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

NCT01509508 | Completed DMC

• 1 other identifier: ANRS 12249 TasP
• Study Type: interventional
• Target: 28,153
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

HIV; Prevention; Treatment; South Africa

Outcome Measures

Primary Outcomes (3)

• Uptake of initial and repeat HIV counselling and testing (Feasibility phase)

  Percentage of the target population tested for HIV

  14 months

• Uptake of ARV treatment among HIV-infected individuals (Feasibility phase)

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

  14 months

• HIV infection incidence

  Serology will be done on Dry Blood Spot collected during repeated surveys

  4 years after enrolment initiation

Secondary Outcomes (7)

• Sexual partnerships

  Repeated measure every 6 months during follow-up

• Safe sex and condom use

  Repeated measure every 6 months during follow-up

• Quality of life

  Repeated measure every 6 months during follow-up

• Health care use and health care expenditures

  Repeated measure every 6 months during follow-up

• Stigma at community level

  Repeated measure every 6 months during follow-up

Study Arms (2)

Immediate ARV treatment initiation

EXPERIMENTAL

Initiation of ARV treatment regardless of participants's immunological and clinical staging

Drug: Immediate ARV treatment initiation with TDF/FTC/EFV

South African recommendation guided ARV initiation

OTHER

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

Interventions

Immediate ARV treatment initiation with TDF/FTC/EFV DRUG

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.

Immediate ARV treatment initiation

South African recommendation guided ARV (TDF/FTC/EFV) initiation OTHER

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.

South African recommendation guided ARV initiation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Africa Centre For Health and Population Studies: collaborator
• University of KwaZulu: collaborator

Study Sites (1)

Hlabisa Hospital

Hlabisa, KwaZulu-Natal, 3937, South Africa

Location

Related Publications (11)

• 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.

  PMID: 23880306 BACKGROUND

• 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.

  PMID: 32970730 DERIVED

• 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.

  PMID: 31637821 DERIVED

• 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.

  PMID: 30412926 DERIVED

• 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.

  PMID: 30321314 DERIVED

• 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.

  PMID: 30027600 DERIVED

• 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.

  PMID: 29890048 DERIVED

• 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.

  PMID: 29199100 DERIVED

• 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.

  PMID: 28329393 DERIVED

• 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.

  PMID: 27504637 DERIVED

• 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.

  PMID: 25880823 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: January 13, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

ZA (1)