Summary of Changes to Questionnaires

Survey (Attachment No.)	Modifications	Question #(s)	Burden (Increase, Decrease, No change)	Total Number of Questions
Att 7a_Phase 1 Enrollment Survey B	The value option "Refuse to answer" has been added for most questions as it is not pre-programmed in REDCap as it was in QDS.	To every question on this survey except FP-1 through FP-11, CT-1, CT-2, SU-1, SU-2, and SU-3	No Change	every question in survey except FP-1 through FP-11, CT-1, CT-2, SU-1, SU-2, and SU-3
Att 7a_Phase 1 Enrollment Survey B Att 8a_Phase 2 Behavioral Survey Att 9a_Phase 2 Symptom and Care Survey	The value option "Don't know" has been aded to several questions as it is not pre-programmed in REDCap as it was in QDS. Additionally, for consistency with value options indicating uncertainty in other questions, “unsure” and “don’t remember” have been replaced with “don’t know”.	HT-1, HT-4, HT-11, HT-12, HT-14, PR-1, SD-1, DU-1, DU-2, DU-3, DU-4, DU-5, DU-6, DU-7, DU-8, SY-6, GS-11, GS-12, GS-20, GS-21	No Change	20
Att 7a_Phase 1 Enrollment Survey B	Instructions on how to complete the date field have been added to several questions to improve comprehension of the participant. The wording added is: Please enter a month and year in MM/YYYY format. If you cannot remember the month, please just enter the year.	HT-9, HT-13, HT-15, HT-18, PR-3, PR-4	No Change	6
Att 7a_Phase 1 Enrollment Survey B Att 9a_Phase 2 Symptom and Care Survey	Instructions on how to complete the date field have been added or edited in several questions to improve comprehension of the participant. The wording added is: Please enter a day, month and year in MM/DD/YYYY format. If you cannot remember the exact day, please enter just the month and year.	SY-3a-SY-3n , SY-4a - SY4n, SX-9, SX-12, HC-3, HC-6, HC-7	No Change	7
Att 7a_Phase 1 Enrollment Survey B Att 8a_Phase 2 Behavioral Survey Att 9a_Phase 2 Symptom and Care Survey	Value option added for second project site –Johns Hopkins University. This field is completed by research staff before participant begins survey. (not to be included in burden count)	2021: Modified FP-1 JHU Study ID, FP-2 JHU Study ID, FP-3 JHU Study	No change	3
Att 7a_Phase 1 Enrollment Survey B (English) (2016): Face Page Att 9a_Phase 2 HIV Symptom and Care Survey (2016), Face Page	This CSID variable is no longer required. Reprogramming in REDCap means that the database is now fully contained in one place, so this information is already there as it is captured via the tube. Minimizes the risk of data entry errors. (not to be included in burden count)	2016: Removed FP-3 CSID, FP-4 CSID	No Change	2
Att 7a_Phase 1 Enrollment Survey B	Start Time has been added so that the amount of time taken to complete the survey can be tracked. This field is completed by research staff before participant begins survey. (not to be included in burden count)	2021: Added FP-3 Start Time: HH:MM:SS	No Change	1
Att 7a_Phase 1 Enrollment Survey B	This question is no longer applicable. (not to be included in burden count)	2021: Remove FP-5: Did the participant complete the kiosk	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Question has been modified to make clear what HIV status the participant is being asked about during the interview. This field is completed by research staff before participant begins survey. (not to be included in burden count)	2021: Modified FP-5: HIV status at start of visit: -HIV-negative/unknown -Established HIV infection – diagnosis >3 months ago -Newly diagnosed HIV infection - diagnosis <=3 months ago	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Value options added to account for the addition of JHU (second project site) and to update names of specific UW sites. Also, the “other, write in response” option does not require a separate question in REDCap platform; the previous FP-8 question from QDS platform is no longer needed. This field is completed by research staff before participant begins survey. (not to be included in burden count)	2021: Modified FP-7 Referral from: -[UW only] One on One [UW only] Private Provider - [UW only] PHSKC Sexual Health Clinic - [UW only] DIS - [UW only] UWHIS - [UW only] Madison Clinic - [UW only] ACTU - [JHU only] Baltimore City STD Clinic - [JHU only] JHH ED - [JHU only] Bartlett Specialty Clinic - Other (Write in response)	No Change	1
Att 7a_Phase 1 Enrollment Survey B	JHU project site is targeting additional risk groups therefore this question has been added so that the site can keep track. This question will only appear in JHU’s version of REDCap. This field is completed by research staff before participant begins survey. (not to be included in burden count)	FP-8 High risk category (check all that apply): - MSM - TG - Screened for STI - Having STI - PWID - Part of high-risk network - Other (Write in response)	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Edits were made to instruction for completing FP-10 and F-11. Also, instructions for entering date if month is unknown were added to end of question. This field is completed by research staff before participant begins survey. (not to be included in burden count)	2021: Modified [IF FP-9 = History of ART, currently off ART OR Currently on ART] FP-10 Last ART start date (if day or month is unknown, please enter “99” in its place): MM/DD/YYYY FP- 11 Last ART end date (if day or month is unknown, please enter “99” in its place): MM/DD/YYYY 2021: Original IF FP-9 = History of ART, currently off ART: FP-10 Last ART start date: MM/DD/YYYY FP- 11 Last ART end date: MM/DD/YYYY	No Change	2
Att 7a_Phase 1 Enrollment Survey B	Question is no longer needed as it is addressed by updating the instructions for completion of question FP-10 in 2021 version of survey. This field is completed by research staff before participant begins survey. (not to be included in burden count)	2016: Remove FP-12	No Change	1
Att 8a_Phase 2 Behavioral Survey	[UW only] Value option added to the question to capture additional reason. [JHU only] This survey will be administered at 4 weeks, 12 weeks, and Final visit. Therefore, the word “Final” will be removed from the question for JHU. And additional value options will be added beyond the options to capture additional reasons for visit. This field is completed by research staff before participant begins survey. (not to be included in burden count)	2021: Modified FP-7 [UW Only] Reason for Final Visit: Day 70 Concordant tests 1 year of serial follow-up Other: ___________________ FP-7 [JHU Only] Reason for Visit: Concordant tests 4-week Visit 12-week Visit 1 year of serial follow-up Final Visit Other: ___________________	No change	1
Att 7a_Phase 1 Enrollment Survey B Att 9a_Phase 2 HIV Symptom and Care Survey	For compliance with REDCap programming rules, a question was added after the paragraph on the purpose of the consent (storage of specimens) and the wording “yes” and “no” were added to the value options. This field is completed by research staff before participant begins survey. (not to be included in burden count)	2021: Modified CT-2 Do you agree to storage of your specimens for future use? Yes, I give consent for my blood and oral fluid specimens to be stored at CDC for the future use as outlined above. No, I DO NOT give consent for my blood and oral fluid specimens to be stored at CDC for future research.	No Change	2
Att 7a_Phase 1 Enrollment Survey B	Wording of open-ended response option was edited and a write-in response option was added for capturing additional gender identities.	2021: Modified SU-1 Are you male, female or transgender? - Male - Female - Transgender Male to Female - Transgender Female to Male - Non-binary or Genderqueer - Another gender not listed (Write in response)	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Modified question for ease of comprehension by participant.	2021: Modified SU-2 What was your sex assigned at birth? - Male - Female 2016: Original Question SU-2 What sex was recorded on your original birth certificate?	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Wording of open-ended response option was edited and a write-in response option was added for for identifying sexual partner.	2021: Modified SU-3 In the past year, who have you had sex with? Check all that apply. Sex includes any oral, anal or vaginal sex. - Men - Women - Transwomen - Transmen - Non-binary or Genderqueer people - People of another gender not listed (Write in response) - I did not have sex in the past year 2021: Modified SU-4 What is your sexual orientation? - Bisexual - Gay - Lesbian - Queer - Straight or Heterosexual - Another identity not listed (Write in response)	No Change	1
Att 7a_Phase 1 Enrollment Survey B Att 8a_Phase 2 Behavioral Survey	Revised “Latino” to read “Latinx”	2021: Modified SU-6, SX-16, SX-19	No Change	3
Att 7a_Phase 1 Enrollment Survey B Att 8a_Phase 2 Behavioral Survey	Edited the wording of the value option to "Another group or groups not listed" to improve comprehension of particpants. Also, a write-in response value option was added for identifying additional race/ethnicity groups.	2021: Modified SU-7, SX-17, SX-20	No Change	3
Att 7a_Phase 1 Enrollment Survey B	For JHU’s use, an additional option has been included; this value option will only be visible in JHU’s REDCap survey platform.	2021: Modified HT-1 Do you have a regular health care provider? - Yes - No - No, I use the emergency room for my medical and health-related issues - Don’t know	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Instruction for responding to this question clarified to include those with unknown status.	2021: Modified [IF FP-5 = HIV-negative/ unknown:] HT-4 Have you ever had an HIV test before today? - Yes - No - Don’t know	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Additional value options have been added to the question to capture additional possibilities that might result in HIV testing. Additionally, instructions to write in response for “Other” option has been added.	2021: Modified - HT-5 How do you usually decide when to test for HIV? Choose the one that best fits how you currently decide to test. - On a regular schedule - After being exposed to HIV - Between sex partners - When I have symptoms of HIV - When I have symptoms of STIs other than HIV - When it’s free and convenient - When recommended by my healthcare provider - I don’t have a reason for testing - Other: _____________________ (Write in response)	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Edits were made to wording of value options to improve comprehension of participants. An additional value option has been added to the question. Additionally, instructions to write in response for “Other” option has been added.	2021: Modified HT-7 What is the main reason you’re getting an HIV test today? - I get tested on a regular schedule and it was time for me to get tested again - I was worried I might have been exposed to HIV - Before having sex with someone new - I had sex with someone new - After stopping having sex with someone - I have symptoms of HIV - I have symptoms of STIs other than HIV - My healthcare provider recommended that I get tested - It is a routine test for any patient - It’s free and convenient - Other (Write in response)	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Edits have been made to the instructions to make clear who should respond to this question and how to complete the number field for this question.	2021: Modified [IF FP-5 = HIV-negative/unknown] HT-8 In the past 12 months, that is, since [insert calculated month and year], how many times have you been tested for HIV? Please enter a number or, if you don’t know, please enter 999. ___ ___ times (0 to N)	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Edits were made to the value options to improve comprehension of participants.	2021: Modified [If HT-4=Yes] HT-10 When you last had an HIV test, what was the result? - Positive (have the infection) - Negative (did not have the infection) - Did not get the results/Unknown	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Edits were made to the instructions for who should complete the question.	2021: Modified [IF HT-10 = Negative OR Did not get the results/Unknown:] [HT-11 Have you ever tested HIV positive? - Yes - No - Don’t know	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Edits have been made to the instructions to make clear who should respond to this question.	2021: Modified [If HT-16 = No or Refuse to answer] HT-17 Have you ever been to a doctor or medical provider for HIV care? Yes No	No Change	1
Att 7a_Phase 1 Enrollment Survey B Att 8a_Phase 2 Behavioral Survey	Additional value options have been added to the question. Additionally, instructions to write in response for “Other” option has been added.	2021: Modified SD-2 You said a healthcare provider told you that you had an STI in the last 3 months. Which one(s)? Check all that apply: a. Gonorrhea b. Chlamydia c. Syphilis d. Herpes e. Trichomonas (“Trich”) f. Other(Write in response) g. Don’t know	No Change	2
Att 7a_Phase 1 Enrollment Survey B Att 9a_Phase 2 Symptom and Care Survey	Edits were made to value options to improve comprehension of participants. Additional value options have been added to the question.	2021: Modified SY-1 In the past 3 months (that is, since insert date) have you had any of these symptoms? Check all that apply. a. Sore throat b. Fever and/or chills c. Nausea d. Vomiting e. Diarrhea f. Headache(s) g. Fatigue h. Soreness or pain in your joints or muscles i. Swollen or sore lymph nodes j. Body Rash k. Sores, bumps, or rashes on your genitals l. Changes in hearing or vision m. Rash on the palms of your hands or the soles of your feet n. Abdominal pain o. I haven’t experienced any of these symptoms in the last 3 months	No Change	2
Att 7a_Phase 1 Enrollment Survey B	Edits have been made to the instructions to make clear who should respond to this question. Added text: [If SY-1 ≠ I haven’t experienced any of these symptoms in the last 3 months]	SY-5, SY-6, SY-10	No Change	3
Att 7a_Phase 1 Enrollment Survey B	Window period definition has been provided to improve comprehension of participant.	2021: Modified [If SY-6 = Yes:] SY-7 Did the doctor or another health care provider talk to you about testing for acute HIV infection and the “window period” for HIV tests? The window period is the average length of time from HIV exposure to when a test will give you a positive result for HIV infection. Yes No	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Edits were made to value options to improve comprehension of participants.	2021: Modified SY-9 What type(s) of HIV tests did they do at the doctor’s? Check all that apply. Rapid test on oral fluid (you got the result when you were still in the office) Rapid test on finger stick (you got the result when you were still in the office) Blood draw for another HIV test Don’t know	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Additional value options have been added to the question. Additionally, instructions to write in response for “Other” option has been added.	2021: Modified [If SY-5 = No AND SY-6 = No] SY-12 What were the reason(s) you did not go to the doctor for your symptom(s)? Check all that apply. I didn’t know where to go I was worried about how much it might cost I didn’t know my symptoms could be a sign of HIV infection I thought I had the flu I thought I had COVID I was afraid to catch COVID I wanted to wait to get my regular HIV test I wanted to wait until after the “window period” There is no clinic in my neighborhood I didn’t want to know if it was HIV Other (Write in response)	No Change	1
Att 7a_Phase 1 Enrollment Survey B Att 8a_Phase 2 Behavioral Survey	Edits were made to the value options to improve comprehension of participants.	2021: Modified DU-5 Have you used methamphetamine (meth or crystal) in the last 3 months? Yes No Don’t know	No Change	2
Att 7a_Phase 1 Enrollment Survey B Att 8a_Phase 2 Behavioral Survey	For Sexual Behavior Section, wording has been added to descriptors for clarity.	2021: Modified Female Sex Partners of Men (male sex at birth and female sex partners in the previous year) Male Sex Partners of Women (female sex at birth and male sex partners in the previous year) Other Sex Partners of Men (male sex at birth and transwomen, transmen, non-binary/genderqueer, and/or other sex partners in the previous year) Male Sex Partners of Men (male sex at birth and male sex partners in the previous year)	No Change	1
Att 7a_Phase 1 Enrollment Survey B Att 8a_Phase 2 Behavioral Survey	In Sexual Behavior Section, "I prefer not to answer" has been removed as a value option and replaced with the option to respond with any number starting from "0" to "N"	FX-1 - FX-3, FM-1 - FM-3, OX-1 - OX-3, SX-1 - SX-3, GS-1 - GS-9, GS-17	No Change	21
Att 7a_Phase 1 Enrollment Survey B Att 8a_Phase 2 Behavioral Survey	Edited the wording of some value options to make more clear for the participants. The wording "Online" was edited to read "Online or on an app"	2021: Modified SX-20 and SX-23	No Change	2
Att 7a_Phase 1 Enrollment Survey B	Additional value options were added to the question. Additionally, write-in response was added to the "Other" option	2021: Modified [If SX-20 = “Online or on an app”] SX-20b Through which online service or phone app did you first meet [insert partner initials]? Facebook Instagram Twitter Tik Tok CraigsList Adam4Adam BarebackRT Manhunt OkCupid Plenty of Fish Grindr Tinder Scruff Jackd Hornet Growlr Skout BoyAhoy Other [Write in response] _________________	No Change	1
Att 7a_Phase 1 Enrollment Survey B	Wording of question has been edited to improve comprehension of participant	2021: Modified SX-33 Was [insert partner initials] diagnosed with an STI in the last 3 months (since [current month - 3])? Yes No Don’t know	No Change	1
Att 7a_Phase 1 Enrollment Survey B Att 8a_Phase 2 Behavioral Survey	Wording of question has been edited to improve comprehension of participant. The wording, "this partner" has replaced "insert partner"	GS-10, GS-13, GS-15, GS-16, GS-22, GS-24	No Change	6
Att 7a_Phase 1 Enrollment Survey B	Wording of question has been edited to improve comprehension of participant	2021: Modified GS-12 Did anyone have anal sex without a condom during the most recent threesome with [partner initials]? Yes No	No Change	1
Att 7a_Phase 1 Enrollment Survey B	In Demographics 2 Section, "I prefer not to answer" has been removed as a value option.	DE-1, DE-3, DE-4	No Change	3
Att 7a_Phase 1 Enrollment Survey B	End Time has been added so that the amount of time taken to complete the survey can be tracked. This field is completed by research staff before participant begins survey. (not to be included in burden count)	End time: HH:MM:SS	No Change	1
Att 8a_Phase 2 Behavioral Survey	[UW only] Value option added to the question to capture additional reason. [JHU only] This survey will be administered at 4 weeks, 12 weeks, and Final visit. So, the word “Final” will be removed from the question for JHU. And additional value options will be added beyond the options to capture additional reasons for visit. This field is completed by research staff before participant begins survey. (not to be included in burden count)	2021: Modified FP-7 [UW Only] Reason for Final Visit: Day 70 Concordant tests 1 year of serial follow-up Other: ___________________ FP-7 [JHU Only] Reason for Visit: Concordant tests 4-week Visit 12-week Visit 1 year of serial follow-up Final Visit Other: ___________________	No change	1
Att 8a_Phase 2 Behavioral Survey	[For JHU only] In STD History Section, the wording "first visit" or "first study visit" will be replaced with "most recent visit" to account for the use of the survey for the 4-week, 12-week, and final visits.	SD-1 and SD-2	No Change	2
Att 8a_Phase 2 Behavioral Survey	[For JHU only] In Sexual Behavior Section, the wording "first visit" or "first study visit" will be replaced with "most recent visit" to account for the use of the survey for the 4-week, 12-week, and final visits.	FX-1, FX-3, FM-1, FM-3, SX-1 to SX-3	No Change	5
Att 8a_Phase 2 Behavioral Survey	[For JHU only] In Sexual Behavior Section, JHU participants will not be completing partner-specific questions.	FX-2, FM-2, SX-4 -SX-32, GS-1 to GS-27	Decrease	58
Att 8a_Phase 2 Behavioral Survey	[JHU only] Pre-Exposure Prophylaxis questions from Enrollment Survey (Att 7a) are added into Final Survey (Att 8a) to be asked of HIV-negative participants at each visit.	PR-1 to PR-4	Increase	4