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Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV (ESTEEM)

25. august 2026 oppdatert av: Wake Forest University Health Sciences
The purpose of this research study is to adapt, implement, and evaluate a 10-session mental health intervention with men who have sex with men at the Regional AIDS Interfaith Network to find out if it will reduce anxiety and depression and increase awareness and use of pre-exposure prophylaxis (PrEP), a medication to prevent HIV.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study will assess the preliminary effectiveness of the PrEPared Minds/ Mentes PrEParadas intervention. After randomizing English and Spanish-speaking men who have sex with men (MSM) to the cognitive behavioral therapy intervention or control group, the study team will conduct quantitative assessments (at baseline, 3-months, 6-months post intervention) and pre/post intervention in-depth interviews with MSM to assess preliminary effectiveness on depression, anxiety, and PrEP uptake. We will also use structural equation modeling to explore the pathways through which the adapted intervention influences mental health and PrEP uptake.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Identify as a man who has sex with men
  • Able to speak, read, and write in Spanish or English
  • Never received and HIV diagnosis
  • Reports HIV acquisition risk in; by having confirmed any of the following in the past 6 months: (a) have had sex with a partner living with HIV; (b) have had sex with a partner whose HIV status was unknown to you; (c) have had anal sex without a condom; or (d) have been diagnosed with gonorrhea, chlamydia or syphillis
  • Not currently using PrEP as prescribed
  • Experiencing mild to moderate anxiety symptoms within the past 2 weeks, defined as a GAD-7 score of 5 - 14, on the GAD-7 anxiety screener or mild to moderate depressive symptoms within the past 2 weeks, defined as a PHQ-9 score of 5 - 14 on the depression screener

Exclusion Criteria:

  • Severe anxiety (≥15 on the GAD-7 screener), depression (≥ 15 on the PHQ-9 screener) or active suicidality
  • Reports minimal depression and anxiety symptoms, defined as both a GAD-7 score ≤ 4 and a PHQ-9 score ≤ 4.
  • Report of current or history of serious mental illness including but not limited to schizophrenia, schizoaffective disorder, bipolar disorder or another psychotic disorder
  • Currently receiving mental health services (for more than 1 month)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention
participants randomized to the intervention
Atferdsmessig: PrEPared Minds/ Mentes PrEParadas - Cognitive Behavioral Therapy
PrEPared Minds/Mentes PrEParadas is an adapted, bilingual (English/Spanish) affirmative cognitive behavioral intervention designed to improve mental health and promote HIV prevention. Intervention includes 10 one-hour sessions of skills-building cognitive behavioral therapy.
Aktiv komparator: Control Group
participants not receiving the intervention
Annen: No Intervention
Participants do not receive PrEPared Minds/ Mentes PrEParadas intervention.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Depression Questionnaire- PHQ-9
Tidsramme: Baseline
The Patient Health Questionnaire-9 (PHQ-9) is a 9-question self-report tool used to screen, diagnose, monitor, and measure the severity of depression. Total score range is 0-27 with higher score indicating higher severity of depression.
Baseline
Depression - PHQ-9 instrument
Tidsramme: Month 3 Post Randomization
The Patient Health Questionnaire-9 (PHQ-9) is a 9-question self-report tool used to screen, diagnose, monitor, and measure the severity of depression. Total score range is 0-27 with higher score indicating higher severity of depression.
Month 3 Post Randomization
Depression - PHQ-9 instrument
Tidsramme: Month 6 Post Randomization
The Patient Health Questionnaire-9 (PHQ-9) is a 9-question self-report tool used to screen, diagnose, monitor, and measure the severity of depression. Total score range is 0-27 with higher score indicating higher severity of depression.
Month 6 Post Randomization
Anxiety Questionnaire - GAD-7
Tidsramme: Baseline
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire used to screen for generalized anxiety disorder and measure symptom severity. Total score range is 0-21 with higher score indicating higher severity of anxiety.
Baseline
Anxiety - GAD-7 instrument
Tidsramme: Month 3 Post Randomization
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire used to screen for generalized anxiety disorder and measure symptom severity. Total score range is 0-21 with higher score indicating higher severity of anxiety.
Month 3 Post Randomization
Anxiety - GAD-7 instrument
Tidsramme: Month 6 Post Randomization
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire used to screen for generalized anxiety disorder and measure symptom severity. Total score range is 0-21 with higher score indicating higher severity of anxiety.
Month 6 Post Randomization
PrEP Uptake
Tidsramme: Baseline
Number of participants that self-report PrEp use
Baseline
PrEP Uptake
Tidsramme: Month 3 Post Randomization
Number of participants that self-report PrEp use
Month 3 Post Randomization
PrEP Uptake
Tidsramme: Month 6 Post Randomization
Number of participants that self-report PrEp use
Month 6 Post Randomization

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Wake Forest University Health Sciences

Samarbeidspartnere

National Institute of Mental Health (NIMH)

Etterforskere

  • Hovedetterforsker: Dirk Davis, PhD, MPH, Wake Forest University Health Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. august 2028

Studiet fullført (Antatt)

1. august 2028

Datoer for studieregistrering

Først innsendt

25. august 2026

Først innsendt som oppfylte QC-kriteriene

25. august 2026

Først lagt ut (Faktiske)

28. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00121001
  • K01MH134676 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data that underlie results reported, after deidentification.

IPD-delingstidsramme

Beginning 9 months and ending 36 months following publication

Tilgangskriterier for IPD-deling

Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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