Study Summary
This trial is testing a 8-session manualized group coping skills intervention focused on reducing sexual risk behaviours and psychosocial distress among sexual and gender minority youth. The intervention is delivered by two facilitators (primarily social workers and peers) in a manner that affirms participants' sexual and gender minority identities and experiences. All participants receive the intervention in clusters over the course of the five-year trial.
- Mental Health Issue
- HIV (Human Immunodeficiency Virus)
- Social Stigma
- Coping Skills
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Waitlisted control
1 of 2
AFFIRM
1 of 2
Active Control
Experimental Treatment
300 Total Participants · 2 Treatment Groups
Primary Treatment: AFFIRM · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 14 - 29 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Craig, Shelley L, Lauren B McInroy, Andrew David Eaton, Gio Iacono, Vivian WY Leung, Ashley Austin, and Cheryl Dobinson. 2019. “An Affirmative Coping Skills Intervention to Improve the Mental and Sexual Health of Sexual and Gender Minority Youth (project Youth AFFIRM): Protocol for an Implementation Study”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/13462.
- Shelley Craig 2017. "An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04318769.