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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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Data file: AHRI.LAPIS.ESource.Clinical.Management.2025.v2

Cases: 9759
Variables: 730

Variables

mc_cabla_lead_in_time
Lead in time: It takes a week (7 days) for the CAB-LA injection to become effect
mc_cabla_side_effects
Side effects Moderate
mc_cabla_stopping
Stopping CAB-LA
mc_cabla_next_appointment
Remember the date of the next appointment
mc_cabla_timed_observation
Client observation done for 5 minutes
mc_oral_use_and_storage
Study product use and storage instructions
mc_oral_side_effects
Possible side effects
mc_oral_missed_dose
Missed dose instructions
mc_oral_take_on_trips
Take study product with you on trips away from home
mc_oral_do_not_share
Do not share study product
mc_oral_use_study_product
Use only the study product assigned to you
mc_oral_lost_product
Information on Product stolen or lost
mc_oral_contact_clinic
Contact the clinic with any problems between visits
mc_oral_product_expiry
Product expiry instructions/guidance
mc_oral_over_dosing
Impact of Over Dosing
mc_oral_any_other
Any other comments?
ei_form_date
Date/time of form
st_switching_treatment
Is the participant switching PrEP treatments?
st_swap_treatment_date
Date treatments are swapped
st_prevoius_treatment
On which PrEP treatment was the participant?
st_new_treatment
What is the new PrEP treatment for the participant?
st_reas_switch_method_1
Why is the participant switching their PrEP Treatment? - Experiencing short term
st_reas_switch_method_10
Why is the participant switching their PrEP Treatment? - Inconvenience of the ty
st_reas_switch_method_11
Why is the participant switching their PrEP Treatment? - Reduced HIV risk - e.g.
st_reas_switch_method_12
Why is the participant switching their PrEP Treatment? - Increased HIV risk (pe
st_reas_switch_method_13
Why is the participant switching their PrEP Treatment? - Feel more confident wit
st_reas_switch_method_14
Why is the participant switching their PrEP Treatment? - Other prevention strate
st_reas_switch_method_15
Why is the participant switching their PrEP Treatment? - Want to try a different
st_reas_switch_method_16
Why is the participant switching their PrEP Treatment? - Pregnancy
st_reas_switch_method_17
Why is the participant switching their PrEP Treatment? - Prefer not to take PrEP
st_reas_switch_method_2
Why is the participant switching their PrEP Treatment? - Worried about experienc
st_reas_switch_method_3
Why is the participant switching their PrEP Treatment? - Don't want to or findin
st_reas_switch_method_4
Why is the participant switching their PrEP Treatment? - Injection site issues e
st_reas_switch_method_5
Why is the participant switching their PrEP Treatment? - Challenges or Discomfor
st_reas_switch_method_6
Why is the participant switching their PrEP Treatment? - Finding it difficult to
st_reas_switch_method_7
Why is the participant switching their PrEP Treatment? - Challenges with the PrE
st_reas_switch_method_8
Why is the participant switching their PrEP Treatment? - Partner/s or family mem
st_reas_switch_method_9
Why is the participant switching their PrEP Treatment? - Stigma (challenges from
st_reas_switch_method_96
Why is the participant switching their PrEP Treatment? - Other reason
st_reas_switch_method_oth
Please provide the other reason why the participant switched PrEP Treatment
ps_report_stop_prep
Did the participant reported that they stopped taking PrEP?
rs_prep_stop_date
On which date did the participant stop taking PrEP?
ps_prep_stop_reas_lapis_1
What are the reasons for stopping PrEP? - Experiencing short term side effects.
ps_prep_stop_reas_lapis_10
What are the reasons for stopping PrEP? - Inconvenience of the type of PrEP
ps_prep_stop_reas_lapis_11
What are the reasons for stopping PrEP? - Reduced HIV risk - e.g. don't have sex
ps_prep_stop_reas_lapis_12
What are the reasons for stopping PrEP? - Increased HIV risk (perceived or actu
ps_prep_stop_reas_lapis_13
What are the reasons for stopping PrEP? - Feel more confident with a different P
ps_prep_stop_reas_lapis_14
What are the reasons for stopping PrEP? - Other prevention strategies are suffic
ps_prep_stop_reas_lapis_15
What are the reasons for stopping PrEP? - Want to try a different PrEP
ps_prep_stop_reas_lapis_16
What are the reasons for stopping PrEP? - Pregnancy
ps_prep_stop_reas_lapis_17
What are the reasons for stopping PrEP? - Prefer not to take PrEP as pregnant or
ps_prep_stop_reas_lapis_18
What are the reasons for stopping PrEP? - Seroconverted
ps_prep_stop_reas_lapis_2
What are the reasons for stopping PrEP? - Worried about experiencing long term s
ps_prep_stop_reas_lapis_3
What are the reasons for stopping PrEP? - Don't want to or finding it difficult
ps_prep_stop_reas_lapis_4
What are the reasons for stopping PrEP? - Injection site issues e.g. pain
ps_prep_stop_reas_lapis_5
What are the reasons for stopping PrEP? - Challenges or Discomfort in inserting
ps_prep_stop_reas_lapis_6
What are the reasons for stopping PrEP? - Finding it difficult to engage with Pr
ps_prep_stop_reas_lapis_7
What are the reasons for stopping PrEP? - Challenges with the PrEP schedule for
