Report Negative* Confirm Test

Report Negative* Confirm Test

Gen Screen HIV ½ (Bio-Rad)

and

Serodia HIV ½ (Flujirebio)

Neg / Neg Neg / Pos Pos / Pos

or

Pos / Neg

Confirm test Inconclusive*** Report Pos

ARCHITECT HIV Ag/Ab Combo (Abbott)

Negative Positive

Report Negative Inconclusive***

* Received within 3 hrs after blood draw

**Wait 3-10 days for confirmatory results

*** Counseling, repeat test again


11.2 Appendix B: WRAIR #1494 Questionnaires (Demographic and risk behavioral assessment)

Study title: WRAIR #1494: Establish and characterize an acute HIV infection cohort in a high risk population

DEMOGRAPHIC QUESTIONNAIRE (To be completed at baseline visit only)

• 
  This questionnaire is used for documenting personal information of volunteers who are participating in the acute HIV infection study of the Thai Red Cross AIDS Research Centre, Bangkok, Thailand. It will take approximately 5 minutes to fill out.
  
• 
  You have the right to not answer any question in this questionnaire without negative consequences to you. However, your answers will help us better understand the general characteristics of clients in this project.
  
• 
  All information will be kept confidential and will only be used for research purposes. This information will not affect you personally or by law.
  
• 
  We would like to apologize if some of the following questions may cause some discomfort to you. We are grateful for your time in completing this questionnaire.
  

Please mark X in the boxes below (unless asked to give specific information)

1. 
   Date of visit dd/mm/year
   
2. 
   Patient number
   
3. 
   Date of birth dd/mm/year
   
4. 
   Nationality  Thai  Non-Thai Asian  Others, specify.......................................
   
5. 
   What sex is your physical appearance?
   

 Female  Male  Transgender (has had sex-change operation)

6. 
   What is your current marital status?
   

 Single  Married or living together  Divorced or separated

 Widowed  Married but not living together (because of work or other reasons)

7. 
   What is your religion?
   

 Buddhism Christian Islam

 Others, specify.......................................

8. 
   What is your highest education?
   

 Lower than primary school Primary school

 Secondary School  High school/ basic technical school

 Advanced technical school/associate degree

 Bachelor degree

Master degree or higher

9. 
   What is your main occupation?
   

 Not working  Student  Home maker

 Private business/merchant  Private business/factory employee

 Laborer  Soldier/police Farmer  Vehicle driver/truck driver

 Government/government-owned company employee

 Commercial sex worker (in entertainment venues/restaurants)

 Others, specify................................................

10. 
    Aside from you, the number of people live in your house is ........ persons, including .......... adults and ......... children younger than 15 years old
    
11. 
    What is your family income.................. Baht/month
    
12. 
    Currently you live in .....................................province and have been living here for ....... years
    
13. 
    You were born in ...............................province
    
14. 
    Where have you heard information about HIV/AIDS? (Can select more than 1 answer)
    

 Hospital/clinic

 Television/radio

 Newspaper/magazine

 Friends/relatives

 Others, specify .....................................................

Study title: WRAIR #1494: Establish and characterize an acute HIV infection cohort in a high risk population

• 
  This questionnaire is used for documenting personal information of volunteers who are participating in the acute HIV infection study of the Thai Red Cross AIDS Research Centre, Bangkok, Thailand. It will take approximately 15 minutes to fill out.
  
• 
  You have the right to not answer any question in this questionnaire without negative consequences to you. However, your answers will help us better understand the general characteristics of clients in this project.
  
• 
  All information will be kept confidential and will only be used for research purposes. This information will not affect you personally or by law.
  
• 
  We would like to apologize if some of the following questions may cause some discomfort to you. We are grateful for your time in completing this questionnaire.
  

1. 
   Date of visit dd/mm/year
   
2. 
   Patient number
   
3. 
   What is your current marital status?
   

 Divorced or separated  Widowed

 Married but not living together (because of work or other reasons)

4. 
   The age at your first sexual intercourse was ............ years
   

Please check this box  if you have never had sexual intercourse, please specify route of lifetime sexual act:

Insertive   vaginal  anal  oral

Receptive   vaginal  anal  oral

5. 
   In the past 4 months, what is your risk level for getting HIV infection?
   

 Minimum risk (sexual intercourse with a single and stable partner regardless of condom use OR with multiple partners and consistent condom use)

 Moderate risk (sexual intercourse with multiple partners with occasional condom use)

 High risk (sexual intercourse with HIV-positive partner(s) regardless of condom use OR sexual

intercourse with multiple partners and no condom use).

6. 
   In the past 4 months, how many sexual partners did you have?
   

One

 5 or more

 Decline to answer

If you answer “No sexual partner”, please skip to question 15)

7. 
   In the past 4 months, who did you have sexual intercourse with? (can select more than one answer)
   

 Women

 Transgender (has had sex-change operation)

 Decline to answer

8. 
   In the past 4 months, have you had receptive anal intercourse?
   

 Yes

9. 
   The last time you had sexual intercourse, what did you/your sexual partner use for contraception? (can select more than one answer)
   

 Oral contraceptive pills (21 or 28 pills/packet)

 Morning after contraceptive pills

 Contraceptive injection

 Implant

 Intrauterine device

 Female sterilization

 Male sterilization

 External ejaculation

 Natural rhythm

 Did not use any method

 Decline to answer

10. 
    In the past 4 months, did you use condoms with your regular sexual partner?
    

 No

 Every time

 Decline to answer

11. 
    In the past 4 months, did you use condoms with your casual sexual partner?
    

 No

 Every time

 Decline to answer

12. 
    In the past 4 months, did you use condoms with commercial sex worker?
    

 No

 Every time

 Decline to answer

13. 
    In the past 4 months, did you use condoms with person who gives you money/goods?
    

 No

 Every time

 Decline to answer

14. 
    In the past 4 months, did you use condoms with your sexual partner who is an illicit intravenous drug user?
    

 No

 Every time

 Decline to answer

15. 
    In the past 4 months, did you share needles with others when using illicit intravenous drugs?
    

 Have used illicit intravenous drugs but not in the past 4 months

 Have used illicit intravenous drugs in the past 4 months but did not share needles with others

 Have used illicit intravenous drugs in the past 4 months and also shared needles with others

 Decline to answer

16. 
    In the past 4 months, did you have any symptoms of sexually transmitted diseases such as pain with urination, pus discharge from the urethra, blisters at genitalia or were diagnosed with sexually transmitted diseases such as herpes, syphilis, gonorrhea, or infections of the urethra other than gonorrhea?
    

 Yes

 Decline to answer

17. 
    In the past 4 months, did you receive blood or blood products?
    

 Yes

18. 
    In the past 4 months, did you have male circumcision?
    

 Have had circumcision previously at age.............. years

 No

 Yes

Study title: WRAIR #1494: Establish and characterize an acute HIV infection cohort in a high risk population

• 
  This questionnaire is used for documenting personal information of volunteers who are participating in the acute HIV infection study of the Thai Red Cross AIDS Research Centre, Bangkok, Thailand. It will take approximately 20 minutes to fill out.
  
• 
  You have the right to not answer any question in this questionnaire without negative consequences to you. However, your answers will help us better understand the general characteristics of clients in this project.
  
• 
  All information will be kept confidential and will only be used for research purposes. This information will not affect you personally or by law.
  
• 
  We would like to apologize if some of the following questions may cause some discomfort to you. We are grateful for your time in completing this questionnaire.
  

1. 
   Date of visit dd/mm/year
   
2. 
   Patient number
   
3. 
   How do you think you can get HIV infection? (can select more than 1 answer)
   

 Have meals with an HIV-infected person

 Receive blood or blood product that has HIV

 Share needles with an HIV-infected person

 Kissing on the lips

 Share toilets with an HIV-infected person

 Taking care of an HIV-infected person

 Bitten by mosquitoes

 Transmit HIV from pregnant mother to infant

 Others, specify.........................................................

4. 
   What are the ways you can decrease your risk of getting HIV infection? )can select more than one answer)
   

 External ejaculation

 Proper use of condoms with every sexual intercourse

 Only choose to have sexual intercourse with persons that look healthy

 Clean Vaginal and external genitalia after every sexual intercourse

 Male circumcision

 Have sexual intercourse with circumcised men

 Others, specify.........................................................

5. 
   Have you had persons close to you with HIV infection (relative, friend, sexual partner, colleagues etc? (Can select more than one answer)?
   

 No

 Decline to answer

6. 
   How do you feel towards a person with HIV infection? (can select more than one answer)
   

 Do not feel like being near that person because of fear of getting HIV

 Rather disgusted because the person likely has risky or inappropriate behavior

 Do not feel anything, can live in the same society

 Pity

 Desire to help

7. 
   What qualities should an HIV vaccine have?)can select more than one answer(
   

 Treat a person already infected with HIV

 Do not know

 Others, specify ..........................................................

8. 
   What do you think HIV vaccine is made of? )can select more than one answer(
   

 Dead HIV virus

 Parts of HIV virus

 Constructed substance that is like the virus or parts of the virus

 Do not know

 Others, specify ..........................................................

9. 
   If there is an HIV vaccine study, who do you think should volunteer? (can select more than one answer)
   

 Men

 Children

 Teenagers

 Elders

 Others, specify..........................................................

10. 
    If there is a study to test whether an HIV vaccine is effective, will you be willing to participate?
    

 Yes

11. 
    What qualities should a product that is inserted in the vagina or the anus to prevent HIV infection have? )can select more than one answer(
    

 Prevent men from being infected/receiving HIV from women via the vagina

 Prevent men from being infected/receiving HIV from men via the anus

 Do not know

 Others, specify..........................................................

12. 
    Who do you think should use a product that is inserted in the vagina or the anus to prevent HIV infection?)can select more than one answer)
    

 Men by inserting in own anus

 Men by using it on sexual partner’s vagina

 Men by using it on sexual partner’s anus

 Do not know

 Others, specify..........................................................

13. 
    If there is a study of a product that is inserted in the vagina or the anus to prevent HIV infection, who do you think should volunteer? (can select more than one answer)
    

 Men

 Children

 Teenagers

 Elders

 Others, specify..........................................................

14. 
    If there is a study to test whether a product that is inserted in the vagina or the anus to prevent HIV infection is effective, will you be willing to participate?
    

 Yes

15. 
    What qualities should an antiretroviral medication to prevent HIV infection have? (can select more than one answer)
    

 Take by mouth before sexual intercourse/risky behavior

 Take by mouth immediately after sexual intercourse/risky behavior to prevent HIV infection

 Do not know

 Others, specify..........................................................

16. 
    Who do you think should use antiretroviral medication to prevent HIV infection? )can select more than one answer)
    

 Men in general

 Women/men sex workers

 Do not know

 Others, specify..........................................................

17. 
    If there is a study of antiretroviral medication to prevent HIV infection, who do you think should volunteer? (can select more than one answer)
    

 Men

 Children

 Teenagers

 Elders

 Others, specify..........................................................

18. 
    If there is a study to test whether a product that is inserted in the vagina to prevent HIV infection is effective, will you be willing to participate?
    

 Yes

19. 
    Did you know that in studies on methods to prevent HIV infection such as using antiretroviral medication, some volunteers may receive the real medication and some may receive a placebo (starch pills without medication)?
    

 Yes

20. 
    What are your concerns that may cause you not to volunteer in studies on methods to prevent HIV infection if such studies happen in the future (can select more than one answer)?
    

 Afraid of pain if it involves injections or blood draws

 Do not want to waste a lot of time to come for appointments

 Concern that personal information will not be kept confidential

 Fear of side effects from the methods to prevent HIV infection

 Do not want to receive placebo

 Husband/wife/close persons do not want me to participate

 No concerns

 Others, specify............................................ \

21. 
    What will be the reasons that you decide to volunteer in studies on methods to prevent HIV infection if such studies happen in the future (can select more than one answer)?
    

 Want to receive special care from staff more than what I would receive with regular services

 Want to have free HIV testing

 Want to receive information about HIV/AIDS and methods to prevent HIV infection

 Want to receive treatment if found to have HIV infection

 Want compensation (money/free blood test/free health check up)

 No reason

 Others, specify .....................................

22. 
    If methods such as HIV vaccine, vaginal inserts or antiretroviral medication can prevent HIV infection, what will be the reasons for you to choose these methods? (can select more than one answer)
    

 Have difficulty in negotiating for sexual partner to use condoms

 To add to the effectiveness of preventing HIV infection when used with condoms

 Do not think I will choose these methods

 May choose these methods without any particular reasons

 Others, specify.....................................

23. 
    If there are studies on methods to prevent HIV infection in the future, what types of advertisement should we use?
    

 Pamphlets by distributing it at area

 News paper/magazine, please specify their names ...................................

 Radio, on wavelength .......................................

 Television, on channel .................................

 Visit communities

 Others, specify .....................................

11.3 Appendix C: Posters and flyers
You are invited to become a volunteer for
A study to establish and characterize an acute hiv infection cohort in a high risk population

we would like to encourage you to come for hiv testing at the anonymous clinic at the thai red cross aids research centre
we have a new blood test which can tell if someone has just had hiv infection within the past month (before the routine blood test is positive)
You may be eligible for this study if you are:

1. 
   Male or Female
   

2. 
   AGe ≥ 18 years old
   

3. 
   blood test shows that you have recently been infected with hiv infection*
   

1. 
   you will have hiv care and blood draw for a total of 21-27 visits in two-FOUR years
   
2. 
   asked to Answer questionnaires
   
3. 
   you Will be given 1000 baht per visit
   
4. 
   there are optional procedures which you may or may not wish to participate. additional reimbursement will be given.
   

Jintanat Ananworanich, MD, PhD

AFRIMS (SEARCH office)

104 Rajdumri Road

Pathumwan, Bangkok 10330

Tel 02-254-2566 to 9

Fax 02-254-2567

Email: JintanatA@afrims.org