Trial Outcomes & Findings for A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence) (NCT NCT04121962)
NCT ID: NCT04121962
Last Updated: 2024-05-20
Results Overview
number of participants who completed 80%
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
163 participants
Primary outcome timeframe
3 month
Results posted on
2024-05-20
Participant Flow
163 participants were consented. 64 participants assigned to Peer Mentor condition (Index and network); 55 participants assigned to the control (Index and network); 44 participants were withdrawn pre-assignment and not assigned to a condition.
Participant milestones
| Measure |
Peer Mentor
Peer Mentor Training is 5 individual sessions with a 30 day check-in session. This condition is focused on training Index with communication skills to promote HIV and Sexually Transmitted Infection (STI) testing and treatment and pre-exposure prophalaxis (PrEP) to individuals in their social networks.
Peer Mentor training is conducted by a one health educator. The sessions are held once a week and will last approximately 60 minutes.
|
Control
Participants will receive information on how to use the website to request at-home test kits
Website only: Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
55
|
|
Overall Study
COMPLETED
|
22
|
16
|
|
Overall Study
NOT COMPLETED
|
42
|
39
|
Reasons for withdrawal
| Measure |
Peer Mentor
Peer Mentor Training is 5 individual sessions with a 30 day check-in session. This condition is focused on training Index with communication skills to promote HIV and Sexually Transmitted Infection (STI) testing and treatment and pre-exposure prophalaxis (PrEP) to individuals in their social networks.
Peer Mentor training is conducted by a one health educator. The sessions are held once a week and will last approximately 60 minutes.
|
Control
Participants will receive information on how to use the website to request at-home test kits
Website only: Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
42
|
39
|
Baseline Characteristics
A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence)
Baseline characteristics by cohort
| Measure |
Peer Mentor
n=64 Participants
Peer Mentor Training is 5 individual sessions with a 30 day check-in session. This condition is focused on training Index with communication skills to promote HIV and STI testing and treatment and pre-exposure prophalaxis (PrEP) to individuals in their social networks. Peer Mentor training is conducted by a one health educator. The sessions are held once a week and will last approximately 60 minutes.
|
Control
n=55 Participants
Participants will receive information on how to use the website to request at-home test kits
Website only: Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing.
|
Not Assigned
n=44 Participants
Participants not randomized to either condition
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
163 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
38.0 year
STANDARD_DEVIATION 10.6 • n=99 Participants
|
38.5 year
STANDARD_DEVIATION 9.20 • n=107 Participants
|
35.25 year
STANDARD_DEVIATION 3.70 • n=206 Participants
|
38.2 year
STANDARD_DEVIATION 9.93 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
160 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
153 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
57 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
112 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 3 monthnumber of participants who completed 80%
Outcome measures
| Measure |
Peer Mentor
n=64 Participants
Peer Mentor Training is 5 individual sessions with a 30 day check-in session. This condition is focused on training Index with communication skills to promote HIV and STI testing and treatment and pre-exposure prophalaxis (PrEP) to individuals in their social networks. Peer Mentor training is conducted by a one health educator. The sessions are held once a week and will last approximately 60 minutes.
|
Control
n=55 Participants
Participants will receive information on how to use the website to request at-home test kits
Website only: Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing.
|
|---|---|---|
|
Session Attendance
|
64 Participants
|
55 Participants
|
PRIMARY outcome
Timeframe: 3 monthsNumber of Index participants who requested test kits is reported
Outcome measures
| Measure |
Peer Mentor
n=64 Participants
Peer Mentor Training is 5 individual sessions with a 30 day check-in session. This condition is focused on training Index with communication skills to promote HIV and STI testing and treatment and pre-exposure prophalaxis (PrEP) to individuals in their social networks. Peer Mentor training is conducted by a one health educator. The sessions are held once a week and will last approximately 60 minutes.
|
Control
n=55 Participants
Participants will receive information on how to use the website to request at-home test kits
Website only: Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing.
|
|---|---|---|
|
Number of Index Participants Who Requested Test Kits
|
9 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 3 monthNumber of participants who returned kits to lab for testing is reported.
Outcome measures
| Measure |
Peer Mentor
n=64 Participants
Peer Mentor Training is 5 individual sessions with a 30 day check-in session. This condition is focused on training Index with communication skills to promote HIV and STI testing and treatment and pre-exposure prophalaxis (PrEP) to individuals in their social networks. Peer Mentor training is conducted by a one health educator. The sessions are held once a week and will last approximately 60 minutes.
|
Control
n=55 Participants
Participants will receive information on how to use the website to request at-home test kits
Website only: Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing.
|
|---|---|---|
|
Number of Participants Who Return Kits for Testing
|
4 Participants
|
3 Participants
|
Adverse Events
Peer Mentor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Dr. Karin Tobin
Johns Hopkins Bloomberg School of Public Health
Phone: 4105025368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place