CompletedNot Applicable

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

South Africa28,153 participantsStarted 2012-03

Plain-language 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.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Uptake of initial and repeat HIV counselling and testing (Feasibility phase)

Timeframe: 14 months

Uptake of ARV treatment among HIV-infected individuals (Feasibility phase)

Timeframe: 14 months

HIV infection incidence

Timeframe: 4 years after enrolment initiation

Trial details

NCT IDNCT01509508

SponsorANRS, Emerging Infectious Diseases

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More HIV Infection trials