HIV InfectionTasPNCT01509508

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

A study testing Immediate ARV treatment initiation with TDF/FTC/EFV and South African recommendation guided ARV (TDF/FTC/EFV) initiation in people with HIV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for: HIV Infection
What is being tested?: Immediate ARV treatment initiation with TDF/FTC/EFV and South African recommendation guided ARV (TDF/FTC/EFV) initiation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28,153 participants
Where: 1 siteSouth Africa
Study dates: Mar 2012to Jun 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Hlabisa Hospital
Hlabisa, KwaZulu-Natal, 3937

Other trials in South Africa

About this study

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.

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.

Read the 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

Conditions: HIV Infection
Being tested: Immediate ARV treatment initiation with TDF/FTC/EFV, South African recommendation guided ARV (TDF/FTC/EFV) initiation
Keywords: HIV, Prevention, Treatment, South Africa
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immediate ARV treatment initiation with TDF/FTC/EFVDrug
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) initiationOther
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.

Study groups in NCT01509508
Study group	Role	What they receive
Immediate ARV treatment initiation	Experimental	Initiation of ARV treatment regardless of participants's immunological and clinical staging Receives: 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 Receives: Other: South African recommendation guided ARV (TDF/FTC/EFV) initiation

What is being measured

The primary outcome is the main question the study is designed to answer.

Uptake of initial and repeat HIV counselling and testing (Feasibility phase)
Percentage of the target population tested for HIV
Measured: 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
Measured: 14 months
HIV infection incidence
Serology will be done on Dry Blood Spot collected during repeated surveys
Measured: 4 years after enrolment initiation

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Jun 2016

First posted13 Jan 2012 (estimated)
Study startMar 2012
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies of the same condition, open and under way.
More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28,153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01509508
Sponsor's protocol ID: ANRS 12249 TasP
Acronym: TasP
Status last verified: Apr 2026
First submitted: 20 Dec 2011
Last updated: 15 Apr 2026
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 23880306
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.
PubMed 32970730
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.
PubMed 31637821
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.
PubMed 30412926
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.
PubMed 30321314
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.
PubMed 30027600
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.
PubMed 29890048
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.
PubMed 29199100
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.
PubMed 28329393
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.
PubMed 27504637
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.
PubMed 25880823

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01509508
Acronym / sponsor ID: TasP / ANRS 12249 TasP
Conditions: HIV Infection
Keywords: HIV, Prevention, Treatment, South Africa
Study type: Interventional
Recruitment status: Completed
Enrolment: 28,153 participants (actual)
Lead sponsor: ANRS, Emerging Infectious DiseasesOther government
Collaborators: Africa Centre For Health and Population Studies, University of KwaZulu
Study start: Mar 2012
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 13 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

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

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Immediate ARV treatment initiation with TDF/FTC/EFVAll 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.	Drug	Immediate ARV treatment initiation
South African recommendation guided ARV (TDF/FTC/EFV) initiationHIV-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.	Other	South African recommendation guided ARV initiation

Primary outcome

Uptake of initial and repeat HIV counselling and testing (Feasibility phase)
Time frame: 14 months
Percentage of the target population tested for HIV
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
HIV infection incidence
Time frame: 4 years after enrolment initiation
Serology will be done on Dry Blood Spot collected during repeated surveys

7 secondary outcomes

Sexual partnerships
Time frame: Repeated measure every 6 months during follow-up
Safe sex and condom use
Time frame: Repeated measure every 6 months during follow-up
Quality of life
Time frame: Repeated measure every 6 months during follow-up
Health care use and health care expenditures
Time frame: Repeated measure every 6 months during follow-up
Stigma at community level
Time frame: Repeated measure every 6 months during follow-up
Adherence to ART
Time frame: Repeated measure every 6 months during follow-up
Retention
Time frame: Repeated measure every 6 months during follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Background: PubMed 23880306Iwuji 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.
Derived from this study: PubMed 32970730Iwuji 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.
Derived from this study: PubMed 31637821Larmarange 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.
Derived from this study: PubMed 30412926Perriat 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.
Derived from this study: PubMed 30321314Derache 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.
Derived from this study: PubMed 30027600Larmarange 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.
Derived from this study: PubMed 29890048Iwuji 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.
Derived from this study: PubMed 29199100Iwuji 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.
Derived from this study: PubMed 28329393Collier 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.
Derived from this study: PubMed 27504637Iwuji 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.
Derived from this study: PubMed 25880823Orne-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.

Related trials for HIV Infection

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

François Dabis, PhD study chair

INSERM unit 897, ISPED, Université Bordeaux II, France

Marie-Louise Newell, PhD study chair

University of Southamton, United Kingdom

Deenan Pillay, PhD study chair

Africa Centre for Health and Population Studies, University of KwaZullu Natal, South Africa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uptake of initial and repeat HIV counselling and testing (Feasibility phase) (time frame: 14 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01509508, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.