Accueil > Recherches / Research > TasP - Antiretroviral Treatment as Prevention

ANRS 12249

TasP - Antiretroviral Treatment as Prevention

lundi 5 septembre 2011
Mis à jour le dimanche 27 avril 2014

Antiretroviral Treatment as Prevention (TasP): a cluster-randomized trial in Hlabisa sub-district, KwaZulu-Natal, South Africa

Ukuphila kwami, ukuphila kwethu (My health for our health)

Le traitement antirétroviral comme moyen de prévention dans la pandémie VIH. Un essai randomisé en grappes à Hlabisa, KwaZulu-Natal, Afrique du Sud.

Responsables scientifiques

Partenariat

Financement

  • ANRS
  • GIZ (Deutsche Gesellschaft fur Internationale Zusammenarbeit)
  • Bill & Melinda Gates Foundation through 3ie

Résumé

Contexte : Trente ans après la découverte du virus de l’immunodéficience humaine (VIH), la question de la prévention du VIH est encore non résolue. Les traitements antirétroviraux (ARV) sont désormais mis en place à large échelle dans les pays à ressources limitées. Or il a été montré qu’un traitement ARV combinant des molécules ayant une forte capacité de suppression virale permettait de réduire la charge virale (CV) dans tous les compartiments corporels et de réduire le risque de transmission du VIH à de très faibles niveaux. Il semble donc légitime de se poser la question suivante : les traitements ARV pourraient-ils contribuer à réduire la transmission du VIH aux niveaux individuels et populationnels ? Non seulement le traitement précoce pourrait réduire l’incidence du VIH (les nouveaux cas d’infection par transmission sexuelle et transmission mère-enfant), mais il pourrait également offrir des bénéfices individuels. Les bénéfices à long terme du traitement précoce seraient d’autant plus grands que l’incidence des maladies opportunistes graves liées au VIH (tuberculose, infections bactériennes invasives et probablement le paludisme) survenant à des taux élevés de CD4 est élevée, comme c’est le cas dans la plus grande partie de l’Afrique sub-saharienne et notamment l’Afrique du Sud.

Hypothèses de recherche : Le dépistage VIH de tous les membres d’une communauté, suivi de la mise sous traitement immédiat de tous, ou quasiment tous, les individus infectés par le VIH, quel que soit leur statut immunologique ou clinique, préviendrait la transmission du VIH et réduirait l’incidence du VIH dans cette population.

Objectifs : Estimer directement l’impact du traitement ARV initié immédiatement après le diagnostic de l’infection par le VIH et quel que soit le niveau de CD4 des patients non encore éligibles au traitement ARV, sur l’incidence de nouvelles infections VIH dans la population générale de la même région.

Environnement : L’essai sera conduit dans le sous-district de Hlabisa, district de Umkhanyakude dans la province du KwaZulu Natal en Afrique du Sud. Cette zone rurale de 1 430km² compte approximativement 220 000 habitants, l’incidence du VIH y est estimée à 3,4%. L’Africa Centre for Health and Population Studies, un institut de recherche de l’Université du KwaZulu Natal (http://www.africacentre.com), y conduit des activités de surveillance démographique et des questions de santé dont l’infection à VIH/Sida. Le Département pour la Santé de la province du KwaZulu Natal et l’Africa Centre ont lancé en 2004 le Programme de Traitement et de Prise en Charge de Hlabisa, décentralisé à l’ensemble des 17 centre de santé primaires du sous-district. Mi-2013, plus de 28 000 individus infectés par le VIH et éligibles au traitement ARV, selon les recommandations actuellement en vigueur en Afrique du Sud, en bénéficiaient.

Méthodologie : Un essai randomisé en grappes (« clusters ») sera conduit dans le sous-district de Hlabisa au sein de 22 (2x11) grappes comprenant un total de 22 000 individus âgés de plus de 15 ans, 17 600 étant séronégatifs au début du programme. Un paquet global et le plus complet possible de services de prévention et de dépistage du VIH sera mis en place dans les deux groupes de grappes. Il s’agira notamment de combiner les services existants de dépistage à la clinique et au sein de la communauté, et la mise en place de cycles de six puis de quatre mois permettant d’offrir le dépistage du VIH à domicile. La population adulte infectée par le VIH et résidant dans les grappes tirées au sort pour constituer le bras « intervention » pourra être mise sous traitement ARV immédiatement tandis que la mise sous traitement de la population des grappes constituant le groupe de comparaison se fera selon les procédures actuelles recommandées par le gouvernement sud-africain, en incluant les individus présentant avec un taux de lymphocytes CD4 < 350 cellules/mL.

Mots-Clés

VIH/Sida, traitements antirétroviraux (ARV), prévention, dépistage, prise en charge.

Abstract

Background: Thirty years after the discovery of the human immunodeficiency virus (HIV), prevention is difficult to achieve and the pandemic does not show any sign of abating. Antiretroviral therapy (ART) is now rolled out at a large scale in lower-income countries. ART with fully suppressive antiretroviral (ARV) drugs combinations lowers HIV viral load (VL) in all body compartments and decreases the risk of transmission to a low level. It is thus legitimate to raise the following question: Could ART contribute to reducing transmission at individual and population level? Not only may earlier treatment reduce HIV incidence (acquisition of new cases of HIV infection through sexual or mother-to-child transmission), it may also benefit the individual. The long-term benefits of starting ART earlier would likely be of particular importance in settings where the incidence of life-threatening HIV-related diseases occurring at relatively high CD4 levels (tuberculosis, invasive bacterial diseases, and possibly malaria) is substantial, a typical situation in most sub-Saharan Africa including South Africa.

Research hypothesis: HIV testing of all adult members of a community, followed by immediate ART initiation of all, or nearly all, HIV-infected participants regardless of immunological or clinical staging will prevent onward transmission and reduce HIV incidence in this population.
Objectives: To estimate the effect of ART initiated immediately after HIV diagnosis, irrespective of CD4 count criteria, on the reduction in incidence of new HIV infections in the general population in the same setting.

Setting: The trial will be conducted in Hlabisa sub-district, Umkhanyakude district, Northern KwaZulu-Natal, South Africa. This rural setting of 1430 km2 in size has a population of approximately 220 000 Zulu-speaking people. In this sub-district, the Africa Centre for Health and Population studies, a research institute at the University of KwaZulu-Natal (http://www.africacentre.com) carries out socio-demographic and HIV surveillance and clinical research. The KwaZulu-Natal Department of Health and the Africa Centre established in 2004 the Hlabisa HIV Treatment and Care Programme, devolved to all 17 primary health care clinics in the sub-district. By mid-2013, over 28 000 HIV-infected people eligible for treatment had been initiated on ART; patients’ treatment eligibility is determined by South African guidelines.

Design: A cluster-randomised trial with 22 (2×11) clusters will be conducted within the Hlabisa sub-district, covering a total population of approximately 22 000 inhabitants aged 16 years and above, of whom an estimated 17 600 will be HIV-negative. A full prevention and HIV testing strategy will be provided in both the intervention and control arms, consisting of the current range of community and clinic testing options plus the implementation of 6-monthly rounds of home-based HIV testing. The adult HIV-infected population residing in the intervention clusters will be offered immediate ART initiation upon HIV diagnosis whereas the HIV-infected population in the control clusters will be offered ART according to national guidelines (CD4 less than 350 cells/ml, WHO stage 3 or 4 disease or MDR/XDR TB).

Zone géographique

KwaZulu-Natal, Afrique du Sud

Calendrier

  • 2011-2013 (phase un)
  • 2014-206 (phase deux)

Publications

2016

Article de revue


  • Boyer Sylvie, Iwuji Collins, Gosset Andréa, Protopopescu Camelia, Okesola Nonhlanhla, Plazy Mélanie, Spire Bruno, Orne-Gliemann Joanna, McGrath Nuala, Pillay Deenan, Dabis François, Larmarange Joseph et group on behalf of the ANRS 12249 TasP study (2016) « 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 », AIDS Care, 28 (sup3) (juin 02), p. 39-51. DOI : 10.1080/09540121.2016.1164808. http://dx.doi.org/10.1080/09540121.2016.1164808.
    Résumé : 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.


  • Camlin Carol S., Seeley Janet, Viljoen Lario, Vernooij Eva, Simwinga Musonda, Reynolds Lindsey, Reis Ria, Plank Rebeca, Orne-Gliemann Joanna, McGrath Nuala, Larmarange Joseph, Hoddinott Graeme, Getahun Monica, Charlebois Edwin D. et Bond Virginia (2016) « Strengthening universal HIV ‘test-and-treat’ approaches with social science research: », AIDS, 30 (6), p. 969-970. DOI : 10.1097/QAD.0000000000001008. http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00002030-201603270-00019.


  • Chikovore Jeremiah, Gillespie Natasha, McGrath Nuala, Orne-Gliemann Joanna, Zuma Thembelihle et Group On Behalf of the ANRS 12249 TasP Study (2016) « Men, masculinity, and engagement with treatment as prevention in KwaZulu-Natal, South Africa », AIDS Care, 28 (sup3) (juin 02), p. 74-82. DOI : 10.1080/09540121.2016.1178953. http://dx.doi.org/10.1080/09540121.2016.1178953.
    Résumé : Men’s poorer engagement with healthcare generally and HIV care specifically, compared to women, is well-described. Within the HIV public health domain, interest is growing in universal test and treat (UTT) strategies. UTT strategies refer to the expansion of antiretroviral therapy (ART) in order to reduce onward transmission and incidence of HIV in a population, through a “treatment as prevention” (TasP). This paper focuses on how masculinity influences engagement with HIV care in the context of an on-going TasP trial. Data were collected in January–November 2013 using 20 in-depth interviews, 10 of them repeated thrice, and 4 focus group discussions, each repeated four times. Analysis combined inductive and deductive approaches for coding and the review and consolidation of emerging themes. The accounts detailed men’s unwillingness to engage with HIV testing and care, seemingly tied to their pursuit of valued masculinity constructs such as having strength and control, being sexually competent, and earning income. Articulated through fears regarding getting an HIV-positive diagnosis, observations that men preferred traditional medicine and that primary health centres were not welcoming to men, descriptions that men used lay measures to ascertain HIV status, and insinuations by men that they were removed from HIV risk, the indisposition to HIV care contrasted markedly with an apparent readiness to test among women. Gendered tensions thus emerged which were amplified in the context where valued masculinity representations were constantly threatened. Amid the tensions, men struggled with disclosing their HIV status, and used various strategies to avoid or postpone disclosing, or disclose indirectly, while women’s ability to access care readily, use condoms, or communicate about HIV appeared similarly curtailed. UTT and TasP promotion should heed and incorporate into policy and health service delivery models the intrapersonal tensions, and the conflict, and poor and indirect communication at the micro-relational levels of couples and families.


  • Iwuji Collins C., Orne-Gliemann Joanna, Larmarange Joseph, Okesola Nonhlanhla, Tanser Frank, Thiebaut Rodolphe, Rekacewicz Claire, Newell Marie-Louise, Dabis Francois et Group ANRS 12249 TasP trial (2016) « Uptake of Home-Based HIV Testing, Linkage to Care, and Community Attitudes about ART in Rural KwaZulu-Natal, South Africa: Descriptive Results from the First Phase of the ANRS 12249 TasP Cluster-Randomised Trial », PLOS Med, 13 (8) (août 09), p. e1002107. DOI : 10.1371/journal.pmed.1002107. http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002107.
    Résumé : Collins Iwuji and colleagues report implementation indicators and early health outcomes from the first phase of a cluster-randomized trial of immediate antiretroviral therapy to all HIV-positive individuals in rural KwaZulu-Natal, South Africa.
    Mots-clés : antiretroviral therapy, Cluster trials, HIV, HIV diagnosis and management, HIV epidemiology, HIV prevention, Questionnaires, South Africa.


  • Moshabela Mosa, Zuma Thembelihle, Orne-Gliemann Joanna, Iwuji Collins, Larmarange Joseph, McGrath Nuala et Group on behalf of the ANRS 12249 TasP Study (2016) « “It is better to die”: experiences of traditional health practitioners within the HIV treatment as prevention trial communities in rural South Africa (ANRS 12249 TasP trial) », AIDS Care, 28 (sup3) (juin 02), p. 24-32. DOI : 10.1080/09540121.2016.1181296. http://dx.doi.org/10.1080/09540121.2016.1181296.
    Résumé : The ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomized trial in rural South Africa uses a “test and treat” approach. Home-based testing services and antiretroviral treatment initiation satellite clinics were implemented in every cluster as part of the trial. A social science research agenda was nested within TasP with the aim of understanding the social, economic and contextual factors that affect individuals, households, communities and health systems with respect to TasP. Considering the rural nature of the trial setting, we sought to understand community perceptions and experiences of the TasP Trial interventions as seen through the eyes of traditional health practitioners (THPs). A qualitative study design was adopted using four repeat focus group discussions conducted with nine THPs, combined with community walks and photo-voice techniques, over a period of 18 months. A descriptive, interpretive and explanatory approach to analysis was adopted. Findings indicate that THPs engaged with the home-based testing services and HIV clinics established for TasP. Specifically, home-based testing services were perceived as relatively successful in increasing access to HIV testing. A major gap observed by THPs was linkage to HIV clinics. Most of their clients, and some of the THPs themselves, found it difficult to use HIV clinics due to fear of labelling, stigma and discrimination, and the ensuing personal implications of unsolicited disclosure. On the one hand, a growing number of patients diagnosed with HIV have found sanctuary with THPs as alternatives to clinics. On the other hand, THPs in turn have been struggling to channel patients suspected of HIV into clinics through referrals. Therefore, acceptability of the TasP test and treat approach by THPs is a major boost to the intervention, but further success can be achieved through strengthened ties with communities to combat stigma and effectively link patients into HIV care, including partnerships with THPs themselves.


  • Orne-Gliemann Joanna, Zuma Thembelihle, Chikovore Jeremiah, Gillespie Natasha, Grant Merridy, Iwuji Collins, Larmarange Joseph, McGrath Nuala, Lert France, Imrie John et Group On Behalf of the TasP Study (2016) « Community perceptions of repeat HIV-testing: experiences of the ANRS 12249 Treatment as Prevention trial in rural South Africa », AIDS Care, 28 (sup3) (juin 02), p. 14-23. DOI : 10.1080/09540121.2016.1164805. http://dx.doi.org/10.1080/09540121.2016.1164805.
    Résumé : In the context of the ANRS 12249 Treatment as Prevention (TasP) trial, we investigated perceptions of regular and repeat HIV-testing in rural KwaZulu-Natal (South Africa), an area of very high HIV prevalence and incidence. We conducted two qualitative studies, before (2010) and during the early implementation stages of the trial (2013–2014), to appreciate the evolution in community perceptions of repeat HIV-testing over this period of rapid changes in HIV-testing and treatment approaches. Repeated focus group discussions were organized with young adults, older adults and mixed groups. Repeat and regular HIV-testing was overall well perceived before, and well received during, trial implementation. Yet community members were not able to articulate reasons why people might want to test regularly or repeatedly, apart from individual sexual risk-taking. Repeat home-based HIV-testing was considered as feasible and convenient, and described as more acceptable than clinic-based HIV-testing, mostly because of privacy and confidentiality. However, socially regulated discourses around appropriate sexual behaviour and perceptions of stigma and prejudice regarding HIV and sexual risk-taking were consistently reported. This study suggests several avenues to improve HIV-testing acceptability, including implementing diverse and personalised approaches to HIV-testing and care, and providing opportunities for antiretroviral therapy initiation and care at home.


  • Plazy Mélanie, Farouki Kamal El, Iwuji Collins, Okesola Nonhlanhla, Orne-Gliemann Joanna, Larmarange Joseph, Lert France, Newell Marie-Louise, Dabis François et Dray-Spira Rosemary (2016) « 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 », Journal of the International AIDS Society, 19 (1) (juin 1). DOI : 10.7448/IAS.19.1.20913. http://www.jiasociety.org/index.php/jias/article/view/20913.
Article de colloque

  • Iwuji Collins, Orne-Gliemann Joanna, Balestre Eric, Larmarange Joseph, Thiébaut Rodolphe, Tanser Frank, Okesola Nonhlanhla, Makowa Thembisa, Dreyer Jaco, Herbst Kobus, McGrath Nuala, Bärnighausen Till, Boyer Sylvie, de Oliveira Tulio, Rekacewicz Claire, Bazin Brigitte, Newell Marie-Louise, Pillay Deenan, Dabis François et ANRS 12249 TasP Study Group (2016) « The impact of universal test and treat on HIV incidence in a rural South African population: ANRS 12249 TasP trial, 2012-2016 » (communication orale n°FRAC0105LB), présenté à 21st International AIDS Conference (AIDS 2016), Durban. http://programme.aids2016.org/Abstract/Abstract/10537.
    Résumé : Background: The population impact of universal test and treat (UTT) on HIV transmission has not yet been evaluated. Methods: A cluster-randomized trial was implemented in 2x11 rural communities in KwaZulu-Natal, South Africa. All residents ≥16 years were offered rapid HIV testing and provided dried blood spots (DBS) during 6-monthly home-based survey rounds. HIV-positive participants were referred to cluster-based trial clinics to receive ART regardless of CD4 count (intervention arm) or according to national guidelines (control arm). Standard of care ART was also available in the Department of Health clinics. HIV incidence was estimated on repeat DBS using cluster-adjusted Poisson regression. Results: Between 03/2012 and 04/2016, 13,239 and 14,916 individuals (63% women, median age 30 years) were registered in the intervention and control arms. Contact frequency per round among registered individuals ranged from 64% to 83%, HIV ascertainment from 74% to 85%. Baseline HIV prevalence was 29.4%(95%CI 28.8-30.0), with 7,578 individuals identified as HIV-positive. 1,513(36%) of 4,172 HIV-positive individuals not previously in care linked to trial clinics within 6 months of referral. ART initiation in trial clinics at 3 months was 90.9%(576/634) and 52.3%(332/635) in the intervention and control arms; viral suppression (< 400 copies/mL) 12 months after ART initiation was 94.9%(300/316) and 94.2%(194/206), respectively. Overall ART coverage at entry was 31% and 36% in the intervention and control arms, reaching 41% in both arms by closing date. Repeat DBS tests were available for 13,693 individuals HIV-negative at baseline, yielding 461 seroconversions in 20,833 person-years (PY). HIV incidence was 2.16 per 100 PY (1.88-2.45) in the intervention arm and 2.26 (1.98-2.54) in the control arm (adjusted relative risk: 0.95 [0.82-1.10]). Severe adverse events rates were 3.4%(45/1,323) and 3.5%(57/1,604) in the intervention and control arms. Follow-up will be completed by 06/2016. Conclusions: Our trial shows high acceptance of home-based HIV testing and high levels of viral suppression among individuals on ART. However overall linkage to care remains poor. No reduction in HIV incidence was demonstrated. Several factors are being investigated, including determinants of poor linkage, change in national ART guidelines, migration and geography of sexual networks. (Funded by ANRS, GiZ and 3ie; Clinical Trials registration NCT00332878).

  • Larmarange Joseph, Iwuji Collins, Orne-Gliemann Joanna, McGrath Nuala, Plazy Mélanie, Baisley Kathy, Bärnighausen Till, Dabis François, Pillay Deenan et ANRS 12249 TasP Study Group (2016) « Measuring the Impact of Test and Treat on the HIV Cascade: the Challenge of Mobility » (communication orale), présenté à Conference on Retroviruses and Opportunistic Infections (CROI), Boston. http://www.croiwebcasts.org/console/player/29736.
    Résumé : Background Universal test and treat (UTT) could substantially improve the HIV care cascade at population level (i.e. the proportion of all HIV-infected people being diagnosed, on ART and virally suppressed at a given date) and thus reduce HIV incidence. Several trials are currently exploring this hypothesis. Due to demographic change, the study population of HIV-infected individuals is composed of people with various degrees of exposure to the trial interventions. This structural effect could potentially dilute the impact observed at population level of a UTT strategy. Here, we describe a dynamic cascade according to both calendar (population) and exposure (individual) time approaches, using preliminary data from the ANRS 12249 TasP cluster-randomized trial ongoing in rural KwaZulu-Natal (South Africa). Methods Analysis was conducted within a subgroup of 4 clusters with the longest follow-up time where five six-monthly rounds of home-based HIV testing had been conducted between March 2012 and July 2015. Resident members 16 years and above were offered rapid HIV testing and asked to provide dried blood spots (DBS) each time. Those ascertained HIV-positive were referred to local trial clinics for ART initiation and follow-up. HIV tests results and information on clinic visits, ART prescription, viral load and CD4 count, migration and death were used to calculate residency status, HIV status and HIV care status for each individual on each calendar day. This calendar cascade was then compared to the exposure cascade, where each status was recalculated for individuals at any given date with exposure time defined as the duration since trial registration. Results Figure 1 - CROI Abstract According to calendar time, the overall cascade improved rapidly during the first 15 months of the trial (from 25 to 40% virally suppressed), but more slowly thereafter (Fig a). Although the target population size of HIV-infected people remained rather stable over time ( 665 individuals, Fig b), population turnover was high (Fig c). According to exposure time, with a decreasing sample size over time (Fig e), the cascade improved continuously between M0 and M30, from 20% to 50% virally suppressed (Fig. d). Conclusions Population mobility dilutes the observed impact of UTT interventions on the cascade at population level. These preliminary findings also suggest that the impact of a UTT approach could be maximized as long as there is a coordination to facilitate continued access to care when people move.

  • Orne-Gliemann Joanna, Zuma Thembelihle, Larmarange Joseph et ANRS 12249 TasP Study Group (2016) « Home-based HIV testing and linkage to care : lessons learned from the ANRS 12249 TasP trial » (communication orale (MOSA4402), présenté à 21st International AIDS Conference (AIDS 2016), Durban. http://programme.aids2016.org/Programme/Session/126.

2015

Article de revue

  • Iwuji Collins, Dray-Spira Rosemary, Calmy Alexandra, Larmarange Joseph, Orne-Gliemann Joanna, Dabis Francois, Pillay Deenan et Porter Kholoud (2015) « Does a universal test and treat strategy impact ART adherence in rural South Africa? ANRS 12249 TasP cluster-randomized trial », Journal of the International Aids Society, 18. DOI : 10.7448/IAS.18.5.20340.


  • Orne-Gliemann Joanna, Larmarange Joseph, Boyer Sylvie, Iwuji Collins, McGrath Nuala, Bärnighausen Till, Zuma Thembelile, Dray-Spira Rosemary, Spire Bruno, Rochat Tamsen, Lert France, Imrie John et ANRS 12249 TasP Study Group (2015) « Addressing social issues in a universal HIV test and treat intervention trial (ANRS 12249 TasP) in South Africa: methods for appraisal », BMC Public Health, 15 (1) (mars 01), p. 209. DOI : 10.1186/s12889-015-1344-y. http://www.biomedcentral.com/1471-2458/15/209/abstract.
    Mots-clés : Antiretroviral treatment, Behaviour, Community, Cost, HIV care, HIV Infections, HIV testing, Social, South Africa.

  • Plazy Melanie, ElFarouki Kamal, Iwuji Collins, Okesola Nonhlanhla, Orne-Gliemann Joanna, Larmarange Joseph, Newell Marie-Louise, Pillay Deenan, Dabis Francois et Dray-Spira Rosemary (2015) « Entry into care following universal home-based HIV testing in rural KwaZulu-Natal, South Africa: the ANRS TasP 12249 cluster-randomized trial », Journal of the International Aids Society, 18. DOI : 10.7448/IAS.18.5.20409.
Article de colloque
  • Iwuji Collins, Dray-Spira Rosemary, Calmy Alexandra, Larmarange Joseph, Orne-Gliemann Joanna, Dabis François, Pillay Deenan et Porter Kholoud (2015) « Does a universal test and treat strategy impact ART adherence in rural South Africa? ANRS 12249 TasP cluster-randomized trial » (communication orale n°MOAC0104), présenté à 8th IAS Conference on HIV Pathogeneis, Treatment & Prevention, Vancouver.
    Résumé : Background: HIV treatment guidelines are recommending ART at increasingly higher CD4 counts for maximizing individual and population benefits. However, the expansion of ART use may be at the expense of optimal adherence. We report on adherence and virological suppression when initiating ART at different CD4 thresholds within the Treatment as Prevention (ANRS 12249) trial of universal home-based testing and immediate ART initiation in rural KwaZulu-Natal. Methods: Using data of a cluster-randomised trial of immediate ART vs. initiation according to current national guidelines (CD4≤350cells/mm3), we compared adherence levels (≥95% vs. < 95%) measured using a visual analogue scale (VAS) and pill count (PC) and virological suppression at 6 months (< 400 c/mL) according to CD4 count at ART initiation through logistic regression models, adjusting for possible confounders (age, sex, marital status, education and employment). Results: During March 2012-May 2014, 601 participants who were not on ART entered care in trial clinics; 382 initiated ART; 254 have completed ≥6 months on ART, 227 of whom had 6 months HIV RNA data and were included in analyses. 169 were women; median (IQR) age and CD4 at ART initiation were 35 years (28, 46) and 313cells/mm3 (206, 513). Adherence ≥95% at 6 months was high (88% and 83% by PC and VAS, respectively) with no evidence that this was associated with CD4 at initiation (aOR=0.97 per 100 cells/mm3 higher, 95%-CI: 0.83-1.12, p=0.65 for VAS; aOR 1.13 per 100cells/mm3 higher, 0.98-1.31, p=0.09 for PC). Male sex was independently associated with < 95% adherence (2.58, 1.24-5.35, p= 0.01; ref. females). 83% (183/227) of those who started ART achieved HIV suppression by 6 months with no association with CD4 at initiation (1.13 per 100cells/mm3 higher, 0.96-1.33, p=0.40). Compared to those with ≥95% adherence by VAS, individuals with < 95% adherence were somewhat less likely to suppress (0.44, 0.19-1.03, p=0.06). Conclusions: We found no evidence that, among people newly entering HIV care, higher CD4 at ART initiation was associated with reduced adherence or poorer virological suppression, at least in the short-term. In this rural South African setting, motivation to adhere to ART may be independent of the presence of symptomatic HIV disease.

  • Larmarange Joseph (2015) « Treatment as Prevention (TasP) studies: the challenge of CD4 count treatment eligibility changes in Africa. Perspectives from the TasP ANRS 12249 trial » (communication orale), présenté à 9th INTEREST Workshop, Harare. http://www.virology-education.com/online-program-9th-interest/.
  • Plazy Mélanie, El Farouki Kamal, Iwuji Collins, Okesola Nonhlanhla, Orne-Gliemann Joanna, Larmarange Joseph, Newell Marie-Louise, Pillay Deenan, Dabis François, Dray-Spira Rosemary et ANRS 12249 TasP Study Group (2015) « Entry into care following universal home-based HIV testing in rural KwaZulu-Natal, South Africa: the ANRS TasP 12249 cluster-randomised trial » (communication orale n°WEAD0103), présenté à 8th IAS Conference on HIV Pathogeneis, Treatment & Prevention, Vancouver.
    Résumé : Background: In a Universal Test and Treat (UTT) strategy, entry into care soon after HIV diagnosis is crucial to achieve optimal population-antiretroviral treatment (ART) coverage. We evaluated the rate of, and factors associated with, entry into care following home-based HIV testing in a cluster-randomised trial of the effect of immediate ART on HIV incidence in rural KwaZulu-Natal, South Africa. Methods: From March 2012 to May 2014, individuals ≥16 years in ten (2 x 5) clusters were offered home-based HIV testing; those ascertained HIV-positive were referred to TasP trial clinics and were offered universal and immediate ART (intervention clusters) or according to national guidelines (control clusters). Entry into care was defined as attending a TasP clinic within three months of referral among adults not actively in HIV care (no visit to local HIV programme within past 13 months). Associated factors were identified separately by sex, using multivariable logistic regression. Results: Overall, 1,205 adults (72.6% women) not actively in HIV care were referred to a TasP clinic. Of these, 405 (33.6%) attended a TasP clinic within three months (no difference between trial arms): 32.5% of women, 36.7% of men. Participants who ever visited the local HIV programme (n=360) were more likely to enter into care than those who didn''t (women: adjusted Odd-Ratio (aOR) 1.76, 95% Confidence Interval [1.26-2.45]; men: 2.07 [1.18-3.64]). In women (n=875), those less likely to attend a TasP clinic within three months had completed some secondary school (0.51 [0.33-0.79]) or at least secondary school (0.47 [0.29-0.76]) versus below primary school; were living 1-2 km from a TasP clinic (0.43 [0.30-0.62]) or 2-5 km (0.40 [0.27-0.61]) versus < 1 km; didn''t know anyone HIV+ within their family (0.60 [0.43-0.81]) and didn''t agree that it is good to initiate ART as soon as possible if infected (0.47 [0.26-0.85]); among men (n=330), none of the factors examined was significantly associated with entry into care. Conclusions: Only one-third of HIV-positive adults referred after home-based HIV testing entered into care within three months in this rural South African community with a 30% HIV prevalence. Innovative interventions should be considered to ensure the success of a UTT strategy.

2014

Article de revue
Article de colloque

  • Iwuji Collins, Orne-Gliemann Joanna, Tanser Frank, Thiébaut Rodolphe, Larmarange Joseph, Okesola Nonhlanhla, Newell Marie-Louise et Dabis François (2014) « Feasibility and acceptability of an antiretroviral treatment as prevention (TasP) intervention in rural South Africa: results from the ANRS 12249 TasP cluster-randomised trial » (communication orale n°WEAC0105LB), présenté à 20th International AIDS Conference, Melbourne. http://pag.aids2014.org/session.aspx?s=1118.

  • Larmarange Joseph, Orne-Gliemann Joanna, Balestre Eric, Iwuji Collins, Okesola Nonhlanhla, Newell Marie-Louise, Dabis François, Lert France et TasP ANRS 12249 Study Group (2014) « HIV ascertainment through repeat home-based testing in the context of a Treatment as Prevention trial (ANRS 12249 TasP) in rural South Africa » (poster P52.05), présenté à HIV Research for Prevention, Cape Town. DOI : 10.1089/aid.2014.5650.abstract.
    Résumé : Background The ANRS 12249 TasP cluster-randomised trial evaluates whether HIV testing of all members of a community, followed by immediate antiretroviral treatment (ART) for infected people, will prevent onward sexual transmission and reduce HIV incidence at population level. Ascertaining the HIV status of a high proportion of the population regularly and repeatedly is key to the success of any universal test and treat strategy, as the first step of the HIV cascade. Methods Between March 2012 and March 2014, we implemented three six-monthly rounds of home-based HIV counselling and testing in ten local communities (clusters). At each home visit, individual questionnaires were administered and a rapid HIV test offered to all trial participants. We report early results on rates of HIV ascertainment, defined as undergoing a rapid HIV test or HIV-positive self-report. Results Of 12,911 eligible individuals (resident in the trial area and ≥16 years), 10,007 were successfully contacted at least once. At first contact, HIV status was ascertained for 7,628 (76.2% [95% CI: 75.4-77.1]) individuals. At second contact, among the 5,885 individuals contacted a second time, HIV status was ascertained for 2,829 (85.0% [95% CI: 83.7-86.2]) of the 3,328 tested negative at first contact and for 543 (45.7% [95% CI: 42.9-48.6]) of the 1,188 who refused a rapid test at first contact. Overall, HIV ascertainment rate was 89.0% (5,239/5,885 [95% CI: 88.2-89.8]) among trial participants contacted twice. Conclusions Repeat home-based HIV testing is acceptable and feasible in this rural area. Socio-demographic characteristics, behaviours, attitudes, household characteristics and experience of HIV infection and ART in the household will be explored for their association with HIV ascertainment uptake. This will inform whether this intervention reaches the individuals at higher risk in a rural South African region.

2013

Article de revue


  • Iwuji Collins C, Orne-Gliemann Joanna, Tanser Frank, Boyer Sylvie, Lessells Richard J, Lert France, Imrie John, Bärnighausen Till, Rekacewicz Claire, Bazin Brigitte, Newell Marie-Louise, Dabis François et ANRS 12249 TasP study group (2013) « Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial », Trials, 14 (1), p. 230. DOI : 10.1186/1745-6215-14-230. http://clinicaltrials.gov/ct2/show/NCT01509508?term=anrs+12249&rank=1.
    Résumé : BACKGROUND: Antiretroviral therapy (ART) suppresses HIV viral load in all body compartments and so limits the risk of HIV transmission. It has been suggested that ART not only contributes to preventing transmission at individual but potentially also at population level. This trial aims to evaluate the effect of ART initiated immediately after identification/diagnosis of HIV-infected individuals, regardless of CD4 count, on HIV incidence in the surrounding population. The primary outcome of the overall trial will be HIV incidence over two years. Secondary outcomes will include i) socio-behavioural outcomes (acceptability of repeat HIV counselling and testing, treatment acceptance and linkage to care, sexual partnerships and quality of life); ii) clinical outcomes (mortality and morbidity, retention into care, adherence to ART, virologic failure and acquired HIV drug resistance), iii) cost-effectiveness of the intervention. The first phase will specifically focus on the trial's secondary outcomes. METHODS/DESIGN: A cluster-randomised trial in 34 (2 × 17) clusters within a rural area of northern KwaZulu-Natal (South Africa), covering a total population of 34,000 inhabitants aged 16 years and above, of whom an estimated 27,200 would be HIV-uninfected at start of the trial. The first phase of the trial will include ten (2 × 5) clusters. Consecutive rounds of home-based HIV testing will be carried out. HIV-infected participants will be followed in dedicated trial clinics: in intervention clusters, they will be offered immediate ART initiation regardless of CD4 count and clinical stage; in control clusters they will be offered ART according to national treatment eligibility guidelines (CD4 <350 cells/μL, World Health Organisation stage 3 or 4 disease or multidrug-resistant/extensively drug-resistant tuberculosis). Following proof of acceptability and feasibility from the first phase, the trial will be rolled out to further clusters. DISCUSSION: We aim to provide proof-of-principle evidence regarding the effectiveness of Treatment-as-Prevention in reducing HIV incidence at the population level. Data collected from the participants at home and in the clinics will inform understanding of socio-behavioural, economic and clinical impacts of the intervention as well as feasibility and generalizability. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01509508; South African Trial Register: DOH-27-0512-3974.
Article de colloque
  • Imrie John, Larmarange Joseph, Orne-Gliemann Joanna, Iwuji Collins, Lert France et ANRS 12249 TasP Study Group (2013) « Issues emerging from universal test and treat (UTT) intervention trials » (communication orale n°CS20#2), présenté à 2nd International Conference for the Social Sciences and Humanities in HIV, Paris.
    Résumé : Universal repeat testing and early antiretroviral treatment (UTT) strategies to reduce onward sexual transmission are major social, as well as biomedical interventions. Several UTT trials are underway or being prepared. This paper discusses some emerging issues arguing extensive social science within UTT trials needs complementary enquiry to guide public health and operational decisions beyond the trials themselves. The issues fall under three broad headings: 1) Social and behavioural consequences of large numbers of people knowing their HIV-status and potentially beginning treatment early. Will the impacts on sexual behaviour, disclosure and stigma all be positive? Harmful? 2) Normative changes at individual and community levels. What normative changes occur in communities exposed to prolonged, intense research around unspoken or socially taboo subjects? Does seeing more healthy people attending clinics alter community perceptions of disease and care? Can salient positive changes be identified and replicated? 3) Operational and ethical implications of transforming research interventions into routine care. Who should lead? Requirements for sustainability. Impacts of institutions ‘knowing’ about individuals’ HIV status and care uptake, especially in contexts of criminalisation and marginalised or vulnerable populations? UTT strategies have potentially great social consequences that need to be explored alongside the actual trials, to guide and inform future decisions and policy.
  • Imrie John, Larmarange Joseph, Orne-Gliemann Joanna, Lert France et ANRS 12249 TasP Study Group (2013) « Taking test and treat interventions to the next level – Beginning to think what additional information needs to guide public health and operational decisions? » (poster n°2289118), présenté à 6th South African AIDS Conference, Durban.
    Résumé : Background The proposition universal repeat HIV testing and early initiation of antiretroviral treatment for all HIV-positives (UTT) can lead to reduced HIV incidence is being, or will be, tested in several studies. UTT interventions are major social, as well as biomedical interventions, for individuals and target communities. Implementing UTT trial (ANRS 12249 TasP Trial) provoked thinking about what is needed for public health and operational decisions to move to the next level if UTT efficacy is demonstrated. Methods In ANRS 12249 Tasp Trial innovative social science tools are implemented at each UTT stage to ensure a comprehensive understanding of the social determinants of intervention uptake at the individual and community-level and the impacts at individual, household and community level. But these alone cannot guide such a decision. Results Additional questions requiring answers: Social and Behavioural consequences of UTT: What are the long-term social and behavioural consequences of large numbers of people knowing their HIV-status and starting treatment early? Will impacts on sexual behaviour, disclosure and stigma necessarily be positive, now and in the long term? Changes in individual and community norms: Will community perceptions of HIV and healthcare be changed seeing healthy people going to clinics? How are community norms around testing and treatment, stigma and discrimination affected by prolonged, intense research? Can salient positive changes be identified and replicated? Operational and ethical implications of moving UTT into routine care: Who should lead? What are the sustainability requirements? What ethical issues are there in authorities ‘knowing’ individuals’ HIV status and care uptake? Conclusions UTT strategies have potentially great social consequences for the individuals and populations involved. Questions emerging from UTT trials need further enquiry before public health and operational decisions to move beyond the trials are made.
  • Larmarange Joseph, Imrie John, Orne-Gliemann Joanna, Iwuji Collins, Lert France et ANRS 12249 TasP Study Group (2013) « Socio-economic issues investigated in an HIV Treatment as Prevention (TasP) trial in rural KwaZulu-Natal: research questions, implementation and progress » (poster n°2288617), présenté à 6th South African AIDS Conference, Durban.
    Résumé : Background HIV testing of all adult members of a community, followed by immediate antiretroviral treatment (ART) initiation of HIV-infected participants, regardless of immunological or clinical staging, could prevent onward transmission and reduce HIV incidence. The community cluster-randomized ANRS 12249 Treatment as Prevention (TasP) trial has been designed to test acceptability, feasibility and efficacy of this strategy in Hlabisa sub-district, KwaZulu-Natal. In addition to epidemiological, clinical and operational challenges, TasP raises unprecedented social challenges at individual and population levels. Methods The trial began in March 2012. Innovative research tools are being implemented at each stage of the TasP intervention: repeat home-based questionnaires with household heads and individual household members; specific questionnaires for the HIV-infected individuals attending trial clinics and for those who choose not enter HIV care; combined with in-depth semi-structured individual qualitative interviews, repeat focus groups discussions (consumer panels) using participatory methods. Results We will be able to describe precisely participation in the trial and to understand the social determinants of uptake in terms of repeat HIV testing, linkage to and retention in HIV care; the impact of this TasP strategy on quality of life; the economic impact on households and the healthcare system; and consequences for people’s life in terms of HIV disclosure, stigma, sexual behaviours, social support, treatment experience and adherence. Conclusions TasP is not just a biomedical intervention. Understanding the consequences of implementing universal HIV testing and ART on individual behaviour changes and community social norms is crucial to explain any observe impact on HIV incidence.
  • Larmarange Joseph, Imrie John, Orne-Gliemann Joanna, Iwuji Collins, Lert France et ANRS 12249 TasP Study Group (2013) « Addressing social science in a HIV Treatment as Prevention trial in South Africa » (communication orale n°CS12#1), présenté à 2nd International Conference for the Social Sciences and Humanities in HIV, Paris.
    Résumé : Models show that universal HIV testing and early antiretroviral treatment (ART) could lead to reduced HIV incidence and potential eradication under assumptions that have yet to be observed in real life – high coverage and frequent repeat HIV testing, high levels of linkage and retention in care. ANRS 12249 Treatment as Prevention (TasP) trial in rural KwaZulu-Natal aims to evaluate acceptability, feasibility and efficacy of this strategy. It has two components: home-based testing of all ≥16 years every six months with immediate versus standard ART initiation for HIV-infected individuals (HIV+). TasP is a biomedical intervention raising unprecedented social challenges. Relationships between individual and community factors, their interactions and implications are all being investigated using innovative quantitative and qualitative tools. Key issues addressed include: Who accepts repeat testing/immediate ART and why? What are the obstacles? How TasP impacts on people’s lives in terms of quality of life; HIV disclosure; stigmatisation, relationships; sexual behaviours; perceptions; social support; treatment experience and adherence? Economic impact for households and health care systems? What are the changes at community level during TasP implementation and influences on individual behaviours? These are investigated in three groups: the general population; HIV+ attending clinics; and those who do not entre care, for a comprehensive understanding of the determinants of uptake.
  • Larmarange Joseph, Orne-Gliemann Joanna, Iwuji Collins, Imrie John, Lert France, Dabis François, Newell Marie-Louise et ANRS 12249 TasP Study Group (2013) « Acceptability and Uptake of Repeat Home-based HIV Counselling and Testing in Rural South Africa. Preliminary Data of the ANRS 12249 TasP Trial » (poster n°2406992), présenté à 17th International Conference on AIDS and STIs in Africa (ICASA), Cape Town.
    Résumé : Background: The ANRS 12249 Treatment as Prevention (TasP) trial is assessing whether HIV testing of all members of a community, followed by immediate ART initiation of all HIV-infected individuals, regardless of immunological or clinical staging, will prevent onward sexual transmission and reduce HIV incidence in the same population. The implementation of universal and repeat home-based HIV testing is not documented yet in a high HIV incidence and prevalence context. Methods: A cluster-randomised trial is implemented using a phased-approach in the Hlabisa sub-district (KwaZulu Natal, South Africa) where more than 20% of adults are living with HIV. The trial started in March 2012; ten clusters are implemented in the first phase to assess the feasibility and acceptability of the two consecutive interventions (test then treat). The HIV testing strategy consists in a large range of community and clinic HIV testing options including the implementation of 6-monthly rounds of home-based HIV counselling and testing by dedicated counsellors. At each home visit, trial participants are administered individual questionnaires and offered a rapid HIV test. Results: As of April 30, 2013, 6 907 eligible subjects (16 years or above) were registered in six clusters and 5 122 (74%) were contacted. HIV status of 3 923 (76.5% of those contacted) was ascertained, 3 256 accepting the rapid HIV test at home and 667 being already aware of their HIV-positive status. We will present updated data from the first four trial clusters, where all eligible members of the community will have been offered three rounds of home-based HIV testing within 18 months. Uptake of HIV testing at each round will be reported. Uptake of repeat HIV testing will be measured among those testing HIV-negative at first round and who accept repeat HIV testing at rounds 2 and 3. We will also describe the reasons for HIV test refusal. Finally, we will present participants' attitudes regarding repeat HIV testing, and changes between rounds 1 and 3. Conclusions: Acceptance of regular and frequent HIV testing is key to the community-based efficacy of treatment as prevention initiatives in settings with very high incidence. Our data will provide first indications of whether repeat home-based HIV testing is acceptable and feasible in such a rural South African region.
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