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

January 3, 2020 updated by: Patrick S Sullivan, Emory University

Mobile Messaging Intervention to Present New HIV Prevention Options for MSM - Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1229

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Michigan
      • Detroit, Michigan, United States, 48109
        • University of Michigan
    • New York
      • New York, New York, United States, 10013
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline, Month 3, Month 6, Month 9
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).
Baseline, Month 3, Month 6, Month 9
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.
Baseline, Month 3, Month 6, Month 9
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.
Baseline, Month 3, Month 6, Month 9
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).
Baseline, Month 3, Month 6, Month 9
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).
Baseline, Month 3, Month 6, Month 9
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.
Baseline, Month 3, Month 6, Month 9
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.
Baseline, Month 3, Month 6, Month 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.
Baseline, Month 3, Month 6, Month 9
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.
Baseline, Month 3, Month 6, Month 9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 3, Month 6, Month 9
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.
Baseline, Month 3, Month 6, Month 9
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.
Baseline, Month 3, Month 6, Month 9
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.
Baseline, Month 3, Month 6, Month 9
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.
Baseline, Month 3, Month 6, Month 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick Sullivan, PhD, DVM, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00087684
  • 1U01PS004977 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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