Format

Send to

Choose Destination
Am J Epidemiol. 2015 Nov 15;182(10):857-60. doi: 10.1093/aje/kwv200. Epub 2015 Oct 19.

Invited commentary: every good randomization deserves observation.

Abstract

Preexposure prophylaxis (PrEP) is a promising approach to prevention of human immunodeficiency virus (HIV) transmission, in which an HIV-negative individual takes a single daily dose of an antiretroviral drug so that, if exposed to HIV, an active antiretroviral drug is already present in his or her system. In this issue of the Journal, Murnane et al. (Am J Epidemiol. 2015;182(10):848-856) use data from the Partners PrEP Study (Kenya and Uganda, 2008-2011) to estimate the efficacy of PrEP under perfect adherence. We discuss Murnane et al.'s work and then examine the larger issues of generalizability or transportability of findings from a randomized trial to a new setting when adherence to an intervention determines its effectiveness. We discuss sufficient conditions for generalizability and use causal directed acyclic graphs to show how these assumptions might play out when trials are used to make inferences about the effect of PrEP in current and future real-world target populations.

KEYWORDS:

HIV; adherence; causal inference; external validity; generalizability; pre-exposure prophylaxis; randomized trials; transportability

PMID:
26487342
PMCID:
PMC4634305
DOI:
10.1093/aje/kwv200
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Silverchair Information Systems Icon for PubMed Central
Loading ...
Support Center