Isisekelo Sempilo:Clinical Management Datasets DDI.AHRI.IsisekeloSempilo.Clinical.Management.Datasets.v2.0 Carina Herbst Jaco Dreyer Natsayi Chimbindi Africa Health Research Institute Nesstar Publisher Isisekelo Sempilo:Clinical Management Datasets AHRI.IsisekeloSempilo.Clinical.Management.Datasets.v2.0

Jaco Dreyer

Africa Health Research Institute Nesstar Publisher 3ie Nationational Institute of Health V2.0.0 HIV prevention, sexual reproductive health, peer navigators, adaptive trial, homebased STI testing HIV prevention, sexual reproductive health, peer navigators, adaptive trial, homebased STI testing South Africa Demographic surveillance area of the Africa Health Research Institute; KwaZulu-Natal, uMkhanyakude district Basic unit(s) of analysis or observation that the study describes: For PANGEA is each record a sequence from a specimen, or are there multiple records for a single specimen or study participant Research assistants will approach n=3000 16-29-year old males and females selected from the demographic surveillance area at their homesteads. We expect that 2000 will still be eligible, i.e. aged 16-29 and still living in the surveillance area. Research assistants will provide information about the study to all eligible participants and consent them to the random offer of HIV or sexual health interventions and follow-up with a survey and HIV testing at 12 months. We anticipate that n=1500 [75% (73-77%)] will consent to participate. Shahmanesh, M. (2022) “Isisekelo Sempilo:Clinical Management Datasets.” Africa Health Research Institute. doi: 10.23664/AHRI.ISISEKELOSEMPILO.CLINICAL.MANAGEMENT.DATASET.V2.0 AHRI.IsisekeloSempilo.AdverseEvents.2022.v2.NSDstat 191 21 Nesstar 200801 AHRI.IsisekeloSempilo.Clinical.CombinedDataset.2022.v2.NSDstat 2610 196 Nesstar 200801 AHRI.IsisekeloSempilo.Clinical.CombinedDataset_Exclu_PInfo.2022.v2.NSDstat 2610 187 Nesstar 200801 AHRI.IsisekeloSempilo.ClinicVisits.2022.v2.NSDstat 2599 21 Nesstar 200801 AHRI.IsisekeloSempilo.ClinScreenHealthPro.2022.v2.NSDstat 73210 10 Nesstar 200801 AHRI.IsisekeloSempilo.Consents.2022.v2.NSDstat 7227 14 Nesstar 200801 AHRI.IsisekeloSempilo.EndOfStudy.2022.v2.NSDstat 1742 9 Nesstar 200801 AHRI.IsisekeloSempilo.PersonalInformation.2022.v2.NSDstat 3000 12 Nesstar 200801 AHRI.IsisekeloSempilo.PhoneCalls.2022.v2.NSDstat 2444 16 Nesstar 200801 AHRI.IsisekeloSempilo.PrEPEligibilityCheck.2022.v2.NSDstat 1633 18 Nesstar 200801 AHRI.IsisekeloSempilo.ReasonsStopPrEP.2022.v2.NSDstat 205 20 Nesstar 200801 AHRI.IsisekeloSempilo.TestResults.2022.v2.NSDstat 22884 11 Nesstar 200801 AHRI.IsisekeloSempilo.VitalSigns.2022.v2.NSDstat 2197 14 Nesstar 200801 AHRI.IsisekeloSempilo.Medications.2022.v2.NSDstat 1815 21 Nesstar 200801 Internal Individual ID 191 0 546 245658 97282.398 61331.208 Clinic Visit Identifier 191 0 Instance 191 0 Did the participant reported any side effects or adverse events since the last v 191 0 1 Yes 1 2 No 190 Common side effects of PrEP - Code 0 191 Common side effects of PrEP - Description 0 0 Details of other side effect or adverse event 0 0 Start date of event 1 2021-07-24 2021-07-24 Is the event ongoing? 1 190 1 Yes 0 2 No 1 Sysmiss 190 Stop date of event 1 2021-07-27 2021-07-27 Severity of event - Code 1 190 Severity of event - Description 1 0 Relationship to study - Code 1 190 Relationship to study - Description 1 0 Action Taken Regarding Drug adverse event - Code 1 190 Action Taken Regarding Drug adverse event - Description 1 0 Please specify details on other action taken 1 Outcome of event - Code 1 190 Outcome of event - Description 1 0 Is this an expected event for this study? 1 190 1 Yes 0 2 No 1 Sysmiss 190 Is this a Serious Adverse Event? 1 190 1 Yes 1 2 No 0 Sysmiss 190 Internal Individual ID 2610 0 33 247317 98991.067 59743.681 Medication Visit Identifier 2610 0 Medication Instance 2610 0 Clinic Visit Description 2610 0 Date of Clinic Visit 2396 2020-03-05 2022-07-14 Clinic Location Code 2394 216 Clinic Location Description 2394 0 Clinic Location Code 2610 0 Clinic Location Name 2148 0 GPS Latitude 1626 0 GPS Longitude 1626 0 CRA Staff Code 2610 0 Nurse Staff Code 2610 0 Was the Clinic attended at this visit? 2610 0 1 Yes 2396 2 No 214 BSID 2610 0 106 92194 14075.041 19518.645 HHID 2610 0 11 45970 15527.359 12936.622 Participant 's date of birth 2610 1990-04-12 2021-10-02 Participant's Age 2610 0 Participant Sex Code 2610 0 Participant Sex Description 2610 0 Participant'sWeek block 2610 0 Participant'sWeek 2610 0 1 44 22.967 12.419 Participant's Isigodi - Description 2610 0 Reason for visiting the Clinic - PrEP Services 253 2357 1 Yes 253 2 No 0 Sysmiss 2357 Reason for visiting the Clinic - ART 87 2523 1 Yes 87 2 No 0 Sysmiss 2523 Reason for visiting the Clinic - Contraception 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reason for visiting the Clinic - HIV Testing 1598 1012 1 Yes 1598 2 No 0 Sysmiss 1012 Reason for visiting the Clinic - STI Screening 330 2280 1 Yes 330 2 No 0 Sysmiss 2280 Reason for visiting the Clinic - Cervical Screening 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reason for visiting the Clinic - Other Non-Medical 311 2299 1 Yes 311 2 No 0 Sysmiss 2299 Reason for visiting the Clinic - Specify Other Non-Medical Services 310 Record height (cm) 1002 1608 50.1 196 163.695 10.491 1001 .. Record weight (kg) 1803 807 30.3 162 65.488 14.639 1001 .. Calculated BMI 1787 823 13.4 641.8 25.173 19.941 1001 .. Assessed to be capable to consent for participation 1723 887 1 Yes 1723 2 No 0 Sysmiss 887 Date of informed consent - HIV Testing 1600 2020-03-13 2022-06-17 Consent to Rapid HIV test to know HIV status? 1600 1010 Consent to record attendance at clinic? 1600 1010 Consent to SMS contact? 1600 1010 Consent to phone call? 1600 1010 HIV Rapid - One step 1594 0 HIV Rapid - One step - repeat 1 0 HIV Rapid - Abon 1594 0 HIV Rapid - Abon - Repeat 0 0 HIV Rapid - Final Calculated Result 1593 0 Specimen Identifier - STI 4 0 STI - Chlamydia Trachomatis 4 0 STI - Neisseria Gonorrhoeae 4 0 STI - Trichomonas Vaginalis 4 0 Hepatitis B - Rapid 0 0 Creatinine - Rapid 0 0 Urine Dipstick Pregnancy 414 0 Urine Dipstick Pregnancy - Repeat 0 0 Glucose - Rapid 1225 0 Glucose - Rapid - Repeat 0 0 Syphilis - Rapid 1628 0 Urinalysis Leukocytes Result 639 0 Urinalysis Nitrites Result 639 0 Urinalysis Urobilinogen Result 639 0 Urinalysis Protein Result 639 0 Urinalysis Blood Result 639 0 Urinalysis Specific Gravity Result 639 0 Urinalysis Ketone Result 639 0 Urinalysis Bilirubin Result 639 0 Urinalysis Glucose Result 638 0 Specimen Identifier - DBS 1529 0 HIV DBS Result 1529 0 Viral Load DBS Result 41 0 Specimen Identifier - Elisa 2 0 HIV Elisa Result 0 0 Viral Load Elisa Result 0 0 CD4 Elisa Result 2 0 Truvado drug level Result 0 0 Hepatitis B Result 0 0 Creatinine Result 0 0 Do you have any of the following symptoms? - Reproductive Tract 1988 0 Please provide details on other symptoms 5 0 Do you have any of the following symptoms? - TB Screening 1994 0 Calculated Variable: Number of TB Symptoms 2120 0 Has this participant been referred to the DoH for TB? 0 0 Have you ever received a test result for HIV? 1978 0 Have you ever had a positive HIV test result? 1911 0 Are you currently receiving ART? 295 0 1888 0 Please provide details on other Past Medical Histories 1 0 Are you currently on Chronic or other Medication? 104 0 Have you been on TB Treatment in the past 3 months? 0 0 Please specify details of TB drugs 103 0 Is the participant allergic to anything? 1888 0 Please provide details on Specific Allergies 0 0 When was your last period? 858 0 How many days do you normally bleed? 852 0 How many times do you change your sanitary towel or cup? 0 0 How often do you have your period? 1126 0 Other details on period frequency? 5 0 Have you ever fathered any children? 749 0 Are you currently pregnant? 1126 0 Have you ever been pregnant? 1050 0 How old were you the first time you got pregnant? [age in years] 778 0 How many times have you been pregnant? (including pregnancies that did not go to 778 0 How many times have you given birth? (include both live births and stillbirths. 778 0 Are you currently using any contraceptive methods to prevent pregnancy? 1044 0 Which contraceptive methods are you currently using? 490 0 Other contraceptive method, please specify: 0 0 Have you ever been circumcised? 749 0 Have you been vaccinated against HPV? 982 0 Have you had your Pap smear? 989 0 What was the result? 14 0 When was the last Pap smear? 14 0 Have you ever had sex? 1977 0 Are you willing to share the number of different people have you had sex with in 1724 0 How many people have you had sex with in the past 12 months (including your husb 1505 0 Have you had any sex without a condom in the last 3 months? (condom less sex)? 1724 0 Do you know the HIV status of your current sexual partner? 1724 0 What is the HIV status of your current sexual partner? 560 0 Did you ever give or were you ever given a gift in order to have sex? It could b 1724 0 IPV (SASA!) Has your partner/most recent partner done at least one of the follow 1977 0 Have you used physical or sexual violence on your partner in the last 12 months? 1975 0 In your whole life up to now, have you ever smoked a cigarette? 1851 0 How many cigarettes do you smoke in a day? 196 0 In your whole life up to now, have you ever drunk one "drink" of alcohol (e.g. a 1850 0 How many days have you drunk at least one drink in the past month? [number of da 597 0 How many days have you drunk 5 or more drinks (in succession) on one or more day 597 0 Have you used any of these drugs in the past 3 months (Tick all that apply) 1849 0 Please specify more details on the kind of other drugs you have used? 2 0 With which of the following population does the participant identify? (Tick all 2001 0 Temperature (Degrees Celsius) 2024 586 35.4 39 36.466 0.388 101 .. Record Heart Rate (bpm) 2022 588 51 114 76.258 10.749 First BP Reading - Systolic 2014 596 10 1102 111.54 25.277 First BP Reading - Diastolic 2014 596 5 114 68.851 10.363 Second BP Reading - Systolic 25 2585 89 151 117.76 14.842 Second BP Reading - Diastolic 25 2585 53 98 69.88 13.068 Final BP Reading - Systolic 25 2585 89 151 114.88 12.191 Final BP Reading - Diastolic 25 2585 53 92 69.28 11.77 Discussing Diet 2034 0 Discussing Exercise 2034 0 Discussing Alcohol consumption 2033 0 Discussing Mental Health Issues 2034 0 Overall fertility advice 1309 0 Types of contraception discussed 1308 0 Counseling on Safer Sex Health 2028 0 Counselling around the benefits of voluntary medical male circumcision (VMMC) 975 0 Does the participant have a HIV Negative confirmatory test result? 1634 976 1 Yes 1440 2 No 194 Sysmiss 976 Is the participant at significant risk of acquiring HIV infection? 1619 991 1 Yes 1475 2 No 144 Sysmiss 991 Is the participant sexually active? 1621 989 1 Yes 1373 2 No 248 Sysmiss 989 With how many different persons did the participants had sex with, 12 months? 1091 1519 Has the participant had unprotected sex with HIV positive partners or partners w 1620 990 1 Yes 1058 2 No 562 Sysmiss 990 Did the participant ever had sex while under the influence of alcohol and/or dru 1618 992 1 Yes 331 2 No 1287 Sysmiss 992 Is the participant willing and able to take a tablet everyday? 1618 992 1 Yes 435 2 No 1183 Sysmiss 992 Does the participant fully understands that the protection provided by PrEP is n 1620 990 1 Yes 1585 2 No 35 Sysmiss 990 Is the participant willing and able to attend 3 monthly Clinic Visits? 1620 990 1 Yes 1191 2 No 429 Sysmiss 990 Is the participant willing to be on contraception during use of PrEP? 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 1634 976 1 Yes 1628 2 No 6 Sysmiss 976 Is the participant consider Eligible to be initiated on PrEP? 1635 975 1 Yes 392 2 No 1243 Sysmiss 975 Reason why the participant is NOT consider Eligible to be initiated on PrEP 1242 Is the participant going to uptake PrEP? 355 2255 Reason whythe participant NOT going to uptake PrEP 10 0 Date of informed consent - PrEP Initiation 123 2020-10-13 2022-03-29 Received enough information about the study? 120 2490 Given an opportunity to ask questions about the study? 123 2487 Agree to take part in this study (PrEP)? 122 2488 Agree to have specimens stored? 122 2488 Agree to be contacted by phone? 123 2487 Person is illiterate? 122 2488 Did the participant reported that they stopped taking PrEP? 172 2438 1 Yes 18 2 No 154 Sysmiss 2438 Staff Code 172 0 On which date did the participant stop taking PrEP? 18 2021-01-31 2022-11-16 Reasons for stopping PrEP - Don't have sex currently. 3 2607 1 Yes 3 2 No 0 Sysmiss 2607 Reasons for stopping PrEP - Have fewer partners. 1 2609 1 Yes 1 2 No 0 Sysmiss 2609 Reasons for stopping PrEP - Partner/s or family member/s objected to me taking P 1 2609 1 Yes 1 2 No 0 Sysmiss 2609 Reasons for stopping PrEP - Trust partner/s or knows their status. 1 2609 1 Yes 1 2 No 0 Sysmiss 2609 Reasons for stopping PrEP - Other prevention strategies are sufficient. 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reasons for stopping PrEP - Finding it difficult to engage with PrEP services. 6 2604 1 Yes 6 2 No 0 Sysmiss 2604 Reasons for stopping PrEP - Worried about experiencing short term side effects. 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reasons for stopping PrEP - Worried about experiencing long term side effects. 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reasons for stopping PrEP - Don't feel adequately protected with PrEP. 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reasons for stopping PrEP - Don't want to or finding it difficult to take a dail 1 2609 1 Yes 1 2 No 0 Sysmiss 2609 Reasons for stopping PrEP - Prefer not to take PrEP as pregnant or trying to bec 1 2609 1 Yes 1 2 No 0 Sysmiss 2609 Reasons for stopping PrEP - Other 5 2605 1 Yes 5 2 No 0 Sysmiss 2605 Reasons for stopping PrEP - Other, specify 5 0 Would you be willing to take PrEP again in the future? 18 2592 1 Yes 13 2 No 5 Sysmiss 2592 Received treatment for - STI 379 0 Received treatment for - PrEP 444 0 Received treatment for - ART 102 0 Received treatment for - Contraceptives 362 0 Received treatment for - Other 147 0 Does this participant needs to be referred to a DoH Clinic? 1536 0 If yes, reason 119 Date of Next Scheduled Clinic Visit 1964 2020-04-30 2022-07-29 Did the participant reported any side effects or adverse events since the last v 189 0 Participant withdraw at this visit? 2609 0 Reason for Withdrawal - Code 2609 1 4 96 13.73 21.931 Reason for Withdrawal - Description 2609 0 Specify other Reason for Withdrawal 174 Date of Death 6 2021-07-27 2022-03-30 Date of Transfer to DoH 246 2021-07-06 2022-07-14 Internal Individual ID 2610 0 33 247317 98991.067 59743.681 Medication Visit Identifier 2610 0 Medication Instance 2610 0 Clinic Visit Description 2610 0 Date of Clinic Visit 2396 2020-03-05 2022-07-14 Clinic Location Code 2394 216 Clinic Location Description 2394 0 Clinic Location Code 2610 0 Clinic Location Name 2148 0 GPS Latitude 1626 0 GPS Longitude 1626 0 CRA Staff Code 2610 0 CRA01 335 CRA02 409 CRA03 391 CRA04 484 CRA06 435 UNK 556 Nurse Staff Code 2610 0 Was the Clinic attended at this visit? 2610 0 1 Yes 2396 2 No 214 Reason for visiting the Clinic - PrEP Services 253 2357 1 Yes 253 2 No 0 Sysmiss 2357 Reason for visiting the Clinic - ART 87 2523 1 Yes 87 2 No 0 Sysmiss 2523 Reason for visiting the Clinic - Contraception 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reason for visiting the Clinic - HIV Testing 1598 1012 1 Yes 1598 2 No 0 Sysmiss 1012 Reason for visiting the Clinic - STI Screening 330 2280 1 Yes 330 2 No 0 Sysmiss 2280 Reason for visiting the Clinic - Cervical Screening 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reason for visiting the Clinic - Other Non-Medical 311 2299 1 Yes 311 2 No 0 Sysmiss 2299 Reason for visiting the Clinic - Specify Other Non-Medical Services 310 Record height (cm) 1002 1608 50.1 196 163.695 10.491 1001 .. Record weight (kg) 1803 807 30.3 162 65.488 14.639 1001 .. Calculated BMI 1787 823 13.4 641.8 25.173 19.941 1001 .. Assessed to be capable to consent for participation 1723 887 1 Yes 1723 2 No 0 Sysmiss 887 Date of informed consent - HIV Testing 1600 2020-03-13 2022-06-17 Consent to Rapid HIV test to know HIV status? 1600 1010 Consent to record attendance at clinic? 1600 1010 Consent to SMS contact? 1600 1010 Consent to phone call? 1600 1010 HIV Rapid - One step 1594 0 HIV Rapid - One step - repeat 1 0 HIV Rapid - Abon 1594 0 HIV Rapid - Abon - Repeat 0 0 HIV Rapid - Final Calculated Result 1593 0 Specimen Identifier - STI 4 0 URI1-39400395 1 VSW1-39400048 1 VSW1-39400096 1 VSW1-39400481 1 STI - Chlamydia Trachomatis 4 0 STI - Neisseria Gonorrhoeae 4 0 STI - Trichomonas Vaginalis 4 0 Hepatitis B - Rapid 0 0 Creatinine - Rapid 0 0 Urine Dipstick Pregnancy 414 0 Urine Dipstick Pregnancy - Repeat 0 0 Glucose - Rapid 1225 0 Glucose - Rapid - Repeat 0 0 Syphilis - Rapid 1628 0 Urinalysis Leukocytes Result 639 0 Urinalysis Nitrites Result 639 0 Urinalysis Urobilinogen Result 639 0 Urinalysis Protein Result 639 0 Urinalysis Blood Result 639 0 Urinalysis Specific