HIV Infection
Conditions
Keywords
HIV, Prevention, Treatment, South Africa
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
Interventions
DRUGImmediate 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.
OTHERSouth 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.
Sponsors
ANRS, Emerging Infectious Diseases
Africa Centre For Health and Population Studies
University of KwaZulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
South Africa
Contacts
STUDY_CHAIRFrançois Dabis, PhD
INSERM unit 897, ISPED, Université Bordeaux II, France
STUDY_CHAIRMarie-Louise Newell, PhD
University of Southamton, United Kingdom
STUDY_CHAIRDeenan Pillay, PhD
Africa Centre for Health and Population Studies, University of KwaZullu Natal, South Africa
Outcome results
None listed