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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
HIV Infection	Drug: Immediate ARV treatment initiation with TDF/FTC/EFV; Other: South African recommendation guided ARV (TDF/FTC/EFV) initiation	Not Applicable

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	28153 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	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.
Study Start Date :	March 2012
Actual Primary Completion Date :	June 2016
Actual Study Completion Date :	June 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Immediate ARV treatment initiation; Initiation of ARV treatment regardless of participants's immunological and clinical staging	Drug: Immediate ARV treatment initiation with TDF/FTC/EFV; 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.
South African recommendation guided ARV initiation; HIV-infected individuals will be assessed clinically and immunologically and when eligible for treatment as per South African guidelines will be offered ART	Other: South African recommendation guided ARV (TDF/FTC/EFV) initiation; 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.

Outcome Measures

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Primary Outcome Measures :

1. Uptake of initial and repeat HIV counselling and testing (Feasibility phase) [ Time Frame: 14 months ]
   Percentage of the target population tested for HIV
2. Uptake of ARV treatment among HIV-infected individuals (Feasibility phase) [ Time Frame: 14 months ]
   Percentage of HIV-infected patients followed-up in the trial clinics receiving ARV treatment when eligible
3. HIV infection incidence [ Time Frame: 4 years after enrolment initiation ]
   Serology will be done on Dry Blood Spot collected during repeated surveys

Secondary Outcome Measures :

1. Sexual partnerships [ Time Frame: Repeated measure every 6 months during follow-up ]
   Percentage of participants reporting a certain number of sexual partnerships in the last 12 months
2. Safe sex and condom use [ Time Frame: Repeated measure every 6 months during follow-up ]
   Percentage of participants using a male condom with their partner during the last sexual intercourse
3. Quality of life [ Time Frame: Repeated measure every 6 months during follow-up ]
   • 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
4. Health care use and health care expenditures [ Time Frame: Repeated measure every 6 months during follow-up ]
   Percentage of participants reporting health care visits (primary care centre, pharmacy, hospitalisation) in the past four weeks and cost incurred
5. Stigma at community level [ Time Frame: Repeated measure every 6 months during follow-up ]
   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
6. Adherence to ART [ Time Frame: Repeated measure every 6 months during follow-up ]
   Measured three-monthly using a visual analogue scale, pill identification test and pill count
7. Retention [ Time Frame: Repeated measure every 6 months during follow-up ]
   Proportion of HIV-infected participants still under active follow-up in the trial at key timepoints

Eligibility Criteria

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Ages Eligible for Study:	16 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Locations

South Africa
Hlabisa Hospital
Hlabisa, KwaZulu-Natal, South Africa, 3937

Sponsors and Collaborators

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Africa Centre For Health and Population Studies

University of KwaZulu

Investigators

Study Chair:	François Dabis, PhD	INSERM unit 897, ISPED, Université Bordeaux II, France
Study Chair:	Marie-Louise Newell, PhD	University of Southamton, United Kingdom
Study Chair:	Deenan Pillay, PhD	Africa Centre for Health and Population Studies, University of KwaZullu Natal, South Africa

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Iwuji C, McGrath N, Calmy A, Dabis F, Pillay D, Newell ML, Baisley K, Porter K. Universal test and treat is not associated with sub-optimal antiretroviral therapy adherence in rural South Africa: the ANRS 12249 TasP trial. J Int AIDS Soc. 2018 Jun;21(6):e25112. doi: 10.1002/jia2.25112.

Iwuji CC, Orne-Gliemann J, Larmarange J, Balestre E, Thiebaut R, Tanser F, Okesola N, Makowa T, Dreyer J, Herbst K, McGrath N, Bärnighausen T, Boyer S, De Oliveira T, Rekacewicz C, Bazin B, Newell ML, Pillay D, Dabis F; ANRS 12249 TasP Study Group. Universal test and treat and the HIV epidemic in rural South Africa: a phase 4, open-label, community cluster randomised trial. Lancet HIV. 2018 Mar;5(3):e116-e125. doi: 10.1016/S2352-3018(17)30205-9. Epub 2017 Nov 30.

Collier D, Iwuji C, Derache A, de Oliveira T, Okesola N, Calmy A, Dabis F, Pillay D, Gupta RK; French National Agency for AIDS and Viral Hepatitis Research (ANRS) 12249 Treatment as Prevention (TasP) Study Group. Virological Outcomes of Second-line Protease Inhibitor-Based Treatment for Human Immunodeficiency Virus Type 1 in a High-Prevalence Rural South African Setting: A Competing-Risks Prospective Cohort Analysis. Clin Infect Dis. 2017 Apr 15;64(8):1006-1016. doi: 10.1093/cid/cix015.

Iwuji CC, Orne-Gliemann J, Larmarange J, Okesola N, Tanser F, Thiebaut R, Rekacewicz C, Newell ML, Dabis F; ANRS 12249 TasP trial group. 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. 2016 Aug 9;13(8):e1002107. doi: 10.1371/journal.pmed.1002107. eCollection 2016 Aug.

Orne-Gliemann J, Larmarange J, Boyer S, Iwuji C, McGrath N, Bärnighausen T, Zuma T, Dray-Spira R, Spire B, Rochat T, Lert F, Imrie J; ANRS 12249 TasP Group. Addressing social issues in a universal HIV test and treat intervention trial (ANRS 12249 TasP) in South Africa: methods for appraisal. BMC Public Health. 2015 Mar 1;15:209. doi: 10.1186/s12889-015-1344-y.

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 Group. 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. 2013 Jul 23;14:230. doi: 10.1186/1745-6215-14-230.

Responsible Party:	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:	NCT01509508 History of Changes
Other Study ID Numbers:	ANRS 12249 TasP
First Posted:	January 13, 2012
Last Update Posted:	July 21, 2016
Last Verified:	July 2016

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

HIV; Prevention; Treatment; South Africa

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases	Tenofovir; Antiviral Agents; Anti-Infective Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Retroviral Agents; Anti-HIV Agents