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Effect of smart phone based group motivational counseling on safe sex behavior of women living with HIV

 View older revisions Content changed at 2021-07-25, 1400/05/03

Protocol summary

Study aim
Determine the Impact of smart phone based group motivational counseling on safe sex behavior of women living with HIV
Design
The study consists of two group, intervention and control groups. Participants were randomly assigned using software. This study not blinded.The sample size is 100, and the trial is in phase three.
Settings and conduct
The study is conducted at the Center for Behavioral Diseases of Emam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
1- Iranian nationality 2- In the age range of 19 to 49 years 3. Reading and writing ability 4. Having smartphone and access to cyberspace 5- Having web-based software on mobile 6. Having sexual activity in the last three months.
Intervention groups
The samples are provided in two groups: Counseling (intervention) and receiving routine care (control). Consultation with the help of the formation of a virtual group takes place.The intervention group will receive five sessions of 45 minutes of cyber-based counseling (Farsi-based web messenger) with a motivational interviewing approach to reduce risk and safe sexual behavior on a weekly basis.The first meeting will be held in person and individually with the participants and other meetings using the formation of a virtual group whose admin is the researcher of the project. It will be on the web and using smartphone. Follow-up to the consultation sessions will also be virtual and If there are questions or to provide an assignment, participants can be privately contacted by admin. In both groups, the questionnaires will be completed before, after completing the sessions and three months later.
Main outcome variables
Knowledge about HIV/AIDS; Safe sex behavior; safe sex negotiation; HIV specific social support

General information

Reason for update
The end of the RCT
Acronym
HIV
IRCT registration information
IRCT registration number: IRCT20161230031662N7
Registration date: 2018-07-28, 1397/05/06
Registration timing: registered_while_recruiting

Last update: 2021-07-25, 1400/05/03
Update count: 1
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
Razieh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
raziehlotfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-03, 1397/04/12
Expected recruitment end date
2018-08-05, 1397/05/14
Actual recruitment start date
2018-07-03, 1397/04/12
Actual recruitment end date
2018-08-05, 1397/05/14
Trial completion date
2018-10-13, 1397/07/21
Scientific title
Effect of smart phone based group motivational counseling on safe sex behavior of women living with HIV
Public title
Effect of motivational counseling on safe sex behavior
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality In the age range of 19 to 49 years Ability to read and write Having smartphone and access to cyberspace Having web-based software on mobile Having sexual activity in the last three months
Exclusion criteria:
Getting Advanced Stages of Disease (AIDS) Those who disable their profile during the course Unwillingness to continue to participate in the study Severe mental illness Not attending similar educational and intervention classes in the last 6 months
Age
From 19 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
First, the sampling will be available and according to the active records in the center. Then they will be divided into two groups based on random blocks. Also for statistical matching, the statistical tests are used to match the underlying variables The randomization method is done using block randomization so that the sample size of both groups is equal.
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 Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, Shahrake Edari, North Taleghai square, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.ABZUMS.REC.1397.031

Health conditions studied

1

Description of health condition studied
Safe sex behavior
ICD-10 code
Z70.1
ICD-10 code description
Counselling related to patient's sexual behaviour and orientation

Primary outcomes

1

Description
safe sex behavior
Timepoint
before, 1 month , and 3 month after intervention
Method of measurement
Self- played questionnaire score

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group, 50 women with positive HIV status, have criteria for entering the study, receive 5 sessions of 45 minute group counseling based on motivational interviewing sessions on a weekly basis. Topics of the content of the sessions include acquaintance, emotion, assessment of advantages and disadvantages, values, final vision
Category
Behavior

2

Description
In the control group they will receive just routine voluntary and counseling protocol for HIV consultation
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Imam khomani hospital volantary and counseling center
Full name of responsible person
Zeinab Talebi Tamajani
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6658 1583
Email
ircha@sina.tums.ac.ir
Web page address
http://ircha.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
دانشگاه علوم پزشکی و خدمات بهداشتی درمانی البرز
Full name of responsible person
دکتر محمد نوری سپهر
Street address
Noor street, Taleghani Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3256 3328
Email
zeinabtalebi23@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
دانشگاه علوم پزشکی و خدمات بهداشتی درمانی البرز
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
ZeinabTalebiTamajani
Position
BsC. in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Department of Nursing and Midwifery, Alborz University of Medical Science, Golestan1, Eshteraki St., Baghestan, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3430 4433
Email
Zeinabtalebi23@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Razieh Lotfi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Department of Nursing and Midwifery, Alborz University of Medical Sciences, Golestan1, Eshteraki St., Baghestan Blv
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3455 1034
Email
lotfi_razieh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zeinab Talebi Tamajani
Position
BSc. in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Department of Nursing and Midwifery, Alborz University of Medical Sciences, Eshteraki St., Golestan1, Baghestan
City
Karaj
Province
Alborz
Postal code
561-31452
Phone
+98 264551034
Email
zeinabtalebi23@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
as an English article we published data.
When the data will become available and for how long
10 month later
To whom data/document is available
Iranian research center for HIV/AIDS , Alborz University of Medical Sciences
Under which criteria data/document could be used
For complementary researches such as Path analysis Sending e-mail to the main researcher
From where data/document is obtainable
Alborz University of nursing and Midwifery and Iranian research center for HIV/AIDS.
What processes are involved for a request to access data/document
send an email to Dr. Razieh Lotfi.
Comments

