HIV trials run on lab data: viral load, CD4, resistance and safety chemistry across many visits and years. Capture holds the lab series, visit windows and confidential participant records in one audit-trailed study. Test free, pay at go-live.
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Week 48 visits in window
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Viral load results entered
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Open lab queries
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Regimen changes logged
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2 outside window
1 outside window
What an HIV trial needs from its EDC
The study data
In registered HIV-1 treatment studies the primary question is usually virologic: the proportion of participants with plasma HIV-1 RNA below 50 copies/mL at week 48, assigned by the FDA snapshot algorithm. Snapshot is a rule on the data, not a lab measurement. It looks at the last on-treatment viral load in a defined window, and participants without a result in that window are classified according to the rules in the statistical analysis plan, for example by reason for discontinuation. The consequence for the EDC is that the date of the sample, the window, and the reason a visit was missed or a treatment stopped are all primary-analysis data. Confirm your window and hierarchy against the current FDA guidance and your own SAP.
Capture lets you define a window around each scheduled visit and record unscheduled visits, so a week 47 or week 51 sample is visible as such. Lab rows can be entered on a laboratory form with unit, result and reference range columns, and site staff can be prompted with an edit check when a result falls outside a range you set. See lab results template and lab data and reference range management for the structure; if sites report in mixed units, lab unit converter helps with conventional versus SI.
A viral blip, a confirmed virologic failure and a resistance test are three different data events, and the protocol usually defines confirmed failure as two consecutive results above a threshold. Capture does not decide failure for you, but an edit check can raise a query when a viral load over your threshold is entered, so the repeat test and resistance sample are not forgotten. The reason is simply that missing resistance data are hard to recover later.
Sample date
LBDTCStudy day
LBDYCalculated from first dose date; inside window
331 CalculatedHIV-1 RNA
VLOADAbove 50: confirm repeat and resistance sample
CD4 count
CD4Regimen at sample date
REGIMENProtocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Virologic primary | HIV-1 RNA, sample date, study day, window | Lab form with calculated study day and a visit window |
| Immunology | CD4 count and percentage | Same lab form, repeating rows if analytes vary |
| Treatment regimen | Start, stop, switch, interruption with dates | Concomitant medication style repeating rows for the study regimen log |
| Adherence | Self-report, pill count or injection attendance | Participant questionnaire or site form, see patient diary software |
| Safety chemistry | Renal, hepatic, lipids, bone markers by visit | Lab results template with range checks |
| Injection site reactions | Long-acting regimens only; onset, grade, duration | Visit form plus adverse event form |
| Co-infection and medical history | Hepatitis B/C, TB, comorbidity | Medical history template |
| Participant identity | Coded IDs for researchers, names only for site staff | PII segregation and role-based access |
Capture does not run snapshot classification for you; keep that in your statistical programme and use the export.
Build visits and windows from the protocol, enter sample participants, and watch the in-window counts. Free sandbox, no credit card.
Confidentiality and long follow-up
Capture separates identity from clinical data. Site coordinators see participant names; researchers see coded IDs, with row-level security in the database. For an HIV study this is the central privacy control. Sites keep a separate screening and enrolment log, and QR-code enrolment with site-level numbering such as 003-0112 means the study record never needs a name. Data is hosted in the EU (Frankfurt) or the USA (N. Virginia), so the choice of region follows your regulator and your data processing agreement. See data processing agreement for clinical trials.
Switch studies in virologically suppressed participants need a clear baseline: the regimen being switched from, the date of the last suppressed viral load, and the reason for eligibility. These belong on the screening form and the regimen log. For multi-region programmes, international multi-site studies covers numbering and regional hosting. For long programmes, long-term follow-up describes keeping a participant record alive across years and epochs.
Prevention trials (PrEP, vaccine) shift the weight from viral load to HIV testing at each visit, adherence and sexual-health behavioural data. The same building blocks work, with test results as repeating rows. The key difference is who the participants are: healthy volunteers at risk, not patients on treatment, so visits are often shorter and more numerous.
Before first participant
Allowed days around week 4, 24, 48 and 96 written into the visit plan.
Central or local reference ranges and units agreed with the lab.
Edit check on the viral load threshold with repeat and resistance prompts.
Switches, interruptions and discontinuations with dates and reasons.
Roles assigned so researchers see coded IDs only.
CSV with data dictionary opened by the programmer, or SDTM with Define-XML for submission datasets.
No. Capture captures the sample date, result, study day, visit window and reason for discontinuation, and exports them. The snapshot classification is done in your statistical programme per the SAP.
Yes, you can set a visit window and a calculated study day from the first dose date, and use an edit check to raise a query when the value is outside the range you define.
Through role-based access, PII segregation and row-level database security: site coordinators see names, researchers see coded IDs. Your protocol and ethics approvals still govern what is collected.
Injection visits are ordinary visit forms with time, site, reaction and vital signs fields, plus a dated regimen log.
Yes. Capture exports SDTM as SAS XPT files with Define-XML, alongside CSV and Excel with an automatic data dictionary.
The sandbox is free. Live studies are billed per the pricing page, with per-participant fees counted from screening. Check the pricing page for the current plans.
Free sandbox with every feature. No credit card, and you pay only when you go live.