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Completed

NCT Number: NCT01509508

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

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hlabisa Hospital

Hlabisa, KwaZulu-Natal, 3937, South Africa

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Africa Centre For Health and Population Studies
  • University of KwaZulu

Registry information

Official study 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.

Acronym: TasP

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2012
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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