Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Mississippi Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP Mobile Messaging Intervention | Behavioral | See group description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 16 weeks |
| Change in PrEP Knowledge-Restricted Sample |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Involved in another PrEP or HIV prevention related study
Study only open to self-identifying male participants.
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Larry K. Brown, M.D. | Rhode Island Hospital | Principal Investigator |
| Laura Whiteley, M.D. | Rhode Island Hospital | Principal Investigator |
| Leandro Mena, M.D. | University of Mississippi Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32130196 | Derived | 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. |
Not provided
Not provided
Of the 70 enrolled participants, 68 completed baseline assessment- 1 did not return to the clinic to complete baseline and another seroconverted and was no longer eligible.
Of the 68 participants who completed baseline, 65 were randomized- 2 were confirmed HIV+ and no longer eligible, and 1 previously worked at UMMC and was removed from the study.
In total, 70 individuals completed consent are were enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PrEP Mobile Messaging Intervention | 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. PrEP Mobile Messaging Intervention: See group description |
| FG001 | Enhanced Standard of Care | 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. Enhanced Standard of Care: See group description |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PrEP Mobile Messaging Intervention | 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. PrEP Mobile Messaging Intervention: See group description |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | visits attended | 16 weeks |
|
Participants were monitored for adverse events over the duration of the study (4 months).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PrEP Mobile Messaging Intervention | 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. PrEP Mobile Messaging Intervention: See group description |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry K. Brown, MD | Rhode Island Hospital | (401) 793 - 8808 | lkbrown@lifespan.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 5, 2020 | Dec 31, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2020 | Feb 12, 2021 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Enhanced Standard of Care | Behavioral | See group description |
|
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. |
| 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. | 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. | 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. | 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. | Baseline, 16 weeks |
| BG001 | Enhanced Standard of Care | 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. Enhanced Standard of Care: See group description |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| OG001 |
| Enhanced Standard of Care |
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. Enhanced Standard of Care: See group description |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | visits attended | 16 weeks |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | 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. | Missing data accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 16 weeks |
|
|
|
| Secondary | 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. | Missing data accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 16 weeks |
|
|
|
| Secondary | 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. | Missing data accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 weeks |
|
|
|
| Secondary | 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. | Missing data accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 weeks |
|
|
|
| Secondary | 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. | Missing data accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 16 weeks |
|
|
|
| Secondary | 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. | Missing data accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 16 weeks |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Enhanced Standard of Care | 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. Enhanced Standard of Care: See group description | 0 | 32 | 0 | 32 | 0 | 32 |
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |