Types of Data
Separate datasets are available for the linkage-to-care and viral suppression components of the HPTN 065 qualitative sub-study. For each component, the datasets contain the following types of data:
- Redacted transcripts of all patient interviews, site investigator interviews, and clinic staff focus group discussions.
- Patient line-level, de-identified demographic data: state, sex, age, race/ethnicity, education category, income category, household size, number of children, relationship status, and sexual orientation.
- Patient line-level, de-identified HPTN 065 study data:
- Viral suppression: recruitment sub-categories, anti-retroviral therapy initiation year, number of financial incentive gift cards received (total and over time), and number of suppressed viral load test results (total and over time).
- Linkage-to-care: linkage with or without financial incentive; timeframe between coupon distribution and HIV test result, first viral load test, first CD4 test, and financial incentive gift card disbursements.
Data may be requested by submitting the following items to the HPTN Leadership and Operations Center (LOC) at HPTN@fhi360.org:
- Data Request Application form. Requestors must submit a completed Data Request Application form. This form collects basic information about the requestor and the nature of the request. It requires the applicant to declare their intended use of the data and to vouch that they have reviewed the list of completed HPTN 065 manuscripts, identifying potential overlap between previously published work and their proposed project.
- Data use agreement. By signing this agreement, the requestor agrees (among other things) that if they are granted data access, they will review the HPTN 065 QSS consent forms and all dataset orientation materials provided upon approval, and they agree to include an HPTN-provided acknowledgement statement in their work which will state that the work is solely the responsibility of the author and not a product of, or endorsed by, the HPTN 065 study team or the HPTN. Upon approval of a request to use data, the HPTN will determine the level of ongoing HPTN review that the proposed project will be subject to. Requestors agree to provide the HPTN 065 study team with updates on what becomes of their work (submitted, published, etc.).
Review of Data Requests
Applications confirmed as complete will be distributed for review to the applicable HPTN oversight group. The reviewing committee will provide feedback to the requestor regarding whether the proposal was approved, sent back for revision/clarification, or rejected.
When a requestor receives approval, the HPTN Statistical and Data Management Center (SDMC) will provide the requestor with access to the requested dataset, as well as a package of materials for dataset interpretation and use, and an acknowledgment statement that must be included in any published or presented work. If a request is approved, it will come with a determination of how much oversight (i.e. review and approval) will be required prior to presentation or publication of results.