Human Immunodeficiency VirusMMI4MSM RCTNCT03666247
Mobile Messaging Intervention to Present New HIV Prevention Options for Men Who Have Sex With Men (MSM)
A study testing HealthMindr Application and Waitlist in people with Human Immunodeficiency Virus, run by Emory University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- HealthMindr Application and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,229 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jan 2018to 18 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30322
University of Michigan
Detroit, Michigan, 48109
Emory University
New York, New York, 10013
About this study
Official title: 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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- HealthMindr Application, Waitlist
- Keywords
- AIDS, Behavioral Science, Infectious Diseases, Health Promotion, Sexually Transmitted Diseases
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Communicable Diseases, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthMindr ApplicationBehavioural
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.
WaitlistBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HealthMindr Application | Experimental | Participants in this study arm will have access to the mobile messaging platform (HealthMindr) for 3 months. Receives: 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. Receives: Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, Month 6, Month 9
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, Month 6, Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start24 Jan 2018
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Patrick S Sullivan, Emory University
- Investigators
- Patrick Sullivan, PhD, DVM, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666247
- Sponsor's protocol ID
- IRB00087684
- Other IDs
- 1U01PS004977
- Acronym
- MMI4MSM RCT
- Status last verified
- Jan 2020
- First submitted
- 10 Sep 2018
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35025755Sullivan 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.
PubMed 31730043
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Messaging Intervention to Present New HIV Prevention Options for MSM - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03666247
- Acronym / sponsor ID
- MMI4MSM RCT / IRB00087684
- Conditions
- Human Immunodeficiency Virus
- Keywords
- AIDS, Behavioral Science, Infectious Diseases, Health Promotion, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,229 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HealthMindr Application | Experimental | Behavioral: HealthMindr ApplicationParticipants in this study arm will have access to the mobile messaging platform (HealthMindr) for 3 months. |
| Waitlist | Other | Behavioral: WaitlistParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthMindr ApplicationFrom 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. | Behavioural | HealthMindr Application |
| WaitlistParticipants 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. | Behavioural | Waitlist |
Primary outcome
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).
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).
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.
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.
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).
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).
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.
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.
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.
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.
5 secondary outcomes
Change in intention to engage in preventive behaviors
Time frame: Baseline, Month 3, Month 6, Month 9
Change in intention to engage in risky behaviors
Time frame: Baseline, Month 3, Month 6, Month 9
Change in intention to seek information
Time frame: Baseline, Month 3, Month 6, Month 9
Change in intention to seek treatment
Time frame: Baseline, Month 3, Month 6, Month 9
Change in communication with partner
Time frame: Baseline, Month 3, Month 6, Month 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Derived from this study: PubMed 35025755Sullivan 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.
- Derived from this study: PubMed 31730043Sullivan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Sullivan, PhD, DVM principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthMindr Application and Waitlist in people with Human Immunodeficiency Virus, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HIV testing (time frame: Baseline, Month 3, Month 6, Month 9). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666247, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.