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

IIntID

Individual ID

event_id

REDCap Event Identifier

event_name

REDCap Event Identifier Name

mt_date_time

Date/time

mt_has_correct_info

Please review the Personal Information above with the Participant. Is all of the

tm_call_made

Was a telephone call made?

si_sch_curr_visit_done

Is the current visit scheduled with the participant?

si_sch_curr_visit_nd_reas

What is the reason for not scheduling an initial visit?

si_sch_date

Date form was completed

si_curr_visitdate

What is the Scheduled Visit Date?

si_curr_clinic_name

Which Clinic will the participant visit?

si_curr_part_location

Calculated field: Isigodi

pv_clinic_name

What is the name of the Clinic?

pv_clinic_location

Location / Isigodi

pv_mobile_point_name

Name of Mobile Clinic Point

pv_verify_partic

By reviewing the Personal information, please verify that this is the correct pa

pv_visit

For what Study Visit is the participant returning?

pv_visit_date

Visit Date

pv_cra_code

Staff Code

pv_calc_age

Participant's age Calculated from Date of Birth and Visit Date

pv_num_months

Number of months since last visit

pp_provided_form

Has a blank copy of the Participant Information Sheet been provided to the parti

pp_staff_code

Provided by: Staff Code

pp_date_provided

Date/time the copy was given.

pp_review_icfs

Will the Participant Informed Sheets be discussed with the participant?

pp_review_lapis

Was the Participant Information sheet discussed with the participant for: LAPIS

pp_review_lapis_starttime

Discussion Start time for: LAPIS Informed Consent

pp_review_lapis_stoptime

Discussion Stop time for LAPIS Informed Consent

pp_review_link

Was the Participant Information sheet discussed with the participant for: Inform

pp_review_link_starttime

Discussion Start time for: Informed Consent to link to the population-based stud

pp_review_link_stoptime

Discussion Stop time for: Informed Consent to link to the population-based study

pp_review_hivtst

Was the Participant Information sheet discussed with the participant for: Inform

pp_review_hivtst_starttime

Discussion Start time for: Informed Consent For HIV Test

pp_review_hivtst_stoptime

Discussion Stop time for: Informed Consent For HIV Test

ls_staff_code

Staff Code

ls_form_date

Date form was completed

ls_clinic_attended

Did the participant attend the clinic for this visit ([event-label])?

ls_services_requested_1

What are the main reasons for visiting the Clinic, which services did the partic

ls_services_requested_2

What are the main reasons for visiting the Clinic, which services did the partic

ls_services_requested_3

What are the main reasons for visiting the Clinic, which services did the partic

ls_services_requested_4

What are the main reasons for visiting the Clinic, which services did the partic

ls_services_requested_5

What are the main reasons for visiting the Clinic, which services did the partic

ls_services_requested_6

What are the main reasons for visiting the Clinic, which services did the partic

ls_services_requested_7

What are the main reasons for visiting the Clinic, which services did the partic

ls_services_requested_96

What are the main reasons for visiting the Clinic, which services did the partic

ls_services_req_osp

Please specify the other service that the participant requested:

ls_medium_health_need_ref

Is the participant a medium health need referral from the Peer Navigator project

ac_assess_done

Was the participant's capability to consent assessed at this visit?

ac_interview_datetime

Date/Time - Assessment of Capacity

ac_assess_step1

HAPPY with Step 1?

ac_assess_step2

HAPPY with Step 2?

ac_assess_step3

HAPPY with Step 3?

ac_assess_result

Is this individual capable to participate?

ic_indv_starttime

Informed Consent for - Start Time

ic_indv_language

What is the participant's preferred language for completing the informed consent

au_date_assessed

Date of assessment

au_ases_understanding

Assessed - understanding of the purpose of the study.

au_score_understanding

Score- understanding of the purpose of the study.

au_ases_choices

Assessed - understanding the choices you have as a participant

au_score_choices

Assessed - understanding the choices you have as a participant

au_ases_who_in_study

Assessed - understanding who will take part in this study

au_score_who_in_study

Score - understanding who will take part in this study

au_ases_other_non_med

Assessed - understanding besides taking the medications / injections / using the

au_score_other_non_med

Score - understanding besides taking the medications / injections / using the ri

au_ases_possible_risks

Assessed - understanding possible risks of being a participant in the study

au_score_possible_risks

Score - understanding possible risks of being a participant in the study

au_ases_possible_benefit

Assessed - understanding possible benefits for participants in the study?

au_score_possible_benefit

Score - understanding possible benefits for participants in the study?

au_ases_pregn_med_info

Assessed - understanding what happens if you become pregnant during the study:Pa

au_ases_pregn_stay_study

Assessed - understanding what happens if you become pregnant during the study:Pa

au_score_become_pregnant

Score- understanding what happens if you become pregnant during the study

au_ases_direct_questions

Assessed - understanding what should participants do if they have questions or c

au_score_direct_questions

Score - understanding what should participants do if they have questions or conc

au_ases_join_stop_study

Assessed - understanding what will happen if a participant decides not to join t

au_ases_continue_services

Assessed - understanding what will happen if a participant decides not to join t

au_score_stop_study

Score - understanding what will happen if a participant decides not to join the

au_ases_info_locked_away

Assessed - understanding how will information about participants in the study be

au_ases_info_access_manage

Assessed - understanding how will information about participants in the study be

au_score_protect_info

Score- understanding how will information about participants in the study be pro

au_outcome

Outcome

ic_indv_age_verify

Has the volunteer's age been verified?

ic_indv_verified_how

If yes, indicate below how the participant's age has been verified?

ic_indv_who_consent

Who has provided consent for this volunteer to participate in this study?

ic_indv_child_dob_full

Please provide child's date of birth (full)

ic_indv_child_dob_part

If full date of birth is not available, please complete the date of birth here

ic_caregv_enough_info

You confirm that I have read and understood the Information Sheet for the above

ic_caregv_ask_questions

Have you been given an opportunity to ask questions about the study and been giv

ic_caregv_consent_voluntar

Do you understand that your participation is voluntary and that you (or your chi

ic_caregv_consent_study

Do you agree for your child/ward to take part in this study?

ic_caregv_id_doc

Take a picture of the parent's ID document

ic_caregv_literate

Is the parent / caregiver literate (able to read and write)?

ic_caregv_willing_witness

Is the illiterate parent / caregiver willing to have a witness present?

ic_indv_enough_info

Have you received enough information about the study?

ic_indv_ask_questions

Have you been given an opportunity to ask questions about the study and been giv

ic_indv_consent_study

Do you agree to take part in this study?

ic_indv_literate

Is the participant literate (able to read and write)?

ic_indv_willing_witness

Is the illiterate participant willing to have a witness present?

ic_indv_agree_contact

Do you agree to be contacted by phone in order to make appointments for follow u

ic_indv_stoptime

Informed Consent - Stop Time

ic_calc_indv_consent

Calculate Individual Consent to Participate in the Study

ic_enrolled_cluster

Calculated - Enrolled Cluster

ic_enrolled_lapis_assign

LAPIS Randomization Assignment

ic_link_starttime

Informed consent for Linkage - Start time

ic_link_language

What is the participant's preferred language for completing the informed consent

ic_link_personal_info

Consent to give personal identifying information?

ic_link_reason_attend

Consent to ask for reason for attendance?

ic_link_past_info

Consent to link to population-based study information that you have given in the

ic_link_paper_consent

Was the informed consent conducted in paper? If so, please upload the file here.

ic_link_literate

Is the participant literate (able to read and write)?

ic_link_willing_witness

Is the illiterate participant willing to have a witness present?

ic_link_stoptime

Informed consent for Linkage - Stop time

ic_hiv_request_to_test

Did the participant requested a HIV Rapid test?

ic_hiv_starttime

Informed consent for HIV Test - Start time

ic_hiv_language

What is the participant's preferred language for completing the informed consent

ic_hiv_know_status

Consent to Rapid HIV test to know HIV status?

ic_hiv_clinic_attend

Consent to record attendance at clinic

ic_hiv_sms_contact

Consent to SMS contact (and choose message)

ic_hiv_phone_contact

Consent to phone call

ic_hiv_result_photo

Consent to have your HIV test result photographed

ic_hiv_paper_consent

Was the informed consent conducted in paper? If so, please upload the file here.

ic_hiv_literate

Is the participant literate (able to read and write)?

ic_hiv_willing_witness

Is the illiterate participant willing to have a witness present?

ic_hiv_stoptime

Informed consent for HIV Test - Stop time

ic_calc_dur_end_consent

Calculate Duration till end of Consent

pi_provided_signed_icfs

Has the participant been provided with signed copies of the ICFs?

pi_icfs_given_1

Which ICFs where given: - LAPIS Informed Consent HIV Pre-Exposure Prophylaxis (P

pi_icfs_given_2

Which ICFs where given: - Informed Consent to link to the population-based study

pi_icfs_given_3

Which ICFs where given: - Informed Consent For HIV Test

pi_date_provided

Date/time the copy was given.

hw_measure_taken

Was measurements taken at this visit?

hw_measure_date

Date measurements taken

hw_height

Record height (cm)

hw_weight

Record weight (kg)

hw_calc_bmi

Calculated BMI

hr_rapidtest_done

Was Rapid HIV test done?

hr_form_date

Date form was completed

hr_pretest_counsel_done

Was the pre test counselling done with the participant?

mh_interview_starttime

Please record Date/Time for starting - Managing HIV Results

mh_rapidscreen_testtype

Rapid Screening Test Type

mh_rapidscreen_lotnum

What was the LOT number for the test kit?

mh_rapidscreen_result

What is the Rapid HIV test result?

mh_rapidscreen_lotnum_rep

What was the LOT number for the test kit?

mh_rapidscreen_result_rep

What is the Rapid HIV test result?

mh_rapidconf1_testtype

Rapid Confirmatory Test Type

mh_rapidconf1_lotnum

What was the LOT number for the test kit?

mh_rapidconf1_result

What is the Rapid HIV test result?

mh_rapidconf1_lotnum_rep

What was the LOT number for the test kit?

mh_rapidconf1_result_rep

What is the Rapid HIV test result?

mh_rapidtest_result

Confirm the Summary HIV test result?

mh_rapidtest_result_txt

Confirm the Summary HIV test result?

mh_rapidtest_picture

Picture of HIV Rapid Test

mh_posttest_counsel_done

Was the post-test counselling done with the participant?

mh_init_art

Is the participant going to be initiated on ART?

mh_not_init_art_reas

Please specify the reason why the participant will not be initiated on ART?

mh_interview_stoptime

Please record Date/Time for stopping - Managing HIV Results

hc_done_tests

Was point of care tests performed on the participant?

hc_starttime

Point of Care Test - Start time

hc_hepb_test_done

Was a Hepatitis B test done?

hc_hepb_test_lotnr

Hepatitis B Lot Number

hc_hepb_test_expdt

Hepatitis B Expiry Date

hc_hepb_result

Hepatitis B Result

hc_creat_test_done

Was a Creatinine test done?

hc_creat_test_lotnr

Creatinine Lot Number

hc_creat_result

Creatinine Result

hc_gluc_test_done

Was a Rapid Glucose test done?

hc_gluc_test_lotnr

Rapid Glucose Test Lot Number

hc_gluc_result

Glucose Test Result

hc_gluc_rep_test_lotnr

Repeated - Rapid Glucose Test Lot Number

hc_gluc_rep_result

Repeated - Glucose Test Result

hc_syphilis_test_done

Was a Rapid Syphilis test done?

hc_syphilis_test_lotnr

Rapid Syphilis Test Lot Number

hc_syphilis_result

Syphilis Test Result

hc_preg_test_done

Was a Pregnancy test done?

hc_preg_test_lotnr

Pregnancy Test Lot Number

hc_preg_result

Pregnancy test Result

hc_preg_test_nd_reas

Please provide a reason for why the Pregnancy test was not done

hc_rep_preg_test_done

Was a Repeat Pregnancy test done?

hc_rep_preg_test_lotnr

Repeat Pregnancy Test Lot Number

hc_rep_preg_result

Repeat Pregnancy test Result

hc_urin_test_done

Was a Urinalysis test done?

hc_urin_test_lotnr

Urinalysis Test Lot Number

hc_urin_result_leuk

Urinalysis Leukocytes Result

hc_urin_result_nit

Urinalysis Nitrites Result

hc_urin_result_urob

Urinalysis Urobilinogen Result

hc_urin_result_prot

Urinalysis Protein Result

hc_urin_result_ph_level

Urinalysis PH Levels

hc_urin_result_blood

Urinalysis Blood Result

hc_urin_result_specg

Urinalysis Specific Gravity Result

hc_urin_result_ketone

Urinalysis Ketone Result

hc_urin_result_bilir

Urinalysis Bilirubin Result

hc_urin_result_gluc

Urinalysis Glucose Result

pv_nurse_verify_partic

By reviewing the Personal information, please verify that this is the correct pa

pv_form_date

Date form completed

ra_peppk_start_med

Did the participant started taking PEP?

ra_peppk_start_date

When did participant started taking PEP?

ra_reviewed_date

Date summary reviewed

ra_discussed_participant

Have the results been discussed with the participant?

pc_review_datetime

Review date and time

pc_review_hiv_result

Have you reviewed the HIV Rapid Test Result?

pc_review_hepb_result

Have you reviewed the Hepatitis B Test Result?

pc_review_creat_result

Have you reviewed the Creatinine Clearance Test Result?

pc_review_gluc_result

Have you reviewed the Blood Glucose Test Result?

pc_review_syphilis_result

Have you reviewed the Rapid Syphilis Test Result?

pc_review_pregnancy_result

Have you reviewed the Pregnancy Test Result?

pc_review_urinalys_result

Have you reviewed the Urinalysis Test Result?

cs_screen_done

Was the participant clinically screened?

cs_starttime

Clinical Screening - Start time

cs_symptoms_done

Was Reproductive Tract Symptoms done?

cs_symptoms_0

Do you have any of the following symptoms? - No symptoms

cs_symptoms_1

Do you have any of the following symptoms? - Pain passing urine

cs_symptoms_2

Do you have any of the following symptoms? - Vaginal discharge

cs_symptoms_3

Do you have any of the following symptoms? - Lower abdominal pain

cs_symptoms_4

Do you have any of the following symptoms? - Genitals blisters or sores

cs_symptoms_5

Do you have any of the following symptoms? - Genitals lumps and bumps

cs_symptoms_6

Do you have any of the following symptoms? - Urethral discharge (men)

cs_symptoms_7

Do you have any of the following symptoms? - Swelling in the groin

cs_symptoms_8

Do you have any of the following symptoms? - Genital itching

cs_symptoms_9

Do you have any of the following symptoms? - Scrotal swelling

cs_symptoms_96

Do you have any of the following symptoms? - Other

cs_symptoms_oth

Please provide details on other symptoms

cs_papsmear_done

Was Pap Smear discussed with the participant?

cs_papsmear_offered

Was a Pap Smear offered to the participant?

cs_papsmear_accepted

Was the Pap Smear accepted by the participant?

cs_papsmear_reasn_accept_1

Reason why the participant did not accept Pap Smear - Having menstrual cycle

cs_papsmear_reasn_accept_2

Reason why the participant did not accept Pap Smear - Severe STI

cs_papsmear_reasn_accept_3

Reason why the participant did not accept Pap Smear - Recent Pap Smear done

cs_papsmear_reasn_accept_96

Reason why the participant did not accept Pap Smear - Other

cs_tb_symp_done

Was TB screening done?

cs_tb_symp_0

Do you have any of the following symptoms - Asymptomatic

cs_tb_symp_1

Do you have any of the following symptoms - Persistent Cough

cs_tb_symp_2

Do you have any of the following symptoms - Drastic weight loss

cs_tb_symp_3

Do you have any of the following symptoms - Drenching Night sweats

cs_tb_symp_4

Do you have any of the following symptoms - Loss of appetite

cs_tb_symp_5

Do you have any of the following symptoms - Haemoptysis

cs_tb_symp_6

Do you have any of the following symptoms - Fever

cs_tb_symp_7

Do you have any of the following symptoms - Chest pain

cs_calc_num_tbsymp

Calculated Variable: Number of TB Symptoms

cs_tb_refmt_doh

Has this participant been referred to the DoH for TB?

cs_hiv_test_hist_done

Was participant asked about HIV Testing History?

cs_hiv_recent_test

Does the participant have a recent HIV test result?

cs_hiv_recent_date

Date of the test

cs_hiv_recent_by

Who performed the recent HIV Test?

cs_hiv_recent_result

What was the recent HIV test's result?

cs_recv_hivresult

Have you ever received a test result for HIV?

cs_pos_hivresult

Have you ever had a positive HIV test result?

cs_curr_arttreat

Are you currently receiving ART?

cs_ever_taken_prep

Have you ever been on PrEP?

cs_past_mh_done

Was PMH / DH / Allergies screening done?

cs_past_mh_0

Please ask about Past Medical Histories and select all that apply - None

cs_past_mh_1

Please ask about Past Medical Histories and select all that apply - Diabetes

cs_past_mh_2

Please ask about Past Medical Histories and select all that apply - Hypertension

cs_past_mh_3

Please ask about Past Medical Histories and select all that apply - Asthma

cs_past_mh_4

Please ask about Past Medical Histories and select all that apply - Congenital A

cs_past_mh_5

Please ask about Past Medical Histories and select all that apply - HIV

cs_past_mh_6

Please ask about Past Medical Histories and select all that apply - TB

cs_past_mh_7

Please ask about Past Medical Histories and select all that apply - Meningitis

cs_past_mh_8

Please ask about Past Medical Histories and select all that apply - Pneumonia

cs_past_mh_9

Please ask about Past Medical Histories and select all that apply - Mental Healt

cs_past_mh_10

Please ask about Past Medical Histories and select all that apply - Hepatitis C

cs_past_mh_96

Please ask about Past Medical Histories and select all that apply - Other

cs_past_mh_oth

Please provide details on other Past Medical Histories

cs_on_curr_on_meds

Are you currently on Chronic or other Medication

cs_on_tb_treat

Have you been on TB Treatment in the past 3 months?

cs_dh

Please specify details of drugs

cs_any_allergies

Is the participant allergic to anything?

cs_allergies_speci

Please provide details on Specific Allergies

cs_hiv_repoduc_hist_done

Was participant asked about Reproductive / Pregnancy History?

cs_often_period

How often do you have your period?

cs_period_oth

Other details on period frequency

cs_last_period

When was your last period?

mt_days_bleed

How many days do you normally bleed

cs_sex_active

Are you sexually active?

cs_fatherclindren

Have you ever fathered any children?

cs_currpregnant

Are you currently pregnant?

cs_everpregnant

Have you ever been pregnant?

cs_agepregnant

How old were you the first time you got pregnant? [age in years]

cs_times_pregnant

How many times have you been pregnant? (including pregnancies that did not go to

cs_times_birth

How many times have you given birth? (include both live births and stillbirths.

cs_areusemeth_avoidpreg

Are you currently using any contraceptive methods to prevent pregnancy?

cs_currmeth_avoidpreg_1

Which methods are you currently using? - Male condom

cs_currmeth_avoidpreg_2

Which methods are you currently using? - Female condom

cs_currmeth_avoidpreg_3

Which methods are you currently using? - Oral contraceptive pills

cs_currmeth_avoidpreg_4

Which methods are you currently using? - Injectable contraceptives

cs_currmeth_avoidpreg_5

Which methods are you currently using? - Implants

cs_currmeth_avoidpreg_6

Which methods are you currently using? - IUD/loop

cs_currmeth_avoidpreg_7

Which methods are you currently using? - Rhythm method

cs_currmeth_avoidpreg_8

Which methods are you currently using? - Traditional methods

cs_currmeth_avoidpreg_9

Which methods are you currently using? - Withdrawal method or thigh sex

cs_currmeth_avoidpreg_10

Which methods are you currently using? - Douching after sex

cs_currmeth_avoidpreg_11

Which methods are you currently using? - Female sterilization ('tubal ligation')

cs_currmeth_avoidpreg_12

Which methods are you currently using? - Male sterilization ('vasectomy')

cs_currmeth_avoidpreg_96

Which methods are you currently using? - Other (specify)

cs_currmeth_avoidpreg_98

Which methods are you currently using? - Prefer not to answer

cs_circumcised

Have you ever been circumcised?

cs_circumcised_referral

Do you wish to be referred to be circumcised?

cs_vac_hpv_done

Was the participant asked about HPV vaccines?

cs_vac_hpv

Have you been vaccinated against HPV?

cs_had_pap_smear

Have you had your Pap smear

cs_pap_result

What was the result?

cs_pap_date

When was the last Pap smear

Total: 690

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