Access to Study Data from HPTN 061

The HPTN 061 Study Team is eager for the data collected during this study to be available for use by researchers, community-based organizations, municipal governments, advocacy groups and others.  Two basic types of data are available, aggregate and line-level. 

Aggregate Data

Aggregate data are available with no restrictions on the ATLAS website maintained by the HPTN Statistics and Data Management Center by clicking here.

Under the ‘Open Reports’ heading you will find tables that provide data on the Demographics, Enrollment Characteristics, Health Care Utilization and Retention of the study participants-- for the entire sample, and broken down for each of the cities where the research was conducted.  It is expected that these data may adequate for many requested needs, such as writing grant proposals or informing  public health budgets at community or regional level.  Interested parties can access and use these data without needing to contact the 061 Publications Team, however they are encouraged to do so if they wish to receive assistance in understanding and contextualizing the data.

Line Level Data

Line-level data reports contain the raw data from the study, by participant, with the participant’s personally-identifying information removed. Line-level reports include data collected on the study Case Report Forms (CRFs), from the study’s audio- and computer-assisted self-interview (ACASI), and from the social and sexual network inventory (SSN).  Interested parties must submit a request, which must be approved by the HPTN 061 publication team, in order to receive access to these data. Requests for line‑level data may be from the baseline (enrollment) visit, or longitudinal data.

The HPTN 061 dataset is very rich and contains data from more Black men who have sex with men (MSM) in the US than any previous HIV research study. However, there are limitations to how representative this sample may be of all American Black MSM, and context to be aware of regarding how men were enrolled, how the data were collected, etc. that users of the data should be aware of. To this end, the team have put together procedures and requirements to promote responsible and informed use of the data. These procedures and requirements are described below.

DATA ACCESS REQUIREMENTS-  OVERVIEW

Baseline Data

Access to baseline, line-level data will be offered after successful completion and review of a data request application. De-identification will be per the ‘safe-harbor’ method, removing all HIPAA identifiers: (http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html). The specific modifications that will be made to de-identify this dataset will include the following:

  • City will be anonymized to City 1, City 2, etc. if the researcher is not working with an 061 team member or Black Caucus member.
  • Date of birth (DOB) will be transformed to age category
  • HIV status will be provided at beginning and end of study only
  • Laboratory data will be restricted to those data used for the primary study manuscript

Steps for application and approval to receive line-level baseline data access are outlined in Table 1Click here for additional detail about requesting line-level baseline data and to access the application form.

Longitudinal Data

Access to longitudinal, line-level data will be offered after successful completion and review of a data request application. De-identification will be per the ‘safe-harbor’ method, removing all HIPAA identifiers: (http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html). The specific modifications that will be made to de-identify this data set will include the following:

  • DOB transformed to age category
  • HIV status will be provided at beginning and end of study only
  • Dates of laboratory testing transformed to Visit 1, 2, 3, rather than actual date
  • Laboratory data restricted to those data used for the primary study manuscript

Steps for application and approval to receive line-level longitudinal data access are outlined in Table 1

Click here for additional detail about requesting line-level longitudinal data and to access the application form.