HIV (Human Immunodeficiency Virus)NCT07423364
Evaluation of A Reproductive Health Education Program in Women Living With HIV
A study testing a reproductive health education program in people with HIV (Human Immunodeficiency Virus), run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effectiveness of a reproductive health education program designed and implemented using Pender's Health Promotion Model for women living with HIV.The study was designed as a prospective controlled experimental study. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- HIV (Human Immunodeficiency Virus)
- What is being tested?
- a reproductive health education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Sampling Inclusion Criteria
- Female individuals
- Individuals diagnosed with HIV
- Individuals aged 18-49 years
- Sexually active individuals
Sample Exclusion Criteria
- Being pregnant
- Being postpartum
- Individuals with disabilities
- Individuals whose gender identity does not match their biological sex at birth, those receiving hormonal therapy, or other conditions that do not fit the specific biological focus of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Reproductive Health Education Program Prepared According to Pender's Health Promotion Model in Women Living With Human Immunodeficiency Virus (HIV)
This study was conducted to evaluate the effectiveness of a reproductive health education program designed and implemented using Pender's Health Promotion Model for women living with HIV.The study was designed as a prospective controlled experimental study.
The hypotheses tested in the study include the following questions:
- Does a "Reproductive Health Education Program" prepared using the Health Promotion Model for women living with HIV increase the reproductive health knowledge level of HIV-positive women?
- Does a "Reproductive Health Education Program" prepared using the Health Promotion Model for women living with HIV positively influence healthy lifestyle behaviors related to women's health among HIV-positive women?
- Does a "Reproductive Health Education Program" prepared using the Health Promotion Model for women living with HIV positively influence lifestyle behaviors related to general health among HIV-positive women?
- Conditions
- HIV (Human Immunodeficiency Virus)
- Being tested
- a reproductive health education program
- Keywords
- HIV, Women, Health Promotion Model, Reproductive Health, Patient Education
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a reproductive health education programBehavioural
The Health Promotion Model used in the study. The first module was the "Women's Reproductive Health-Sexual Health Module," and the second module was the "HIV/AIDS Healthy Lifestyle Behaviors Module.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | a reproductive health education program Receives: Behavioral: a reproductive health education program |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Scale for Determining the Reproductive Health Preventive Attitudes of Married Women
It is a 5-point Likert-type scale consisting of a total of 39 items. The scale scores range from 39 to 195. The increase in scores indicates that women's attitudes and behaviors regarding protecting their reproductive health are positive.
Measured: From enrollment to the end of education modules at 4 weeks
AIDS/HIV Knowledge
AIDS/HIV Knowledge Scale
Measured: From enrollment to the end of education modules at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jul 2020
- Primary completion1 Jul 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Akgöl, Okan University
- Investigators
- Kenan Oztop, Study chair, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423364
- Sponsor's protocol ID
- 38299
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Restricted because they are disadvantaged group.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reproductive Health Education Program Prepared According to Pender's Health Promotion Model in Women Living With Human Immunodeficiency Virus (HIV)
- ClinicalTrials.gov ID
- NCT07423364
- Acronym / sponsor ID
- 38299
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- HIV, Women, Health Promotion Model, Reproductive Health, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to evaluate the effectiveness of a reproductive health education program designed and implemented using Pender's Health Promotion Model for women living with HIV.The study was designed as a prospective controlled experimental study.
The hypotheses tested in the study include the following questions:
- Does a "Reproductive Health Education Program" prepared using the Health Promotion Model for women living with HIV increase the reproductive health knowledge level of HIV-positive women?
- Does a "Reproductive Health Education Program" prepared using the Health Promotion Model for women living with HIV positively influence healthy lifestyle behaviors related to women's health among HIV-positive women?
- Does a "Reproductive Health Education Program" prepared using the Health Promotion Model for women living with HIV positively influence lifestyle behaviors related to general health among HIV-positive women?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: a reproductive health education programa reproductive health education program |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a reproductive health education programThe Health Promotion Model used in the study. The first module was the "Women's Reproductive Health-Sexual Health Module," and the second module was the "HIV/AIDS Healthy Lifestyle Behaviors Module. | Behavioural | Experimental |
Primary outcome
The Scale for Determining the Reproductive Health Preventive Attitudes of Married Women
Time frame: From enrollment to the end of education modules at 4 weeks
It is a 5-point Likert-type scale consisting of a total of 39 items. The scale scores range from 39 to 195. The increase in scores indicates that women's attitudes and behaviors regarding protecting their reproductive health are positive.
AIDS/HIV Knowledge
Time frame: From enrollment to the end of education modules at 4 weeks
AIDS/HIV Knowledge Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No. Restricted because they are disadvantaged group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenan Oztop study chair
Okan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a reproductive health education program in people with HIV (Human Immunodeficiency Virus), run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Scale for Determining the Reproductive Health Preventive Attitudes of Married Women (time frame: From enrollment to the end of education modules at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.