HIV InfectionsMAPNCT03404531
Project Minority AIDS Prevention: Reaching Black and Hispanic MSM About PrEP and TasP Using Social Media
A study testing Social Media Messages Intervention Group and Website Only Group in people with HIV Infections, run by Brown University at 1 site in United States.
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. 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
- HIV Infections
- What is being tested?
- Social Media Messages Intervention Group and Website Only Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2017to 30 Apr 2021
- 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
- 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
- -
Who cannot join
- Individuals who are intoxicated
- Individuals report being coerced to participate
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02912
Jacob J. van den Berg, PhD, 401-863-7566, jacob_vandenberg@brown.edu
Don Operario, PhD, 401-863-6657, don_operario@brown.edu
About this study
Official title: Reaching Black/African American and Hispanic/Latino MSM Through Social Media About Treatment as Prevention and Pre-Exposure Prophylaxis
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Social Media Messages Intervention Group, Website Only Group
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Media Messages Intervention GroupBehavioural
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 GroupBehavioural
The Website Only group will have access to the newly developed, culturally-tailored website but will not receive social media messages.
| Study group | Role | What they receive |
|---|---|---|
| Social Media Messages Intervention Group | Experimental | Participants randomized to this condition will have access to a newly developed, culturally-tailored interactive website and theoretically-grounded social media messages. Receives: Behavioral: Social Media Messages Intervention Group |
| Website Only Group | Active comparator | Participants randomized to this condition will have access to a newly developed, culturally-tailored interactive website only. Receives: Behavioral: Website Only Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment as prevention and pre-exposure prophylaxis uptake
Participants uptake of treatment as prevention and pre-exposure prophylaxis
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start10 Nov 2017
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Brown 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
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Jacob J. van den Berg, PhD, Brown University
- Investigators
- Jacob J van den Berg, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404531
- Sponsor's protocol ID
- U01PS005117
- Acronym
- MAP
- Status last verified
- Jul 2020
- First submitted
- 12 Jan 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data will be shared openly, proactively, and timely in accordance with the most recent NIH guidelines (http://grants.nih.gov/grants/policy/data\_sharing/) while being mindful that the confidentiality and privacy of participants in research must be protected at all times. Specific plans to share data, including an overview of what will be shared, when it will be shared, how it will be shared, and who will have access to the data will be proposed in a data sharing agreement that all investigators and prospective users of the data will complete when requesting access to the data.
Publications
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.
PubMed 30012549
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Black/African American and Hispanic/Latino MSM Through Social Media About Treatment as Prevention and Pre-Exposure Prophylaxis
- ClinicalTrials.gov ID
- NCT03404531
- Acronym / sponsor ID
- MAP / U01PS005117
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 19 Jan 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Media Messages Intervention Group | Experimental | Behavioral: Social Media Messages Intervention GroupParticipants randomized to this condition will have access to a newly developed, culturally-tailored interactive website and theoretically-grounded social media messages. |
| Website Only Group | Active comparator | Behavioral: Website Only GroupParticipants randomized to this condition will have access to a newly developed, culturally-tailored interactive website only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
- -
Key exclusion criteria (2 listed)
- Individuals who are intoxicated
- Individuals report being coerced to participate
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 |
|---|---|---|
| Social Media Messages Intervention GroupThe 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. | Behavioural | Social Media Messages Intervention Group |
| Website Only GroupThe Website Only group will have access to the newly developed, culturally-tailored website but will not receive social media messages. | Behavioural | Website Only Group |
Primary outcome
treatment as prevention and pre-exposure prophylaxis uptake
Time frame: 6 months
Participants uptake of treatment as prevention and pre-exposure prophylaxis
1 secondary outcome
treatment as prevention and pre-exposure prophylaxis knowledge, attitudes, and behavioral intentions
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 30012549van 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.
- Individual participant dataSharing planned: Yes. Research data will be shared openly, proactively, and timely in accordance with the most recent NIH guidelines (http://grants.nih.gov/grants/policy/data_sharing/) while being mindful that the confidentiality and privacy of participants in research must be protected at all times. Specific plans to share data, including an overview of what will be shared, when it will be shared, how it will be shared, and who will have access to the data will be proposed in a data sharing agreement that all investigators and prospective users of the data will complete when requesting access to the data.
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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.
Jacob J van den Berg, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Media Messages Intervention Group and Website Only Group in people with HIV Infections, run by Brown University at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob J. van den Berg, PhD (401-863-7566, jacob_vandenberg@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment as prevention and pre-exposure prophylaxis uptake (time frame: 6 months). 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 NCT03404531, which also lists 1 linked publication.
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 8 Jul 2020.