- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05968755
Chatbot inzetten om PrEP in het zuiden van de Verenigde Staten te verbeteren
Gebruikmaken van chatbottechnologie om het bewustzijn en de acceptatie van PrEP onder zwarte MSM in het zuiden van de Verenigde Staten te verbeteren
The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and uptake among Black men who have sex with men (MSM) in the Southern United States.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
In the United States (US), the epicenter of the HIV epidemic is in the South. The HIV-related death rate in the US South is high, but engagement with quality HIV prevention services and care is low. Although only 38% of the US population lives in the South, the region accounts for 51% of new HIV infections. Gay, bisexual, and other men who have sex with men (MSM) account for 60% of new infections among African Americans in the South. Black MSM are one of the most vulnerable groups to HIV transmission in the US. HIV testing and PrEP uptake in Black MSM, however, remain low (10%) due to multiple factors including stigma, sexual-orientation based discrimination and low PrEP awareness among Black MSM. Innovative strategies that motivate and provide guidance for PrEP among Black MSM in the US South are therefore urgently needed. Chatbot technology should be tested and implemented to help improve PrEP awareness and uptake in the US South. In this project, the investigators aim to develop and pilot test to assess the acceptability and feasibility of a chatbot for PrEP awareness and uptake relative to treatment as usual (control).
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Zhao Ni
- Telefoonnummer: 203-737-3039
- E-mail: Zhao.ni@yale.edu
Studie Locaties
-
-
Florida
-
Miami, Florida, Verenigde Staten, 33127
- Werving
- Care 4 U Community Health Center
-
Contact:
- Chief Operating Officer
- Telefoonnummer: 305-835-0101
- E-mail: aichite@care4uchc.org
-
Pembroke Pines, Florida, Verenigde Staten, 33027
- Werving
- Community Care Resources of FL (CCRSFL)
-
Contact:
- Executive Director
- Telefoonnummer: 877-287-2520
- E-mail: victoria@ccrsfl.com
-
-
Georgia
-
Atlanta, Georgia, Verenigde Staten, 30318
- Werving
- NAESM, Inc
-
Contact:
- Research Coordinator
- Telefoonnummer: 404-691-8880
- E-mail: ak@naesminc.org
-
-
North Carolina
-
Charlotte, North Carolina, Verenigde Staten, 28202
- Werving
- RAO Community Health
-
Contact:
- Director of Programs
- Telefoonnummer: 704-237-8793
- E-mail: zharris@raoassist.org
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Being cisgender Black male
- Being aged ≥ 18 years
- Having Internet access
- Speaking English
- Self-reporting condomless sex with another man in the past 6 months
- Living in the U.S. South
- HIV negative or untested.
Exclusion Criteria:
- Not residing in a U.S. Census Bureau-defined Southern state: AL, AR, DE, FL, GA, KY, LA, MD, MS, NC, OK, SC, TN, TX, VA, WV.
- Having received antiretroviral therapy (ART) treatment.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Interventie groep
|
Participants in the intervention group will have access to a theory-informed (Self-Determination Theory) chatbot and receive an automated personalized question message (root-node message) from the chatbot. The root-node messages are questions written into the chatbot algorithms to initiate interactive communication with participants. In each round of the interactive communication, the chatbot will provide automated personalized PrEP-related information, autonomous motivation, and psychological needs based on Self-Determination Theory constructs. |
|
Placebo-vergelijker: Controlegroep
|
Participants in the control group will received general education messages from a research assistant including healthy diet, exercise, and COVID-19 prevention. The frequency of contact will be pre-specified by participants in interviews prior to the RCT. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline PrEP awareness in 90 days
Tijdsspanne: At the baseline, 30, 60, and 90 days
|
PrEP awareness will be measured as the proportion of participants who are aware of PrEP. Specifically, the investigators will collect PrEP awareness by asking participants standardized questions through a Qualtrics survey. |
At the baseline, 30, 60, and 90 days
|
|
Change from baseline PrEP uptake in 90 days
Tijdsspanne: At the baseline, 30, 60, and 90 days
|
PrEP uptake will be measured as the mean of the frequency of taking PrEP medication. Specifically, the investigators will collect PrEP uptake by asking participants through a Qualtrics survey if they have been taken PrEP at baseline and every 30 days. If participants respond that they have taken PrEP, the investigators will ask them the date and frequency of taking it and ask them to upload a photo of their PrEP for verification to reduce social desirability bias in responses. |
At the baseline, 30, 60, and 90 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Usability score
Tijdsspanne: At 90 days
|
The usability score will be measured by the System Usability Scale, which is 5-point Likert scale consisted of 10 questions. Participants' scores range from 0 to 100. A score of 68 is average, below 68 is poor, above 68 is good, and above 80.3 is excellent. |
At 90 days
|
|
Recommendation score
Tijdsspanne: At 90 days
|
The recommendation score will be calculated by a Net Promote Score, which measures MSM's likelihood to recommend the chatbot to other MSM friends. The score ranges from 0 to 10. The higher the score, the better the recommendation score. |
At 90 days
|
|
Acceptability score
Tijdsspanne: At 90 days
|
Acceptability, defined as the extent to which the chatbot is suitable and satisfactory to MSM, will be measured using the standardized Customer Satisfaction Scale "How would you rate your overall satisfaction with the chatbot?" and a 5-point Likert question "How would you rate the likelihood of continuing to use the chatbot?" |
At 90 days
|
|
Practicality score
Tijdsspanne: At 90 days
|
Practicality defined as the extent to which the chatbot provides real-time Self-Determination theory inputs, will be measured using a 5-point Likert question "How would you rate the overall quality of the chatbot?" |
At 90 days
|
|
Demand score
Tijdsspanne: At 90 days
|
Demand, defined as the level of integration to which the chatbot fits into the MSM-preferred online platform, will be measured by the number of actual use documented on developer's platform. |
At 90 days
|
|
Adaptation score
Tijdsspanne: At 90 days
|
Adaptation, defined as the extent to which the chatbot can be integrated into other social-networking apps, will be measured by asking "How likely would you use the chatbot if embedded on other apps?" |
At 90 days
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Zhao Ni, Yale University
Publicaties en nuttige links
Algemene publicaties
- Centers for Disease Control and Prevention. HIV and African American Gay and Bisexual Men. [cited 2022 August 4]; Available from: https://www.cdc.gov/hiv/group/msm/bmsm.html.
- Adeagbo O, Harrison S, Qiao S, Li X. Pre-Exposure Prophylaxis (PrEP) Uptake among Black Men Who Have Sex with Men (BMSM) in the Southern U.S. Int J Environ Res Public Health. 2021 Sep 15;18(18):9715. doi: 10.3390/ijerph18189715.
- Watson RJ, Eaton LA, Maksut JL, Rucinski KB, Earnshaw VA. Links Between Sexual Orientation and Disclosure Among Black MSM: Sexual Orientation and Disclosure Matter for PrEP Awareness. AIDS Behav. 2020 Jan;24(1):39-44. doi: 10.1007/s10461-019-02696-1.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2000035242
- 000 (Andere identificatie: CTGTY)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .