ArticleHIV clinical trials
The impact of the 2013 WHO antiretroviral therapy guidelines on the feasibility of HIV population prevention trials.
Article in HIV clinical trials. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Burden of hepatitis B virus and syphilis co-infections and its impact on HIV treatment outcome in Ethiopia: nationwide community-based study.Annals of medicine · 2023Article
- CD56International journal of general medicine · 2022Article
- The evolution and adoption of World Health Organization policy guidelines on antiretroviral therapy initiation in sub-Saharan Africa: A scoping review.Southern African journal of HIV medicine · 2020Article
- A systematic review and cost-effectiveness analyses of the new World Health Organization guidelines for the treatment of HIV-positive adults in India.Medical journal, Armed Forces India · 2019Article
- Laboratory Monitoring of Antiretroviral Therapy for HIV Infection: Cost-Effectiveness and Budget Impact of Current and Novel Strategies.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
backgroundSeveral cluster-randomized HIV prevention trials aim to demonstrate the population-level preventive impact of antiretroviral therapy (ART). 2013 World Health Organization (WHO) guidelines raising the ART initiation threshold to CD4 <500/µL could attenuate these trials' effect size by increasing ART usage in control clusters.
methodsWe used a computational model to simulate strategies from a hypothetical cluster-randomized HIV prevention trial. The primary model outcome was the relative reduction in 24-month HIV incidence between control (ART offered with CD4 below threshold) and intervention (ART offered to all) strategies. We assessed this incidence reduction using the revised (CD4 <500/µL) and prior (CD4 <350/µL) control ART initiation thresholds. Additionally, we evaluated changes to trial characteristics that could bolster the incidence reduction.
resultsWith a control ART initiation threshold of CD4 <350/µL, 24-month HIV incidence under control and intervention strategies was 2.46/100 person-years (PY) and 1.96/100 PY, a 21% reduction. Raising the threshold to CD4 <500/µL decreased the incidence reduction by more than one-third, to 12%. Using this higher threshold, moving to a 36-month horizon (vs 24-month), yearly control-strategy HIV screening (vs bian-nual), and intervention-strategy screening every 2 months (vs biannual), resulted in a 31% incidence reduction that was similar to effect size projections for ongoing trials. Alternate assumptions regarding cross-cluster contamination had the greatest influence on the incidence reduction.
conclusionsImplementing the 2013 WHO HIV treatment threshold could substantially diminish the incidence reduction in HIV population prevention trials. Alternative HIV testing frequencies and trial horizons can bolster this incidence reduction, but they could be logistically and ethically challenging. The feasibility of HIV population prevention trials should be reassessed as the implementation of treatment guidelines evolves.
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