Protocol summary

Study aim
1. Examining the Effectiveness of Motivational Interviewing on Quality of Life in Women with HIV in Tabriz 2. Examining the Effectiveness of Motivational Interviewing on Self-Esteem in Women with HIV in Tabriz 3. Examining the Effectiveness of Motivational Interviewing on Reducing Psychopathological Symptoms in Women with HIV in Tabriz
Design
quasi-experimental pretest-posttest control group design
Settings and conduct
This study will be a quasi-experimental study with a pretest-posttest design with a control group that will be conducted on 32 HIV-infected women referring to the Tabriz Behavioral Diseases Counseling Center. Participants will be randomly divided into two experimental and control groups. The experimental group will be received 5 sessions of motivational interviewing, while the control group continued with usual care only. Assessments will be conducted in three stages: pretest, posttest, and 3-month follow-up.
Participants/Inclusion and exclusion criteria
Confirmed HIV diagnosis through clinical tests. No concurrent psychological treatments were allowed during the study period. Aged 18 years or older. Female gender. Minimum literacy skills (ability to read and write).
Intervention groups
Intervention group (n = 16): Receives motivational interviewing.
Main outcome variables
Quality of Life Self-Esteem Psychopathological Symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190924044866N2
Registration date: 2025-07-15, 1404/04/24
Registration timing: prospective

Last update: 2025-07-15, 1404/04/24
Update count: 0
Registration date
2025-07-15, 1404/04/24
Registrant information
Name
Ali Asgharzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6649 2712
Email address
ali.asgharzadeh72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of motivational interviewing on reducing psychopathological symptoms, increasing self-esteem, and quality of life in women with HIV in Tabriz
Public title
The Effectiveness of Motivational Interviewing on HIV
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed HIV diagnosis through clinical tests. No concurrent psychological treatments during the study period Aged 18 years or older Female gender Minimum literacy skills (ability to read and write)
Exclusion criteria:
Not applicable in this study
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz - El Goli Road, Razi Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Approval date
2024-08-19, 1403/05/29
Ethics committee reference number
IR.TBZMED.REC.1403.407

Health conditions studied

1

Description of health condition studied
HIV
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease

Primary outcomes

1

Description
Quality of life
Timepoint
before intervention, after intervention and 3 month follow up
Method of measurement
World Health Organization Quality of Life Instrument - Short Form

2

Description
self-esteem
Timepoint
before intervention, after intervention and 3 month follow up
Method of measurement
Eysenck Self-Esteem Test

3

Description
psychopathological symptoms
Timepoint
before intervention, after intervention and 3 month follow up
Method of measurement
General Health Questionnaire,Cross-Symptom Measurement Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in the intervention group (n = 16) will receive five individual motivational interviewing (MI) sessions, each lasting 60 minutes. These sessions will employ evidence-based MI techniques—including change talk, reflective listening, and goal-setting strategies—to enhance intrinsic motivation and facilitate behavioral change.Standardized assessment tools will be administered to evaluate outcomes, and sessions will be audio-recorded (with participant consent) to ensure treatment fidelity. All procedures will adhere to ethical guidelines, including informed consent and data confidentiality.
Category
Treatment - Other

2

Description
Control group: Includes (n=16) who will not receive any intervention. It should be noted that pre-test, post-test, and follow-up assessments will be conducted
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Behavioral Diseases Counseling Center in Tabriz
Full name of responsible person
Ali Asgharzadeh
Street address
El Goli Road, Razi Educational and Medical Center
City
TABRIZ
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 5135 2308
Fax
+98 41 5135 2308
Email
ali.asgharzadeh72@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khosro Adibkia: (Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences)
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, , Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 4280
Email
ali.asgharzadeh72@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Asgharzadeh
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
El Goli Road, Razi Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 5135 2308
Email
ali.asgharzadeh72@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Asgharzadeh
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
El Goli Road, Razi Educational and Medical Center
City
TABRIZ
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 5135 2308
Email
ali.asgharzadeh72@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Asgharzadeh
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
El Goli Road, Razi Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 5135 2308
Email
ali.asgharzadeh72@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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