Trial results

Please tick if results have been published
Yes
Summary result posting date
2021-07-25, 1400/05/03
Table of baseline comparison
Control group intervention group
Variables p-value SD±Mean SD±Mean
Age* 0.662 6.64± 34.45 7.10± 34.97
Age at first sex** 0.434 4.03 ± 20.08 4.4± 19.31
Duration of the disease** 0.908 3.57 ± 5.32 5.10 ± 6
Duration of membership in a Positive club** 0.595 2.45 ± 3.10 3.68 ± 3.43
Average monthly income (IRR) ** 0.674 910317.9 ± 1198649 2079496 ±1634146
 (%)N  (%)N
Marital status ** 0.398
Married (permanent marriage) (54%) 27 (48%) 24
Married (temporary marriage) (14%) 7 (20%)10
Single (10%) 5 (2%) 1
Widow (6%) 3 (6%) 3 
Divorced (16%)8 (24%) 12
Number of partners**** 0.251
1 (50%) 25 (50%) 25
2-3 (38%) 19 (32%) 16
4-5 (10%) 5 (6%) 3
6 or more (2%) 1 (12%) 6
Having a contraception method*** 0.326 (84%) 42 (74%) 37
Type of contraception method**** 0.975
Withdrawal (34.9%) 15 (30.8%) 12
Condom (53.5%) 23 (59%) 23
Intra uterine device (4.7%) 2 (5.1%) 2
Tubal ligation (7%) 3 (5.1%) 2
Level of education *** 0.557
Elementary and middle school  (20%)10 (30%)15
High school and diploma ( 64%)32 (56%)28
Academic (16% )8 (14%)7
Spouse’s condition (HIV+)**** 0.408 (78%) 39 (64%) 32
Spouse education level **** 0.643
Illiterate (8.2%) 4 (8.2%) 4
Elementary and middle school (34.7%) 17 (40.8%)20
High school and diploma (40.8%) 20 (28.6%) 14
Academic (16.3%) 8 (22.4%) 11
Employment status *** 0.416
Unemployed (54%) 27 (64%)32
Employed (46%) 23 (36%)18
Route of HIV contamination **** 0.408
Unsafe sex (66%) 65 (64%)32
Injecting drug use (2%) 1 (6%) 3
Blood injection (0%) 0 (6%) 3
Unknown (22%) 11 (16%)8
Other cases (10%) 5 (8%) 4
Reasons not to use condom**** 0.693
No condom (6.9%) 2 (11.5%) 3
Expensive (6.9%) 2 (0%) 0
Missing woman's interest in using (20.7%) 6 (15.4%) 4
Opposition by husband /  sex partner (48.3%) 14 (50%)13 1
Use of other preventive methods (10.3%) 3 (7.7%) 2
inattentiveness of condom use (3.4%) 1 (7.7%) 2
Negative husband / partner test (3.4%) 1 (0%) 0
Confidence in husband / partner (0%) 0 (7.7%) 2
Use of antiretroviral drugs*** 0.678 (96%) 48 (92%) 46

* Independent T-test.  ** U- Mann-Whitney Test. *** Chi-Square test.      **** Fisher's exact test

Significant at P < 0.05                                                                                                  

Participant flow diagram
Table of variable outcomes' results

 ​

Variables Groups Before intervention one month months after intervention three month months after intervention Friedman test results in each group(** p-value)
SD ±Mean SD ±Mean SD ±Mean
Safe  sex behavior intervention 2.08 ± 7.76 1.84 ± 8.04 1.88 ± 8.00 0.187
Control 1.90 ± 7.02 1.90 ± 7.02 1.95 ± 6.92 0.368
Result              p-value* 0.068 0.008 0.008
knowledge  about HIV / AIDS and ways of transmission and prevention intervention 3.46 ± 7.86 1.53 ± 10.63 1.39 ± 10.71 0.000
Control 2.88 ± 7.50 2.54 ± 8.14 2.39 ± 8.66 0.000
Result              p-value* 0.194 0.000 0.000
Ability of Condom negotiation intervention 4.14± 16.84 3.79 ± 18.63 4.18 ± 18.08 0.000
Control 4.89± 15.19 4.93 ± 15.000 4.99 ± 14.76 0.069
Result              p-value* 0.044 0.000 0.000
HIV specific perceived social support intervention 3.000±12.41 2.47± 13.06 2.45 ±13.10 0.000
Control 2.95 ± 11.28 2.74 ±11.11 2.87 ± 11.04 0.016
Result              p-value* 0.195 0.001 0.002

  

Table of adverse events
First publication date
2019-09-09, 1398/06/18
Abstract of published paper
Condom use was practiced only by 22.2% in all their vaginal and anal sexual intercourse during the three months, and 77.8% of the women never used condoms or failed to use them continuously. Their sexual partners were HIV-positive in 71% of cases. The mean ± SD of awareness score about HIV/AIDS was 7.60 ± 3.31, indicating average awareness of the subjects in the study. A total of 49.1% of the participants stated that their sexual partners’ reluctance was the most important reason for non-use of condoms, while women were not willing to use condoms in 18.2% of cases
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