Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV (ESTEEM)
25 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Dirk Davis, PhD, MPH
- Telefonnummer: 704-609-9752
- E-post: dirk.davis@wfusm.edu
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention
participants randomized to the intervention
|
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
|
Participants do not receive PrEPared Minds/ Mentes PrEParadas intervention.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Depression Questionnaire- PHQ-9
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
|
Number of participants that self-report PrEp use
|
Baseline
|
|
PrEP Uptake
Tidsram: Month 3 Post Randomization
|
Number of participants that self-report PrEp use
|
Month 3 Post Randomization
|
|
PrEP Uptake
Tidsram: Month 6 Post Randomization
|
Number of participants that self-report PrEp use
|
Month 6 Post Randomization
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Dirk Davis, PhD, MPH, Wake Forest University Health Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 augusti 2028
Avslutad studie (Beräknad)
1 augusti 2028
Studieregistreringsdatum
Först inskickad
25 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
25 augusti 2026
Första postat (Faktisk)
28 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00121001
- K01MH134676 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Individual participant data that underlie results reported, after deidentification.
Tidsram för IPD-delning
Beginning 9 months and ending 36 months following publication
Kriterier för IPD Sharing Access
Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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