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Mobile Messaging Intervention to Present New HIV Prevention Options for Men Who Have Sex With Men (MSM) (MMI4MSM RCT)

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ClinicalTrials.gov Identifier: NCT03666247
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Patrick S Sullivan, Emory University

Brief Summary:
The study will evaluate the use and effectiveness of mobile-messaging platforms as a public health strategy for improving sexual health outcome measures among men who have sex with men (MSM) by determining whether exposure to the message-delivery platform results in improvements in participants' self-reported sexual health and prevention behaviors, beliefs and attitudes. The study will enroll men into a randomized controlled trial. Participants randomized to the messaging intervention will have access to a smartphone-based messaging platform for three months while those assigned to the waitlist group will be offered access to the messaging platform after all follow up is complete. Participants will complete surveys at baseline, after the end of the 3 month intervention, and follow up surveys 6 and 9 months after the baseline survey.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: HealthMindr Application Behavioral: Waitlist Not Applicable

Detailed Description:
This study aims to evaluate the use and effectiveness of a smartphone-based messaging platform as a public health strategy for improving participants' self-reported sexual health and prevention behaviors, beliefs and attitudes. The study will enroll 1,206 men into a randomized controlled trial. They will be assigned to either the immediate intervention group ("intervention arm") or the waitlist-control group ("waitlist-control arm"). All participants will take an assessment survey at baseline, and the intervention group will be oriented on the installation and use of the messaging app upon randomization to that group. All men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 9-month follow-up period. When the intervention arm activities and assessments have concluded, participants in the waitlist-control arm will then be given the option of accessing to the intervention app and participation in intervention post-test activities.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mobile Messaging Intervention to Present New HIV Prevention Options for MSM - Randomized Controlled Trial
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: HealthMindr Application
Participants in this study arm will have access to the mobile messaging platform (HealthMindr) for 3 months.
Behavioral: HealthMindr Application
From baseline to 3-month post-test, participants in the intervention arm are granted access and instructed to interact regularly with the HealthMindr messaging platform. The HealthMindr messaging platform delivers messages relevant to both general audiences of sexually-active MSM, as well as messages relevant only to specific subgroups of HIV-positive men, and currently higher and lower risk HIV-negative men. Answers provided during the assessments determine which subset of messages are delivered to app users, with information such as HIV status, changes in self-reported risk behaviors, or other factors that influence the relevance of any given message. The HealthMindr application also offers free condoms, lube, and a HIV and STI testing kits.

Waitlist
Participants in this study arm will not have access to the mobile messaging application during the course of the study. After the Month 9 follow up assessment participants in this study arm will be offered access to HealthMindr.
Behavioral: Waitlist
Participants assigned to the waitlist-control arm will be given a welcome sheet orienting them to the study. The message they view will include the same resources links provided to the intervention arm. The information will cover the importance of testing, links to an online mapping tool about the HIV epidemic in the United States (AIDSVu) and resources to locate HIV testing services and prevention information in their area. No information recommending frequency of testing will be given in the welcome greeting.




Primary Outcome Measures :
  1. Change in HIV testing [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    HIV-negative men will be asked if they have received an HIV test (ever for the baseline measure and in the past 3 months for follow up surveys).

  2. Change in engagement in HIV care [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    HIV-positive men will be asked if they have seen a doctor, nurse, or other health provider for HIV care (ever for the baseline measure and in the past 3 months for follow up surveys).

  3. Change in antiretroviral therapy (ART) uptake [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    HIV-positive men will be asked if they have ever been prescribed and taken antiretroviral medications to treat HIV.

  4. Change in ART adherence [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    HIV-positive men currently taking antiretroviral medications to treat HIV will be asked if they have been taking their ART as prescribed in the past 3 months.

  5. Change in engagement in HIV preventative care [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    HIV-negative men will be asked if they have seen a doctor, nurse, or other health care provider (ever for the baseline measure and in the past 3 months for follow up surveys).

  6. Change in pre-exposure prophylaxis (PrEP) uptake [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    HIV-negative men will be asked if they are taking PrEP (baseline measure) or if they began taking PrEP in the past 3 months (for follow-up measurements).

  7. Change in PrEP adherence [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    HIV-negative MSM currently taking PrEP will be asked if they have been taking their PrEP medication as prescribed during the past 3 months.

  8. Change in condom use compliance [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    Proportion of men reporting 100% condom use (stratified by partner type) during the prior 3 months.

  9. Change in condom use [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    Participants will be asked if they have had any anal sex in which a condom was not used from start to finish in the past 3 months.

  10. Change in testing for sexually transmitted infections (STIs) [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    Sexually active participants will be asked if they have been tested for STIs in the past 3 months.


Secondary Outcome Measures :
  1. Change in intention to engage in preventive behaviors [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    Participants will report how likely they are to engage in preventive behaviors (such as taking PrEP or ART and increasing condom use) over the next 3 months. Intention to engage in preventive behaviors will be assessed by 11 questions, designed for this study, which are answered on a scale of 1 to 5 where 1 = "definitely not likely" and 5 = "definitely likely". Summed scores can range from 11 to 55 where higher scores indicate increased intention to engage in healthy activities related to HIV prevention and care.

  2. Change in intention to engage in risky behaviors [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    Participants will report how likely they are to engage in risky behaviors (such as missing doses of PrEP or ART and not using a condom) over the next 3 months. Intention to engage in risky behaviors will be assessed by 3 questions, designed for this study, which are answered on a scale of 1 to 5 where 1 = "definitely not likely" and 5 = "definitely likely". Summed scores can range from 3 to 15 where higher scores indicate increased intention to engage in risky activities related to HIV prevention and care.

  3. Change in intention to seek information [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    Participants will report how likely they are to seek out information on HIV prevention during the next 3 months.

  4. Change in intention to seek treatment [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    Participants will report how likely they are to seek out HIV treatment during the next 3 months.

  5. Change in communication with partner [ Time Frame: Baseline, Month 3, Month 6, Month 9 ]
    Participants will be asked if they have talked with their sexual partners about ART or PrEP treatment (depending on HIV status) during the past 3 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Assigned male at birth
  • Current, self-reported gender identity as "Male"
  • Aged 18 or over
  • Self-reported ability to read and understand English-language
  • Resides in the Atlanta, Georgia (GA), New York, New York (NY), or Detroit, Michigan (MI) Metropolitan Statistical Area.
  • Self-reported anal sex with a male partner in the past 12 months
  • Owns and uses an Android or Apple (iOS) smartphone
  • Is included in one of the following risk groups, by self-report:

    • HIV seropositive
    • HIV seronegative at "higher risk" (condomless anal sex and not taking PrEP as prescribed in the past 3 months)
    • HIV seronegative at "lower risk" (no condomless anal sex in the past 3 months, or condomless and sex while taking PrEP as prescribed in the past 3 months)

Exclusion Criteria:

  • Currently participating in another HIV prevention research study or program
  • Participant's phone or device does not support HealthMindr application
  • Tested positive for HIV for the first time in the past 6 months
  • Has a plan to move out of the Atlanta, GA, New York, NY or Detroit, MI, Metropolitan Statistical Area within in the next 9 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666247


Contacts
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Contact: Ryan Zahn, MSPH 404-712-0123 ryan.j.zahn@emory.edu
Contact: Patrick Sullivan 404-727-2038 pssulli@emory.edu

Locations
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United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Patrick Sullivan, PhD    404-727-2038    pssulli@emory.edu   
Contact: Ryan Zahn, MSP    404-712-0123    ryan.j.zahn@emory.edu   
United States, Michigan
University of Michigan Recruiting
Detroit, Michigan, United States, 48109
Contact: Rob Stephenson, PhD    734-763-1188    rbsteph@med.umich.edu   
United States, New York
Emory University Recruiting
New York, New York, United States, 10013
Contact: Patrick Sullivan, PhD    404-727-2038    pssulli@emory.edu   
Contact: Ryan Zahn, MSPH    404-712-0123    ryan.j.zahn@emory.edu   
Sponsors and Collaborators
Emory University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Patrick Sullivan, PhD, DVM Emory University

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Responsible Party: Patrick S Sullivan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT03666247     History of Changes
Other Study ID Numbers: IRB00087684
1U01PS004977 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrick S Sullivan, Emory University:
AIDS
Behavioral Science
Infectious Diseases
Health Promotion
Sexually Transmitted Diseases

Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections