New category of Observational studies: We added 12 new observational studies under the new tab “Pregnant and postpartum (lactating) women”. This important at risk population is separated from the other observational studies because pregnant/lactating women usually are excluded from adult prevention trials testing new products, but are included in Mother-to-Child-Transmission-Prevention trials.
In Intervention trials: A new column was added listing the type of product tested in the intervention group.
In Observational studies: A recently published study on Fiebig Stage 1 HIV infection conducted in South Africa was added.
How should this table be used?
The table contains two tabs, one listing efficacy trials and the other – observational studies. The table is intended to be used as a reference to identify studies that may have information useful for study design and statistical power calculations. The user is encouraged to refer to listed publications and other resources for a better understanding of the context in which the incidence was observed.
Critically, the user should consider the following limitations when interpreting incidence data derived from experimental trials and/or observational studies:
- HIV incidence in the control group of a clinical trial may not reflect the background incidence in the community
Efficacy trials provide an incidence estimate in a specific population in the context of a specific experimental intervention used as part of the trial. Incidence estimates reflect the effect of standard of care provided to the control group and may be lower than in the community from which the study population is drawn. The decrease may be large or small, depending on the offered prevention package in the trial and on the rate of uptake of the provided prevention package. Incidence observed in the trial may also be higher than background incidence in the community if high-risk individuals are recruited in the trial.
With respect to HIV incidence data derived from observational studies, e.g. HIV tracking studies, it is important to keep in mind that prospective epidemiological studies are not always purely observational, but often provide study participants with regular HIV testing and risk reduction counselling, possibly leading to lower HIV incidence among study participants as compared to the actual incidence within their respective source communities.
- The positive effect of clinical research in communities:
Clinical research often not only affects HIV incidence within the study cohort itself, but can also have transforming effects on the community overall, leading to a decline in HIV incidence within the communities from which study cohorts are drawn.
In addition, given the large number of past HIV prevention trials and the generally improving state of HIV prevention in communities around the world, incidence rates in many populations have been going down. Investigators assessing new HIV prevention strategies are trying to work with communities that have not yet been positively affected by past HIV prevention research. These communities cannot directly be identified by our summary table.
- The dynamics of available prevention packages over time:
Available prevention packages are changing constantly due to the advancement in prevention technologies. Over the years, adequate prevention packages for study participants have evolved towards combination prevention packages, including not only the provision of free condoms but also STI testing and treatment, health education, risk reduction counselling, pre-exposure prophylaxis (PrEP), among others. Trial sponsors are striving to provide the most current, up-to-date prevention packages tailored to their specific study cohort. This leads to variations in trial protocols over time and across study cohorts. Hence, prevention packages are a very dynamic element of this table and need to be reviewed with caution.
The HIV Incidence Summary Table – Version 1.1 was released in June 2017 as an update to the initial release in January 2017. Larger updates will be implemented yearly; the next update is scheduled for fall of 2019.
How to cite this table:
If you wish to acknowledge the use of this table or refer to the data contained in it, please cite as follows:
“HIV Incidence in Prevention Trials and Observational Studies: A Summary Table” by Global HIV Vaccine Enterprise, November 2017 version, accessed at https://vaccineenterprise.org/portfolio-item/hiv-incidence-in-prevention-trials-and-observational-studies-a-summary-table/
Help us to help you:
This is a living document that will evolve through successive updates, changes, and adjustments. Because it may not be entirely comprehensive at this early stage, we encourage you to suggest additional studies to add, including past missed studies and those that have recently finished enrollment or follow-up.
HIV Incidence in Prevention Trials and Observational Studies: A Summary Table was developed with contributions from many experts.
The first draft of the table was created by Holly Janes (HIV Vaccine Trials Network, HVTN) and it was further developed and improved by Iris Corbasson (Global HIV Vaccine Enterprise).
The Oversight Committee provides guidance on the overall direction of the project and includes:
- Myron Cohen (University of North Carolina)
- Shelly Karuna (HIV Vaccine Trials Network)
- Matt Price (International AIDS Vaccine Initiative)
- Merlin Robb (Military HIV Research Program)
We also want to thank all members of the Efficacy Trials Working Group who reviewed the tables and provided feedback on organization and description of the included data.
If you used this tool for your own work, please give us feedback on the utility of this table and what kind of shortcomings you have encountered. We welcome any feedback that will help the improvement of this tool and will consider your suggestions for future updates. For any questions or feedback, please email firstname.lastname@example.org