HivMobilePrEPNCT03308097

A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM

A study testing PrEP Mobile Messaging Intervention in people with Hiv, run by Rhode Island Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hiv
What is being tested?: PrEP Mobile Messaging Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: 20 Nov 2018to 12 Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

English speaking
Black MSM
Eligible for PrEP
Visit STI/HIV testing clinics at University of Mississippi Medical Center
Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment

Who cannot join

Involved in another PrEP or HIV prevention related study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Mississippi Medical Center
Jackson, Mississippi, 39216

Other trials in United States

About this study

This study will develop and test an interactive mobile messaging intervention to improve engagement in care related to Pre-exposure Prophylaxis (PrEP) and decrease HIV risk behaviors for Black men who have sex with men living in the Southern U.S. The mobile messaging intervention will include interactive text messaging and free, publicly available links to websites and YouTube videos. During the intervention participants will gain information about their health, improve motivation for engagement in PrEP related care, and build skills for healthy behaviors. Participants will also receive intervention materials to help decrease frequent barriers to care. If the intervention is found to be effective, it can be tested in a larger study and then disseminated.

Read the detailed description

The uptake of Pre-Exposure Prophylaxis (PrEP) has been slow for young Black men who have sex with men (BMSM) living in the Southern United States. This is a significant issue because eight of the ten states with the highest rates of new HIV infections are located in the South. Jackson, Mississippi (MS) (the site of this project) has the second highest AIDS diagnosis rate in the nation, and the highest rate of HIV infection for young urban Black men who have sex with men. This study will develop and test an engaging, interactive, and cost effective mobile messaging intervention to improve linkage to PrEP care for BMSM (18-35 yrs) living in Jackson, MS. BMSM eligible for PrEP, receiving care at the University of Mississippi Medical Center sexually-transmitted infections (STI)/HIV testing clinics, will be texted interactive links to publicly available, online content about PrEP and HIV prevention. Links will be sent to PrEP eligible BMSM by 8-16 interactive text messages over 4 weeks. The material used in the intervention will be consistent with the Information Motivation Behavior (IMB) Model and will address cultural and structural barriers to initiating PrEP care. A small randomized controlled study among 66 new participants in the clinics will examine the preliminary efficacy of the intervention compared to enhanced standard of care on attendance at a PrEP Services Appointment (the first step in initiating PrEP care). It is hypothesized that, compared to BMSM receiving enhanced standard of care, BMSM receiving the PrEP Mobile Messaging Intervention will show greater attendance at a PrEP Services Appointment and decreased HIV risk behavior at 4 and 16 weeks.

Conditions: Hiv
Being tested: PrEP Mobile Messaging Intervention, Enhanced Standard of Care
Keywords: PrEP, Uptake, MSM, Black
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrEP Mobile Messaging InterventionBehavioural
See group description
Enhanced Standard of CareBehavioural
See group description

Study groups in NCT03308097
Study group	Role	What they receive
PrEP Mobile Messaging Intervention	Experimental	Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires. Receives: Behavioral: PrEP Mobile Messaging Intervention
Enhanced Standard of Care	Active comparator	As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires. Receives: Behavioral: Enhanced Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of PrEP Services Appointments Attended-Full Sample
With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.
Measured: 16 weeks
Number of PrEP Services Appointments Attended- Restricted Sample
With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.
Restricted Sample is only those who did not receive a PrEP prescription the same day as enrollment.
Measured: 16 weeks
Number of Participants Who Received a PrEP Prescription-Full Sample
Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.
Measured: 16 weeks
Number of Participants Who Received a PrEP Prescription-Restricted Sample
Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.
Measured: 16 weeks

Secondary outcomes (6)

Change in PrEP Knowledge-Full Sample
Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.
Measured: Baseline, 16 weeks
Change in PrEP Knowledge-Restricted Sample
Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.
Measured: Baseline, 16 weeks
Change in Social Motivational Readiness for PrEP Care-Full Sample
Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.
Measured: Baseline, 16 weeks
Change in Social Motivational Readiness for PrEP Care-Restricted Sample
Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.
Measured: Baseline, 16 weeks
Change in PrEP Self-efficacy-Full Sample
Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.
Measured: Baseline, 16 weeks
Change in PrEP Self-efficacy-Restricted Sample
Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.
Measured: Baseline, 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 201812 Aug 2020

First posted12 Oct 2017
Study start20 Nov 2018
Primary completion12 Aug 2020
Study completion12 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HivStudies of the same condition, open and under way.
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: Single blind
Who is masked: Participant
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03308097
Sponsor's protocol ID: R34MH111342
Acronym: MobilePrEP
Status last verified: Jan 2020
First submitted: 2 Oct 2017
Last updated: 21 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Rouffiac AE, Whiteley L, Brown L, Mena L, Craker L, Healy M, Haubrick K. A Mobile Intervention to Improve Uptake of Pre-Exposure Prophylaxis for Southern Black Men Who Have Sex With Men: Protocol for Intervention Development and Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 20;9(2):e15781. doi: 10.2196/15781.
PubMed 32130196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hiv trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM
ClinicalTrials.gov ID: NCT03308097
Acronym / sponsor ID: MobilePrEP / R34MH111342
Conditions: Hiv
Keywords: PrEP, Uptake, MSM, Black
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Rhode Island HospitalUniversity, hospital or other
Collaborators: University of Mississippi Medical Center
Study start: 20 Nov 2018 (actual)
Primary completion: 12 Aug 2020 (actual)
Study completion: 12 Aug 2020 (actual)
First posted: 12 Oct 2017 (actual)
Results: Posted 21 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
PrEP Mobile Messaging Intervention	Experimental	Behavioral: PrEP Mobile Messaging InterventionParticipants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.
Enhanced Standard of Care	Active comparator	Behavioral: Enhanced Standard of CareAs part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.

Who may qualify

Ages: 18 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

English speaking
Black MSM
Eligible for PrEP
Visit STI/HIV testing clinics at University of Mississippi Medical Center
Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment

Key exclusion criteria (1 listed)

Involved in another PrEP or HIV prevention related study

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
PrEP Mobile Messaging InterventionSee group description	Behavioural	PrEP Mobile Messaging Intervention
Enhanced Standard of CareSee group description	Behavioural	Enhanced Standard of Care

Primary outcome

Number of PrEP Services Appointments Attended-Full Sample
Time frame: 16 weeks
With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.
Number of PrEP Services Appointments Attended- Restricted Sample
Time frame: 16 weeks
With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care. Restricted Sample is only those who did not receive a PrEP prescription the same day as enrollment.
Number of Participants Who Received a PrEP Prescription-Full Sample
Time frame: 16 weeks
Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.
Number of Participants Who Received a PrEP Prescription-Restricted Sample
Time frame: 16 weeks
Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant. Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.

6 secondary outcomes

Change in PrEP Knowledge-Full Sample
Time frame: Baseline, 16 weeks
Change in PrEP Knowledge-Restricted Sample
Time frame: Baseline, 16 weeks
Change in Social Motivational Readiness for PrEP Care-Full Sample
Time frame: Baseline, 16 weeks
Change in Social Motivational Readiness for PrEP Care-Restricted Sample
Time frame: Baseline, 16 weeks
Change in PrEP Self-efficacy-Full Sample
Time frame: Baseline, 16 weeks
Change in PrEP Self-efficacy-Restricted Sample
Time frame: Baseline, 16 weeks

Results and safety

Results posted to the registry on 21 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PrEP Mobile Messaging Intervention	33	31
Enhanced Standard of Care	32	31

Primary outcome: Number of PrEP Services Appointments Attended-Full Sample

Time frame: 16 weeks. Mean (Standard Deviation). Unit: visits attended

Measure	PrEP Mobile Messaging Intervention n = 31	Enhanced Standard of Care n = 31
Value	0.58 (0.72)	0.55 (0.68)

Primary outcome: Number of PrEP Services Appointments Attended- Restricted Sample

Time frame: 16 weeks. Mean (Standard Deviation). Unit: visits attended

Measure	PrEP Mobile Messaging Intervention n = 27	Enhanced Standard of Care n = 26
Value	0.56 (0.75)	0.50 (0.65)

Primary outcome: Number of Participants Who Received a PrEP Prescription-Full Sample

Time frame: 16 weeks. Count of participants. Unit: Participants

Measure	PrEP Mobile Messaging Intervention n = 31	Enhanced Standard of Care n = 31
Did not receive PrEP Prescription	16	17
Received PrEP Prescription	15	14

Primary outcome: Number of Participants Who Received a PrEP Prescription-Restricted Sample

Time frame: 16 weeks. Count of participants. Unit: Participants

Measure	PrEP Mobile Messaging Intervention n = 27	Enhanced Standard of Care n = 26
Did not receive PrEP Prescription	16	16
Received PrEP Prescription	11	10

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were monitored for adverse events over the duration of the study (4 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PrEP Mobile Messaging Intervention	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Enhanced Standard of Care	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32130196Rouffiac AE, Whiteley L, Brown L, Mena L, Craker L, Healy M, Haubrick K. A Mobile Intervention to Improve Uptake of Pre-Exposure Prophylaxis for Southern Black Men Who Have Sex With Men: Protocol for Intervention Development and Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 20;9(2):e15781. doi: 10.2196/15781.

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Not yet recruiting
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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.

Larry K. Brown, M.D. principal investigator

Rhode Island Hospital

Laura Whiteley, M.D. principal investigator

Rhode Island Hospital

Leandro Mena, M.D. study director

University of Mississippi Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PrEP Mobile Messaging Intervention in people with Hiv, run by Rhode Island Hospital 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 21 Feb 2021. 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?

Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of PrEP Services Appointments Attended-Full Sample (time frame: 16 weeks). The study lists 4 primary outcomes in all. 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 NCT03308097, 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 21 Feb 2021.