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

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: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: HealthMindr Application; Behavioral: Waitlist

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: Interventional
• Enrollment (Actual): 1229
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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

Outcome Measure	Measure Description	Time Frame
Change in HIV testing	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	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	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	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	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	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	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	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	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)	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

Outcome Measure	Measure Description	Time Frame
Change in intention to engage in preventive behaviors	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	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	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	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	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

• Sponsor: Emory University
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Patrick Sullivan, PhD, DVM, Emory University

Publications and helpful links

General Publications

• Sullivan PS, Stephenson R, Hirshfield S, Mehta CC, Zahn R, Bauermeister JA, Horvath K, Chiasson MA, Gelaude D, Mullin S, Downing MJ Jr, Olansky EJ, Wiatrek S, Rogers EQ, Rosenberg E, Siegler AJ, Mansergh G. Behavioral Efficacy of a Sexual Health Mobile App for Men Who Have Sex With Men: Randomized Controlled Trial of Mobile Messaging for Men. J Med Internet Res. 2022 Feb 2;24(2):e34574. doi: 10.2196/34574.
• Sullivan PS, Zahn RJ, Wiatrek S, Chandler CJ, Hirshfield S, Stephenson R, Bauermeister JA, Chiasson MA, Downing MJ Jr, Gelaude DJ, Siegler AJ, Horvath K, Rogers E, Alas A, Olansky EJ, Saul H, Rosenberg ES, Mansergh G. HIV Prevention Via Mobile Messaging for Men Who Have Sex With Men (M-Cubed): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Nov 15;8(11):e16439. doi: 10.2196/16439.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2018
• Primary Completion (Actual): December 18, 2019
• Study Completion (Actual): December 18, 2019

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Health Promotion; AIDS; Infectious Diseases; Sexually Transmitted Diseases; Behavioral Science
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID 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