Gravity Result 639 0 Urinalysis Ketone Result 639 0 Urinalysis Bilirubin Result 639 0 Urinalysis Glucose Result 638 0 Specimen Identifier - DBS 1529 0 HIV DBS Result 1529 0 Viral Load DBS Result 41 0 Specimen Identifier - Elisa 2 0 HIV Elisa Result 0 0 Viral Load Elisa Result 0 0 CD4 Elisa Result 2 0 Truvado drug level Result 0 0 Hepatitis B Result 0 0 Creatinine Result 0 0 Do you have any of the following symptoms? - Reproductive Tract 1988 0 Please provide details on other symptoms 5 0 Do you have any of the following symptoms? - TB Screening 1994 0 Calculated Variable: Number of TB Symptoms 2120 0 Has this participant been referred to the DoH for TB? 0 0 Have you ever received a test result for HIV? 1978 0 Have you ever had a positive HIV test result? 1911 0 Are you currently receiving ART? 295 0 1888 0 Please provide details on other Past Medical Histories 1 0 Are you currently on Chronic or other Medication? 104 0 Have you been on TB Treatment in the past 3 months? 0 0 Please specify details of TB drugs 103 0 Is the participant allergic to anything? 1888 0 Please provide details on Specific Allergies 0 0 When was your last period? 858 0 How many days do you normally bleed? 852 0 How many times do you change your sanitary towel or cup? 0 0 How often do you have your period? 1126 0 Other details on period frequency? 5 0 Have you ever fathered any children? 749 0 Are you currently pregnant? 1126 0 Have you ever been pregnant? 1050 0 How old were you the first time you got pregnant? [age in years] 778 0 How many times have you been pregnant? (including pregnancies that did not go to 778 0 How many times have you given birth? (include both live births and stillbirths. 778 0 Are you currently using any contraceptive methods to prevent pregnancy? 1044 0 Which contraceptive methods are you currently using? 490 0 Other contraceptive method, please specify: 0 0 Have you ever been circumcised? 749 0 Have you been vaccinated against HPV? 982 0 Have you had your Pap smear? 989 0 What was the result? 14 0 When was the last Pap smear? 14 0 Have you ever had sex? 1977 0 Are you willing to share the number of different people have you had sex with in 1724 0 How many people have you had sex with in the past 12 months (including your husb 1505 0 Have you had any sex without a condom in the last 3 months? (condom less sex)? 1724 0 Do you know the HIV status of your current sexual partner? 1724 0 What is the HIV status of your current sexual partner? 560 0 Did you ever give or were you ever given a gift in order to have sex? It could b 1724 0 IPV (SASA!) Has your partner/most recent partner done at least one of the follow 1977 0 Have you used physical or sexual violence on your partner in the last 12 months? 1975 0 In your whole life up to now, have you ever smoked a cigarette? 1851 0 How many cigarettes do you smoke in a day? 196 0 In your whole life up to now, have you ever drunk one "drink" of alcohol (e.g. a 1850 0 How many days have you drunk at least one drink in the past month? [number of da 597 0 How many days have you drunk 5 or more drinks (in succession) on one or more day 597 0 Have you used any of these drugs in the past 3 months (Tick all that apply) 1849 0 Please specify more details on the kind of other drugs you have used? 2 0 With which of the following population does the participant identify? (Tick all 2001 0 Temperature (Degrees Celsius) 2024 586 35.4 39 36.466 0.388 101 .. Record Heart Rate (bpm) 2022 588 51 114 76.258 10.749 First BP Reading - Systolic 2014 596 10 1102 111.54 25.277 First BP Reading - Diastolic 2014 596 5 114 68.851 10.363 Second BP Reading - Systolic 25 2585 89 151 117.76 14.842 Second BP Reading - Diastolic 25 2585 53 98 69.88 13.068 Final BP Reading - Systolic 25 2585 89 151 114.88 12.191 Final BP Reading - Diastolic 25 2585 53 92 69.28 11.77 Discussing Diet 2034 0 Discussing Exercise 2034 0 Discussing Alcohol consumption 2033 0 Discussing Mental Health Issues 2034 0 Overall fertility advice 1309 0 Types of contraception discussed 1308 0 Counseling on Safer Sex Health 2028 0 Counselling around the benefits of voluntary medical male circumcision (VMMC) 975 0 Does the participant have a HIV Negative confirmatory test result? 1634 976 1 Yes 1440 2 No 194 Sysmiss 976 Is the participant at significant risk of acquiring HIV infection? 