- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07808541
Juntas Adelante: A Peer-Coaching Intervention to Promote Chemoprophylaxis for HIV Prevention Among Latina Transgender Women in the Washington DC Metropolitan Area.
The goal of this clinical trial is to evaluate the impact of the Juntas Adelante intervention on awareness and use of chemoprophylaxis for HIV prevention (Pre- and Post-Exposure prophylaxis, or PrEP and PEP) among Latina Transgender Women in the Washington DC Metropolitan Area. Secondary outcomes included awareness and use of Doxy-PEP (i.e., Doxycycline for prevention of Sexually Transmitted Infections - STI), and awareness of Undetectable = Untransmittable (U=U).
The main questions are:
- Is the Juntas Adelante intervention acceptable and feasible to implement with this population?
- Is participating in the Juntas Adelante intervention associated with increased awareness and use of PrEP and PEP? All participants in the study will view 5 online short videos on HIV and STI prevention and will receive up to two virtual coaching sessions with a peer coach. They will also complete a brief survey after viewing each video (5 total) and three longer surveys/interviews over the course of 3 months.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Using a community-based participatory research (CBPR) approach, we developed Juntas Adelante, an intervention to increase awareness and use of PrEP and PEP for HIV prevention among Latina transgender women in the DC metropolitan area. The Juntas Adelante intervention includes two components:
- Peer coaching sessions: Up to two virtual coaching sessions with another Latina transgender woman (peer coach) who has been trained to encourage dialogue around HIV prevention goals.
- Video mini-series: Five short informational videos covering 5 topics (one per episode): 1) Latina transgender women and HIV (duration: 2:29 min); 2) Post-exposure prophylaxis - PEP (duration: 3:49 min); 3) Pre-exposure prophylaxis - PrEP (duration: 1:58 min); 4) Doxy-PEP (duration: 3:25 min); and 5) Undetectable equals Untransmittable - U=U (duration: 3:47 min). Videos were housed into the Vimeo platform, and were embedded into REDCap surveys for distribution.
Participant recruitment and eligibility: Participants will be recruited via referrals from community members (i.e., members of the Community Council, other study participants). Eligibility criteria include: 1) Male sex assigned at birth, currently identifying as a woman, transgender woman, transgender, or transsexual, irrespective of gender transition stage; 2) identifying as Latina, regardless of country of birth; 3) being 18 years old or older; 4) living in the DC metropolitan area; 5) self-reporting HIV negative status at study enrollment 6) reporting having receptive anal and/or neovaginal sex with at least one cisgender man or transgender woman in the previous 12 months; 7) not currently using PrEP or report less than 3 months of use; 8) have access to a cellphone with internet capabilities, and 9) not planning to move from the DC metropolitan area in the next 12 months.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
District of Columbia
-
Washington D.C., District of Columbia, États-Unis, 20037
- The George Washington University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Male sex assigned at birth, currently identifying as a woman, transgender woman, transgender, or transsexual, irrespective of gender transition stage;
- Identifying as Latina, regardless of country of birth;
- Being 18 years old or older;
- Living in the DC metropolitan area;
- Self-reporting HIV negative status at study enrollment
- Reporting having receptive anal and/or neovaginal sex with at least one cisgender man or transgender woman in the previous 12 months;
- Not currently using PrEP or report less than 3 months of use;
- Must have access to a cellphone with internet capabilities,
- Not planning to move from the DC metropolitan area in the next 12 months
Exclusion Criteria:
- Not meeting all of the inclusion criteria.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
|
The Juntas Adelante intervention includes two components:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PrEP initiation/persistence and/or PEP use
Délai: "Final follow up, 3 months after last coaching session"
|
Our primary outcome is PrEP initiation/persistence or PEP use at the 3-month follow up, defined as the combination of any:
|
"Final follow up, 3 months after last coaching session"
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in PrEP awareness
Délai: Baseline survey to final follow-up 3 months after last coaching session.
|
Whether participant knows about PrEP for HIV prevention, evaluated by comparing baseline to 3-month follow-up surveys.
|
Baseline survey to final follow-up 3 months after last coaching session.
|
|
Change in PEP awareness
Délai: Baseline survey to final follow-up 3 months after last coaching session.
|
Whether participant knows about PEP for HIV prevention, evaluated by comparing baseline to 3-month follow-up surveys.
|
Baseline survey to final follow-up 3 months after last coaching session.
|
|
Change in Doxy-PEP awareness and use
Délai: Baseline survey to final follow-up 3 months after last coaching session.
|
Whether participant knows about (awareness) or has used Doxy-PEP for STI prevention, evaluated by comparing baseline to 3-month follow-up surveys.
|
Baseline survey to final follow-up 3 months after last coaching session.
|
|
Change in U=U awareness
Délai: Baseline survey to final follow-up 3 months after last coaching session.
|
Whether participant knows about Undetectable equals Untransmittable as a treatment-as-prevention message, evaluated by comparing baseline to 3-month follow-up surveys.
|
Baseline survey to final follow-up 3 months after last coaching session.
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- IRBPH 2024.16
- U01PS005218 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .