Clinical trial NCT03404531: Project Minority AIDS Prevention: Reaching Black and Hispanic MSM About PrEP and TasP Using Social Media
Official title: Reaching Black/African American and Hispanic/Latino MSM Through Social Media About Treatment as Prevention and Pre-Exposure Prophylaxis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2018-01-19
Enrollment: 164
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: This project has the potential to improve the implementation science of treatment as prevention and pre-exposure prophylaxis uptake as a public health strategy for reducing new HIV infections in the United States. The investigators will develop and pilot test an intervention that combines messages sent over social media plus a newly developed interactive website specifically developed by and for Black/African American and Hispanic/Latino MSM to encourage treatment as prevention and pre-exposure prophylaxis use. Findings from this research can guide policy guidelines and recommendations for treatment as prevention and pre-exposure prophylaxis uptake for high-risk groups.

Detailed description: For this Minority AIDS Research Project, the investigators will develop and pilot test an intervention to improve the science of treatment as prevention and pre-exposure prophylaxis uptake as a public health strategy to decrease new HIV infections among Black/African American and Hispanic/Latino men who have sex with men. This project uses a 3-phase study design to address the proposed Specific Aims. First, the investigators will use focus groups to gather feedback on our existing interactive Men2MenRI website that was developed for and by predominately White men who have sex with men in Rhode Island that includes information on treatment as prevention and pre-exposure prophylaxis, as well as other health and wellness topics to make it more culturally-tailored to Black/African American and Hispanic/Latino MSM. Second, the investigators will use cognitive interviewing techniques to develop and assess the acceptability of Information-Motivation-Behavioral/Social Cognitive Theory-grounded social media message content designed to motivate and encourage access to a newly developed and culturally-tailored interactive website. Third, the investigators will pilot test a two-arm trial comparing the combination of sending Information-Motivation-Behavioral/Social Cognitive Theory-guided messages plus the newly developed and culturally-tailored interactive website (active arm) to the website alone (control arm) to examine whether the combination approach will: 1) increase treatment as prevention and pre-exposure prophylaxis uptake (primary outcome); 2) increase knowledge of, more favorable attitudes toward, and increase behavioral intentions of treatment as prevention and pre-exposure prophylaxis use behaviors (exploratory outcome). This study is innovative in the use of a combination approach to treatment as prevention and pre-exposure prophylaxis uptake that leverages advances in social media as a platform for motivating behavior change.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 or older 2. Biological male 3. Black/African American or Hispanic/Latino 4. History of condomless receptive or insertive anal intercourse with other men in the past 6 months 5. Currently using or have access and willingness to use social media over the next 6 months 6. Self-identify as HIV-negative or HIV-positive at enrollment 7. Self-identify as not being on HIV treatment (antiretroviral therapy or pre-exposure prophylaxis) or in HIV care at enrollment 8. Able to give informed consent

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Exclusion Criteria:

1. Individuals who are intoxicated
2. Individuals report being coerced to participate

Primary outcomes:
measure: treatment as prevention and pre-exposure prophylaxis uptake
timeFrame: 6 months
Secondary outcomes:
measure: treatment as prevention and pre-exposure prophylaxis knowledge, attitudes, and behavioral intentions
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Center for Alcohol and Addiction Studies
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jacob J van den Berg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van den Berg JJ, Silverman T, Fernandez MI, Henny KD, Gaul ZJ, Sutton MY, Operario D. Using eHealth to Reach Black and Hispanic Men Who Have Sex With Men Regarding Treatment as Prevention and Preexposure Prophylaxis: Protocol for a Small Randomized Controlled Trial. JMIR Res Protoc. 2018 Jul 16;7(7):e11047. doi: 10.2196/11047.