NCT05897177

Brief Summary

Debate continues on whether or not male homosexuality (MH) is a result of biological or cultural factors. The debate persists despite the fact that these two sides have different abilities to create a scientific environment to support their cause. Biological theorists produced evidence, however, that these are not always robust. On the other hand, social theorists, without direct evidence confirming their positions, criticize, with good argument, methods and results of the other side.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress59%
Jul 2023Apr 2028

First Submitted

Initial submission to the registry

May 28, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

4.3 years

First QC Date

May 28, 2023

Last Update Submit

March 12, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change of Symptom Checklist-90-Revised (SCL-90-R) from baseline to 34 weeks

    The SCL-90-R Is an inventory developed to assess the intensity of symptoms inventoried during the last weeks. Each of the 90 items that is integrated in the self-report questionnaire is answered in a likert scale from 0 (nothing) to 4 (a lot), depending on the intensity with which the subject has lived in the last weeks the discomfort that each one explores. It is evaluated and interpreted in function of 10 primary dimensions (somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychotic and diverse symptoms and three global indexes of psychological disorders.

    from baseline to 34 weeks

  • Change of Sexual Compulsivity Scale (SCS) from baseline to 34 weeks

    The SCS contains 10 items (e.g., "my desires to have sex have disrupted my daily life"), rated from 1 (not at all like me) to 4 (very much like me). Item responses are summed to derive an overall score (range 10-40). A score of 24 or higher is frequently used to distinguish problematic sexual compulsivity

    from baseline to 34 weeks

  • Change of Safer Sex Self-Efficacy Questionnaire (SSSE) from baseline to 34 weeks

    The 13-item SSSE assesses self-efficacy for condom use in various situations (e.g., "When you really need affection," "When your partner says he/she does not want to use a condom") in response to the prompt, "How confident are you that you could avoid having anal sex without a condom?" using a scale ranging from 1 (not at all tempted) to 5 (extremely tempted). The SSSE predicts condomless anal intercourse among men who have sex with men (MSM; Rendina, 2014).

    from baseline to 34 weeks

Secondary Outcomes (3)

  • Change of Measure of Gay-Related Stress (MOGS) from baseline to 34 weeks

    from baseline to 34 weeks

  • Change of Internalized Homophobia Scale (IHP) from baseline to 34 weeks

    from baseline to 34 weeks

  • Change of Sexual Orientation Concealment Scale (SOCS) from baseline to 34 weeks

    from baseline to 34 weeks

Study Arms (2)

Normal patients

Behavioral: Subjective Scale of Stigma and Discrimination (SISD).

Observational group

Behavioral: Subjective Scale of Stigma and Discrimination (SISD).

Interventions

Subjective Scale of Stigma and Discrimination (SISD) A sixdimension self-administered scale will be used that included statements with which the participants agreed or disagreed. The scale consists of 23 Likert-type items and responses range from 1 ("completely in disagreement") to 5 ("completely in agreement"), grouped together to represent the six indicators making up this part of the scale

Normal patientsObservational group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All individuals with homosexuality from these different locations, Egypt, England, China, and Mexico.

You may qualify if:

  • Age ≥ 18 years
  • Male will be included

You may not qualify if:

  • Patients taking testosterone or its derivative.
  • Patients taking anabolic steroids.
  • Multi-sexual behaviours.
  • HIV patients.
  • not having and addictive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Teaching assisstant

Study Record Dates

First Submitted

May 28, 2023

First Posted

June 9, 2023

Study Start

July 20, 2023

Primary Completion (Estimated)

November 20, 2027

Study Completion (Estimated)

April 20, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations