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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41661

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

Cases:	9759
Variables:	730

Variables

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_10

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

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_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_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_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_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

cs_quest_stoptime

Questionnaire - Stop time

partic_capapble_self_int

For Interviewer: Is the participant comfortable to complete the self-interview b

cs_sex_hist_done

Was the participant asked about Sexual History?

cs_everhadsex

Have you ever had sex?

cs_share12mth_numsexpartn

Are you willing to share the number of different people have you had sex with in

cs_12mth_numsexpartn

How many people have you had sex with in the past 12 months (including your husb

cs_condomless_3months

Have you had any sex without a condom in the last 3 months? (condom less sex)?

cs_condomless_72hours

Have you had any sex without a condom in the last 72 hours / last 3 days (condom

cs_knwpartnstatus_curr

Do you know the HIV status of your current sexual partner?

cs_partnstatus_curr

What is the HIV status of your current sexual partner?

cs_gift_forsex

Did you ever give or were you ever given a gift in order to have sex? It could b

cs_sasa_expr

Has your partner/most recent partner done at least one of the following things t

srs_useviol_12mths

Have you used physical or sexual violence on your partner in the last 12 months?

cs_drug_alc_smok_done

Was the Participant asked about Tobacco, Alcohol and Drug Use?

cs_smoke_hist

In your whole life up to now, have you ever smoked a cigarette?

cs_smoked_perday

How many cigarettes do you smoke in a day?

cs_everdrink

In your whole life up to now, have you ever drunk one drink of alcohol (e.g. a b

cs_daysdrunk_mths

How many days have you drunk at least one drink in the past month? [number of da

cs_more5drinks_day

How many days have you drunk 5 or more drinks (in succession) on one or more day

cs_usedoth_drugs_0

Have you used any of these drugs in the past 3 months (Tick all that apply) - No

cs_usedoth_drugs_1

Have you used any of these drugs in the past 3 months (Tick all that apply) - Ca

cs_usedoth_drugs_2

Have you used any of these drugs in the past 3 months (Tick all that apply) - Sn

cs_usedoth_drugs_3

Have you used any of these drugs in the past 3 months (Tick all that apply) - In

cs_usedoth_drugs_4

Have you used any of these drugs in the past 3 months (Tick all that apply) - Me

cs_usedoth_drugs_5

Have you used any of these drugs in the past 3 months (Tick all that apply) - Co

cs_usedoth_drugs_6

Have you used any of these drugs in the past 3 months (Tick all that apply) - He

cs_usedoth_drugs_7

Have you used any of these drugs in the past 3 months (Tick all that apply) - Cl

cs_usedoth_drugs_93

Have you used any of these drugs in the past 3 months (Tick all that apply) - Pr

cs_usedoth_drugs_96

Have you used any of these drugs in the past 3 months (Tick all that apply) - Ot

cs_othdrug_oth

Please specify more details on the kind of other drugs you have used?

cs_population_done

Was the Participant asked with which population group they associated with?

cs_populations_1

With which of the following population does the participant identify? (Tick all

cs_populations_2

With which of the following population does the participant identify? (Tick all

cs_populations_3

With which of the following population does the participant identify? (Tick all

cs_populations_4

With which of the following population does the participant identify? (Tick all

cs_populations_5

With which of the following population does the participant identify? (Tick all

cs_populations_6

With which of the following population does the participant identify? (Tick all

cs_populations_93

With which of the following population does the participant identify? (Tick all

cs_admin_date

Date form was administered

fd_screen_date

Follow Up Screening date

fd_condom_first_24h

Did the participant use condoms/abstain for the first 24 hours after insertion?

fd_kept_ring_28days

Did the participant kept the ring insitu for the last 28 days since insertion?

fd_any_negative_experience

Does the participant has any negative experience to report?

fd_list_neg_experience_1

Please list the the negative experience/s - Felt Discomfort

fd_list_neg_experience_2

Please list the the negative experience/s - Came out during sex

fd_list_neg_experience_3

Please list the the negative experience/s - Came out on its own

fd_list_neg_experience_4

Please list the the negative experience/s - Doesn't want the ring anymore

fd_list_neg_experience_5

Please list the the negative experience/s - Having an STI

fd_list_neg_experience_6

Please list the the negative experience/s - Abnormal pain

fd_list_neg_experience_7

Please list the the negative experience/s - Don't feel protected by the Ring

fd_list_side_effects_0

Does the participant has any of the following side effects? - No side effects

fd_list_side_effects_1

Does the participant has any of the following side effects? - Urinary tract infe

fd_list_side_effects_2

Does the participant has any of the following side effects? - Vaginal discharge

fd_list_side_effects_3

Does the participant has any of the following side effects? - Pelvic or lower ab

po_assess_date

Assessment date

po_given_birth

Since the last visit, has the participant given birth?

po_num_infants

Number of infants

po_preg_outcome

Pregnancy outcome

po_preg_outcome_date

Date of pregnancy outcome

po_oth_ae_outcome

Any other adverse outcomes (incl encephaly, hernia, HIV)?

po_oth_ae_outcome_desc

Please describe other adverse outcomes

po_delivery_mode

Mode of delivery

po_weeks_to_misc_term

How many weeks pregnant were you when you had the miscarriage/termination or chi

po_any_problem_anom

Any other problems or anomalies with birth?

po_specify_problem_anom

Please specify details on other problems or anomalies with birth

po_data_source

How were the data reported and captured?

ih_infant_sex

Infant Gender

ih_birth_weight

Birthweight

ih_infant_alive

Is the infant still alive?

ih_time_to_death

When did your baby die?

ih_how_is_baby_fed_current

How is your baby currently being fed?

ih_descr_baby_health

How would you describe your baby's health from birth until now?

ih_calc_low_birth_weight

Calculate - Low birth weight

ec_discuss_emcontrac

Was emergency contraceptives discussed with the participant?

ec_form_date

Date form completed

ec_used_emcontrac_3mths

Did the participant take emergency contraceptives within the last 3 months?

ec_uptake_emcontrac

Did the participant uptake Emergency Contraception?

vs_exam_done

Was the participant's Vital Signs measured and Physical examination done?

vs_starttime

Vitals - Start time

vs_meas_temp

Was Temperature measured?

vs_heart_temp

Temperature (Degrees Celsius)

vs_meas_heart_rate

Was Heart Rate measured?

vs_heart_rate

Record Heart Rate (bpm)

vs_meas_bp

Was Blood Pressure measured?

vs_r1_bp_sys

First BP Reading - Systolic

vs_r1_bp_dia

First BP Reading - Diastolic

vs_r2_bp_sys

Second BP Reading - Systolic

vs_r2_bp_dia

Second BP Reading - Diastolic

vs_r3_bp_sys

Third BP Reading - Systolic

vs_r3_bp_dia

Third BP Reading - Diastolic

vs_pe_nerve

Central Nervous System

vs_pe_nerve_abn

Specify abnormality for: Central Nervous System

vs_pe_cardio

Cardiovascular System

vs_pe_cardio_abn

Specify abnormality for: Cardiovascular System

vs_pe_resp

Respiratory System

vs_pe_resp_abn

Specify abnormality for: Respiratory System

vs_pe_gastro

Gastrointestinal System

vs_pe_gastro_abn

Specify abnormality for: Gastrointestinal System

vs_pe_skin

Skin

vs_pe_skin_abn

Specify abnormality for: Skin

vs_pe_joints

Joints

vs_pe_joints_abn

Specify abnormality for: Joints

vs_stoptime

Vitals - Stop time

sp_sti_reas_not_collect

What is the reason why the person is not willing to provide a sample?

rl_reviewed_date

Review date

rl_reviewed_elisa_hiv

Was the Elisa HIV Result reviewed?

rl_recall_for_elisa_hiv

Should the participant be recalled to the clinic for a visit with the Study Doct

rl_reviewed_dbs_hiv

Was the DBS HIV Result reviewed?

rl_recall_for_dbs_hiv

Should the participant be recalled to the clinic for a visit with the Study Doct

rl_reviewed_elisa_vl

Was the Elisa Viral Load Result reviewed?

rl_recall_for_elisa_vl

Should the participant be recalled to the clinic for a visit with the Study Doct

rl_reviewed_dbs_vl

Was the DBS Viral Load Result reviewed?

rl_recall_for_dbs_vl

Should the participant be recalled to the clinic for a visit with the Study Doct

rl_reviewed_cd4

Was the CD4 Result reviewed?

rl_recall_for_cd4

Should the participant be recalled to the clinic for a visit with the Study Doct

rl_reviewed_truv

Was the Truvado drug level Result reviewed?

rl_recall_for_truv

Should the participant be recalled to the clinic for a visit with the Study Doct

rl_reviewed_nhls

Was the NHLS Result reviewed?

rl_recall_for_nhls

Should the participant be recalled to the clinic for a visit with the Study Doct

rl_upload_docs

Please use this field to upload any lab reports and documents. (Optional)

rl_calc_recall

Calculated - Recalling participant for a clinic visit

rp_was_recalled

Was the participant recalled to the clinic?

rp_recalled_date

On which date was the participant Recalled?

fs_health_pro_done

Was the participant counselled about Health Promotion?

fc_starttime

Health Promotion - Start time

fc_diet

Discussing Diet:

fc_exercise

Discussing Exercise:

fc_alcohol

Discussing Alcohol consumption:

fc_mental_health

Discussing Mental Health Issues: Anxious, depresses, sleeplessness, worried

fc_fertility_advice

Overall fertility advice

fc_contraception_1

Types of contraception discussed - Condoms

fc_contraception_2

Types of contraception discussed - Oral contraceptive pills

fc_contraception_3

Types of contraception discussed - Injectable contraceptives

fc_contraception_4

Types of contraception discussed - Implants

fc_contraception_5

Types of contraception discussed - IUD/loop

fc_contraception_6

Types of contraception discussed - Sterilization

fc_safmt_sex_counseling_1

Counseling on Safer Sex Health - Condom

fc_safmt_sex_counseling_2

Counseling on Safer Sex Health - Regular HIV Testing

fc_safmt_sex_counseling_3

Counseling on Safer Sex Health - Partner HIV Testing (know your partner's status

fc_safmt_sex_counseling_4

Counseling on Safer Sex Health - Genital Hygiene

fs_was_condom_disp

Did you dispense condoms to the participant?

fs_num_male_condom

How many male condoms were dispensed? (Number of individual condoms, not package

fc_counsel_vmmc

Counselling around the benefits of voluntary medical male circumcision (VMMC)

fc_stoptime

Health Promotion - Stop time

ce_check_elig_done

Was the participant's Suitability for PrEP checked?

ce_starttime

Checking Eligibility - Start time

ce_elig_known_hiv_pos

Is the participant known to be HIV Positive?

ce_elig_hiv_neg

Does the participant have a HIV Negative confirmatory test result?

ce_elig_sexual_activ

Is the participant sexually active?

ce_pep_unpotect_sex

Have you had unprotected Sex with a stranger or a person of unknown HIV status?

ce_pep_took_prep

Have you been taking your PrEP medication continuously for 7 days before having

ce_pep_busted_condom

Have you had a Busted condom while having sex with a person of unknown status?

ce_pep_sex_assaulted

Have you been sexually assaulted?

ce_pep_shared_needle

Have you shared a Needle or any other sharp equipment to inject drugs?

ce_pep_expos_fluids

Have you been exposed to contagious body fluids/semen/blood?

ce_update_pep

Did the participant uptake PEP?

ce_will_contin_prep

Is the participant happy to continue on PrEP?

ce_contin_same_prep

Is the participant continuing on the same method of PrEP ([end_of_study_arm_1][c

ce_elig_risk_hiv

Is the participant at significant risk of acquiring HIV infection? *Adolescents

ce_elig_num_sex_partner

With how many different persons did the participants had sex with, 12 months?

ce_elig_num_unpotect

Has the participant had unprotected sex with HIV positive partners or partners w

ce_elig_under_influe

Did the participant ever had sex while under the influence of alcohol and/or dru

ce_elig_trans_sex

Over the past year, has the participant ever engaged in the exchange of sex for

ce_elig_will_take_tablet

Is the participant willing and able to take a tablet for HIV prevention?

ce_elig_will_use_condom

Does the participant fully understands that the protection provided by PrEP is n

ce_elig_will_attnd_visits

Is the participant willing and able to attend 3 monthly Clinic Visits?

ce_elig_confirm_cntdetails

Have you checked that you have the correct Contact Details to track the the Part

ce_consid_elig_prep

Is the participant consider Suitable to be initiated on PrEP?

ce_not_consid_prep_reas

Please provide the reason why the participant is not deemed suitable for PrEP

ce_oral_info_discussed

Has the information regarding the Oral PrEP (TDF/FTC) been discussed with the pa

ce_oral_info_questions

Does the participant have any questions about the Injectable Oral PrEP (TDF/FTC)

ce_screen_oral

Continue with screening for Oral PrEP (TDF/FTC)?

ce_oral_in_population

All young men and women aged 15-30 who are residing in the 40 administrative clu

ce_oral_in_hiv_neg

Documented HIV negative test?

ce_oral_in_elig_prep

Eligible for PrEP according to South African guidelines and/or already on oral P

ce_oral_in_schedule

Understand the required dosing schedule and HIV testing?

ce_oral_in_share_peernav

Aware that their details can be shared with a peer navigator to support their fo

ce_oral_ex_allergy_ip

History or presence of allergy to the study drugs or their components?

ce_oral_ex_egrf

Persistent eGFR of < 60 mmol/l at baseline?

ce_cab_info_discussed

Has the information regarding the Injectable PrEP (CABLA) been discussed with th

ce_cab_info_questions

Does the participant have any questions about the Injectable PrEP (CABLA)?

ce_screen_cab

Continue with screening for Injectable PrEP (CABLA)?

ce_cabla_in_population

Is the participant a Young man and woman aged 16-30 who are residing in the 20 a

ce_cabla_und_schedule

Does the participant understand the required dosing schedule and HIV testing?

ce_cabla_und_pregnant

Does the participant sufficiently understand that CABLA can and will be offered

ce_cabla_aware_peernav

Is the participant aware that there details can be shared with a peer navigator

ce_cabla_consented

Did the participant provide informed consent (aged 18 and over) or, informed ass

ce_cabla_ex_allergy

Does the participant has a history or presence of allergy to the study drugs or

ce_cabla_ex_no_understand

Is the following statement true for the participant?: Provide informed consent (

ce_cabla_ex_any_conditions

Does the participant has any of these conditions?: Severe mental health disorder

ce_cabla_ex_liver_test

Does the participant had an Abnormal liver function tests (ALT more than two tim

ce_cabla_ex_prohibit_meds

Is the participant taking medication that is contraindicated: Carbamazepine, Oxc

ce_dap_info_discussed

Has the information regarding the Dapi ring been discussed with the participant?

ce_dap_info_questions

Does the participant have any questions about the Dapi ring?

ce_screen_dapi_ring

Continue with screening for Dapi ring?

ce_born_female

Was the participant born a female?

ce_genital_reassign

Have the participant undergone any genital reassignment?

ce_vaginal_sex_only

Does the participant normally have vaginal sex only?

ce_curr_pregnant

Is the participant currently pregnant or delivered/miscarried in the last 6 week

ce_have_sti_sores

Does the participant have any vaginal discharge or sores around the vagina?

ce_dap_in_population

All women aged 18-30 who are residing in the 40 administrative clusters?

ce_dap_in_hiv_neg

Documented HIV negative test?

ce_dap_in_elig_prep

Eligible for PrEP according to South African guidelines and/or already on oral P

ce_dap_in_schedule

Understand the required dosing schedule and HIV testing?

ce_dap_in_share_peernav

Aware that their details can be shared with a peer navigator to support their fo

ce_dap_ex_allergy_ip

History or presence of allergy to the study drugs or their components?

ce_uptake_prep

Did the participant uptake PrEP?

ce_prep_method

What method of PrEP Treatment will the participant be taking?

ce_not_uptake_prep_reas

Please provide the reason why the participant is not uptake PrEP

ce_uptake_peppack

Would the participant accept a PEP pack?

ce_not_uptake_peppack_reas

Please provide the reason why the participant did not uptake the PEP pack

ce_uptake_peer_supp

Would the participant like to uptake Peer Support for adhering to PrEP?

ce_checked_by_doctor

Was the Eligibility for PrEP checked by the Study Physician?

ce_checked_date

Date checked

ce_checked_approved

Is the participant approved to start PrEP?

ce_stoptime

Checking Eligibility - Stop time

ce_calc_prep_visit

Calculated PrEP Visit 1 = Initial PrEP visit

ce_calc_elig_cabla

Calculate - Eligible for Injectable PrEP - CABLA

ce_calc_screen_dapi

Calculate - Screening Outcome for Dapi ring

ce_calc_elig_dapi

Calculate - Eligible for Dapi ring

ce_calc_dur_end_elig

Calculate Duration till end of Checking Eligibility

ep_date

Date:

ep_diagnosis

Diagnosis

ep_any_allergies

Any known allergies?

ep_allergies

Known allergies

ep_medication

Medication name

ep_med_unit_oral

Medication unit - Oral PrEP

ep_med_unit_ring

Medication unit - Dapi ring

ep_med_unit_injection

Medication unit - Injectable PrEP CABLA

ep_who_dispense

Who is the dispenser?

ep_disp_date

Date dispensed

ep_disp_com

Additional Comments

mc_counsel_date

Medication Counselling Date

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:

Total: 730

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