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

HIV Infection Clinical Trial

— TasP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509508
• Other study ID #: ANRS 12249 TasP
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: July 20, 2016
• Start date: March 2012
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Department of Health
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28153
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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 (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.

Locations

Country	Name	City	State
South Africa	Hlabisa Hospital	Hlabisa	KwaZulu-Natal

Sponsors (3)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Africa Centre For Health and Population Studies, South Africa, University of KwaZulu

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of initial and repeat HIV counselling and testing (Feasibility phase)	Percentage of the target population tested for HIV	14 months	No
Primary	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	No
Primary	HIV infection incidence	Serology will be done on Dry Blood Spot collected during repeated surveys	4 years after enrolment initiation	No
Secondary	Sexual partnerships	Percentage of participants reporting a certain number of sexual partnerships in the last 12 months	Repeated measure every 6 months during follow-up	No
Secondary	Safe sex and condom use	Percentage of participants using a male condom with their partner during the last sexual intercourse	Repeated measure every 6 months during follow-up	No
Secondary	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	Repeated measure every 6 months during follow-up	No
Secondary	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	Repeated measure every 6 months during follow-up	No
Secondary	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	Repeated measure every 6 months during follow-up	No
Secondary	Adherence to ART	Measured three-monthly using a visual analogue scale, pill identification test and pill count	Repeated measure every 6 months during follow-up	No
Secondary	Retention	Proportion of HIV-infected participants still under active follow-up in the trial at key timepoints	Repeated measure every 6 months during follow-up	No