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

NCT03666247 | Completed

• 2 other identifiers: IRB000876841U01PS004977
• Study Type: interventional
• Target: 1,229
• Locations: 1 country
• Sites: 3

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.

Conditions

Human Immunodeficiency Virus

Keywords

AIDS; Behavioral Science; Infectious Diseases; Health Promotion; Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (5)

• Change in intention to engage in preventive behaviors

  Baseline, Month 3, Month 6, Month 9

• Change in intention to engage in risky behaviors

  Baseline, Month 3, Month 6, Month 9

• Change in intention to seek information

  Baseline, Month 3, Month 6, Month 9

• Change in intention to seek treatment

  Baseline, Month 3, Month 6, Month 9

• Change in communication with partner

  Baseline, Month 3, Month 6, Month 9

Study Arms (2)

HealthMindr Application

EXPERIMENTAL

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

Behavioral: HealthMindr Application

Waitlist

OTHER

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

Interventions

HealthMindr Application BEHAVIORAL

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.

HealthMindr Application

Waitlist BEHAVIORAL

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.

Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Michigan

Detroit, Michigan, 48109, United States

Location

Emory University

New York, New York, 10013, United States

Location

Related Publications (2)

• 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.

  PMID: 35025755 DERIVED

• 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.

  PMID: 31730043 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Communicable Diseases; Sexually Transmitted Diseases

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Patrick Sullivan, PhD, DVM

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 11, 2018
• Study Start: January 24, 2018
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Locations

US (3)