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DREAMS

cRCT of Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) – Clinical Management

South Africa, 2024 - 2025
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Reference ID
AHRI.LAPIS.Clinical.Management.ESource.2025.v2
Producer(s)
Prof. Maryam Shahmanesh, Dr. Limakatso Lebina
Collections
Multilevel HIV Prevention
Metadata
Documentation in PDF DDI/XML JSON
Created on
Dec 17, 2025
Last modified
Dec 17, 2025
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1167
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Data file: AHRI.LAPIS.ESource.SAEs.2025.v2

Cases: 5
Variables: 34

Variables

IIntID
Individual ID
event_id
REDCap Event Identifier
instance
REDCap Instance Identifier
sae_date_recorded
Date SAE was recorded
sae_calc_num
SAE Number
sae_report_type
Type of report
sae_on_prep
Is the participant receiving PrEP?
sae_prep_method
Which method of PrEP?
sae_relate_ae
Is the SAE related on an AE?
sae_relate_ae_num
Select related AE number?
sae_death
Death
sae_death_date
If Death, Date of Death:
sae_life_threat
Life-threatening Adverse Experience
sae_inpatient
Inpatient Hospitalization and / or prolongation of Hospitalization
sae_admit_date
If hospitalisation/prolonged hospitalisation, provide date of hospital admission
sae_discharge_date
If hospitalisation/prolonged hospitalisation, provide date of hospital discharge
sae_disability
Persistent or significant Disability / Incapacity
sae_anomaly
Congenital Anomaly / Birth Defect
sae_med_event
Other Important Medical Event
sae_pi_aware_date
Date investigator became aware of event
sae_relation_to_prep
Evaluation of causal relationship with PrEP
sae_other_relation
Is the event likely to have been caused by anything other than the investigation
sae_other_relate_notes
If yes, specify (include history, medical, surgical, allergy, family or associat
sae_participant_referred
Was the participant referred for further management?
sae_main_diagnosis
Main diagnosis/symptom
sae_onset_date
Date and Time of Onset:
sae_description
Description:
sae_grade
Maximum grade:
sae_outcome
Outcome Status
sae_resolved_date
Date resolved:
sae_full_description
Description of SAE: Describe diagnosis, symptoms (if local swelling/cutaneous pl
sae_event_location
Where did the event take place?
sae_event_location_oth
Other location where event took place?
sae_last_prep_taken_date
Date most recent PrEP medicine was taken:
Total: 34
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