NCT04417946

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

4.8 years

First QC Date

June 2, 2020

Last Update Submit

October 19, 2023

Conditions

Keywords

pre-exposure prophylaxis (PrEP)social media intervention

Outcome Measures

Primary Outcomes (2)

  • PrEP uptake

    Actual PrEP uptake: participants self report if they use prep (Yes/No)

    PrEP uptake at baseline

  • PrEP uptake

    Actual PrEP uptake: participants self report if they use prep (Yes/No)

    PrEP uptake (Yes/No) at 24-weeks

Secondary Outcomes (14)

  • HIV testing

    baseline

  • HIV testing

    24-weeks

  • PrEP use intention

    PrEP use intention at baseline

  • PrEP use intention

    PrEP use intention at 24-weeks

  • PrEP knowledge

    PrEP knowledge at baseline

  • +9 more secondary outcomes

Study Arms (2)

PrEP Messages

EXPERIMENTAL

The peer leaders and the study staff will post PrEP related health messages

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.

Behavioral: Heath messages

Interventions

PrEP messagesBEHAVIORAL

The peer leaders and the study staff will post PrEP related health messages

PrEP Messages
Heath messagesBEHAVIORAL

The peer leaders and study staff will post general health messages that are not related to sexual health

Health messages

Eligibility Criteria

Age18 Years - 29 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBiologically male or transgender man
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

APNH: A Place to Nourish your Health (APNH)

New Haven, Connecticut, 06510, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Frederick Altice, M.D., M.A.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 5, 2020

Study Start

June 5, 2018

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

All data will be kept confidential.

Locations