An interventional study of PrEP Mobile Messaging Intervention and Enhanced Standard of Care in Hiv, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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.
Behavioral: PrEP Mobile Messaging Intervention
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.
Behavioral: Enhanced Standard of Care
See group description
See group description
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 16 weeks
In total, 70 individuals completed consent are were enrolled.
| Milestone | PrEP Mobile Messaging Intervention | Enhanced Standard of Care |
|---|---|---|
| Started | 33 | 32 |
| Completed | 31 | 31 |
| Not completed | 2 | 1 |
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.
| visits attended | PrEP Mobile Messaging Intervention | Enhanced Standard of Care |
|---|---|---|
| Number of PrEP Services Appointments Attended-Full Sample | 0.58 ± 0.72 | 0.55 ± 0.68 |
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.
| visits attended | PrEP Mobile Messaging Intervention | Enhanced Standard of Care |
|---|---|---|
| Number of PrEP Services Appointments Attended- Restricted Sample | 0.56 ± 0.75 | 0.50 ± 0.65 |
Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.
| Participants | PrEP Mobile Messaging Intervention | Enhanced Standard of Care |
|---|---|---|
| Did not receive PrEP Prescription | 16 | 17 |
| Received PrEP Prescription | 15 | 14 |
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.
| Participants | PrEP Mobile Messaging Intervention | Enhanced Standard of Care |
|---|---|---|
| Did not receive PrEP Prescription | 16 | 16 |
| Received PrEP Prescription | 11 | 10 |
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.
| score on a scale | PrEP Mobile Messaging Intervention | Enhanced Standard of Care |
|---|---|---|
| Change in PrEP Knowledge-Full Sample | 0.50 ± 0.83 | 1.00 ± 1.15 |
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.
| score on a scale | PrEP Mobile Messaging Intervention | Enhanced Standard of Care |
|---|---|---|
| Change in PrEP Knowledge-Restricted Sample | 0.55 ± 0.86 | 0.83 ± 1.15 |
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.
| units on a scale | PrEP Mobile Messaging Intervention | Enhanced Standard of Care |
|---|---|---|
| Change in Social Motivational Readiness for PrEP Care-Full Sample | -1.00 ± 3.59 | 0.29 ± 4.46 |
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.
| units on a scale | PrEP Mobile Messaging Intervention | Enhanced Standard of Care |
|---|---|---|
| Change in Social Motivational Readiness for PrEP Care-Restricted Sample | -1.35 ± 3.48 | 0.47 ± 4.72 |
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.
| score on a scale | PrEP Mobile Messaging Intervention | Enhanced Standard of Care |
|---|---|---|
| Change in PrEP Self-efficacy-Full Sample | -0.33 ± 3.11 | -0.37 ± 2.91 |
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.
| score on a scale | PrEP Mobile Messaging Intervention | Enhanced Standard of Care |
|---|---|---|
| Change in PrEP Self-efficacy-Restricted Sample | -0.36 ± 3.23 | -0.20 ± 3.21 |
Collected over Participants were monitored for adverse events over the duration of the study (4 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PrEP Mobile Messaging Intervention | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Enhanced Standard of Care | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(years) | PrEP Mobile Messaging Intervention | Enhanced Standard of Care | Total |
|---|---|---|---|
| Mean | 23.9 ± 4.8 | 23.6 ± 4.8 | 23.7 ± 4.8 |
| Sex: Female, Male(Participants) | PrEP Mobile Messaging Intervention | Enhanced Standard of Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 33 | 32 | 65 |
| Ethnicity (NIH/OMB)(Participants) | PrEP Mobile Messaging Intervention | Enhanced Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 30 | 31 | 61 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | PrEP Mobile Messaging Intervention | Enhanced Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 28 | 28 | 56 |
| White | 0 | 0 | 0 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Sexual Orientation(Participants) | PrEP Mobile Messaging Intervention | Enhanced Standard of Care | Total |
|---|---|---|---|
| Heterosexual | 0 | 1 | 1 |
| Homosexual | 19 | 24 | 43 |
| Bisexual | 10 | 5 | 15 |
| Asexual | 1 | 0 | 1 |
| Undecided | 0 | 1 | 1 |
| Unknown/Not reported | 3 | 1 | 4 |
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Rhode Island Hospital