Factors associated with antiretroviral treatment initiation amongst HIV-positive individuals linked to care within a universal test and treat programme: early findings of the ANRS 12249 TasP trial in rural South Africa

Prompt uptake of antiretroviral treatment (ART) is essential to ensure the success of universal test and treat (UTT) strategies to prevent HIV transmission in high-prevalence settings. We describe ART initiation rates and associated factors within an ongoing UTT cluster-randomized trial in rural South Africa. HIV-positive individuals were offered immediate ART in the intervention arm vs. national guidelines recommended initiation (CD4≤350 cells/mm3) in the control arm. We used data collected up to July 2015 among the ART-eligible individuals linked to TasP clinics before January 2015. ART initiation rates at one (M1), three (M3) and six months (M6) from baseline visit were described by cluster and CD4 count strata (cells/mm3) and other eligibility criteria: ≤100; 100–200; 200–350; CD4>350 with WHO stage 3/4 or pregnancy; CD4>350 without WHO stage 3/4 or pregnancy. A Cox model accounting for covariate effect changes over time was used to assess factors associated with ART initiation. The 514 participants had a median [interquartile range] follow-up duration of 1.08 [0.69; 2.07] months until ART initiation or last visit. ART initiation rates at M1 varied substantially (36.9% in the group CD4>350 without WHO stage 3/4 or pregnancy, and 55.2–71.8% in the three groups with CD4≤350) but less at M6 (from 85.3% in the first group to 96.1–98.3% in the three other groups). Factors associated with lower ART initiation at M1 were a higher CD4 count and attending clinics with both high patient load and higher cluster HIV prevalence. After M1, having a regular partner was the only factor associated with higher likelihood of ART initiation. These findings suggest good ART uptake within a UTT setting, even among individuals with high CD4 count. However, inadequate staffing and healthcare professional practices could result in prioritizing ART initiation in patients with the lowest CD4 counts

Access to HIV care in the context of universal test and treat: challenges within the ANRS 12249 TasP cluster-randomized trial in rural South Africa

Introduction: We aimed to quantify and identify associated factors of linkage to HIV care following home-based HIV counselling and testing (HBHCT) in the ongoing ANRS 12249 treatment-as-prevention (TasP) cluster-randomized trial in rural KwaZulu-Natal, South Africa. Methods: Individuals ]16 years were offered HBHCT; those who were identified HIV positive were referred to cluster-based TasP clinics and offered antiretroviral treatment (ART) immediately (five clusters) or according to national guidelines (five clusters). HIV care was also available in the local Department of Health (DoH) clinics. Linkage to HIV care was defined as TasP or DoH clinic attendance within three months of referral among adults not in HIV care at referral. Associated factors were identified using multivariable logistic regression adjusted for trial arm. Results: Overall, 1323 HIV-positive adults (72.9% women) not in HIV care at referral were included, of whom 36.9% (n488) linked to care B3 months of referral (similar by sex). In adjusted analyses (n1222), individuals who had never been in HIV care before referral were significantly less likely to link to care than those who had previously been in care (B33% vs. 42%, pB0.001). Linkage to care was lower in students (adjusted odds-ratio [aOR] 0.47; 95% confidence interval [CI] 0.240.92) than in employed adults, in adults who completed secondary school (aOR0.68; CI 0.490.96) or at least some secondary school (aOR0.59; CI 0.410.84) versus 5 primary school, in those who lived at 1 to 2 km (aOR0.58; CI 0.440.78) or 25 km from the nearest TasP clinic (aOR0.57; CI 0.410.77) versus B1 km, and in those who were referred to clinic after ]2 contacts (aOR0.75; CI 0.580.97) versus those referred at the first contact. Linkage to care was higher in adults who reported knowing an HIV-positive family member (aOR1.45; CI 1.121.86) versus not, and in those who said that they would take ART as soon as possible if they were diagnosed HIV positive (aOR2.16; CI 1.134.10) versus not. Conclusions: Fewer than 40% of HIV-positive adults not in care at referral were linked to HIV care within three months of HBHCT in the TasP trial. Achieving universal test and treat coverage will require innovative interventions to support linkage to HIV care

PLoS One

BACKGROUND: Limited engagement in clinic-based care is affecting the HIV response. We explored the field experiences and perceptions of local health care workers regarding home-based strategies as opportunities to improve the cascade of care of people living with HIV in rural South Africa as part of a Universal Test-and-Treat approach. METHODS: In Hlabisa sub-district, home-based HIV services, including rapid HIV testing and counselling, and support for linkage to and retention in clinic-based HIV care, were implemented by health care workers within the ANRS 12249 Treatment-as-Prevention (TasP) trial. From April to July 2016, we conducted a mixed-methods study among health care workers from the TasP trial and from local government clinics, using self-administrated questionnaires (n = 90 in the TasP trial, n = 56 in government clinics), semi-structured interviews (n = 13 in the TasP trial, n = 5 in government clinics) and three focus group discussions (n = 6-10 health care workers of the TasP trial per group). Descriptive statistics were used for quantitative data and qualitative data were analysed thematically. RESULTS: More than 90% of health care workers assessed home-based testing and support for linkage to care as feasible and acceptable by the population they serve. Many health care workers underlined how home visits could facilitate reaching people who had slipped through the cracks of the clinic-based health care system and encourage them to successfully access care. Health care workers however expressed concerns about the ability of home-based services to answer the HIV care needs of all community members, including people working outside their home during the day or those who fear HIV-related stigmatization. Overall, health care workers encouraged policy-makers to more formally integrate home-based services in the local health system. They promoted reshaping the disease-specific and care-oriented services towards more comprehensive goals. CONCLUSION: Because home-based services allow identification of people early during their infection and encourage them to take actions leading to viral suppression, HCWs assessed them as valuable components within the panel of UTT interventions, aiming to reach the 90-90-90 UNAIDS targets, especially in the rural Southern African region. TRIAL REGISTRATION: The registration number of the ANRS 12249 TasP trial on ClinicalTrials.gov is NCT01509508

Temporal trends of population viral suppression in the context of Universal Test and Treat: the ANRS 12249 TasP trial in rural South Africa

Introduction: The universal test-and-treat (UTT) strategy aims to maximize population viral suppression (PVS), that is, the proportion of all people living with HIV (PLHIV) on antiretroviral treatment (ART) and virally suppressed, with the goal of reducing HIV transmission at the population level. This article explores the extent to which temporal changes in PVS explain the observed lack of association between universal treatment and cumulative HIV incidence seen in the ANRS 12249 TasP trial conducted in rural South Africa. Methods: The TasP cluster-randomized trial (2012 to 2016) implemented six-monthly repeat home-based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2 9 11 clusters opened sequentially. ART was initiated according to national guidelines in control clusters and regardless of CD4 count in intervention clusters. We measured residency status, HIV status, and HIV care status for each participant on a daily basis. PVS was computed per cluster among all resident PLHIV (≥16, including those not in care) at cluster opening and daily thereafter. We used a mixed linear model to explore time patterns in PVS, adjusting for sociodemographic changes at the cluster level. Results: 8563 PLHIV were followed. During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001). That increase was similar in both arms (p = 0.514). In the final adjusted model, PVS increase was most associated with increased RHBCT and the implementation of local trial clinics (measured by time since cluster opening). Contextual changes (measured by calendar time) also contributed slightly. The effect of universal ART (trial arm) was positive but limited. Conclusions: PVS was improved significantly but similarly in both trial arms, explaining partly the null effect observed in terms of cumulative HIV incidence between arms. The PVS gains due to changes in ART-initiation guidelines alone are relatively small compared to gains obtained by strategies to maximize testing and linkage to care. The achievement of the 90-90-90 targets will not be met if the operational and implementational challenges limiting access to care and treatment, often context-specific, are not properly addressed. Clinical trial number: NCT01509508 (clinicalTrials.gov)/DOH-27-0512-3974 (South African National Clinical Trials Register)

Retention in care prior to antiretroviral treatment eligibility in sub-Saharan Africa: a systematic review of the literature

International audienceObjective We aimed at summarising rates and factors associated with retention in HIV care prior to antiretroviral treatment (ART) eligibility in sub-Saharan Africa.Design We conducted a systematic literature review (2002–2014). We searched Medline/Pubmed, Scopus and Web of Science, as well as proceedings of conferences. We included all original research studies published in peer-reviewed journals, which used quantitative indicators of retention in care prior to ART eligibility.Participants People not yet eligible for ART.Primary and secondary outcomes Rate of retention in HIV care prior to ART eligibility and associated factors.Results 10 papers and 2 abstracts were included. Most studies were conducted in Southern and Eastern Africa between 2004 and 2011 and reported retention rates in pre-ART care up to the second CD4 measurement. Definition of retention in HIV care prior to ART eligibility differed substantially across studies. Retention rates ranged between 23% and 88% based on series ranging from 112 to 10 314 individuals; retention was higher in women, individuals aged >25 years, those with low CD4 count, high body mass index or co-infected with tuberculosis, and in settings with free cotrimoxazole use.Conclusions Retention in HIV care prior to ART eligibility in sub-Saharan Africa has been insufficiently described so far leaving major research gaps, especially regarding long-term retention rates and sociodemographic, economic, clinical and programmatic logistic determinants. The prospective follow-up of newly diagnosed individuals is required to better evaluate attrition prior to ART eligibility among HIV-infected people

“We used to treat a bit blindly: it was a syndromic diagnosis”. Physicians’ perceptions of comprehensive management of sexually transmitted infections among sex workers in Côte d'Ivoire

International audienceBACKGROUND: The ANRS 12381 PRINCESSE project proposed a comprehensive, community-based sexual and reproductive health (SRH) care package, including the management of sexually transmitted infections (STIs), for female sex workers (FSWs) aged = 18 years in the San Pedro area. Our objective was the analysis of physicians’ perceptions of the overall management of STIs.METHODS: The PRINCESSE health package (November 2019 - June 2023) included quarterly syndromic STI screening, vaginal and anal swabs for annual testing for chlamydia trachomatis and neisseria gonorrhoea, and appropriate free STI treatment. It was offered in both mobile and fixed clinics. At cohort closure in June/July 2023, in-depth individual interviews were conducted with the four physicians involved in the project.RESULTS: The offer of STI screening and treatment was well received by the medical team. For the physicians, the acquisition of new knowledge about STI treatment, the opportunity to carry out laboratory tests directly on site and in a fixed clinic, and the fact that they could provide STI treatment kits directly to clients were an asset of the project and a source of motivation to work in the long term. This has also fostered a relationship of trust between the physicians and FSWs.However, operational difficulties, including frequent delays in the supply of STI kits and the late return of medical analyses, have at times undermined this relationship of trust and made it difficult to provide timely and appropriate STI treatment and regular follow-up in a context that was already tense due to the high mobility of FSWs. Another limitation was the lack of care for the stable partner(s) of treated FSWs, as this did not allow the chain of contamination to be broken and possible re-acquisition to be avoided. Finally, the inaccessibility of certain sites due to poor road conditions during the rainy season also made STI treatment difficult.CONCLUSIONS: STI screening and treatment were seen as an appropriate response to the SRH needs of FSWs. However, both structural and operational barriers have made implementation complex. Point-of-care tools, such as rapid STI testing, could be useful for this particularly mobile population

Change of treatment guidelines and evolution of ART initiation in rural South Africa: data of a large HIV care and treatment programme

International audienceBackground: While WHO recommendations are to treat people earlier and earlier, it will considerably increase the number of HIV infected people eligible for antiretroviral therapy (ART). In South Africa, a country which carries one of the highest HIV burden worldwide, very few studies are available on the impact of the ART guidelines on time to ART initiation in both individuals with low CD4 count and those newly eligible for ART. We thus aimed to describe ART initiation percentages in a large HIV programme in rural KwaZulu-Natal, South Africa, according to the temporal changes of national ART eligibility guidelines from 2007 to 2012. Methods: Adults who accessed the decentralized Hlabisa HIV treatment programme in 2007–2012 were included. Three periods following the temporal change of ART eligibility guidelines were defined (Period 1: until). Percentages of ART initiation within three months of programme entry were estimated in men, in women of childbearing age (<40 years old) and in older women, and stratifying by CD4 count. Trend tests and logistic regression models were used to study the effects of change of guidelines on ART initiation percentages. Results: In individuals with CD4 count ≤200 cells/μL (N = 5709 men, N = 6743 women <40 years old and N = 2017 older women), percentages of ART initiation did not differ over time (p trend = 0.25; 0.28; and 0.14, respectively). In individuals with CD4 count = 201–350 cells/μL (N = 2680 men, N = 6086 women <40 years old and N = 1415 older women), percentages of ART initiation significantly increased over time (p trend <0.01 for the three groups): from 6 % in Period 1 to 20 % in Period 2 to 40 % in Period 3 in women of childbearing age, and from 7 % to 8-10 % to 42 % in men and in older women.Conclusions : As temporal changes of guidelines, percentages of ART initiation significantly increased in newly ART eligible people and did not decrease in individuals with very low CD4 counts. It will be crucial to continue verifying the evolution of these percentages of ART initiation with future recommendations reaching near-to-universal access to ART, to ensure that individuals most in need of ART receive it

Implementing PrEP among Female Sex Workers in Côte d’Ivoire: new challenges for models of care (PrEP-CI ANRS 12361)

In the past few years, two biomedical interventions have been added to classical tools of HIV prevention: early treatment (TasP) and oral pre-exposure prophylaxis (PrEP). Despite the high quality evidence from recent PrEP trials, research on how best to deliver PrEP in ‘real life’ in different populations and settings remains crucial.In Côte d’Ivoire, female sex workers (FSWs) have very high HIV prevalence (29%, UNAIDS 2015) and do not systematically use condoms: a 2014 survey showed condom use of 90% at last sexual act with a client and 15% with ‘non-client’ partner (Bamba et al. 2014). This strongly suggests that PrEP could be of great value to protect the ‘remaining risky sexual acts’.In this context, we conducted a qualitative survey among 60 FSWs reached by two community NGOs, to identify potential obstacles to regular clinical monitoring of HIV negative FSWs that any incoming program of PrEP will have to take into account. Results showed that barriers remain for HIV negative FSWs to access services offered in dedicated health centres. Implementing a program of PrEP for this population necessitate rethinking health care services and delivery system, as PrEP cannot be delivered without implementing a global package of sexual health services

« C'est difficile de la prendre tous les jours » : Initiations, arrêts précoces et perceptions de la prophylaxie pré-exposition (PrEP) orale parmi les travailleuses du sexe en Côte d'Ivoire

International audienceObjectifsLe projet PRINCESSE ANRS 12381 (12/2019 à 06/2023) a proposé une offre élargie en santé sexuelle et reproductive, incluant la prophylaxie pré-exposition (PrEP) orale, au sein d'une cohorte de travailleuses du sexe (TS) âgées de ≥18 ans dans la région de San Pedro en Côte d’Ivoire. Nous décrivons ici les initiations et les arrêts de la PrEP chez les participantes et explorons leurs perceptions pour en comprendre les obstacles et facilitateurs.Matériels et MéthodesLes soins étaient offerts dans une clinique communautaire et une clinique mobile opérant sur 10 sites de prostitution. L'analyse repose sur une méthodologie mixte incluant des entretiens qualitatifs avec 38 TS menés tout au long du projet et les fiches cliniques remplies par les médecins auprès de 416 TS VIH & VHB négatives.RésultatsDe nombreuses femmes reconnaissaient l'effet protecteur de la PrEP et témoignaient d’un fort intérêt pour initier (n=398 ; >96%). Parmi elles, 225 (57%) n’ont pas été revues dans les 6 semaines, 4 n'étaient plus intéressées, et seulement 169 (42%) ont effectivement initié.L’arrêt après l’initiation était fréquemment reporté par les TS, et les raisons incluaient les effets secondaires, la difficulté à prendre un traitement quotidien ou encore les périodes de mobilité avec arrêt du travail du sexe. Parmi les 169 ayant initié, 60 (36%) ont réalisé leur première visite de suivi, dont 16 (27%) ayant signalé avoir arrêté la PrEP. Parmi ces dernières, 4 (25%) ont déclaré ne plus être intéressées ; les autres ont reçu une nouvelle ordonnance.À chaque visite ultérieure de suivi, certaines TS avaient interrompu un temps la PrEP, et d’autres décidaient d’arrêter. Plus largement, la confiance dans la PrEP n'était pas totale parmi les femmes interrogées. Certaines ont rapporté des rumeurs et la crainte d'être identifiées comme séropositives par leurs collègues. D'autres semblaient ne pas avoir compris le fonctionnement de la PrEP quotidienne et utilisaient simultanément d'autres moyens pour se protéger contre le VIH, comme le lavement après un rapport sexuel sans préservatif.ConclusionBien que la perte de vue des TS ait été un problème majeur, ce n'était pas la seule barrière à l'initiation et au maintien de la PrEP. Malgré un fort intérêt, peu ont initié et l'arrêt était fréquent, en partie lié aux périodes de mobilité. La PrEP orale n'est pas une solution miracle : il semble difficile pour les TS de l’articuler avec d'autres priorités quotidiennes. Elles (ré)évaluent, à chaque étape du processus, la balance bénéfices (« théoriques ») / contraintes (« palpables ») de la PrEP. Dans cette population spécifique de TS, il est urgent de trouver de nouvelles façons de simplifier la prévention biomédicale du VIH, que ce soit en termes de dispositifs (PrEP à longue durée d’action par exemple) ou d’allègement du suivi

Défis de la prise en charge des condylomes acuminés en stratégie avancée dans une cohorte de travailleuses du sexe en Côte d’Ivoire : leçons apprises dans la cohorte ANRS 12381 Princesse

International audienceObjectifsLes condylomes acuminés résultent d’une infection du papillomavirus humain et peuvent évoluer vers des formes graves comme des cancers. Du fait de leurs pratiques, les travailleuses du sexe (TS) y sont particulièrement exposées. Nous décrivons ici les défis d’une prise en charge des condylomes en stratégie avancée.Matériels et MéthodesLe projet Princesse est une cohorte interventionnelle avec une offre de soins élargies en santé sexuelle, incluant un dépistage et une prise en charge des infections sexuellement transmissibles (IST), pour des TS de ≥ 18 ans dans la région de San Pedro, Côte d’Ivoire. Un suivi trimestriel est proposé, disponible à la fois sur sites prostitutionnels via une clinique mobile et à la clinique fixe d’Aprosam à San Pedro.RésultatsSur 381 TS suivies entre 11/2019 et 11/2020, 11 présentaient des condylomes à l’inclusion ou lors d’une visite de suivi. Dix présentaient des condylomes très développés (multiples, volumineux, kératosiques). Toutes présentaient des condylomes au niveau pubien et vaginal. Deux TS présentaient en plus des condylomes anaux.L’âge des patientes variait entre 19 et 42 ans. L’ancienneté dans le travail du sexe était variable (entre 1 et 17 ans), mais la majorité (10) travaillait dans des maisons closes, signe d’un nombre élevé de clients.Une participante a été vue en clinique fixe. Elle a bénéficié d’un traitement local à base de podophyllotoxine pour éviter de multiples cicatrices, suivi d’une cryothérapie.Les dix autres cas ont été diagnostiqués en clinique mobile qui, pour des raisons logistiques, ne dispose pas d’un appareil de cryothérapie. Les participantes vues en cliniques mobiles ont été référées vers laclinique fixe pour une prise en charge adéquate. À ce jour, aucune ne s’y est encore présentée, malgré des relances et le constat d’une extension du nombre de condylomes lors de visites de suivi.La clinique mobile disposant d’un appareil portatif de thermoablation pour la prise en charge des dysplasies du col (un dépistage annuel étant inclus), une thermoablation des condylomes a été essayée chez 6 TS pour lesquelles les condylomes étaient de bonne taille. En effet, si les condylomes sont plus petits que la sonde d’ablation, il y a un risque d’abimer des tissus sains. Aucun effet n’a été constaté immédiatement après la pose de la sonde, ni au cours des visites de suivi. Une TS s’est plainte de douleurs et de brûlures persistantes au bout de deux semaines.ConclusionLes TS sont exposées aux condylomes ano-génitaux et le diagnostic survient à un stade avancé. C’est une population difficile à engager dans les soins et le référencement vers une clinique fixe ne fonctionne pas. Une solution de prise en charge sur site est donc essentielle. Les appareils de cryothérapie sont peu adaptés pour un camion mobile. La thermoablation ne fonctionne pas sur les condylomes. L’arrivée d’appareil portatif d’électrocoagulation pourrait être une solution. Elle sera testée en 2022 dans Princesse