1619 991 1 Yes 1475 2 No 144 Sysmiss 991 Is the participant sexually active? 1621 989 1 Yes 1373 2 No 248 Sysmiss 989 With how many different persons did the participants had sex with, 12 months? 1091 1519 Has the participant had unprotected sex with HIV positive partners or partners w 1620 990 1 Yes 1058 2 No 562 Sysmiss 990 Did the participant ever had sex while under the influence of alcohol and/or dru 1618 992 1 Yes 331 2 No 1287 Sysmiss 992 Is the participant willing and able to take a tablet everyday? 1618 992 1 Yes 435 2 No 1183 Sysmiss 992 Does the participant fully understands that the protection provided by PrEP is n 1620 990 1 Yes 1585 2 No 35 Sysmiss 990 Is the participant willing and able to attend 3 monthly Clinic Visits? 1620 990 1 Yes 1191 2 No 429 Sysmiss 990 Is the participant willing to be on contraception during use of PrEP? 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 1634 976 1 Yes 1628 2 No 6 Sysmiss 976 Is the participant consider Eligible to be initiated on PrEP? 1635 975 1 Yes 392 2 No 1243 Sysmiss 975 Reason why the participant is NOT consider Eligible to be initiated on PrEP 1242 Is the participant going to uptake PrEP? 355 2255 Reason whythe participant NOT going to uptake PrEP 10 0 Date of informed consent - PrEP Initiation 123 2020-10-13 2022-03-29 Received enough information about the study? 120 2490 Given an opportunity to ask questions about the study? 123 2487 Agree to take part in this study (PrEP)? 122 2488 Agree to have specimens stored? 122 2488 Agree to be contacted by phone? 123 2487 Person is illiterate? 122 2488 Did the participant reported that they stopped taking PrEP? 172 2438 1 Yes 18 2 No 154 Sysmiss 2438 Staff Code 172 0 On which date did the participant stop taking PrEP? 18 2021-01-31 2022-11-16 Reasons for stopping PrEP - Don't have sex currently. 3 2607 1 Yes 3 2 No 0 Sysmiss 2607 Reasons for stopping PrEP - Have fewer partners. 1 2609 1 Yes 1 2 No 0 Sysmiss 2609 Reasons for stopping PrEP - Partner/s or family member/s objected to me taking P 1 2609 1 Yes 1 2 No 0 Sysmiss 2609 Reasons for stopping PrEP - Trust partner/s or knows their status. 1 2609 1 Yes 1 2 No 0 Sysmiss 2609 Reasons for stopping PrEP - Other prevention strategies are sufficient. 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reasons for stopping PrEP - Finding it difficult to engage with PrEP services. 6 2604 1 Yes 6 2 No 0 Sysmiss 2604 Reasons for stopping PrEP - Worried about experiencing short term side effects. 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reasons for stopping PrEP - Worried about experiencing long term side effects. 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reasons for stopping PrEP - Don't feel adequately protected with PrEP. 0 2610 1 Yes 0 2 No 0 Sysmiss 2610 Reasons for stopping PrEP - Don't want to or finding it difficult to take a dail 1 2609 1 Yes 1 2 No 0 Sysmiss 2609 Reasons for stopping PrEP - Prefer not to take PrEP as pregnant or trying to bec 1 2609 1 Yes 1 2 No 0 Sysmiss 2609 Reasons for stopping PrEP - Other 5 2605 1 Yes 5 2 No 0 Sysmiss 2605 Reasons for stopping PrEP - Other, specify 5 0 Would you be willing to take PrEP again in the future? 18 2592 1 Yes 13 2 No 5 Sysmiss 2592 Received treatment for - STI 379 0 Received treatment for - PrEP 444 0 Received treatment for - ART 102 0 Received treatment for - Contraceptives 362 0 Received treatment for - Other 147 0 Does this participant needs to be referred to a DoH Clinic? 1536 0 If yes, reason 119 Date of Next Scheduled Clinic Visit 1964 2020-04-30 2022-07-29 Did the participant reported any side effects or adverse events since the last v 189 0 Participant withdraw at this visit? 2609 0 Reason for Withdrawal - Code 2609 1 4 96 13.73 21.931 Reason for Withdrawal - Description 2609 0 Specify other Reason for Withdrawal 174 Date of Death 6 2021-07-27 2022-03-30 Date of Transfer to DoH 246 2021-07-06 2022-07-14 Internal Individual ID 2599 0 33 247317 98994.123 59701.924 Clinic Visit Identifier 2599 0 Instance 2599 0 Clinic Visit Description 2599 0 Date of Clinic Visit 2385 2020-03-05 2022-07-14 Clinic Location Code 2383 216 Clinic Location Description 2383 0 Clinic Location Code 2599 0 Clinic Location Name 2139 0 CRA Staff Code 2599 0 Nurse Staff Code 2599 0 Was the Clinic attended at this visit? 2599 0 1 Yes 2385 2 No 214 Reason for visiting the Clinic - PrEP Services 252 2347 1 Yes 252 2 No 0 Sysmiss 2347 Reason for visiting the Clinic - Contraception 0 2599 1 Yes 0 2 No 0 Sysmiss 2599 Reason for visiting the Clinic - HIV Testing 1590 1009 1 Yes 1590 2 No 0 Sysmiss 1009 Reason for visiting the Clinic - ART 85 2514 1 Yes 85 2 No 0 Sysmiss 2514 Reason for visiting the Clinic - STI Screening 326 2273 1 Yes 326 2 No 0 Sysmiss 2273 Reason for visiting the Clinic - Cervical Screening 0 2599 1 Yes 0 2 No 0 Sysmiss 2599 Reason for visiting the Clinic - Other Non-Medical 310 2289 1 Yes 310 2 No 0 Sysmiss 2289 Reason for visiting the Clinic - Specify Other Non-Medical Services 309 Date of Next Scheduled Clinic Visit 1953 2020-04-30 2022-07-29 Internal Individual ID 73210 0 33 247317 98096.723 61145.18 Clinic Visit Identifier 73210 0 Instance 73210 0 Type of Questions - Code 73210 0 Type of Questions - Description 73210 0 Question - Code 73210 0 Question - Description 73210 Response in Text 73210 Response - Code 63934 0 Response - Description 73210 Internal Individual ID 7227 0 33 247317 100696.788 59570.283 Clinic Visit Identifier 7227 0 Instance 7227 0 Assessed to be capable to consent for participation 7227 0 1 Yes 7227 2 No 0 Date of Informed Consent 7227 2020-03-13 2022-06-17 Consent form - Code 7227 0 Consent form - Description 7227 0 Question - Code 7227 0 Question - Description 7227 0 Response to the question 7227 0 1 Yes 7119 2 No 108 Was the participant illiterate? 7227 0 1 Yes 12 2 No 7215 Did the witness sign the consent form? 7227 0 1 Yes 12 2 No 7215 Did the participant sign the consent form? 7227 0 1 Yes 7213 2 No 14 Did the staff member sign the consent form? 7227 0 1 Yes 7218 2 No 9 Internal Individual ID 1742 0 33 247317 100278.179 56961.62 Clinic Visit Identifier 1742 0 Instance 1742 0 Participant withdraw at this visit? 1742 0 1 Yes 1742 2 No 0 Reason for Withdrawal - Code 1742 0 4 96 10.635 15.128 Reason for Withdrawal - Description 1742 0 Specify other Reason for Withdrawal 54 Date of Death 2 2021-07-27 2022-03-30 Date of Transfer to DoH 58 2021-07-06 2022-07-14 Internal Individual ID 3000 0 33 247677 101957.494 62006.943 BSID 3000 0 21 92261 13304.395 18312.546 HHID 2998 2 11 46046 15872.925 12941.776 Participant Sex Code 3000 0 Participant Sex Description 3000 0 Participant 's date of birth 3000 1987-05-02 2021-10-02 Participant's Age 3000 0 Participant'sWeek block 3000 0 Participant'sWeek 3000 0 1 44 22.591 12.424 Participant's Isigodi - Description 3000 0 Is BSID location categorised as urban or rural? 2998 0 Is BSID location categorised as urban or rural? - Description 2998 0 Internal Individual ID 2444 0 89 247317 93059.512 54490.217 Clinic Visit Identifier 2444 0 Instance 2444 0 Clinic Visit Description 2431 0 Type of Phone Call - Code 2443 1 1 96 5.043 10.47 Type of Phone Call - Description 2412 0 Attempt Number 2444 0 Date of Attempt 2443 1 1898850595000 1930489419000 1923701807248.87 4586373001.055 10000000000001 .. Staff Code 2443 0 Attempt Outcome - Code 2443 1 Attempt Outcome - Description 2443 0 Phone Call Outcome - Code 1446 998 1 96 24.613 34.087 Phone Call Outcome - Description 1446 0 Specify other Outcome of Phone Call 269 Next Scheduled Clinic Visit Date 542 2020-05-25 2021-11-03 Next Scheduled Phone Call Date 121 2020-09-28 2021-05-18 Internal Individual ID 1633 0 33 247317 99430.79 59846.686 Clinic Visit Identifier 1633 0 Instance 1633 0 Does the participant have a HIV Negative confirmatory test result? 1630 3 1 Yes 1436 2 No 194 Sysmiss 3 Is the participant at significant risk of acquiring HIV infection? 1615 18 1 Yes 1471 2 No 144 Sysmiss 18 Is the participant sexually active? 1617 16 1 Yes 1369 2 No 248 Sysmiss 16 With how many different persons did the participants had sex with, 12 months? 1088 545 Has the participant had unprotected sex with HIV positive partners or partners w 1616 17 1 Yes 1055 2 No 561 Sysmiss 17 Did the participant ever had sex while under the influence of alcohol and/or dru 1614 19 1 Yes 331 2 No 1283 Sysmiss 19 Is the participant willing and able to take a tablet everyday? 1614 19 1 Yes 435 2 No 1179 Sysmiss 19 Does the participant fully understands that the protection provided by PrEP is n 1616 17 1 Yes 1581 2 No 35 Sysmiss 17 Is the participant willing and able to attend 3 monthly Clinic Visits? 1616 17 1 Yes 1190 2 No 426 Sysmiss 17 Is the participant willing to be on contraception during use of PrEP? 0 1633 1 Yes 0 2 No 0 Sysmiss 1633 1630 3 1 Yes 1624 2 No 6 Sysmiss 3 Is the participant consider Eligible to be initiated on PrEP? 1631 2 1 Yes 392 2 No 1239 Sysmiss 2 Reason why the participant is NOT consider Eligible to be initiated on PrEP 1238 Is the participant going to uptake PrEP? 355 1278 Reason whythe participant NOT going to uptake PrEP 10 0 Internal Individual ID 205 0 33 246998 100287.859 63555.865 Clinic Visit Identifier 205 0 Instance 205 0 Did the participant reported that they stopped taking PrEP? 205 0 1 Yes 46 2 No 159 Staff Code 205 0 On which date did the participant stop taking PrEP? 46 2020-10-19 2022-11-16 Reasons for stopping PrEP - Don't have sex currently. 9 196 1 Yes 9 2 No 0 Sysmiss 196 Reasons for stopping PrEP - Have fewer partners. 1 204 1 Yes 1 2 No 0 Sysmiss 204 Reasons for stopping PrEP - Partner/s or family member/s objected to me taking P 1 204 1 Yes 1 2 No 0 Sysmiss 204 Reasons for stopping PrEP - Trust partner/s or knows their status. 2 203 1 Yes 2 2 No 0 Sysmiss 203 Reasons for stopping PrEP - Other prevention strategies are sufficient. 2 203 1 Yes 2 2 No 0 Sysmiss 203 Reasons for stopping PrEP - Finding it difficult to engage with PrEP services. 8 197 1 Yes 8 2 No 0 Sysmiss 197 Reasons for stopping PrEP - Worried about experiencing short term side effects. 0 205 1 Yes 0 2 No 0 Sysmiss 205 Reasons for stopping PrEP - Worried about experiencing long term side effects. 0 205 1 Yes 0 2 No 0 Sysmiss 205 Reasons for stopping PrEP - Don't feel adequately protected with PrEP. 0 205 1 Yes 0 2 No 0 Sysmiss 205 Reasons for stopping PrEP - Don't want to or finding it difficult to take a dail 10 195 1 Yes 10 2 No 0 Sysmiss 195 Reasons for stopping PrEP - Prefer not to take PrEP as pregnant or trying to bec 2 203 1 Yes 2 2 No 0 Sysmiss 203 Reasons for stopping PrEP - Other 15 190 1 Yes 15 2 No 0 Sysmiss 190 Reasons for stopping PrEP - Other, specify 15 Would you be willing to take PrEP again in the future? 46 159 1 Yes 33 2 No 13 Sysmiss 159 Internal Individual ID 22884 0 33 247317 99863.878 58714.653 Clinic Visit Identifier 22884 0 2277 2442 2392.562 63 Instance 22884 0 Was test performed 22884 0 1 Yes 22884 2 No 0 Reason why test was not performed 0 0 Type of test - Code 22884 0 1 99 28.798 29.698 Type of test - Description 22884 0 Unique specimen identifier sent to the Lab 8231 0 Manufacturing Lot Number 12680 0 Expiry date of Medication 0 0 Test Result 22884 0 Internal Individual ID 2197 0 33 247317 98523.223 60051.02 Clinic Visit Identifier 2197 0 Instance 2197 0 Record height (cm) 992 1205 50.1 196 163.728 10.536 1001 .. Record weight (kg) 1794 403 30.3 162 65.501 14.656 1001 .. Calculated BMI 1778 419 13.4 641.8 25.177 19.99 1001 .. Temperature (Degrees Celsius) 2012 185 35.4 39 36.466 0.389 101 .. Record Heart Rate (bpm) 2010 187 51 114 76.297 10.748 First BP Reading - Systolic 2003 194 10 1102 111.542 25.338 First BP Reading - Diastolic 2003 194 5 114 68.883 10.366 Second BP Reading - Systolic 24 2173 89 151 118 15.111 Second BP Reading - Diastolic 24 2173 53 98 70.542 12.914 Final BP Reading - Systolic 24 2173 89 151 115 12.438 Final BP Reading - Diastolic 24 2173 53 92 69.917 11.576 Internal Individual ID 1815 0 33 247317 98588.036 63034.082 Medication Visit Identifier 1815 0 Medication Instance 1815 0 Type of Medication - Code 1815 0 1 96 10.228 26.243 Type of Medication - Description 1815 Medication Code 1815 0 Generic Name of Medication 1815 Generic Name of Medication - Other 174 Unique Medication stock QR Code - 1 1811 0 Unique Medication stock QR Code - 2 268 0 Unique Medication stock QR Code - 3 183 0 Quantity of Medication dispensed 0 0 Dose 1812 0 Route - Code 1812 3 Route - Description 1812 Manufacturing Lot Number 1808 0 Expiry date of Medication 1813 2020-06-30 2025-10-31 Date Medication was dispensed 1814 1 1900149827000 1973933464000 1944016337957 15383819692.056 10000000000001 .. Date of Clinic Visit 1732 83 1900146972000 1973413591000 1943438607051.39 15033838420.779 10000000000001 .. Clinic Visit Identifier 1732 83 Instance 1732 83