Determine the effect of preconception counseling based on motivational interview on knowledge, attitude, and pregnancy related behavior among women in reproductive age suffering from HIV
Determine the effect of preconception counseling based on motivational interview on knowledge, attitude, and pregnancy related behavior among women in reproductive age suffering from HIV
Design
Controlled clinical trial with parallel groups, without blinding, with sample size of 30, randomized via permuted block method
Settings and conduct
Researcher will refer to four centers (Mashhad1(Imamhadi), Mashhad2 (Basij), Mashhad3 (Resalt), Mashhad5 (Vahdat)) of behavioral and infectious diseases in Mashhad and will select cases consequently from women who have the inclusion criteria. Then will randomly allocate participants to the intervention and control groups through the permuted block method using Random Allocation Software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: HIV-infected women; Age 15 to 49 years; Married; Sexual activity during last 6 months; Written informed consent to participate in project; Writing and reading literacy; ability to get pregnant. Non-inclusion criteria: hysterectomy; menopause; pregnancy; addiction; occurrence of unpleasant accidents in the last 6 months
Intervention groups
Intervention group: three 60-90 minute weekly preconception counselling sessions with the use of motivational interview.
Control group: routine cares, i.e., contraceptive counselling, gynecology examination if necessary and conducting annual Pap smear test
Main outcome variables
Knowledge, attitude, and pregnancy related behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201214049722N1
Registration date:2021-02-17, 1399/11/29
Registration timing:registered_while_recruiting
Last update:2021-02-17, 1399/11/29
Update count:0
Registration date
2021-02-17, 1399/11/29
Registrant information
Name
Motahare Mohamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3521 4325
Email address
mohammadimt972@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-08, 1399/11/20
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determine the effect of preconception counseling based on motivational interview on knowledge, attitude, and pregnancy related behavior among women in reproductive age suffering from HIV
Public title
The effect of preconception counseling on knowledge, attitude, and pregnancy related behavior
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
HIV-infected women
Age 15 to 49 years
Married
Sexual active since last 6 months
Written informed consent to participate in project
Writing and reading literacy
Capable of conception
Refer to counselling centers of septic and behavioral diseases in Mashhad city
Having contact number
Exclusion criteria:
History of hysterectomy
Menopause
Pregnancy
Addiction
Occurrence of unpleasant accidents in the last 6 months
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Researcher will refer to four centers (Mashhad1(Imamhadi), Mashhad2 (Basij), Mashhad3 (Resalt), Mashhad5 (Vahdat)) of behavioral and infectious diseases in Mashhad and will select cases consequently from women who have the inclusion criteria. Then will randomly allocate participants to the intervention and control groups through the permuted block method using Random Allocation Software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research; Mashhad University of Medical Sciences; Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9188667656
Approval date
2020-11-17, 1399/08/27
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.055
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
Z21
ICD-10 code description
Asymptomatic human immunodeficiency virus [HIV] infection status
Primary outcomes
1
Description
Knowledge
Timepoint
before the intervention, immediately and four weeks after the intervention
Method of measurement
Knowledge questionnaire
2
Description
Attitude
Timepoint
before the intervention, immediately and four weeks after the intervention
Method of measurement
Attitude researcher-made questionnaire
3
Description
Behavior
Timepoint
before the intervention, immediately and four weeks after the intervention
Method of measurement
Behavior researcher-made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Three sixty-to-ninety minute weekly preconception counselling sessions with the use of motivational interview.
Category
Behavior
2
Description
Control group: routine cares, i.e., contraceptive counselling, gynecology examination if necessary and conducting annual Pap smear test
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Navid Tandorosti counselling center
Full name of responsible person
Dr. Sepehri
Street address
Navid Tandorosti counselling center, inside health center number 2, near the Vahdat park, at the beginning of Vahdat boulevard, Panjrah district.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185684538
Phone
+98 51 3365 7731
Email
Aids@mums.ac.ir
2
Recruitment center
Name of recruitment center
Mashhad 1 Behavioral and infectious diseases counselling center
Full name of responsible person
Dr. Karimian
Street address
First of Imam Hadi 12 street, Imam Hadi Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9185684538
Phone
+98 51 3691 3199
Email
Aids@mums.ac.ir
3
Recruitment center
Name of recruitment center
Mashhad 5 Behavioral and infectious diseases counselling center