Clinical trial NCT03666247: Mobile Messaging Intervention to Present New HIV Prevention Options for Men Who Have Sex With Men (MSM)
Official title: Mobile Messaging Intervention to Present New HIV Prevention Options for MSM - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: AIDS
Behavioral Science
Infectious Diseases
Health Promotion
Sexually Transmitted Diseases
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2018-09-11
Enrollment: 1229
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in HIV testing
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in engagement in HIV care
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in antiretroviral therapy (ART) uptake
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in ART adherence
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in engagement in HIV preventative care
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in pre-exposure prophylaxis (PrEP) uptake
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in PrEP adherence
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in condom use compliance
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in condom use
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in testing for sexually transmitted infections (STIs)
timeFrame: Baseline, Month 3, Month 6, Month 9
Secondary outcomes:
measure: Change in intention to engage in preventive behaviors
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in intention to engage in risky behaviors
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in intention to seek information
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in intention to seek treatment
timeFrame: Baseline, Month 3, Month 6, Month 9
measure: Change in communication with partner
timeFrame: Baseline, Month 3, Month 6, Month 9
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Detroit
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Emory University
state: New York
Study officials:
affiliation: Emory University
name: Patrick Sullivan, PhD, DVM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.