Trial Outcomes & Findings for A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM (NCT NCT03308097)
NCT ID: NCT03308097
Last Updated: 2021-02-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
16 weeks
Results posted on
2021-02-21
Participant Flow
In total, 70 individuals completed consent are were enrolled.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
|
Overall Study
COMPLETED
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM
Baseline characteristics by cohort
| Measure |
PrEP Mobile Messaging Intervention
n=33 Participants
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
|
Enhanced Standard of Care
n=32 Participants
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
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.9 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
23.6 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
23.7 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sexual Orientation
Heterosexual
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sexual Orientation
Homosexual
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sexual Orientation
Bisexual
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sexual Orientation
Asexual
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sexual Orientation
Undecided
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sexual Orientation
Unknown/Not reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksWith 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.
Outcome measures
| Measure |
PrEP Mobile Messaging Intervention
n=31 Participants
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
|
Enhanced Standard of Care
n=31 Participants
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
|
|---|---|---|
|
Number of PrEP Services Appointments Attended-Full Sample
|
0.58 visits attended
Standard Deviation 0.72
|
0.55 visits attended
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: 16 weeksWith 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.
Outcome measures
| Measure |
PrEP Mobile Messaging Intervention
n=27 Participants
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
|
Enhanced Standard of Care
n=26 Participants
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
|
|---|---|---|
|
Number of PrEP Services Appointments Attended- Restricted Sample
|
0.56 visits attended
Standard Deviation 0.75
|
0.50 visits attended
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: 16 weeksStaff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.
Outcome measures
| Measure |
PrEP Mobile Messaging Intervention
n=31 Participants
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
|
Enhanced Standard of Care
n=31 Participants
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
|
|---|---|---|
|
Number of Participants Who Received a PrEP Prescription-Full Sample
Did not receive PrEP Prescription
|
16 Participants
|
17 Participants
|
|
Number of Participants Who Received a PrEP Prescription-Full Sample
Received PrEP Prescription
|
15 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 16 weeksStaff 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.
Outcome measures
| Measure |
PrEP Mobile Messaging Intervention
n=27 Participants
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
|
Enhanced Standard of Care
n=26 Participants
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
|
|---|---|---|
|
Number of Participants Who Received a PrEP Prescription-Restricted Sample
Did not receive PrEP Prescription
|
16 Participants
|
16 Participants
|
|
Number of Participants Who Received a PrEP Prescription-Restricted Sample
Received PrEP Prescription
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data accounts for the discrepancy in the analytic sample for this measure.
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.
Outcome measures
| Measure |
PrEP Mobile Messaging Intervention
n=24 Participants
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
|
Enhanced Standard of Care
n=28 Participants
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
|
|---|---|---|
|
Change in PrEP Knowledge-Full Sample
|
0.50 score on a scale
Standard Deviation 0.83
|
1.00 score on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data accounts for the discrepancy in the analytic sample for this measure.
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.
Outcome measures
| Measure |
PrEP Mobile Messaging Intervention
n=22 Participants
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
|
Enhanced Standard of Care
n=23 Participants
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
|
|---|---|---|
|
Change in PrEP Knowledge-Restricted Sample
|
0.55 score on a scale
Standard Deviation 0.86
|
0.83 score on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data accounts for the discrepancy in the analytic sample for this measure.
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.
Outcome measures
| Measure |
PrEP Mobile Messaging Intervention
n=19 Participants
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
|
Enhanced Standard of Care
n=24 Participants
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
|
|---|---|---|
|
Change in Social Motivational Readiness for PrEP Care-Full Sample
|
-1.00 units on a scale
Standard Deviation 3.59
|
0.29 units on a scale
Standard Deviation 4.46
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data accounts for the discrepancy in the analytic sample for this measure.
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.
Outcome measures
| Measure |
PrEP Mobile Messaging Intervention
n=17 Participants
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
|
Enhanced Standard of Care
n=19 Participants
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
|
|---|---|---|
|
Change in Social Motivational Readiness for PrEP Care-Restricted Sample
|
-1.35 units on a scale
Standard Deviation 3.48
|
0.47 units on a scale
Standard Deviation 4.72
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data accounts for the discrepancy in the analytic sample for this measure.
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.
Outcome measures
| Measure |
PrEP Mobile Messaging Intervention
n=15 Participants
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
|
Enhanced Standard of Care
n=19 Participants
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
|
|---|---|---|
|
Change in PrEP Self-efficacy-Full Sample
|
-0.33 score on a scale
Standard Deviation 3.11
|
-0.37 score on a scale
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data accounts for the discrepancy in the analytic sample for this measure.
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.
Outcome measures
| Measure |
PrEP Mobile Messaging Intervention
n=14 Participants
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
|
Enhanced Standard of Care
n=15 Participants
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
|
|---|---|---|
|
Change in PrEP Self-efficacy-Restricted Sample
|
-0.36 score on a scale
Standard Deviation 3.23
|
-0.20 score on a scale
Standard Deviation 3.21
|
Adverse Events
PrEP Mobile Messaging Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place