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

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9847

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Data file: AHRI.LAPIS.ESource.Clinical.Management.2025.v1

Cases:	3457
Variables:	690

Variables

mc_dapi_menstruation

Use during Menstruation

mc_dapi_sti_pelvic

Sexually Transmitted or Vaginal Infections and Pelvic Inflammatory disease.

mc_dapi_preg_breast_fertil

Pregnancy, breastfeeding and fertility

mc_dapi_how_to_use

How to use DapiRing

mc_dapi_how_to_remove

How to remove DapiRing

mc_dapi_disposal

Disposal of the used DapiRing

mc_dapi_do_not_stop

Do not stop using DapiRing

mc_dapi_side_effects

Possible Side effects

mc_dapi_storage

Storage of the DapiRing

mc_cabla_how_it_works

What is CAB-LA and how it works to prevent an HIV infection

mc_cabla_explain_schedule

Explain the schedule to the client:

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?

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_info_why_not_linked

Provide information regarding why the participant was not linked with the Peer N

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_support_narrative

Please provide a short narrative describing the support the participant have:

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_qc_date

Date of QC

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

Total: 690

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