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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.

Iwuji CC, Orne-Gliemann J, Tanser F, Boyer S, Lessells RJ, Lert F, Imrie J, Bärnighausen T, Rekacewicz C, Bazin B, Newell ML, Dabis F, ANRS 12249 TasP Study Gro - Trials (2013)

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Somkhele, KwaZulu-Natal, South Africa. ciwuji@africacentre.ac.za

ABSTRACT

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.

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Description of the different components of the ANRS 12249 TasP trial.
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Figure 1: Description of the different components of the ANRS 12249 TasP trial.

Mentions: This is a cluster-randomised controlled trial planned to take place over five years (2012 to 2016). The overall trial consists of 34 (2 × 17) clusters divided into two arms, covering a total population of 34,000 eligible inhabitants, of whom an estimated 27,200 would be HIV-uninfected at trial commencement. In the trial communities HIV testing of all members will take place at regular intervals (component 1). The impact of two different ART initiation strategies on HIV incidence (component 2) will then be compared as illustrated in Figure 1. During the first phase of the trial, three consecutive rounds of home-based HIV testing are implemented in the first four clusters; the duration of the first calendar round of testing (CR) is six months, the second and the third CRs are four months. Six-monthly CR is planned in the subsequent six clusters and for the rest of the clusters if the second phase is implemented. Follow up of HIV-infected participants in trial clinics (one in each cluster) is planned for 24 months in the overall trial, and for a maximum of 20 months during the first phase if the trial does not continue into the second phase.


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.

Iwuji CC, Orne-Gliemann J, Tanser F, Boyer S, Lessells RJ, Lert F, Imrie J, Bärnighausen T, Rekacewicz C, Bazin B, Newell ML, Dabis F, ANRS 12249 TasP Study Gro - Trials (2013)

Description of the different components of the ANRS 12249 TasP trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3750830&req=5

Figure 1: Description of the different components of the ANRS 12249 TasP trial.
Mentions: This is a cluster-randomised controlled trial planned to take place over five years (2012 to 2016). The overall trial consists of 34 (2 × 17) clusters divided into two arms, covering a total population of 34,000 eligible inhabitants, of whom an estimated 27,200 would be HIV-uninfected at trial commencement. In the trial communities HIV testing of all members will take place at regular intervals (component 1). The impact of two different ART initiation strategies on HIV incidence (component 2) will then be compared as illustrated in Figure 1. During the first phase of the trial, three consecutive rounds of home-based HIV testing are implemented in the first four clusters; the duration of the first calendar round of testing (CR) is six months, the second and the third CRs are four months. Six-monthly CR is planned in the subsequent six clusters and for the rest of the clusters if the second phase is implemented. Follow up of HIV-infected participants in trial clinics (one in each cluster) is planned for 24 months in the overall trial, and for a maximum of 20 months during the first phase if the trial does not continue into the second phase.

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Somkhele, KwaZulu-Natal, South Africa. ciwuji@africacentre.ac.za

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus