Demographics. 2. What was your sex at birth? If female, participant is ineligible. End of form.

Transcription

1 Demographics (DEM) - English SCHARP SAMPLE: DO NOT FAX TO DATAFAX MTN-017 (198) DEM-1 (001) DEM-1, Page 1 of 1 Participant ID Site Number Participant Number Chk Demographics Visit Date 1. What is your date of birth? If unknown, record age: years The next question is about your sex. When I ask about your sex, I am asking about what sex you were determined to be at birth. When babies are born, they are generally labeled by someone as male or female based on their genitals (sex organs). 2. What was your sex at birth? male female If female, participant is ineligible. End of form. The next question asks about gender. Gender is the social part of being male or female. It relates to your self-identity. When I ask about gender, I am asking about whether you regard yourself to be male, female, transgender female, or if you identify yourself in an additional category. 3. How do you identify your gender? Mark all that apply. 3a. male 3b. female 3c. transgender female (male to female) 3d. additional category, specify: 3e. decline to state 4. Are you circumcised? By circumcised, I mean when the foreskin of your penis is removed. Use visual aid. yes no don t know N/A (transgender) 5. What is your highest level of education? no schooling primary school, complete primary school, complete secondary school, complete secondary school, complete attended college or university 6. Do you consider yourself to be Latino/a or of Hispanic origin? yes no 7. What is your race/ethnicity? race/ethnic group code If other, specify: 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_DEM.fm x English Staff Initials/Date

2 Demographics (DEM-1) Purpose: General Information/ Instructions: This form is used to collect participants demographic and socioeconomic information. It is intervieweradministered. This form is faxed to SCHARP DataFax only if the participant enrolls in the study. This form is completed at the Screening Visit. Responses are based on participant self-report. Item-specific Instructions: Item 1: Item 3: Item 4: Item 5: Item 7: If any portion of the date of birth is unknown, record age at time of Screening. If age is unknown, record the participant's best estimate of his/her age. Do complete both answers. This item must be self-reported by the participant. Site staff is encouraged to document in chart es if the participant, during study participation, prefers to be referred to by a specific pronoun or gender. The intent of this item is to capture the participant's circumcision status at the time this form is administered. If the participant is circumcised after the Screening Visit, do update this response. If the participant attended or completed a post-secondary diploma or certificate program, including vocational or technical school, mark the attended college or university box. Record the 2-digit country-specific code below that is associated with the participant s self-reported race or ethnicity. If the participant identifies as other, record, 99 and the participant s response. THAILAND U.S.A. PERU and PUERTO RICO SOUTH AFRICA 13 - Thai 10 - American Indian or Alaska Native 12 - Indigenous 05 - Zulu 14 - Chinese 01 - Asian 04 - Mixed 06 - Xhosa 04 - Mixed 02 - Black or African-American 03 - White 07 - Indian 07 - Indian 11 - Native Hawaiian or other Pacific Islander 01 - Asian 08 - Colored 99 - Other 03 - White 02 - Black 09 - Other African tribe 04 - Mixed 99 - Other 03 - White 99 - Other 99 - Other Version 1, 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_DEM.fm

3 Abbreviated Physical Exam (APX) - English SCHARP SAMPLE: DO NOT FAX TO DATAFAX MTN-017 (198) APX-1 (136) Visit Code APX-1, Page 1 of 1. Participant ID Site Number Participant Number Chk VITAL SIGNS Abbreviated Physical Exam Visit Date 1. Weight kg 4. Pulse beats per minute 2. Body Temp. C 5. Respirations breaths per minute 3. Blood Pressure (BP) / mmhg 6. Height cm OR done Required at Screening only. SYMPTOM-DIRECTED FINDINGS Items 7 and 8 are. Assess items 9 18 only if clinically indicated. 7. General appearance 8. Abdomen/ Gastrointestinal 9. Neck 10. Lymph Nodes 11. Heart/Cardiovascular 12. Lungs/Respiratory 13. Extremities 14. Neurological 15. Skin 16. Eyes 17. Ears, Nose, Throat 18. Other done normal abnormal Record abnormal findings on the Pre-existing Conditions or the Adverse Experience Log, if applicable. 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_APX.fm x English Staff Initials/Date

4 Abbreviated Physical Exam (APX-1) Purpose: General Information/ Instructions: This form is used to document the participant s vital signs and physical exam findings as specified in the protocol. Complete this form at visits where a physical exam is done as or indicated. Item-specific Instructions: Visit Code: Vital Signs: Item 2: Item 3: Items 7 8: Items 9 18: Item 18: Record the visit code assigned to this visit. Refer to the Study-Specific Procedures (SSP) Manual for more specific information on assigning visit codes. Use leading zeros when needed. Body temperature must be measured orally (non-axillary) to assess severity according to the DAIDS Toxicity Table. The CRF and database can only capture one blood pressure reading per visit. If more than one blood pressure reading is performed at a visit, record the blood pressure reading used for clinical assessment/management. Record in the participant s file all other blood pressure readings taken at the visit, including an explanation as to why multiple readings were taken. These items are to be assessed at screening, enrollment, and the final clinic or early termination visit. If abnormal, describe the findings in the Notes section. If evaluated, mark done. The Notes section also may be used to describe any normal findings. For each organ system or body part evaluated, indicate whether the findings were normal or abnormal. If abnormal, describe the findings in the Notes section. If evaluated, mark done. The Notes section also may be used to describe any normal findings. If no other organ system or body part was evaluated, mark done. If abnormal, specify the body system being referenced and describe the findings in Notes. The Notes section also may be used to describe any normal findings. Version 1, 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_APX.fm

5 Anorectal Exam (ARE) - English SCHARP SAMPLE: DO NOT FAX TO DATAFAX MTN-017 (198) ARE-1 (041) Visit Code ARE-1, Page 1 of 1. Participant ID Site Number Participant Number Chk PERIANAL EXAMINATION 1. Findings from the perianal examination: 1a. Abnormal findings. Mark all that apply. Anorectal Exam no abnormal abnormal findings findings done Exam Date If done, specify reason(s) in Comments. Go to item 2. If no abnormal findings, go to item 2. Warts Fissure Ulceration Pigmentation Hemorrhoids Skin tags DIGITAL RECTAL EXAMINATION 2. Findings from the digital rectal examination: 2a. Abnormal findings, specify: ANOSCOPY Leukoplakia Fistula Petechiae (< 3 mm) Purpura (0.3 1 cm) Ecchymosis (> 1 cm) Discharge no abnormal abnormal findings findings done Erythema Bleeding Other abnormal findings specify: If done, specify reason(s) in Comments. Go to item 3. If no abnormal findings, go to item Was an anoscopy performed at this visit? 4. Rectal mucosa findings: yes no, specify: If or no, end of form. no abnormal abnormal findings findings If no abnormal findings, end of form. 4a. Abnormal rectal mucosa findings: Mark all that apply. Erythema Abnormal vessels Ulceration Friability Bleeding Discharge Polyps Hemorrhoids Other abnormal findings, specify: Comments: 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_ARE.fm x English Staff Initials/Date

6 Anorectal Exam (ARE-1) Purpose: General Information/ Instructions: This form is used to document the anorectal exam findings identified via perianal visual inspection, digital rectal examination, and anoscopy. An anorectal exam is at Screening, Enrollment, and each regularly scheduled follow-up visit. At Screening and Enrollment, evaluate any abnormalities for eligibility. At Enrollment, update Pre-existing Conditions when applicable. During follow-up, complete or update Adverse Experience Log when applicable. Item-specific Instructions: Visit Code: Item 1: Items 1a and 4a: Item 2: Item 2a: Item 3: Record the visit code assigned to this visit. Refer to the Study-Specific Procedures (SSP) Manual for more specific information on assigning visit codes. If the perianal visual examination was but done, mark the done box and record the reason the visual examination was done in the Comments. Mark the box to the left of each abnormal finding observed. If an observed abnormal finding is listed, mark Other abnormal findings, specify and describe the abnormal finding on the lines provided. If a digital rectal examination was but done, mark done and record the reason the digital rectal examination was done in the Comments. If an abnormal finding is observed, record the finding(s) on the line provided. Mark only if anoscopy was done and the visit was either a Screening Visit or an Interim Visit. If anoscopy was but done, mark no and record the reason on the adjacent line. Version 1, 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_ARE.fm

7 Specimen Storage (SS) - English SCHARP SAMPLE: DO NOT FAX TO DATAFAX MTN-017 (198) SS-1 (149) Visit Code SS-1, Page 1 of 1. Participant ID Site Number Participant Number Chk Specimen Storage Initial Specimen Collection Date 1. PBMC for PK: 2. Plasma for PK: 3. Anal swab for anal HPV typing: 4. Rectal sponge for adherence PK: 5. Rectal sponge for PD: 6. Date and time of last dose: 6a. Is the date/time of last dose a best estimate, or did the participant provide source documentation? best estimate 24-hour clock hr min : source documentation OR If, end of form. 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_SS.fm x English Staff Initials/Date

8 Specimen Storage (SS-1) Purpose: General Information/ Instructions: This form is used to document collection and storage of plasma, PBMC, and rectal specimens by the local site laboratory during Enrollment and follow-up. Complete this form at Enrollment, at each regularly scheduled follow-up visit, and, if the participant terminates the study early, the Early Termination Visit. Initial Specimen Collection Date: Record the date that the first specimen was collected (NOT the date the results were reported or recorded on the form) for this visit. A complete date is. : This date is to be completed ONLY if the specimen was collected on a date after the Initial Specimen Collection Date. A specimen collected for the same visit but on a different date should be recorded on the same form. A complete date is. Item-specific Instructions: Visit Code: Items 1 5: Item 6: Item 6a: Record the visit code assigned to this visit. Refer to the Study-Specific Procedures (SSP) Manual for more specific information on assigning visit codes. If the specimen was collected because it was at this visit, mark the box. If the specimen was to be, but for some reason it was, mark the box and record the reason on the line provided. Documentation of the date and time of last dose is at each Mid-period and End Period Visit. Only mark the box at Enrollment, Initiate Period, and Interim Visits. Only mark source documentation if the participant provided written documentation of the actual date and time s/he used his/her last dose of study product prior to the visit. Otherwise, mark best estimate. Version 1, 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_SS.fm

9 Rectal Biopsy/Fluid Subset Specimens (RBF) - English SCHARP SAMPLE: DO NOT FAX TO DATAFAX MTN-017 (198) RBF-1 (130) Visit Code RBF-1, Page 1 of 1. Participant ID Site Number Participant Number Chk Rectal Biopsy/ Fluid Subset Specimens Initial Specimen Collection Date 1. Rectal sponge for mucosal immunology: 2. Was a sigmoidoscopy performed at this visit? yes no, specify: End of form. 3. Sigmoidoscopy findings: 3a. Abnormal sigmoidoscopy findings: Mark all that apply. no abnormal findings abnormal findings If no abnormal findings, go to item 4. Erythema Abnormal vessels Ulceration Friability Bleeding Discharge Polyps Hemorrhoids Other abnormal findings, specify: At Enrollment, evaluate any abnormalities for eligibility. Update Pre-existing Conditions when applicable. During follow-up, complete or update AE Log when applicable. 4. Rectal biopsies for PK: 5. Rectal biopsies for PD: 6. Rectal biopsies for mucosal T-cell pheyping: 7. Rectal biopsies for mucosal gene expression: 8. Rectal biopsy for histology: 9. Rectal biopsy for proteomics: 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_RBF.fm x English Staff Initials/Date

10 Rectal Biopsy/ Fluid Subset Specimens (RBF-1) Purpose: General Information/ Instructions: This form is used to document collection and storage of rectal biopsy and fluid by the local site laboratory for those participants in the PK/PD/mucosal immunology subset only. It is also used to document the findings identified via flexible sigmoidoscopy. Complete this form for participants in the PK/PD/mucosal immunology subset only at Enrollment and at each end-ofperiod visit. If the participant terminates the study early, complete this form at the Early Termination Visit. Initial Specimen Collection Date: Record the date that the first specimen was collected (NOT the date the results were reported or recorded on the form) for this visit. A complete date is. : This date is to be completed ONLY if the specimen was collected on a date after the Initial Specimen Collection Date. A specimen collected for the same visit but on a different date should be recorded on the same form. A complete date is. Item-specific Instructions: Visit Code: Items 1 and 4 9: Item 3a: Record the visit code assigned to this visit. Refer to the Study-Specific Procedures (SSP) Manual for more specific information on assigning visit codes. If the specimen was to be collected at this visit, mark. If the specimen was to be, but for some reason it was, mark and record the reason on the line provided. Mark the box to the left of each abnormal finding observed. If an observed abnormal finding is listed, mark Other abnormal findings, specify and describe the abnormal finding on the line provided. Version 1, 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_RBF.fm

11 STI Test Results (STI) - English SCHARP SAMPLE: DO NOT FAX TO DATAFAX MTN-017 (198) STI-1 (190) Visit Code STI-1, Page 1 of 1. Participant ID Site Number Participant Number Chk STI Test Results Initial Specimen Collection Date Go to item SYPHILIS SEROLOGY Not done/ Not collected 1a. Syphilis RPR If non-reactive, go to item 2. non-reactive reactive 1a1. Syphilis titer 1: 1b. Syphilis confirmatory test Not done/ Not collected Not done/ Not collected negative negative positive positive indeterminate 2. N. gonorrhea URINE 3. C. trachomatis URINE 4. N. gonorrhea RECTAL SWAB 5. C. trachomatis RECTAL SWAB 6. HSV-1 BLOOD 7. HSV-2 BLOOD 8. HSV-1 RECTAL SWAB 9. HSV-2 RECTAL SWAB 10. Hepatitis B Surface Antigen (HBsAg) Not done/ Not collected non-reactive reactive 11. Hepatitis B Surface Antibody 12. Hepatitis C Antibody Comments: 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_STI.fm x English Staff Initials/Date

12 STI Test Results (STI-1) Purpose: General Information/ Instructions: This form is used to document results from STI tests done by the local site laboratory (and MTN Network Laboratory, when needed). Complete this form at Screening, Enrollment, and at each End-of-period visit. If the participant terminates the study early, complete this form at the Early Termination Visit. Initial Specimen Collection Date: Record the date that the first specimen was collected (NOT the date results were reported or recorded on the form). A complete date is. : This date is to be completed ONLY if the specimen was collected on a date after the Initial Specimen Collection Date. A specimen collected for the same visit but on a different date should be recorded on the same form. Not done/not collected: Mark this box in the event that a specimen was collected or if the specimen was collected, but a result is available due to specimen loss or damage. Record the reason why the result is available in Comments. Repeat testing: If any or all of the lab tests listed on this form are repeated (re-drawn) between the Screening and Enrollment Visit, document the repeated results on the same STI form assigned Visit Code 1.0. Line through the original result(s), record the new result(s) and the for each repeat test result. Item-specific Instructions: Visit Code: Record the visit code assigned to this visit. Refer to the Study-Specific Procedures (SSP) Manual for more specific information on assigning visit codes. Items 1 12: At Screening and Enrollment, if a test result recorded on this form indicates that the participant has a new (or increased severity) laboratory-confirmed infection or diagnosis, evaluate for eligibility. During follow-up, if a test result recorded on this form indicates that the participant has a new (or increased severity) laboratory-confirmed infection or diagnosis, record as an adverse experience on an Adverse Experience (AE) Log. Version 1, 12-NOV-12 N:\hivnet\forms\MTN_017\forms\m017_STI.fm