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Project Minority AIDS Prevention: Reaching Black and Hispanic MSM About PrEP and TasP Using Social Media (MAP)

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Media Messages Intervention Group
Website Only Group
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

1. 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

-

Exclusion Criteria:

  1. Individuals who are intoxicated
  2. Individuals report being coerced to participate

Sites / Locations

  • Center for Alcohol and Addiction StudiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social Media Messages Intervention Group

Website Only Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

treatment as prevention and pre-exposure prophylaxis uptake
Participants uptake of treatment as prevention and pre-exposure prophylaxis

Secondary Outcome Measures

treatment as prevention and pre-exposure prophylaxis knowledge, attitudes, and behavioral intentions
assessment of knowledge, attitudes, and behavioral intentions toward treatment as prevention and pre-exposure prophylaxis use

Full Information

First Posted
January 12, 2018
Last Updated
July 7, 2020
Sponsor
Brown University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03404531
Brief Title
Project Minority AIDS Prevention: Reaching Black and Hispanic MSM About PrEP and TasP Using Social Media
Acronym
MAP
Official Title
Reaching Black/African American and Hispanic/Latino MSM Through Social Media About Treatment as Prevention and Pre-Exposure Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
For this Minority AIDS Research Project, the investigators will develop and pilot test an intervention to improve the science of treatment as prevention and pre-exposure prophylaxis uptake as a public health strategy to decrease new HIV infections among Black/African American and Hispanic/Latino men who have sex with men. This project uses a 3-phase study design to address the proposed Specific Aims. First, the investigators will use focus groups to gather feedback on our existing interactive Men2MenRI website that was developed for and by predominately White men who have sex with men in Rhode Island that includes information on treatment as prevention and pre-exposure prophylaxis, as well as other health and wellness topics to make it more culturally-tailored to Black/African American and Hispanic/Latino MSM. Second, the investigators will use cognitive interviewing techniques to develop and assess the acceptability of Information-Motivation-Behavioral/Social Cognitive Theory-grounded social media message content designed to motivate and encourage access to a newly developed and culturally-tailored interactive website. Third, the investigators will pilot test a two-arm trial comparing the combination of sending Information-Motivation-Behavioral/Social Cognitive Theory-guided messages plus the newly developed and culturally-tailored interactive website (active arm) to the website alone (control arm) to examine whether the combination approach will: 1) increase treatment as prevention and pre-exposure prophylaxis uptake (primary outcome); 2) increase knowledge of, more favorable attitudes toward, and increase behavioral intentions of treatment as prevention and pre-exposure prophylaxis use behaviors (exploratory outcome). This study is innovative in the use of a combination approach to treatment as prevention and pre-exposure prophylaxis uptake that leverages advances in social media as a platform for motivating behavior change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social Media Messages Intervention Group
Arm Type
Experimental
Arm Description
Participants randomized to this condition will have access to a newly developed, culturally-tailored interactive website and theoretically-grounded social media messages.
Arm Title
Website Only Group
Arm Type
Active Comparator
Arm Description
Participants randomized to this condition will have access to a newly developed, culturally-tailored interactive website only.
Intervention Type
Behavioral
Intervention Name(s)
Social Media Messages Intervention Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Website Only Group
Intervention Description
The Website Only group will have access to the newly developed, culturally-tailored website but will not receive social media messages.
Primary Outcome Measure Information:
Title
treatment as prevention and pre-exposure prophylaxis uptake
Description
Participants uptake of treatment as prevention and pre-exposure prophylaxis
Time Frame
6 months
Secondary Outcome Measure Information:
Title
treatment as prevention and pre-exposure prophylaxis knowledge, attitudes, and behavioral intentions
Description
assessment of knowledge, attitudes, and behavioral intentions toward treatment as prevention and pre-exposure prophylaxis use
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. 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 - Exclusion Criteria: Individuals who are intoxicated Individuals report being coerced to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob J. van den Berg, PhD
Phone
401-863-7566
Email
jacob_vandenberg@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Don Operario, PhD
Phone
401-863-6657
Email
don_operario@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob J van den Berg, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Alcohol and Addiction Studies
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob J. van den Berg, PhD
Phone
401-863-7566
Email
jacob_vandenberg@brown.edu
First Name & Middle Initial & Last Name & Degree
Don Operario, PhD
Phone
401-863-6657
Email
don_operario@brown.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be made available to the public three years after study has been completed.
IPD Sharing 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.
Citations:
PubMed Identifier
30012549
Citation
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.
Results Reference
derived

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Project Minority AIDS Prevention: Reaching Black and Hispanic MSM About PrEP and TasP Using Social Media

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