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

Emory University

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Behavioral: Waitlist; Behavioral: HealthMindr Application

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03666247

1U01PS004977 (U.S. NIH Grant/Contract)

IRB00087684

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,229 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,229 participants in 2 patient groups

HealthMindr Application

Experimental group

Description:

Participants in this study arm will have access to the mobile messaging platform (HealthMindr) for 3 months.

Treatment:

Behavioral: HealthMindr Application

Waitlist

Other group

Description:

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.

Treatment:

Behavioral: Waitlist