Trial designs for evaluating combination HIV prevention approaches.

HIV Research & Clinical Practice
Ying Qing ChenThomas R Fleming

Abstract

Combination HIV prevention approaches that include both biomedical and non-biomedical interventions often hold greater promise to improve health outcomes and reduce the risk of HIV transmission. Evaluate the relative properties of four leading candidate trial designs - 'single-factor', 'multi-arm', 'all-in-one', and 'factorial' designs - for assessing individual and/or combination prevention intervention approaches. Monte-Carlo simulations are conducted, assuming a putative combination approach could choose its components from two candidate biomedical interventions, i.e. Treatment-as-Prevention (TasP) and Pre-exposure Prophylaxis (PrEP), and three candidate behavioral interventions, i.e. linkage-to-care, counseling, and use of condoms. Various scenarios for individual components' effect sizes, their possible interaction, and the sample size based on real clinical studies are considered. The all-in-one and factorial designs used to assess a combination approach and the multi-arm design used to assess multiple individual components are consistently more powerful than single-factor designs. The all-in-one design is powerful when the individual components are effective without negative interaction, while the factorial design is mor...Continue Reading

References

Mar 9, 2006·American Journal of Obstetrics and Gynecology·Robert L GoldenbergUNKNOWN Hptn024 Team
Jun 15, 2006·Sexually Transmitted Diseases·Newton KumwendaTaha Taha
Nov 13, 2010·PloS One·Katharina KranzerRobin Wood
Nov 26, 2010·The New England Journal of Medicine·Robert M GrantUNKNOWN iPrEx Study Team
Jul 20, 2011·The New England Journal of Medicine·Myron S CohenUNKNOWN HPTN 052 Study Team
Jul 13, 2012·The New England Journal of Medicine·Michael C ThigpenUNKNOWN TDF2 Study Group
Jul 13, 2012·The New England Journal of Medicine·Lut Van DammeUNKNOWN FEM-PrEP Study Group
Jun 21, 2013·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Thomas J Coates
Jun 6, 2014·Sexually Transmitted Infections·M Bradford GuffeyUNKNOWN HIV Prevention Trials Network (HPTN) 035 Study Team
Dec 19, 2014·The Journal of Infectious Diseases·Laura PattaciniUNKNOWN Partners PrEP Study Team
Feb 5, 2015·The New England Journal of Medicine·Jeanne M MarrazzoUNKNOWN VOICE Study Team
Dec 2, 2015·The New England Journal of Medicine·Jean-Michel MolinaUNKNOWN ANRS IPERGAY Study Group
Feb 24, 2016·The New England Journal of Medicine·Jared M BaetenUNKNOWN MTN-020–ASPIRE Study Team
Nov 3, 2016·The New England Journal of Medicine·Mary G FowlerUNKNOWN IMPAACT 1077BF/1077FF PROMISE Study Team

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.