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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03404531
Other study ID # U01PS005117
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 10, 2017
Est. completion date April 30, 2021

Study information

Verified date July 2020
Source Brown University
Contact Jacob J. van den Berg, PhD
Phone 401-863-7566
Email jacob_vandenberg@brown.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 164
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

-

Exclusion Criteria:

1. Individuals who are intoxicated

2. Individuals report being coerced to participate

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Social Media Messages Intervention Group
The Social Media Messages Intervention Group will receive theoretically-grounded messages through social media in order to encourage participants to regularly access the newly developed, culturally-tailored website that includes information about treatment as prevention and pre-exposure prophylaxis.
Website Only Group
The Website Only group will have access to the newly developed, culturally-tailored website but will not receive social media messages.

Locations

Country Name City State
United States Center for Alcohol and Addiction Studies Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Brown University Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary treatment as prevention and pre-exposure prophylaxis uptake Participants uptake of treatment as prevention and pre-exposure prophylaxis 6 months
Secondary treatment as prevention and pre-exposure prophylaxis knowledge, attitudes, and behavioral intentions assessment of knowledge, attitudes, and behavioral intentions toward treatment as prevention and pre-exposure prophylaxis use 6 months
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