Trial Outcomes & Findings for Tajik Migrant Health Education Study (NCT NCT04853394)
NCT ID: NCT04853394
Last Updated: 2024-12-06
Results Overview
injected with a previously used syringe
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
420 participants
Primary outcome timeframe
3 months
Results posted on
2024-12-06
Participant Flow
Participant milestones
| Measure |
MASLIHAT Peer Education
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
MASLIHAT: peer educator intervention
|
TANSIHAT Health Education
A health education program consisting of five weekly 2-hour sessions small group sessions.
TANSIHAT: health education intervention
|
|---|---|---|
|
Baseline Interview
STARTED
|
210
|
210
|
|
Baseline Interview
COMPLETED
|
210
|
210
|
|
Baseline Interview
NOT COMPLETED
|
0
|
0
|
|
Intervention Sessions
STARTED
|
70
|
70
|
|
Intervention Sessions
COMPLETED
|
70
|
70
|
|
Intervention Sessions
NOT COMPLETED
|
0
|
0
|
|
Follow-up Interviews
STARTED
|
210
|
210
|
|
Follow-up Interviews
COMPLETED
|
188
|
195
|
|
Follow-up Interviews
NOT COMPLETED
|
22
|
15
|
Reasons for withdrawal
| Measure |
MASLIHAT Peer Education
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
MASLIHAT: peer educator intervention
|
TANSIHAT Health Education
A health education program consisting of five weekly 2-hour sessions small group sessions.
TANSIHAT: health education intervention
|
|---|---|---|
|
Follow-up Interviews
Lost to Follow-up
|
22
|
15
|
Baseline Characteristics
Among participants with reported test results
Baseline characteristics by cohort
| Measure |
MASLIHAT Peer Education
n=210 Participants
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
MASLIHAT: peer educator intervention
|
TANSIHAT Health Education
n=210 Participants
A health education program consisting of five weekly 2-hour sessions small group sessions.
TANSIHAT: health education intervention
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=210 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=420 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
210 Participants
n=210 Participants
|
210 Participants
n=210 Participants
|
420 Participants
n=420 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=210 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=420 Participants
|
|
Age, Continuous
|
29.7 years
STANDARD_DEVIATION 6.1 • n=210 Participants
|
30.3 years
STANDARD_DEVIATION 6.3 • n=210 Participants
|
30.0 years
STANDARD_DEVIATION 6.2 • n=420 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=210 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=420 Participants
|
|
Sex: Female, Male
Male
|
210 Participants
n=210 Participants
|
210 Participants
n=210 Participants
|
420 Participants
n=420 Participants
|
|
Race/Ethnicity, Customized
Tajik
|
210 Participants
n=210 Participants
|
210 Participants
n=210 Participants
|
420 Participants
n=420 Participants
|
|
Region of Enrollment
Russia
|
210 participants
n=210 Participants
|
210 participants
n=210 Participants
|
420 participants
n=420 Participants
|
|
Receptive syringe sharing
|
158 Participants
n=210 Participants
|
161 Participants
n=210 Participants
|
319 Participants
n=420 Participants
|
|
Condomless sex
|
85 Participants
n=210 Participants
|
85 Participants
n=210 Participants
|
170 Participants
n=420 Participants
|
|
Binge alcohol use
|
45 Participants
n=210 Participants
|
43 Participants
n=210 Participants
|
88 Participants
n=420 Participants
|
|
Days of alcohol use past month
|
5.2 days
STANDARD_DEVIATION 3.2 • n=210 Participants
|
5.3 days
STANDARD_DEVIATION 3.4 • n=210 Participants
|
5.3 days
STANDARD_DEVIATION 3.3 • n=420 Participants
|
|
HIV positive test result
|
19 Participants
n=207 Participants • Among participants with reported test results
|
9 Participants
n=206 Participants • Among participants with reported test results
|
28 Participants
n=413 Participants • Among participants with reported test results
|
|
Hepatitis C antibody positive test result
|
4 Participants
n=207 Participants • Among participants with reported test results
|
8 Participants
n=206 Participants • Among participants with reported test results
|
12 Participants
n=413 Participants • Among participants with reported test results
|
PRIMARY outcome
Timeframe: 3 monthsinjected with a previously used syringe
Outcome measures
| Measure |
MASLIHAT Peer Education
n=210 Participants
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
MASLIHAT: peer educator intervention
|
TANSIHAT Health Education
n=210 Participants
A health education program consisting of five weekly 2-hour sessions small group sessions.
TANSIHAT: health education intervention
|
|---|---|---|
|
Syringe Sharing
3-month follow-up
|
16 Participants
|
167 Participants
|
|
Syringe Sharing
6-month follow-up
|
15 Participants
|
175 Participants
|
|
Syringe Sharing
9-month follow-up
|
22 Participants
|
163 Participants
|
|
Syringe Sharing
12-month follow-up
|
36 Participants
|
163 Participants
|
PRIMARY outcome
Timeframe: 3 monthsvaginal or anal sex without a condom in the past 3 months
Outcome measures
| Measure |
MASLIHAT Peer Education
n=210 Participants
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
MASLIHAT: peer educator intervention
|
TANSIHAT Health Education
n=210 Participants
A health education program consisting of five weekly 2-hour sessions small group sessions.
TANSIHAT: health education intervention
|
|---|---|---|
|
Sex Without Condom
6-months
|
25 Participants
|
91 Participants
|
|
Sex Without Condom
3-months
|
27 Participants
|
77 Participants
|
|
Sex Without Condom
9-months
|
25 Participants
|
86 Participants
|
|
Sex Without Condom
12-months
|
26 Participants
|
93 Participants
|
PRIMARY outcome
Timeframe: 30 daysNumber of days drinking alcohol in past month
Outcome measures
| Measure |
MASLIHAT Peer Education
n=210 Participants
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
MASLIHAT: peer educator intervention
|
TANSIHAT Health Education
n=210 Participants
A health education program consisting of five weekly 2-hour sessions small group sessions.
TANSIHAT: health education intervention
|
|---|---|---|
|
Alcohol Use
3-months
|
4.5 days
Standard Deviation 2.4
|
5.1 days
Standard Deviation 2.8
|
|
Alcohol Use
6-months
|
4.6 days
Standard Deviation 2.3
|
5.2 days
Standard Deviation 2.6
|
|
Alcohol Use
9-months
|
5.6 days
Standard Deviation 3.4
|
5.3 days
Standard Deviation 2.6
|
|
Alcohol Use
12-months
|
5.7 days
Standard Deviation 2.3
|
6.1 days
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 12 monthsincident HIV infection
Outcome measures
| Measure |
MASLIHAT Peer Education
n=179 Participants
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
MASLIHAT: peer educator intervention
|
TANSIHAT Health Education
n=188 Participants
A health education program consisting of five weekly 2-hour sessions small group sessions.
TANSIHAT: health education intervention
|
|---|---|---|
|
HIV Infection
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsincident hepatitis C virus (HCV) infection
Outcome measures
| Measure |
MASLIHAT Peer Education
n=179 Participants
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
MASLIHAT: peer educator intervention
|
TANSIHAT Health Education
n=187 Participants
A health education program consisting of five weekly 2-hour sessions small group sessions.
TANSIHAT: health education intervention
|
|---|---|---|
|
Hepatitis C Infection
|
3 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsused shared injection equipment
Outcome measures
| Measure |
MASLIHAT Peer Education
n=210 Participants
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
MASLIHAT: peer educator intervention
|
TANSIHAT Health Education
n=210 Participants
A health education program consisting of five weekly 2-hour sessions small group sessions.
TANSIHAT: health education intervention
|
|---|---|---|
|
Injection Equipment Sharing
3-months
|
16 Participants
|
168 Participants
|
|
Injection Equipment Sharing
6-months
|
16 Participants
|
170 Participants
|
|
Injection Equipment Sharing
9-months
|
15 Participants
|
160 Participants
|
|
Injection Equipment Sharing
12-months
|
15 Participants
|
164 Participants
|
Adverse Events
MASLIHAT Peer Education
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TANSIHAT Health Education
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MASLIHAT Peer Education
n=210 participants at risk
A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.
MASLIHAT: peer educator intervention
|
TANSIHAT Health Education
n=210 participants at risk
A health education program consisting of five weekly 2-hour sessions small group sessions.
TANSIHAT: health education intervention
|
|---|---|---|
|
Infections and infestations
hepatitis C infection
|
1.4%
3/210 • Number of events 3 • 12 months
|
1.4%
3/210 • Number of events 3 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place