Pre-Exposure ProphylaxisNCT04417946
Peer-led Social Media Intervention to Prevent HIV Among Young Men Who Have Sex With Men (YMSM)
A study testing PrEP messages and Heath messages in people with Pre-Exposure Prophylaxis and Hiv, run by Yale University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Exposure Prophylaxis, Hiv, Men
- What is being tested?
- PrEP messages and Heath messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2018to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
APNH: A Place to Nourish your Health (APNH)
New Haven, Connecticut, 06510
Yale University
New Haven, Connecticut, 06510
About this study
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.
Read the detailed 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.
- Conditions
- Pre-Exposure Prophylaxis, Hiv, Men
- Being tested
- PrEP messages, Heath messages
- Keywords
- pre-exposure prophylaxis (PrEP), social media intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP messagesBehavioural
The peer leaders and the study staff will post PrEP related health messages
Heath messagesBehavioural
The peer leaders and study staff will post general health messages that are not related to sexual health
| Study group | Role | What they receive |
|---|---|---|
| PrEP Messages | Experimental | The peer leaders and the study staff will post PrEP related health messages Receives: Behavioral: PrEP messages |
| Health messages | Active comparator | The peer leaders and study staff will post general health messages that are not related to sexual health. Receives: Behavioral: Heath messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP uptake
Actual PrEP uptake: participants self report if they use prep (Yes/No)
Measured: PrEP uptake at baseline
PrEP uptake
Actual PrEP uptake: participants self report if they use prep (Yes/No)
Measured: PrEP uptake (Yes/No) at 24-weeks
Secondary outcomes (14)
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.
Measured: baseline
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.
Measured: 24-weeks
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)
Measured: PrEP use intention at baseline
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)
Measured: PrEP use intention at 24-weeks
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
Measured: PrEP knowledge at baseline
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
Measured: PrEP knowledge at 24-weeks
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)
Measured: self efficacy to use PrEP at baseline
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)
Measured: self efficacy to use PrEP at 24-weeks
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)
Measured: motivation to use PrEP at baseline
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)
Measured: motivation to use PrEP at 24-weeks
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)
Measured: PrEP stigma at baseline
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)
Measured: PrEP stigma at 24-weeks
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)
Measured: Social support for PrEP use at baseline
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)
Measured: Social support for PrEP use at 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start5 Jun 2018
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Exposure ProphylaxisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Sponsor
- Investigators
- Frederick Altice, M.D., M.A., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417946
- Sponsor's protocol ID
- 2000022728
- Other IDs
- 1H79TI080736
- Status last verified
- Oct 2023
- First submitted
- 2 Jun 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-led Social Media Intervention to Prevent HIV Among Young Men Who Have Sex With Men (YMSM)
- ClinicalTrials.gov ID
- NCT04417946
- Acronym / sponsor ID
- 2000022728
- Conditions
- Pre-Exposure Prophylaxis, Hiv, Men
- Keywords
- pre-exposure prophylaxis (PrEP), social media intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEP Messages | Experimental | Behavioral: PrEP messagesThe peer leaders and the study staff will post PrEP related health messages |
| Health messages | Active comparator | Behavioral: Heath messagesThe peer leaders and study staff will post general health messages that are not related to sexual health. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- • Women will not be included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP messagesThe peer leaders and the study staff will post PrEP related health messages | Behavioural | PrEP Messages |
| Heath messagesThe peer leaders and study staff will post general health messages that are not related to sexual health | Behavioural | Health messages |
Primary outcome
PrEP uptake
Time frame: PrEP uptake at baseline
Actual PrEP uptake: participants self report if they use prep (Yes/No)
PrEP uptake
Time frame: PrEP uptake (Yes/No) at 24-weeks
Actual PrEP uptake: participants self report if they use prep (Yes/No)
14 secondary outcomes
HIV testing
Time frame: baseline
HIV testing
Time frame: 24-weeks
PrEP use intention
Time frame: PrEP use intention at baseline
PrEP use intention
Time frame: PrEP use intention at 24-weeks
PrEP knowledge
Time frame: PrEP knowledge at baseline
PrEP knowledge
Time frame: PrEP knowledge at 24-weeks
self efficacy to use PrEP
Time frame: self efficacy to use PrEP at baseline
self efficacy to use PrEP
Time frame: self efficacy to use PrEP at 24-weeks
motivation to use PrEP
Time frame: motivation to use PrEP at baseline
motivation to use PrEP
Time frame: motivation to use PrEP at 24-weeks
PrEP stigma
Time frame: PrEP stigma at baseline
PrEP stigma
Time frame: PrEP stigma at 24-weeks
Social support for PrEP use
Time frame: Social support for PrEP use at baseline
Social support for PrEP use
Time frame: Social support for PrEP use at 24-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No. All data will be kept confidential.
Related trials for Pre-Exposure Prophylaxis
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
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Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
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Not yet recruiting
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HIV, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Altice, M.D., M.A. principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP messages and Heath messages in people with Pre-Exposure Prophylaxis and Hiv, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP uptake (time frame: PrEP uptake at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.