Trial Outcomes & Findings for HealthMindr App to Increase Pre-exposure Prophylaxis (PrEP) Uptake and Retention Among Men Who Have Sex With Men (MSM) (NCT NCT03763942)
NCT ID: NCT03763942
Last Updated: 2024-06-04
Results Overview
PrEP uptake was assessed at each follow-up timepoint (3, 6, 9, and 12 months) in the intervention and control groups. The primary measure of PrEP uptake will be self-report. Validation will occur through submission of a dried blood spot self-collection kit to detect tenofovir diphosphate (TFV-DP) and/or upload of a photo of a PrEP prescription bottle.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
658 participants
Primary outcome timeframe
3, 6, 9, and 12 months post-randomization
Results posted on
2024-06-04
Participant Flow
The following report is based on 658 consented participants that took part in the study.
Participant milestones
| Measure |
HealthMindr App
Participants in the intervention arm will receive access to all HealthMindr app capabilities. The app information will cover the importance of testing, links to HIV prevention resources, resources to locate HIV testing and PrEP services, the Substance Abuse and Mental Health Services Administration (SAMHSA) substance abuse treatment resource locator, and other prevention information specific to their area.
HealthMindr App: Participants in the intervention arm will receive access to the HealthMindr app with basic prevention services (HIV test planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test kit, and at-home STI specimen collection kit distribution) plus monthly PrEP eligibility assessments, PrEP provider locator, enhanced information about PrEP, and referrals to local PrEP navigators. The app also provides information about obtaining health insurance coverage and paying for PrEP.
|
Control App
Participants in the control arm will be directed to download a study app that allows study staff to interact with them.
Control App: Men in the control arm will have access to an app with information pertinent to their participation in the study, including a study events timeline. The app will also allow participants and study staff to communicate via a messaging feature. The control arm app will not contain HIV prevention information.
|
|---|---|---|
|
Overall Study
STARTED
|
437
|
221
|
|
Overall Study
COMPLETED
|
318
|
164
|
|
Overall Study
NOT COMPLETED
|
119
|
57
|
Reasons for withdrawal
| Measure |
HealthMindr App
Participants in the intervention arm will receive access to all HealthMindr app capabilities. The app information will cover the importance of testing, links to HIV prevention resources, resources to locate HIV testing and PrEP services, the Substance Abuse and Mental Health Services Administration (SAMHSA) substance abuse treatment resource locator, and other prevention information specific to their area.
HealthMindr App: Participants in the intervention arm will receive access to the HealthMindr app with basic prevention services (HIV test planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test kit, and at-home STI specimen collection kit distribution) plus monthly PrEP eligibility assessments, PrEP provider locator, enhanced information about PrEP, and referrals to local PrEP navigators. The app also provides information about obtaining health insurance coverage and paying for PrEP.
|
Control App
Participants in the control arm will be directed to download a study app that allows study staff to interact with them.
Control App: Men in the control arm will have access to an app with information pertinent to their participation in the study, including a study events timeline. The app will also allow participants and study staff to communicate via a messaging feature. The control arm app will not contain HIV prevention information.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
114
|
54
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Other
|
2
|
3
|
Baseline Characteristics
Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
Baseline characteristics by cohort
| Measure |
HealthMindr App
n=437 Participants
Participants in the intervention arm will receive access to all HealthMindr app capabilities. The app information will cover the importance of testing, links to HIV prevention resources, resources to locate HIV testing and PrEP services, the Substance Abuse and Mental Health Services Administration (SAMHSA) substance abuse treatment resource locator, and other prevention information specific to their area.
HealthMindr App: Participants in the intervention arm will receive access to the HealthMindr app with basic prevention services (HIV test planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test kit, and at-home STI specimen collection kit distribution) plus monthly PrEP eligibility assessments, PrEP provider locator, enhanced information about PrEP, and referrals to local PrEP navigators. The app also provides information about obtaining health insurance coverage and paying for PrEP.
|
Control App
n=221 Participants
Participants in the control arm will be directed to download a study app that allows study staff to interact with them.
Control App: Men in the control arm will have access to an app with information pertinent to their participation in the study, including a study events timeline. The app will also allow participants and study staff to communicate via a messaging feature. The control arm app will not contain HIV prevention information.
|
Total
n=658 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.83 years
STANDARD_DEVIATION 4.23 • n=437 Participants
|
27.08 years
STANDARD_DEVIATION 4.47 • n=221 Participants
|
26.91 years
STANDARD_DEVIATION 4.31 • n=658 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=437 Participants
|
0 Participants
n=221 Participants
|
0 Participants
n=658 Participants
|
|
Sex: Female, Male
Male
|
437 Participants
n=437 Participants
|
221 Participants
n=221 Participants
|
658 Participants
n=658 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
100 Participants
n=437 Participants
|
52 Participants
n=221 Participants
|
152 Participants
n=658 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
337 Participants
n=437 Participants
|
169 Participants
n=221 Participants
|
506 Participants
n=658 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=437 Participants
|
0 Participants
n=221 Participants
|
0 Participants
n=658 Participants
|
|
Region of Enrollment
United States
|
437 participants
n=437 Participants
|
221 participants
n=221 Participants
|
658 participants
n=658 Participants
|
|
Household Income
$0-29,999/year
|
135 Participants
n=436 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
75 Participants
n=220 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
210 Participants
n=656 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
|
Household Income
$30,000-74,999/year
|
187 Participants
n=436 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
91 Participants
n=220 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
278 Participants
n=656 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
|
Household Income
$75,000+
|
91 Participants
n=436 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
42 Participants
n=220 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
133 Participants
n=656 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
|
Household Income
Unknown
|
23 Participants
n=436 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
12 Participants
n=220 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
35 Participants
n=656 Participants • Discrepancies in number of participants analyzed are due to missing data for one participant in each study group.
|
|
Educational Status
High school or less
|
42 Participants
n=437 Participants
|
22 Participants
n=221 Participants
|
64 Participants
n=658 Participants
|
|
Educational Status
Less than 4 years of college (Includes technical or vocational school)
|
96 Participants
n=437 Participants
|
48 Participants
n=221 Participants
|
144 Participants
n=658 Participants
|
|
Educational Status
4-year college grad or higher
|
299 Participants
n=437 Participants
|
151 Participants
n=221 Participants
|
450 Participants
n=658 Participants
|
|
Employment status
Not currently employed
|
82 Participants
n=436 Participants • Discrepancy in total number of patients analyzed is due to missing data for one participant in the HealthMindr App Group.
|
47 Participants
n=221 Participants • Discrepancy in total number of patients analyzed is due to missing data for one participant in the HealthMindr App Group.
|
129 Participants
n=657 Participants • Discrepancy in total number of patients analyzed is due to missing data for one participant in the HealthMindr App Group.
|
|
Employment status
Employed full time
|
288 Participants
n=436 Participants • Discrepancy in total number of patients analyzed is due to missing data for one participant in the HealthMindr App Group.
|
129 Participants
n=221 Participants • Discrepancy in total number of patients analyzed is due to missing data for one participant in the HealthMindr App Group.
|
417 Participants
n=657 Participants • Discrepancy in total number of patients analyzed is due to missing data for one participant in the HealthMindr App Group.
|
|
Employment status
Employed part time
|
66 Participants
n=436 Participants • Discrepancy in total number of patients analyzed is due to missing data for one participant in the HealthMindr App Group.
|
45 Participants
n=221 Participants • Discrepancy in total number of patients analyzed is due to missing data for one participant in the HealthMindr App Group.
|
111 Participants
n=657 Participants • Discrepancy in total number of patients analyzed is due to missing data for one participant in the HealthMindr App Group.
|
|
Health Insurance Status
Private
|
303 Participants
n=437 Participants
|
143 Participants
n=221 Participants
|
446 Participants
n=658 Participants
|
|
Health Insurance Status
Public
|
41 Participants
n=437 Participants
|
19 Participants
n=221 Participants
|
60 Participants
n=658 Participants
|
|
Health Insurance Status
Other/Don't know
|
8 Participants
n=437 Participants
|
8 Participants
n=221 Participants
|
16 Participants
n=658 Participants
|
|
Health Insurance Status
No insurance
|
85 Participants
n=437 Participants
|
51 Participants
n=221 Participants
|
136 Participants
n=658 Participants
|
|
Housing
Stable/permanent
|
358 Participants
n=435 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
174 Participants
n=219 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
532 Participants
n=654 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
|
Housing
Transitional/temporary
|
68 Participants
n=435 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
39 Participants
n=219 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
107 Participants
n=654 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
|
Housing
Homeless
|
7 Participants
n=435 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
4 Participants
n=219 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
11 Participants
n=654 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
|
Housing
Other
|
1 Participants
n=435 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
0 Participants
n=219 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
1 Participants
n=654 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
|
Housing
Unknown
|
1 Participants
n=435 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
2 Participants
n=219 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
3 Participants
n=654 Participants • Discrepancies in number of participants analyzed are due to missing data for two participants in each study group.
|
|
Food Insecurity
Yes
|
83 Participants
n=437 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
48 Participants
n=217 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
131 Participants
n=654 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
|
Food Insecurity
No
|
343 Participants
n=437 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
162 Participants
n=217 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
505 Participants
n=654 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
|
Food Insecurity
Unknown
|
2 Participants
n=437 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
3 Participants
n=217 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
5 Participants
n=654 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
|
Food Insecurity
Prefer not to answer
|
9 Participants
n=437 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
4 Participants
n=217 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
13 Participants
n=654 Participants • Discrepancies in number of participants analyzed are due to missing data for 4 participants in the Control App group.
|
PRIMARY outcome
Timeframe: 3, 6, 9, and 12 months post-randomizationPopulation: Number of participants analyzed per different time point are based on number of patient that were able to complete the corresponding study visit.
PrEP uptake was assessed at each follow-up timepoint (3, 6, 9, and 12 months) in the intervention and control groups. The primary measure of PrEP uptake will be self-report. Validation will occur through submission of a dried blood spot self-collection kit to detect tenofovir diphosphate (TFV-DP) and/or upload of a photo of a PrEP prescription bottle.
Outcome measures
| Measure |
HealthMindr App
n=358 Participants
Participants in the intervention arm will receive access to all HealthMindr app capabilities. The app information will cover the importance of testing, links to HIV prevention resources, resources to locate HIV testing and PrEP services, the Substance Abuse and Mental Health Services Administration (SAMHSA) substance abuse treatment resource locator, and other prevention information specific to their area.
HealthMindr App: Participants in the intervention arm will receive access to the HealthMindr app with basic prevention services (HIV test planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test kit, and at-home STI specimen collection kit distribution) plus monthly PrEP eligibility assessments, PrEP provider locator, enhanced information about PrEP, and referrals to local PrEP navigators. The app also provides information about obtaining health insurance coverage and paying for PrEP.
|
Control App
n=190 Participants
Participants in the control arm will be directed to download a study app that allows study staff to interact with them.
Control App: Men in the control arm will have access to an app with information pertinent to their participation in the study, including a study events timeline. The app will also allow participants and study staff to communicate via a messaging feature. The control arm app will not contain HIV prevention information.
|
|---|---|---|
|
PrEP Uptake
PrEP Uptake at 3 months post-randomization
|
2.764 events per 1000 person-months
Interval 2.211 to 3.414
|
2.116 events per 1000 person-months
Interval 1.482 to 2.929
|
|
PrEP Uptake
PrEP Uptake at 6 months post-randomization
|
2.104 events per 1000 person-months
Interval 1.737 to 2.525
|
1.837 events per 1000 person-months
Interval 1.384 to 2.391
|
|
PrEP Uptake
PrEP Uptake at 9 months post-randomization
|
1.762 events per 1000 person-months
Interval 1.477 to 2.085
|
1.509 events per 1000 person-months
Interval 1.157 to 1.935
|
|
PrEP Uptake
PrEP Uptake at 12 months post-randomization
|
1.241 events per 1000 person-months
Interval 1.033 to 1.48
|
1.462 events per 1000 person-months
Interval 1.146 to 1.838
|
Adverse Events
HealthMindr App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control App
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