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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04417946
Other study ID # 2000022728
Secondary ID 1H79TI080736
Status Completed
Phase N/A
First received
Last updated
Start date June 5, 2018
Est. completion date April 1, 2023

Study information

Verified date October 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to examine the effect of social media intervention on the use of pre-exposure prophylaxis (PrEP) by young men who have sex with men (YMSM) in the greater New Haven area.


Description:

There are three specific aims of this study. In the first specific aim, two focus group discussions (FGDs) of YMSM will be conducted to assess the feasibility and acceptability of social media intervention. In the second specific aim of the study, a quasi-pre-post experimental study will be conducted to examine the effect of social media intervention on PrEP uptake (primary outcome) and PrEP use intention, HIV testing, PrEP knowledge, self-efficacy and social support (secondary outcome). In the third specific aim of the study, the most important topics around PrEP will be assessed on the Facebook page of the intervention group by conducting a content analysis.


Recruitment information / eligibility

Status Completed
Enrollment 227
Est. completion date April 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 29 Years
Eligibility Inclusion Criteria: - Biologically male or transgender man - Self-identification as gay or bi-sexual - Resident of greater New Haven area - Willing and able to use Facebook during the span of the study Exclusion Criteria: - • Women will not be included in the study - Under the age of 18 and over the age of 29 - Unable to provide informed consent - Verbally or physically threatening to research staff

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PrEP messages
The peer leaders and the study staff will post PrEP related health messages
Heath messages
The peer leaders and study staff will post general health messages that are not related to sexual health

Locations

Country Name City State
United States APNH: A Place to Nourish your Health (APNH) New Haven Connecticut
United States Yale University New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University Substance Abuse and Mental Health Services Administration (SAMHSA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PrEP uptake Actual PrEP uptake: participants self report if they use prep (Yes/No) PrEP uptake at baseline
Primary PrEP uptake Actual PrEP uptake: participants self report if they use prep (Yes/No) PrEP uptake (Yes/No) at 24-weeks
Secondary HIV testing Date of the last HIV test: participants self report the date of their last HIV test as a function of time in days. baseline
Secondary HIV testing Date of the last HIV test: participants self report the date of their last HIV test as a function of time in days. 24-weeks
Secondary PrEP use intention Willingness to use/likelihood of using PrEP in the next 6 months : self reported assessment to measure participants' willingness to use prep in the next 6 month s on a single question using Likert scale from 1(very unlikely) to 7 (very likely) PrEP use intention at baseline
Secondary PrEP use intention Willingness to use/likelihood of using PrEP in the next 6 months : self reported assessment to measure participants' willingness to use prep in the next 6 month s on a single question using Likert scale from 1(very unlikely) to 7 (very likely) PrEP use intention at 24-weeks
Secondary PrEP knowledge Knowledge of PrEP for HIV prevention: self reported assessment to measure participants' knowledge on PrEP on a set of True or False questions PrEP knowledge at baseline
Secondary PrEP knowledge Knowledge of PrEP for HIV prevention: self reported assessment to measure participants' knowledge on PrEP on a set of True or False questions PrEP knowledge at 24-weeks
Secondary self efficacy to use PrEP Beliefs in his/her ability of using PrEP: participants self report their level of confidence in taking PrEP on a set of items using Likert scales from 1 (Not at all confident) to 5 (completely confident) self efficacy to use PrEP at baseline
Secondary self efficacy to use PrEP Beliefs in his/her ability of using PrEP: participants self report their level of confidence in taking PrEP on a set of items using Likert scales from 1 (Not at all confident) to 5 (completely confident) self efficacy to use PrEP at 24-weeks
Secondary motivation to use PrEP How motivated s/he is to use PrEP and what motivates s/he to use PrEP: self reported assessment to measure participants' different types of motivation to use PrEP on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree) motivation to use PrEP at baseline
Secondary motivation to use PrEP How motivated s/he is to use PrEP and what motivates s/he to use PrEP: self reported assessment to measure participants' different types of motivation to use PrEP on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree) motivation to use PrEP at 24-weeks
Secondary PrEP stigma Perceived stigma related to PrEP use: self reported assessment to measure perception of stigma related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree) PrEP stigma at baseline
Secondary PrEP stigma Perceived stigma related to PrEP use: self reported assessment to measure perception of stigma related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree) PrEP stigma at 24-weeks
Secondary Social support for PrEP use Help and support that individuals receive that can facilitate PrEP uptake: Perceived stigma related to PrEP use: self reported assessment to measure perception of social support related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree) Social support for PrEP use at baseline
Secondary Social support for PrEP use Help and support that individuals receive that can facilitate PrEP uptake: Perceived stigma related to PrEP use: self reported assessment to measure perception of social support related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree) Social support for PrEP use at 24-weeks
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