NCT07423364

Brief 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. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

January 30, 2026

Last Update Submit

February 17, 2026

Conditions

HIV (Human Immunodeficiency Virus)

Keywords

HIVWomen, Health Promotion ModelReproductive HealthPatient Education

Outcome Measures

Primary Outcomes (2)

  • 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.

    From enrollment to the end of education modules at 4 weeks

  • AIDS/HIV Knowledge

    AIDS/HIV Knowledge Scale

    From enrollment to the end of education modules at 4 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

a reproductive health education program

Behavioral: a reproductive health education program

Control

NO INTERVENTION

Interventions

a reproductive health education programBEHAVIORAL

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.

Experimental

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiological sex at birth being female
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female individuals
  • Individuals diagnosed with HIV
  • Individuals aged 18-49 years
  • Sexually active individuals

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Non-Governmental Organizations

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Kenan Oztop

    Okan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 20, 2026

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

June 1, 2022

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Restricted because they are disadvantaged group.

Locations

TU(1)