NCT03404531

Brief Summary

This project has the potential to improve the implementation science of treatment as prevention and pre-exposure prophylaxis uptake as a public health strategy for reducing new HIV infections in the United States. The investigators will develop and pilot test an intervention that combines messages sent over social media plus a newly developed interactive website specifically developed by and for Black/African American and Hispanic/Latino MSM to encourage treatment as prevention and pre-exposure prophylaxis use. Findings from this research can guide policy guidelines and recommendations for treatment as prevention and pre-exposure prophylaxis uptake for high-risk groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

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

November 10, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

3.5 years

First QC Date

January 12, 2018

Last Update Submit

July 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • treatment as prevention and pre-exposure prophylaxis uptake

    Participants uptake of treatment as prevention and pre-exposure prophylaxis

    6 months

Secondary Outcomes (1)

  • treatment as prevention and pre-exposure prophylaxis knowledge, attitudes, and behavioral intentions

    6 months

Study Arms (2)

Social Media Messages Intervention Group

EXPERIMENTAL

Participants randomized to this condition will have access to a newly developed, culturally-tailored interactive website and theoretically-grounded social media messages.

Behavioral: Social Media Messages Intervention Group

Website Only Group

ACTIVE COMPARATOR

Participants randomized to this condition will have access to a newly developed, culturally-tailored interactive website only.

Behavioral: Website Only Group

Interventions

The Social Media Messages Intervention Group will receive theoretically-grounded messages through social media in order to encourage participants to regularly access the newly developed, culturally-tailored website that includes information about treatment as prevention and pre-exposure prophylaxis.

Social Media Messages Intervention Group

The Website Only group will have access to the newly developed, culturally-tailored website but will not receive social media messages.

Website Only Group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Aged 18 or older 2. Biological male 3. Black/African American or Hispanic/Latino 4. History of condomless receptive or insertive anal intercourse with other men in the past 6 months 5. Currently using or have access and willingness to use social media over the next 6 months 6. Self-identify as HIV-negative or HIV-positive at enrollment 7. Self-identify as not being on HIV treatment (antiretroviral therapy or pre-exposure prophylaxis) or in HIV care at enrollment 8. Able to give informed consent

You may not qualify if:

  • Individuals who are intoxicated
  • Individuals report being coerced to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

RECRUITING

Related Publications (1)

  • van den Berg JJ, Silverman T, Fernandez MI, Henny KD, Gaul ZJ, Sutton MY, Operario D. Using eHealth to Reach Black and Hispanic Men Who Have Sex With Men Regarding Treatment as Prevention and Preexposure Prophylaxis: Protocol for a Small Randomized Controlled Trial. JMIR Res Protoc. 2018 Jul 16;7(7):e11047. doi: 10.2196/11047.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jacob J van den Berg, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob J. van den Berg, PhD

CONTACT

Don Operario, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 19, 2018

Study Start

November 10, 2017

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Research data will be shared openly, proactively, and timely in accordance with the most recent NIH guidelines (http://grants.nih.gov/grants/policy/data\_sharing/) while being mindful that the confidentiality and privacy of participants in research must be protected at all times. Specific plans to share data, including an overview of what will be shared, when it will be shared, how it will be shared, and who will have access to the data will be proposed in a data sharing agreement that all investigators and prospective users of the data will complete when requesting access to the data.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be made available to the public three years after study has been completed.
Access Criteria
Requests for data will be reviewed by the PI and persons who request data will be required to submit a proposal and to sign an agreement form.

Locations