Mobile Messaging Intervention to Present New HIV Prevention Options for Men Who Have Sex With Men (MSM)
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Behavioral: WaitlistBehavioral: HealthMindr Application
- Registration Number
- NCT03666247
- Lead Sponsor
- Emory University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1229
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Assigned male at birth
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Current, self-reported gender identity as "Male"
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Aged 18 or over
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Self-reported ability to read and understand English-language
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Resides in the Atlanta, Georgia (GA), New York, New York (NY), or Detroit, Michigan (MI) Metropolitan Statistical Area.
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Self-reported anal sex with a male partner in the past 12 months
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Owns and uses an Android or Apple (iOS) smartphone
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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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Waitlist Waitlist 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. HealthMindr Application HealthMindr Application Participants in this study arm will have access to the mobile messaging platform (HealthMindr) for 3 months.
- Primary Outcome Measures
Name Time Method Change in engagement in HIV care 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 pre-exposure prophylaxis (PrEP) uptake 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 condom use 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 HIV testing 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 ART adherence 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 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 PrEP adherence 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 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 antiretroviral therapy (ART) uptake 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 testing for sexually transmitted infections (STIs) 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.
- Secondary Outcome Measures
Name Time Method Change in communication with partner Baseline, Month 3, Month 6, Month 9 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.
Change in intention to engage in preventive behaviors Baseline, Month 3, Month 6, Month 9 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.
Change in intention to seek treatment Baseline, Month 3, Month 6, Month 9 Participants will report how likely they are to seek out HIV treatment during the next 3 months.
Change in intention to engage in risky behaviors Baseline, Month 3, Month 6, Month 9 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.
Change in intention to seek information Baseline, Month 3, Month 6, Month 9 Participants will report how likely they are to seek out information on HIV prevention during the next 3 months.
Trial Locations
- Locations (2)
Emory University
🇺🇸New York, New York, United States
University of Michigan
🇺🇸Detroit, Michigan, United States