Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence
NCT ID: NCT01509508
Last Updated: 2016-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
28153 participants
INTERVENTIONAL
2012-03-31
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services
NCT01691768
Extended Follow-Up of the ISS T-003 Trial Volunteers (ISS T-003 EF-UP2020)
NCT05680948
Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
NCT06485154
A Roll-over Observational Study for the Extended Follow-up of the Volunteers of the ISS T-003 Trial
NCT02712489
Reducing Antiretroviral Treatments
NCT04051970
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immediate ARV treatment initiation
Initiation of ARV treatment regardless of participants's immunological and clinical staging
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 (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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
16 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Africa Centre For Health and Population Studies
OTHER
University of KwaZulu
OTHER
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
François Dabis, PhD
Role: STUDY_CHAIR
INSERM unit 897, ISPED, Université Bordeaux II, France
Marie-Louise Newell, PhD
Role: STUDY_CHAIR
University of Southamton, United Kingdom
Deenan Pillay, PhD
Role: STUDY_CHAIR
Africa Centre for Health and Population Studies, University of KwaZullu Natal, South Africa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hlabisa Hospital
Hlabisa, KwaZulu-Natal, South Africa
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Iwuji C, Chimukuche RS, Zuma T, Plazy M, Larmarange J, Orne-Gliemann J, Siedner M, Shahmanesh M, Seeley J. Test but not treat: Community members' experiences with barriers and facilitators to universal antiretroviral therapy uptake in rural KwaZulu-Natal, South Africa. PLoS One. 2020 Sep 24;15(9):e0239513. doi: 10.1371/journal.pone.0239513. eCollection 2020.
Larmarange J, Diallo MH, McGrath N, Iwuji C, Plazy M, Thiebaut R, Tanser F, Barnighausen T, Orne-Gliemann J, Pillay D, Dabis F; ANRS 12249 TasP Study Group. Temporal trends of population viral suppression in the context of Universal Test and Treat: the ANRS 12249 TasP trial in rural South Africa. J Int AIDS Soc. 2019 Oct;22(10):e25402. doi: 10.1002/jia2.25402.
Perriat D, Plazy M, Gumede D, Boyer S, Pillay D, Dabis F, Seeley J, Orne-Gliemann J; ANRS 12249 TasP Study Group. "If you are here at the clinic, you do not know how many people need help in the community": Perspectives of home-based HIV services from health care workers in rural KwaZulu-Natal, South Africa in the era of universal test-and-treat. PLoS One. 2018 Nov 9;13(11):e0202473. doi: 10.1371/journal.pone.0202473. eCollection 2018.
Derache A, Iwuji CC, Baisley K, Danaviah S, Marcelin AG, Calvez V, de Oliveira T, Dabis F, Porter K, Pillay D. Impact of Next-generation Sequencing Defined Human Immunodeficiency Virus Pretreatment Drug Resistance on Virological Outcomes in the ANRS 12249 Treatment-as-Prevention Trial. Clin Infect Dis. 2019 Jul 2;69(2):207-214. doi: 10.1093/cid/ciy881.
Larmarange J, Diallo MH, McGrath N, Iwuji C, Plazy M, Thiebaut R, Tanser F, Barnighausen T, Pillay D, Dabis F, Orne-Gliemann J; ANRS 12249 TasP Study Group. The impact of population dynamics on the population HIV care cascade: results from the ANRS 12249 Treatment as Prevention trial in rural KwaZulu-Natal (South Africa). J Int AIDS Soc. 2018 Jul;21 Suppl 4(Suppl Suppl 4):e25128. doi: 10.1002/jia2.25128.
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, Barnighausen 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, Barnighausen 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, Barnighausen 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANRS 12249 TasP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.