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

July 20, 2016 updated by: ANRS, Emerging Infectious Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Repeated measure every 6 months during follow-up
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
Repeated measure every 6 months during follow-up
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
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
Percentage of participants reporting health care visits (primary care centre, pharmacy, hospitalisation) in the past four weeks and cost incurred
Repeated measure every 6 months during follow-up
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
Repeated measure every 6 months during follow-up
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
Repeated measure every 6 months during follow-up
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
Repeated measure every 6 months during follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

University of KwaZulu
Africa Centre For Health and Population Studies

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 13, 2012

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 12249 TasP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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