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

South Africa, 2024 - 2026

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Reference ID

AHRI.LAPIS.ESource.Clinical.Management.2025.v1

Producer(s)

Prof. Maryam Shahmanesh, Dr. Limakatso Lebina

Collections

Multilevel HIV Prevention

Metadata

Documentation in PDF DDI/XML JSON

Created on

Feb 06, 2025

Last modified

Feb 06, 2025

Page views

9847

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Data file: AHRI.LAPIS.ESource.AEs.2025.v1

Cases:	1
Variables:	27

Variables

IIntID

Individual ID

event_id

REDCap Event Identifier

instance

REDCap Instance Identifier

ae_any_events

Did the participant reported any side effects or adverse events since the last v

ae_on_prep_treatm

Is the participant currently on PrEP treatment?

ae_on_art_treatm

Is the participant currently on ART treatment?

ae_event_detail

Please provide details on the Event

ae_prep_detail_1

Common side effects of PrEP - Nausea

ae_prep_detail_2

Common side effects of PrEP - Headache

ae_prep_detail_3

Common side effects of PrEP - Dizziness

ae_prep_detail_4

Common side effects of PrEP - Insomnia

ae_prep_detail_96

Common side effects of PrEP - Other

ae_details_oth

Details of other side effect or adverse event

ae_start_date

Start date of event

ae_ongoing

Is the event ongoing?

ae_stop_date

Stop date of event

ae_severity

Severity of event

ae_study_rel

Relationship to study

ae_study_drug_rel

Relationship to study drug

ae_study_procedure_rel

Relationship to study procedure

ae_action_taken

Action Taken Regarding Drug adverse event

ae_action_taken_oth

Please specify details on other action taken

ae_outcome

Outcome of event

ae_expected

Is this an expected event for this study?

ae_serious

Is this a Serious Adverse Event?

ae_add_comments

Additional Comments (optional)

ae_calc_num

AE Number

Total: 27

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