative study (observations of consultations, interviews with distributing agents) carried out in two clinics in Mali highlight implementation challenges associated with the counselling on self-testing and kit distribution currently done by the medical staff (doctor/nurse) and reported time-consuming. While implementation teams are considering the possibility of delegating certain tasks, it is important to consider the cost of alternative delivery models.Materials & Methods: We analysed preliminary economic costs data for the provision of rapid HIV testing services (HTS) (analysis period: October 2018 – September 2019) and HIVST services (August 2019 – October 2019) in these same two Malian clinics. Above service level costs are excluded. We then modelled the costs of provision using alternative cadres of medical and non-medical staff (psychosocial counsellors/peer educators) and the consumables used to simulate task shifting scenarios for the provision of HTS and HIVST services. The three scenarios correspond to 1. partial delegation: individual counselling done by non-medical staff and HIVST distribution by the medical staff ; 2. total delegation: individual counselling and distribution done by non-medical staff only; and 3. total delegation with group counselling: where group counselling and distribution are done by non-medical staff only.Results: Findings show that the unit costs per HIVST provided for the observed model are 58% higher than those of a conventional rapid test: $7,50 and$4.75, respectively. The costs are less high in scenarios of partial ($5.45, +15$5.29, +11%) delegation but always higher than those of a rapid test due to the greater costs of consumables (HIVST kit). Finally, in the case where counselling on self-testing were carried out in a group, the costs per kit provided ($4.44, -6%) would become slightly lower than those of a rapid test, where counselling is always done individually.Conclusion: Task delegation from medical to non-medical staff can generate substantial cost savings. These preliminary results can guide the implementation strategy of HIVST in care consultations, to ensure sustainability from early introduction through scale-up

Economic Analysis of Low Volume Interventions Using Real-World Data: Costs of HIV Self-Testing Distribution and HIV Testing Services in West Africa From the ATLAS Project

International audienceAchieving the first 95 of the UNAIDS targets requires the implementation of innovative approaches to knowing one's HIV status. Among these innovations is the provision of HIV self-testing (HIVST) kits in west Africa by the international partner organization Solthis (IPO). In order to provide guidance for the optimal use of financial resources, this study aims to estimate the program and site level costs of dispensing HIVST as well as HIV testing services (HTS)-excluding HIVST-in health facilities in Côte d'Ivoire, Mali and Senegal as part of the ATLAS project. We estimated from the provider's perspective, HIVST and HTS incremental costs using top-down and bottom-up costing approaches and conducted a time and motion study. We identified costs at the program level for HIVST (including IPO central costs) and at the site level for HIVST and HTS. The economic costs of distributing HIVST kits were assessed in 37 health facilities between July 2019 and March 2021 (21 months). Sensitivity analyses were also performed on unit costs to examine the robustness of our estimates related to key assumptions. In total, 16,001 HIVST kits were dispensed for 32,194 HTS sessions carried out. Program level HIVST average costs ranged $12–286, whereas site level costs ranged$4–26 across distribution channels and countries. Site level HTS costs ranged $7–8 per testing session, and ranged$72–705 per HIV diagnosis. Across countries and channels, HIVST costs were driven by personnel (27–68%) and HIVST kits (32–73%) costs. The drivers of HTS costs were personnel costs ranging between 65 and 71% of total costs across distribution channels and countries, followed by supplies costs between 21 and 30%. While program level HIVST average costs were high, site level HIVST average costs remained comparable to HTS costs in all countries. Health facility-based distribution channels operating at low volume exhibit high proportion of central costs which should be considered carefully for financial planning when run alongside high volumes mobile outreach distribution channels. HIVST can diversify the HIV testing offer at health facilities, thus improving access to screening for target populations not reached by HTS services

Costs and scale-up costs of integrating HIV self-testing into civil society organisation-led programmes for key populations in Côte d'Ivoire, Senegal, and Mali

Despite significant progress on the proportion of individuals who know their HIV status in 2020, Côte d'Ivoire (76%), Senegal (78%), and Mali (48%) remain far below, and key populations (KP) including female sex workers (FSW), men who have sex with men (MSM), and people who use drugs (PWUD) are the most vulnerable groups with a HIV prevalence at 5-30%. HIV self-testing (HIVST), a process where a person collects his/her own specimen, performs a test, and interprets the result, was introduced in 2019 as a new testing modality through the ATLAS project coordinated by the international partner organisation Solthis (IPO). We estimate the costs of implementing HIVST through 23 civil society organisations (CSO)-led models for KP in Côte d'Ivoire (N = 7), Senegal (N = 11), and Mali (N = 5). We modelled costs for programme transition (2021) and early scale-up (2022-2023). Between July 2019 and September 2020, a total of 51,028, 14,472, and 34,353 HIVST kits were distributed in Côte d'Ivoire, Senegal, and Mali, respectively. Across countries, 64-80% of HIVST kits were distributed to FSW, 20-31% to MSM, and 5-8% to PWUD. Average costs per HIVST kit distributed were $15 for FSW (Côte d'Ivoire:$13, Senegal: $17, Mali:$16), $23 for MSM (Côte d'Ivoire:$15, Senegal: $27, Mali:$28), and $80 for PWUD (Côte d'Ivoire:$16, Senegal: $144), driven by personnel costs (47-78$11 for FSW (Côte d'Ivoire: $9, Senegal:$13, Mali: $10),$16 for MSM (Côte d'Ivoire: $9, Senegal:$23, Mali: $17), and$32 for PWUD (Côte d'Ivoire: $14, Senegal:$50). Cost reductions were mainly explained by the spreading of IPO costs over higher HIVST distribution volumes and progressive IPO withdrawal at scale-up. In all countries, CSO-led HIVST kit provision to KP showed relatively high costs during the study period related to the progressive integration of the programme to CSO activities and contextual challenges (COVID-19 pandemic, country safety concerns). In transition to scale-up and integration of the HIVST programme into CSO activities, this model shows large potential for substantial economies of scale. Further research will assess the overall cost-effectiveness of this model

“When you provide an HIV self-testing kit […] you also need to know the results”: lay providers’ concerns on HIV self-testing provision to peers, ATLAS project

Background: HIV self-testing (HIVST) is a process in which a person collects his or her own specimen (oral fluid or blood), using a simple rapid HIV test and then performs the test and interprets the result, often in a private setting, either alone or with someone he/she trusts (WHO, 2018). HIVST is convenient to reach stigmatized groups such as key populations. In the ATLAS project, provision of HIVST kits is done by lay providers to sex workers, drug users and men who have sex with men, or through secondary distribution by primary contacts to their partners and other peers. There is a shifting of paradigm because the result of an HIVST is not necessarily shared with the lay provider. How do lay providers responsible for HIVST kits distribution to key populations in West Africa adopt this new testing strategy? This abstract discusses the concerns of lay providers who offer HIVST kits to peers in the ATLAS Project (Cote d’Ivoire, Mali and Senegal).Material and Methods: We conducted seven focus group discussions with fifty-six lay providers who had experience in offering HIVST to peers (sex workers, men who have sex with men, drug users) in the three countries two months after the ATLAS project started.Results: Lay providers report no major opposition or conflict in offering HIVST kits. Testimonies from primary recipients also suggest that the HIVST was performed correctly in the case of secondary distribution. However, lay providers’ concerns remain with the lack of knowledge of the self-test results. In previous HIV testing strategies, providers usually played a key role to support their client during pre- and post-test counselling, especially when the test result was positive. Therefore, their question is how can they continue to support peers while respecting the private nature of self-testing? The concern is at two levels. At the individual level, lay providers fear that the continuum of care is not guaranteed and peers who self-test with a reactive test result may stay alone. At the collective level, lay providers fear to miss their performance objectives linked to the number of new HIV-positive cases they found and requested by some donors. Consequently, alongside HIVST provision, lay providers share their phone numbers, call back their primary recipients, or apply other indirect strategies to know the self-test result of their recipients.Conclusion: Lay providers develop strategies to learn about the issue of the HIVST they offer and to provide support to their peers following HIVST provision. Is this behaviour related to a cultural context that values social relationships or a sign of empathy to key populations and people living with HIV in a context of high stigmatization? Or is it related to existing performance objectives for new HIV-positive cases finding requested by donors? The meanings of this practice call for a deep reflection on whether or not the WHO guidelines need to be adapted to this context

Introducing and Implementing HIV Self-Testing in Côte d'Ivoire, Mali, and Senegal: What Can We Learn From ATLAS Project Activity Reports in the Context of the COVID-19 Crisis?

Background: The ATLAS program promotes and implements HIVST in Côte d'Ivoire, Mali, and Senegal. Priority groups include members of key populations—female sex workers (FSW), men having sex with men (MSM), and people who use drugs (PWUD)—and their partners and relatives. HIVST distribution activities, which began in mid-2019, were impacted in early 2020 by the COVID-19 pandemic.Methods: This article, focusing only on outreach activities among key populations, analyzes quantitative, and qualitative program data collected during implementation to examine temporal trends in HIVST distribution and their evolution in the context of the COVID-19 health crisis. Specifically, we investigated the impact on, the adaptation of and the disruption of field activities.Results: In all three countries, the pre-COVID-19 period was marked by a gradual increase in HIVST distribution. The period corresponding to the initial emergency response (March-May 2020) witnessed an important disruption of activities: a total suspension in Senegal, a significant decline in Côte d'Ivoire, and a less pronounced decrease in Mali. Secondary distribution was also negatively impacted. Peer educators showed resilience and adapted by relocating from public to private areas, reducing group sizes, moving night activities to the daytime, increasing the use of social networks, integrating hygiene measures, and promoting assisted HIVST as an alternative to conventional rapid testing. From June 2020 onward, with the routine management of the COVID-19 pandemic, a catch-up phenomenon was observed with the resumption of activities in Senegal, the opening of new distribution sites, a rebound in the number of distributed HIVST kits, a resurgence in larger group activities, and a rebound in the average number of distributed HIVST kits per primary contact.Conclusions: Although imperfect, the program data provide useful information to describe changes in the implementation of HIVST outreach activities over time. The impact of the COVID-19 pandemic on HIVST distribution among key populations was visible in the monthly activity reports. Focus groups and individual interviews allowed us to document the adaptations made by peer educators, with variations across countries and populations. These adaptations demonstrate the resilience and learning capacities of peer educators and key populations

Utilisation et redistribution de l’autodépistage du VIH parmi les populations clés et leurs réseaux en Afrique de l’Ouest : pratiques et expériences vécues dans le projet ATLAS

International audienceObjectifsL’autodépistage du VIH (ADVIH), notamment la distribution dans les réseaux des personnes en contact avec des programmes de prévention (distribution secondaire), permet de rejoindre des personnes ayant faiblement accès au dépistage. Dans le cadre du projet ATLAS, une analyse des pratiques d’utilisation et de redistribution de l’ADVIH parmi les hommes qui ont des rapports sexuels avec des hommes (HSH), les travailleuses du sexe (TS), les usagers de drogues (UD) et leurs partenaires a été réalisée en Côte d’Ivoire, au Mali et au Sénégal.Matériels et MéthodesUne enquête qualitative a été conduite de janvier à juillet 2021. Des entretiens face-à-face et par téléphone ont été réalisés avec des utilisateurꞏtrices de l’ADVIH identifiéꞏes par (i) des pairsꞏes éducateurꞏtrices HSH, TS et UD ou (ii) via une enquête téléphonique anonyme.RésultatsAu total 80 personnes ont été interviewées (65 en face-à-face, 15 par téléphone). À la première utilisation, la majorité a réalisé l’ADVIH sans la présence d’unꞏe professionnelꞏle (2/3). Ils l’ont justifié par la facilité de réalisation de l’ADVIH et l’existence d’outils de supports. La majorité a redistribué des kits d’ADVIH à des partenaires sexuelsꞏles, pairꞏes/amiꞏes, clients pour les TS et d’autres types derelations sans difficulté majeure. Leur motivation commune était l’intérêt de la connaissance du statut VIH pour l’utilisateurꞏtrice finalꞏe. Cependant vis-à-vis des partenaires sexuelsꞏles et des clients des TS, il s’agissait surtout de s’informer du statut de ce/cette dernier-ère pour décider des mesures préventives à adopter. Les réactions des utilisateurꞏtrices secondaires étaient majoritairement positives parce que ce nouvel outil répondait à une attente liée au besoin de connaître leur statut VIH, certainꞏes n’ayant par ailleurs jamais fait de dépistage VIH. Quelques cas de refus ont été rencontrés, surtout de la part des clients occasionnels pour les TS. Un cas de violence physique de la part d’un client a été rapporté.Les raisons de non-proposition de l’ADVIH à son réseau variaient suivant les catégories de populations clés et les utilisateurꞏtrices secondaires. Les trois populations clés, surtout les UD, ont rapporté des craintes de réactions négatives de certainꞏes partenaires sexuelsꞏles. Les HSH et les UD en ont moins distribué à leurs pairꞏes/amiꞏes par rapport aux partenaires sexuelꞏles parce qu’ils/elles estimaient que ceux/celles-ci étaient dans les mêmes réseaux de distribution des kits d’ADVIH et en avaient donc déjà reçus. Chez les TS, l’ADVIH était moins souvent proposé aux clients et aux partenaires qui acceptaient l’utilisation du préservatif.ConclusionLes résultats montrent une bonne acceptation de l’ADVIH tant en distribution primaire que secondaire. La redistribution de l’ADVIH dans les réseaux des populations clés peut permettre d’accroitre l’accès au dépistage parmi les populations peu dépistées, sans répercussion négative pour les personnes qui le proposent

Can HIV self-testing reach first-time testers? A telephone survey among self-test end users in Côte d’Ivoire, Mali, and Senegal

International audienceAbstract Background Coverage of HIV testing remains sub-optimal in West Africa. Between 2019 and 2022, the ATLAS program distributed ~400 000 oral HIV self-tests (HIVST) in Côte d’Ivoire, Mali, and Senegal, prioritising female sex workers (FSW) and men having sex with men (MSM), and relying on secondary redistribution of HIVST to partners, peers and clients to reach individuals not tested through conventional testing. This study assesses the proportion of first-time testers among HIVST users and the associated factors. Methods A phone-based survey was implemented among HIVST users recruited using dedicated leaflets inviting them to anonymously call a free phone number. We collected socio-demographics, sexual behaviours, HIV testing history, HIVST use, and satisfaction with HIVST. We reported the proportion of first-time testers and computed associated factors using logistic regression. Results Between March and June 2021, 2 615 participants were recruited for 50 940 distributed HIVST (participation rate: 5.1%). Among participants, 30% received their HIVST kit through secondary distribution (from a friend, sexual partner, family member, or colleague). The proportion who had never tested for HIV before HIVST (first-time testers) was 41%. The main factors associated with being a first-time tester were sex, age group, education level, condom use, and secondary distribution. A higher proportion was observed among those aged 24 years or less (55% vs 32% for 25–34, aOR: 0.37 [95%CI: 0.30–0.44], and 26% for 35 years or more, aOR: 0.28 [0.21–0.37]); those less educated (48% for none/primary education vs 45% for secondary education, aOR: 0.60 [0.47–0.77], and 29% for higher education, aOR: 0.33 [0.25–0.44]). A lower proportion was observed among women (37% vs 43%, aOR: 0.49 [0.40–0.60]); those reporting always using a condom over the last year (36% vs 51% for those reporting never using them, aOR: 2.02 [1.59–2.56]); and those who received their HISVST kit through primary distribution (39% vs 46% for secondary distribution, aOR: 1.32 [1.08–1.60]). Conclusion ATLAS HIVST strategy, including secondary distribution, successfully reached a significant proportion of first-time testers. HIVST has the potential to reach underserved populations and contribute to the expansion of HIV testing services in West Africa

Potential population-level effects of HIV self-test distribution among key populations in Côte d'Ivoire, Mali, and Senegal: a mathematical modelling analysis

International audienceBackgroundDuring 2019–21, the AutoTest VIH, Libre d'accéder à la connaissance de son Statut (ATLAS) programme distributed around 380 000 HIV self-testing kits to key populations, including female sex workers, men who have sex with men, and their partners, in Côte d'Ivoire, Mali, and Senegal. We aimed to estimate the effects of the ATLAS programme and national scale-up of HIV self-test distribution on HIV diagnosis, HIV treatment coverage, HIV incidence, and HIV-related mortality.MethodsWe adapted a deterministic compartmental model of HIV transmission in Côte d'Ivoire, parameterised and fitted to country-specific demographic, behavioural, HIV epidemiological, and intervention data in Côte d'Ivoire, Mali, and Senegal separately during 1980–2020. We simulated dynamics of new HIV infections, HIV diagnoses, and HIV-related deaths within scenarios with and without HIV self-test distribution among key populations. Models were separately parameterised and fitted to country-specific sets of epidemiological and intervention outcomes (stratified by sex, risk, age group, and HIV status, if available) over time within a Bayesian framework. We estimated the effects on the absolute increase in the proportion of people with HIV diagnosed at the end of 2021 for the ATLAS-only scenario and at the end of 2028 and 2038 for the HIV self-testing scale-up scenario. We estimated cumulative numbers of additional HIV diagnoses and initiations of antiretroviral therapy and the proportion and absolute numbers of new HIV infections and HIV-related deaths averted during 2019–21 and 2019–28 for the ATLAS-only scenario and during 2019–28 and 2019–38 for the HIV self-testing scale-up scenario.FindingsOur model estimated that ATLAS could have led to 700 (90% uncertainty interval [UI] 500–900) additional HIV diagnoses in Côte d'Ivoire, 500 (300–900) in Mali, and 300 (50–700) in Senegal during 2019–21, a 0·4 percentage point (90% UI 0·3–0·5) increase overall by the end of 2021. During 2019–28, ATLAS was estimated to avert 1900 (90% UI 1300–2700) new HIV infections and 600 (400–800) HIV-related deaths across the three countries, of which 38·6% (90% UI 31·8–48·3) of new infections and 70·1% (60·4–77·3) of HIV-related deaths would be among key populations. ATLAS would avert 1·5% (0·8–3·1) of all HIV-related deaths across the three countries during this period. Scaling up HIV self-testing would avert 16·2% (90% UI 10·0–23·1) of all new HIV infections during 2019–28 in Senegal, 5·3% (3·0–8·9) in Mali, and 1·6% (1·0–2·4) in Côte d'Ivoire. HIV self-testing scale-up among key populations was estimated to increase HIV diagnosis by the end of 2028 to 1·3 percentage points (90% UI 0·8–1·9) in Côte d'Ivoire, 10·6 percentage points (5·3–16·8) in Senegal, and 3·6 percentage points (2·0–6·4) in Mali.InterpretationScaling up HIV self-test distribution among key populations in western Africa could attenuate disparities in access to HIV testing and reduce infections and deaths among key populations and their partners.FundingUnitaid, Solthis, the UK Medical Research Council Centre for Global Infectious Disease Analysis, the EU European & Developing Countries Clinical Trials Partnership programme, and the Wellcome Trust