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

Not Applicable

Completed

• Conditions: HIV Infection
• Interventions: Drug: Immediate ARV treatment initiation with TDF/FTC/EFV; Other: South African recommendation guided ARV (TDF/FTC/EFV) initiation

• Registration Number: NCT01509508
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

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 Timeline

• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-13
• Study Start: 2012-03
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28153

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate ARV treatment initiation	Immediate ARV treatment initiation with TDF/FTC/EFV	Initiation of ARV treatment regardless of participants's immunological and clinical staging
South African recommendation guided ARV initiation	South African recommendation guided ARV (TDF/FTC/EFV) initiation	HIV-infected individuals will be assessed clinically and immunologically and when eligible for treatment as per South African guidelines will be offered ART

Primary Outcome Measures

Name	Time	Method
Uptake of initial and repeat HIV counselling and testing (Feasibility phase)	14 months	Percentage of the target population tested for HIV
Uptake of ARV treatment among HIV-infected individuals (Feasibility phase)	14 months	Percentage of HIV-infected patients followed-up in the trial clinics receiving ARV treatment when eligible
HIV infection incidence	4 years after enrolment initiation	Serology will be done on Dry Blood Spot collected during repeated surveys

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hlabisa Hospital; 🇿🇦 Hlabisa, KwaZulu-Natal, South Africa