Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01PS004977 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HealthMindr Application | Experimental | Participants in this study arm will have access to the mobile messaging platform (HealthMindr) for 3 months. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrick Sullivan, PhD, DVM | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35025755 | Derived | 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. | |
| 31730043 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003141 | Communicable Diseases |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |
| 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 |
| Detroit |
| Michigan |
| 48109 |
| United States |
| Emory University | New York | New York | 10013 | United States |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |