Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence (TasP)

A Cluster Randomised Trial Comparing the Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence. The ARNS 12249 TasP (Treatment as Prevention) Trial in Hlabisa Sub-district, KwaZulu-Natal, South Africa.

This trial is evaluating a public health intervention strategy trial which aims to reduce the incidence of HIV at a population-level. The proposed strategy is a two steps process: Extensive HIV counselling and testing, and comprehensive prevention programme among a target population Immediate ART initiation after HIV diagnosis, irrespective of CD4 count criteria. The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in the population. This is a cluster randomised controlled trial with a total of 22 communities used as the units for randomisation. Enrolment of a population of 22 000 individuals among which 4 400 are expected to be HIV-Infected.

The trial objective is to estimate the effect of ART initiated immediately after HIV diagnosis on the reduction in incidence of new HIV infections in the general population. It will be conducted in two phases: First phase: aiming to evaluate the feasibility and acceptability of extensive HIV testing and early ARV treatment initiation on a subset of the target population (Hlabisa sub-district in KwaZulu Natal, South Africa); completion on February 2014. Second phase: full implementation of the trial in the target population from May 2014. The proposed intervention has two components : Component 1 "Test": HIV counselling and testing, and comprehensive prevention programme among the entire target population Component 2 "Treat": ART treatment initiation for HIV infected individuals following two strategies control group: ART initiation when eligible for treatment as per WHO guidelines intervention group: immediate ART initiation regardless of immunological and clinical staging

HIV-infected individuals will be assessed clinically and immunologically and when eligible for treatment as per South African guidelines will be offered ART

All HIV-infected adults will be offered ART regardless of their immunological and clinical staging. The first line regimen proposed will be Atripla (R), a fixed dose combination containing tenofovir disoproxil (245 mg)/emtricitabine (200 mg)/efavirenz (600 mg)(FTC/TDF/EFV). The dosing will be 1 tablet OD.

HIV-infected adult participants will be eligible for ART as per the South African guidelines (August 2011) if: CD4 count ≤ 350 cells/mm3 irrespective of clinical symptoms WHO clinical stage 3 or 4 irrespective of CD4 count MDR or XDR TB The first line regimen proposed will be Atripla (R), a fixes dose combination containing tenofovir disoproxil (245 mg)/emtricitabine (200 mg)/efavirenz (600 mg)(TDF/FTC/EFV). The dosing will be 1 tablet OD.

Percentage of HIV-infected patients followed-up in the trial clinics receiving ARV treatment when eligible

the EQ-5D scale among the whole sample the Patient Reported Outcomes Quality Of Life specific to HIV (PROQOL-HIV) instrument and the HIV/AIDS stigma instrument for PLWHA (HASI-P) tool among HIV-infected participants

Percentage of participants reporting health care visits (primary care centre, pharmacy, hospitalisation) in the past four weeks and cost incurred

Percentage of participants agreeing that people in the community do not blame people for having HIV Percentage of participants agreeing that people in the community avoid people with HIV

Inclusion Criteria: Aged 16 and more Member of a household in the designated cluster within the Hlabisa sub-district of KwaZulu Natal in South Africa Able and willing to give written informed consent for trial participation and/or HIV counselling and testing

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