ps_prep_stop_reas_lapis_8
What are the reasons for stopping PrEP? - Partner/s or family member/s objected
ps_prep_stop_reas_lapis_9
What are the reasons for stopping PrEP? - Stigma (challenges from hiding the PrE
ps_prep_stop_reas_lapis_96
What are the reasons for stopping PrEP? - Other
ps_prep_stop_reas_oth
Describe other reason/s for stopping PrEP
rs_prep_fut_uptake
Would you be willing to take PrEP again in the future?
ds_hiv_offered
Were a HIV Self Tests offered to the participant?
ds_hiv_offered_date
Date when HIV Self Test was offered?
ds_hiv_accept_kit
Did the participant accept the HIV Self Test Kit?
ds_hiv_dispensed
Was a HIV Self Test/s dispensed?
ai_administered
Was the injectable PrEP administered?
ai_admin_datetime
Administration Date/Time
ai_injection_side
Which side of the buttocks is injected?
ai_admin_monitored
Was the participant monitored for a time after administration of the injectable
ai_admin_side_effects
Did the participant experience any side effects relating to the administration o
ai_admin_desc_side_effect
Please describe the side effects
ai_admin_action_taken
Please describe the actions taken
ai_monitoring_time
For how long was the participant monitored (in minutes)?
dr_prep_done
Was the drug accountability for PrEP medication done?
dr_prep_miss_any_doses
Did the participant report not taking any of their doses in the last two weeks?
dr_art_done
Was the drug accountability for ART medication done?
dr_art_miss_any_doses
Did the participant report not taking any of their doses in the last two weeks?
as_reconsider_support
Would the participant reconsider taking adherence support from a Peer Navigator?
as_linked_to_peernav
Was participant able to link up with a Peer Navigator regarding their adherence
as_relink_to_peernav
If you stopped your Medication Adherence support with the Peer Navigator, would
as_link_to_peernav
Would the participant like us to link them with the Peer Navigator?
as_on_treatmemt
Is the participant on any treatment? Either given by us or other chronic medicat
as_has_support_system
Does the participant have a treatment adherence support system via family or som
as_uptake_adhere_support
Would the participant like to be supported a Peer Navigator?
as_list_of_medications
Make a list of medications for which the participant needs support on.
as_list_what_support
Describe the kind of adherence the participant needs support on
rf_doh_referral
Does this participant needs to be referred to a DoH Clinic?
rf_doh_referral_date
Referral date to DoH
rf_doh_referral_reas
If yes, reason
rd_doh_refer_slip
Please upload a copy of the referral slip here
rf_doctor_referral
Does this participant needs to be referred to the Study Doctor?
rf_dr_referral_date
Referral date to study doctor
rf_doctor_referral_reas
If yes, please provide a detailed reason
rf_doctor_schedule_date
Please provide the scheduled visit date with the Study Doctor
va_date_completed
Date when summary was reviewed and action plan completed
va_abnorm_measure
Were any of the measurements abnormal or of concern?
va_followup_hiv_history
Is there any follow-up action for HIV History?
va_followup_health_promot
Is there any follow-up action for Health Promotion?
va_followup_family_plan
Is there any follow-up action for Family planning?
va_followup_prep_eligible
Is there any follow-up action for PrEP Eligibility?
va_followup_pep_eligible
Is there any follow-up action for PEP Eligibility?
va_followup_sample_collec
Is there any follow-up action for Samples collected?
va_followup_med_dispens
Is there any follow-up action for Medication dispensed?
va_7day_call_done
Was the participant available for the 7 day call?
va_followup_peppk_dispens
Is there a follow up action for PEP pack dispensed?
va_add_gen_comment
Are there any general comments to add?
va_sch_next_visit_done
Is a follow up visit scheduled with the participant?
va_next_visitdate
Record the next Scheduled Visit Date
va_calc_days_next_visit
Calculated field: Days to next visit?
va_calc_next_visit_remind
Calculated field: Date on which to start with the next visit reminders?
va_calc_hivstatus_at_visit
Calculate Participant's HIV status at this visit
va_calc_seroconvert
Calculate Participant's HIV status at this visit 1 = Yes 0 = No
va_calc_dur_start_summary
Calculate Duration till start of Summary Action plan
ev_send_to_qc
Are all information completed and can this record be sent for QC?
ev_complete_time
Date/Time
ev_qc_performed
Was the Internal QC Step completed?
ev_calc_prep_visit
Calculated PrEP Visit 1 = Initial PrEP visit
ev_calc_dur_endvisit
Calculate Duration till End of Visit form
es_withdraw
Did the participant withdraw from the study?
es_complete_time
End of Study Completed date/time
es_withdraw_reas
What was the main reason for withdraw?
es_withdraw_reas_oth
Please specify other reason for withdraw:
es_dateofdeath
Date of Death
es_dateoftransf_doh
Date of Transfer to DoH
es_calc_prep_visit
Calculated PrEP Visit 1 = Initial PrEP visit
rn_request_assist
Was Peer Navigator Assistance requested?
rn_request_date
When was Peer Navigator Assistance requested?
rn_next_clinic_date
Next available Clinic date
Total: 730
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