NCT04494477

Brief Summary

The INclued program was implemented in 16 states across the US. The purpose of this study is to measure: Nine months after the end of the program and one year after the workshop, are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,401

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

3.1 years

First QC Date

July 22, 2020

Last Update Submit

July 28, 2020

Conditions

Teen PregnancySTD Prevention

Keywords

LGBTQ sex education

Outcome Measures

Primary Outcomes (1)

  • Nine months after the end of the program are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants?

    If participants had recent (in the past three months) vaginal sex without a condom or birth control, recent oral sex without protection, or recent anal sex without a condom, they were coded as having engaged in recent unprotected or risky sexual behavior.

    One year after baseline

Study Arms (2)

The IN•clued program

EXPERIMENTAL

The IN•clued program for youth consists of a three-hour in-person workshop for youth which includes lessons about safe sex practices and self-efficacy at healthcare centers, exam room roleplays, and a discussion on patient rights. Youth receive a Zine, or a magazine-style booklet, that they may take home. They also receive a list of local healthcare providers that highlights those that have participated in the IN•clued healthcare provider workshop or have had training on working with the LGBTQ population. Program youth can also receive text messages with health tips and reminders to visit a healthcare center.

Behavioral: The IN•clued program

Control

NO INTERVENTION

The youth control group receives a 10-minute presentation and a list of local sexual healthcare providers, with no indication of which providers have been trained to be more LGBTQ friendly and accepting. This 10-minute presentation is a part of a longer three-hour activity unrelated to sexual health or accessing sexual healthcare. During the three-hour session, the list of approved activities includes but is not limited to: * Films by, and for, LGBTQ youth about sexual orientation and gender identity; * Community scavenger hunts; * Poetry slams; * Discussions about relationships; and * Activities related to the appreciation of individuals' unique strengths.

Interventions

The IN•clued programBEHAVIORAL

The INclued program as previously described.

The IN•clued program

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Youth participants are already in LGBTQ groups, such as gay-straight alliances in schools or local community groups or those who are recruited to attend a special event at a community-based organization or conference. Participants must be at least 14 and preferably younger than 20. Ideally, they are part of the LGBTQ community, although this is not required.

You may not qualify if:

  • Cannot require ESL support.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philliber Research & Evaluation

Accord, New York, 12404, United States

Location

Related Publications (1)

  • Philliber A. The IN.clued Program: A Randomized Control Trial of an Effective Sex Education Program for Lesbian, Gay, Bisexual, Transgender, Queer, and Questioning Youths. J Adolesc Health. 2021 Oct;69(4):636-643. doi: 10.1016/j.jadohealth.2021.04.002. Epub 2021 May 14.

    PMID: 33994311DERIVED

Study Officials

  • Ash Philliber, PhD

    Philliber Research & Evaluation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 31, 2020

Study Start

February 22, 2017

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

July 31, 2020

Record last verified: 2020-07

Locations

US(1)