Proforma
Questionnaire ID
Regional Medical Research Center NE Region (ICMR), Dibrugarh.
(“To assess the seroprevalence of HSV-2 in pregnant women in North Eastern State.”)
Note to the interviewers:
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Welcome and greet the participants.
Introduce yourself.
Give a short overview of the purpose of the study.
Ensure and explain the participant the confidentiality of the study.
Some of the questions are very personal, try to generate confidence and outspokenness among
the study subjects.
Take written and well informed consent explaining the motives of the study in patients own
language.
Thank participant for taking time to participate.
1.
Name and code number of the Interviewer:
Name: _____________________________________code No.__________.
2.
Date of interview: _______________.
3.
Compilation status of the Interview: Complete [01], Incomplete [02].
4.
Status of the biological sample collection: Obtained blood sample only [01], obtained vaginal
smear/cervical smear/genital ulcer smear only [02], obtained both Blood sample and vaginal
smear/cervical smear/genital ulcer smear [03].
5.
Supervision work and checks done by the supervisor. Yes [01], No [02].
6.
Name and signature of the Supervisor/Investigator: __________________________________.
Consent form
“To assess the seroprevalence of HSV-2 among pregnant women in North Eastern state.”
Regional Medical Research Centre, N. E. Region
(Indian Council of Medical Research)
Post Box: 105, Dibrugarh-786001
Ph: 0373 2381494
CONSENT FORM
I Mrs……………………………………………………. is exercising my free power of choice, hereby give my consent
to be included as a subject in the study “To assess the seroprevalence of HSV-2 in pregnant women in
North Eastern state.”
Introduction: Herpes simplex virus (HSV) infections occur worldwide and can only be transmitted
between humans. HSV-2 is associated with genital infection (herpes genitalium or genital herpes). HSV-2
is usually transmitted by sexual contact. HSV-2 is one of the commonest causes of genital ulceration
worldwide. It is usually mild-so mild that two- thirds of infected people don't even know they have it.
HSV-2 apart from its primary infection may result in recurrent bouts of genital herpes with painful
ulcers. HSV-2 rarely causes complications or spreads to other parts of the body, but is the most common
cause of neonatal herpes, a rare but dangerous infection in newborns. It is recognized that the chances
of acquiring other sexually transmitted disease like HIV increases with HSV-2 infection.
Purpose of the study: The study will try to assess the seroprevalence and risk factors of HSV-2 in
pregnant women in Northeastern states. The increasing evidence that HSV-2 facilitates HIV acquisition
and transmission makes the development of HSV control methods a priority. Since up to 70% of genital
HSV infections are unrecognized, so sero-epidemiological studies are critical to understanding the
pattern and distribution of infection within population in order to reduce the HSV-2 related HIV
incidence in the communities.
Your participation in this study:
If you agree to participate in this study, we will ask you some personal questions about you, your
antenatal history, sexual behavior, and sexually transmitted infections etc. The interview is likely to last
for about 30 minutes. We will request you to permit us to collect blood sample and vaginal swab
samples. Our study doctor will perform external physical examination and if you have certain symptoms,
you will be requested to permit us to collect samples from secretions from an ulcer on the genital area.
At the end of this form, we will request you to give consent for each of these procedures. You may
participate, only if you are willing to. You may choose not to answer certain questions. If it is found that
you are having symptoms suggestive of sexually transmitted infections, our study doctor will refer you
to available sources of medical care. The result of the HSV-2 serology test syphilis serology test will be
kept confidential.
Who is eligible? : Pregnant women above 18 years age group and willing to participate in the survey.
Risks and benefits of participating in the study: You may feel discomfort when your blood sample is
drawn. Some may feel dizzy or uneasiness. You may have a bruise or a swelling where the needle was
pricked. You may become embarrassed when discussing sexual behaviors. You will talk with a trained
staff member who will help you deal with any feelings or questions you have.
Confidentiality:
The study staff will keep your personal information confidential. In all other forms beside this consent
form, and on all samples, instead of name, only a code number shall be mentioned. The forms linking
your name and the assigned code number will be kept under lock and key. This information will not be
given to anybody else without your permission.
We will make every effort to protect your privacy and confidentiality. This study may be of no direct
benefit to you. However, you and other community members may benefit in the future from
information learned from this study. If you wish, you will be referred for STD treatment if needed. This
study cannot provide you with other medical care, but study staff will refer you to other available
sources of medical care.
Compensation for your participation: There is no cost to you to participate in the study. You will be
examined by a trained doctor, who will help you in availing proper care if required.
If you decide not to participate in this study: You may decide not to take part or to withdraw from the
study at any time.
Permission to use samples for future Research work:
Of the blood/vaginal swab that are going to be collected, a small quantity of sample may be left over. In
such circumstances, we would request you to permit us to keep this leftover sample for future research
instead of throwing it off. It will be only used for research and not for any commercial gains. If you agree
to this, it means that you also give us permission to do such studies on these samples. The result will not
be used to identify participants individually.
Sample Identification: All samples will have only unique numbers, nowhere in the study your name will
be linked with the results. Your leftover samples will have your unique number and not name. Though
we would be able to link the test result with other data we have collected, we will not be able to get
back to you with the test results as we will not be recording your address.
Risks:
There are no risks to you from the study as well as from future use of your specimens. Reports about
research done with your sample will only be presented in publications and meetings and shall not have
your name or any other personal identifier.
Freedom to refuse: you can decide not to allow use of your leftover samples for future research or you
may change your mind at any time about allowing your samples to be used for future research.
Voluntary Consent: I certify that all my questions and concerns have been answered and I willingly
agree that samples can be used for future research. I give permission for the use of my leftover samples
in future research for the purpose described above.
(Please check one)
1.
2.
Yes
No (If no, my specimens will be destroyed)
Statement to be made by a person willing to participate in the study:
I have read this consent form completely/ this consent form has been read out to me. All my doubts
have in cleared. I can withdraw my participation anytime, if I feel so. I have understood this. I have
received and understood the information about my rights and have been promised that my personal
information shall be kept confidential.
I want to participate in this study myself by own free will and am willing to (Circle number/s that is
accepted):
1.
Answer the questionnaire
2.
Consult the study doctor
3.
Provide blood, and vaginal swab samples
4.
All 1+2+3.
I have been offered a copy of my consent form and (Circle number that is accepted):
1.
I want a copy of my consent.
2.
I don’t want a copy of my consent form.
Ethics Committee Stamp of Certification
Date of Expiry of Consent Form
Please do not sign after date of expiration
Signature
Signature of witness
Participant’s name
Name of witness.
Date:
“To assess the seroprevalence of HSV-2 among pregnant women in North Eastern state.”
Regional Medical Research Centre, N. E. Region
(Indian Council of Medical Research)
Post Box: 105, Dibrugarh-786001
Questionnaire
Sample/Subject/Questionnaire ID No.
State
code
Subject serial
Month
7.
Age: _________ Years.
8.
Religion : Hinduism [01], Christian [02], Buddhist [03],Muslim [04], Sikh [05], others [06].
9.
Race: Mongoloid [01], Caucasoid [02], Mix between mongoloids and Caucasoid [03].
10.
Caste: Schedule tribes [01], Schedule caste [02], other backward class [03], General [04].
11.
Name of Town/village/locality:
_________________________________________________
12.
Staying at present location for how long ______________ Months/ years.
13.
Are you literate? Speak only [01], Speak, read and write [02].
14.
Occupation: Only Housewife [1], Govt. or private Regular Employee [2], Unemployed [3], Casual
worker/unskilled worker [4], Female Sex Worker (FSW) [5], migrant worker [6],
others[7]____________(specify).
15.
Level of Education: Illiterate [1], Primary [2], M. E. School [3], High School [4], Higher
Secondary [5], Graduate [6], Postgraduate [7], Professional Degree/ Doctor / Engineer [8].
16.
Income per month:
a. within Rs: 2,500/- ------1
b. Rs: 2,500-5,000/------2
c. Rs: 5,000- Rs: 10,000/- ----3
d. Above Rs 10,000/-----4
17.
Socio-economic status: Low [1],
18.
Type of family: Single [1],
19.
Marital status: Unmarried [1],
20.
Age at Marriage ______________years.
21.
Last menstruation period (LMP) ___________
22.
Gestational weeks _______________
23.
Trimester of pregnancy ___________
24.
Number of living children _____________________
25.
Number of spontaneous abortions/terminations _______________
Middle [2],
Nuclear family [2],
Married [2],
High [3].
Joint family [3].
Separated [3],
Widow [4].
26.
Number of still births ______________
27.
Number of neonatal deaths _________.
28.
Gestation _____ Parturition _______.
29.
Present weight _______________Kg.
30.
Present Height ________________cm.
31.
At present do you suffer from any/some of the following:
a)
Fever [01]
b)
Weakness [02]
c)
Fatigue [03]
d)
Anorexia [04]
e)
Vomiting [05]
f)
Cough [06]
g)
Jaundice [07]
h)
Joint pain [08]
i)
Urinary problem [09]
j)
Excess Vaginal discharge [10]
k)
Lower abdominal/pelvic pain [11]
l)
Genital ulcers [12]
m)
Swelling in the groin area [13]
n)
Warts [14]
o)
Itching in the groin area [15]
p)
Skin rashes [16]
q)
None [17].
32.
In last one year, did you have genital ulcers: Yes [01], No [02].
33.
If yes how many episodes and flare-ups in one year: only once [01], twice [02], three or more
[03].
34.
Did you suffer from excess vaginal discharge in last one year: Yes [01], No [02].
35.
If yes, specify the type of vaginal discharge: White mucoid discharge [01], White curdy
discharge [02], watery discharge [03], greenish discharge [04].
36.
If yes, how many episodes in one year: only once [01], twice [02], three or more [03].
37.
Sexual history: A) type of sexual partner: Spouse [01], Friends [02], Relatives [03], Unknown/
Casual contact [04], no answer [05].
38.
Age at first sexual intercourse ___________ years.
39.
Number of sexual partners in last one year: One [01],
[04]. No answer [05].
40.
Did anyone give you money/ other favor for having sex with you/ Are you involve in commercial
sex work? Yes [01], No [02].
41.
Do you inject illicit drugs? Yes [01], No [02].
42.
If you are engage in Commercial sex work, what factors do you think lead you into this trade?
(Multiple response possible): As a source of income [01], To sustain family and child [02], to
sustain my addiction to drugs/alcohol [03], domestic violence [04], personal recreation [05], due
divorced from partner [06], lured by agents/friends [07], others ________(specify) [08].
43.
What Contraceptive method do you use frequently: Condoms [01], pills [02], IUCD [03], vaginal
cap [04], Spermicidal agent [05], none [06].
44.
Does your husband/partner resist the use of condoms? Yes [01], No [02].
45.
Have you encountered domestic violence/ beating by husband/ partner/ in-laws? Yes [01], No
[02].
46.
H/O alcoholic consumption: Regular [01],
47.
Past H/O viral hepatitis (Jaundice): Yes [01],
48.
If yes when: within last 6 months [01],
> 5 years [04].
Two [02], three [03], more than three
Occasional [02],
No [02],
none [03].
don’t know [03].
6 m-1year [02],
2-5 years [03],
49.
H/O any other major illness: Yes [01],
50.
51.
If yes, specify:__________________________________________________________________
H/O A) Blood transfusion: Yes [01], No [02];
If yes, when & how many times: _____________
B) Surgery:
No [02].
Yes [01],
No [02].
C) Infusions:
Yes [01],
No [02].
D Tattooing:
Yes [01],
No [02].
E) Injecting drug user (IDU):
Yes [01],
No [02].
F) Body piercing/ Ear piercing
Yes [01],
No [02]
52.
If IDU: How long have you been injecting drugs? <1years [01],
> 10 years [04].
1-5 years [02], 5-10 years [03],
53.
If IDU: how often do you inject drugs? >2 times a day [01],
week [03], less than once a week [04].
54.
If IDU: Do you share needle, syringe or containers with others? Yes [01], No [02].
55.
If IDU: With how many IDUs do you share? 2 [01],
56.
IF IDU: Are you engaging in commercial sex work? Yes [01], No [02].
57.
If IDU: What kind of drugs do you use?
Heroin [01],
Proxyvon/ Dextropropoxyphene [03], others specify___________ [04].
58.
If IDU: Do you visit drop-in centers regularly for exchanging your syringes? Yes [01], No [02].
59.
If IDU: Did you ever use a needle or syringe that has been previously used by someone else? Yes
[01], No [02].
60.
If IDU: With whom do you share while injecting drugs? Spouse [01], boyfriend [02], relatives
[03], strangers [04], others _______ (specify) [05], none [06].
1-2 times a day [02], 2-3 times a
3-4 [02],
> 4 [03].
Brown sugar [02],
61.
If IDU: Do you support your drug habits through commercial sex work? Yes [01], No [02].
62.
Awareness about STD and AIDS: Have you ever heard of HIV/AIDS? Yes [01], No [02].
63.
How do you think a person can get HIV/AIDS:
A)
Touching a HIV positive person: Yes [01], No [02], No idea [03].
B)
Kissing a HIV positive person: Yes [01], No [02], No idea [03].
C)
Having sexual intercourse with a HIV positive person: Yes [01], No [02],
No idea [03].
D)
Sharing toothbrush/ shaving blades/razors with a HIV infected person:
Yes [01], No [02], No idea [03].
E)
Getting blood transfusion/ blood products from an HIV infected person:
Yes [01], No [02], No idea [03].
F)
By using or sharing needles or syringes with an HIV infected person: Yes
[01], No [02], No idea [03].
64.
Have you ever heard of sexually transmitted disease (STD/STI)? Yes [01], No [02].
65.
Do you think people suffering from STD/STI have higher chances of contracting HIV/AIDS? Yes
[01], No [02], no idea [03].
66.
Do you think engaging in commercial sex work and injection drug use increases the risk of
acquiring HIV/AIDS? Yes [01], No [02], No idea [03].
67.
Do you think use of condoms can protect you from contracting HIV/AIDS and STD? Yes [01], No
[02], no idea [03].
68.
Did you in past one year suffer from any of the following symptoms (multiple response
possible):
A)
Genital ulcers: yes [01], No [02].
B)
Genital Warts: Yes [01], No [02].
C)
Excess Vaginal Discharge: Yes [01], No [02].
D)
Swelling in the groin: yes [01], No [02].
E)
Itching/ reddening: Yes [01], No [02].
F)
Skin rashes: Yes [01], No [02].
G)
Burning or pain during urination: Yes [01], No [02].
H)
Pain during sexual intercourse: Yes [01], No [02].
I)
recurrent lower pain abdomen/pelvic pain: Yes [01], No [02].
69.
Do your spouse/ partner suffer from similar symptoms? Yes [01], No [02].
70.
Did you seek medical treatment after suffering from any of the above symptoms? Yes [01], No
[02].
71.
Were your partner/ spouse given medicines/ treatment when you were treated? Yes [01], No
[02].
72.
Did your symptoms recur even after seeking medical treatment? Yes [01], No [02].
73.
On which day of your menstrual cycle the genital swab/smear and blood sample collected?
_________day.
Findings of clinical examination (by Obst. & Gynecologist): __________________________________
_____________________________________________________________________________
Status of the interview: Complete [01]
Incomplete [02]
Investigator’s Name: …………………………………………………..
Supervisor’s signature: …………………………………..………….
Date:
Place:
************