Trial Outcomes & Findings for Feasibility of Interventions on People Who Inject Drugs in Vietnam (NCT NCT02573948)

NCT ID: NCT02573948

Last Updated: 2018-09-18

Results Overview

Number of participants who were followed up and not lost to follow-up after enrolment into cohort.

• Recruitment status: COMPLETED
• Target enrollment: 603 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2018-09-18

Participant Flow

People Who Injected Drugs (PWID), age > 18 years, with history of injecting drug use confirmed by a positive urine test and visual inspection of injection marks

Participant milestones

Measure	People Who Injected Drugs (PWID) Respondent Driven Sample (RDS 603 participants recruited through Respondent Driven Sample survey
RDS STARTED	603
RDS COMPLETED	603
RDS NOT COMPLETED	0
Longitudinal Cohort STARTED	250
Longitudinal Cohort COMPLETED	194
Longitudinal Cohort NOT COMPLETED	56

Reasons for withdrawal

Measure	People Who Injected Drugs (PWID) Respondent Driven Sample (RDS 603 participants recruited through Respondent Driven Sample survey
Longitudinal Cohort Death	9
Longitudinal Cohort Lost to Follow-up	22
Longitudinal Cohort Incarcerated	25

Baseline Characteristics

Feasibility of Interventions on People Who Inject Drugs in Vietnam

Baseline characteristics by cohort

Measure	PWID RDS n=603 Participants 603 participants
Age, Continuous	36.5 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	542 Participants n=5 Participants
Region of Enrollment Vietnam	603 participants n=5 Participants
Medical Insurance	105 Participants n=5 Participants
Duration of Injection use	8 years n=5 Participants
Number of drug injection (typical day)	2.7 injection per day STANDARD_DEVIATION 1 • n=5 Participants
Injecting drug: heroin alone	602 Participants n=5 Participants
Injection with syringe already used by someone else (last 3 months)	33 Participants n=5 Participants
HIV positive	152 Participants n=5 Participants
Currently under Methadone Maintenance Therapy	36 Participants n=5 Participants
HCV positive	398 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Participants were invited to follow-up visits at W4, W12, W24 and W52

Number of participants who were followed up and not lost to follow-up after enrolment into cohort.

Outcome measures

Measure	PWID Cohort n=250 Participants 250 participants selected among 603 RDS participants
Number of Cohort Participants Attending the Last Follow-up Visit at W52	194 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: HCV negative cohort participants with HCV test result available at W24 and/or W52.

Number of new HCV infection among HCV negative (at RDS) cohort participants over 1 year period

Outcome measures

Measure	PWID Cohort n=92 Participants 250 participants selected among 603 RDS participants
HCV Seroconversion	18 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: HIV negative cohort participants with HIV test result available at W24 and/or W52.

Number of new HIV infection among HIV negative (at RDS) cohort participants over 1 year period.

Outcome measures

Measure	PWID Cohort n=180 Participants 250 participants selected among 603 RDS participants
HIV Seroconversion	0 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: HCV negative cohort participants with HCV test result available at W24 a/or W52

The HCV incidence was calculated by 100person/year

Outcome measures

Measure	PWID Cohort n=92 Participants 250 participants selected among 603 RDS participants
Incidence of HCV Infection	19.4 infections per 100 person-years Interval 11.5 to 30.7

SECONDARY outcome

Timeframe: 52 weeks

Population: HIV negative cohort participants with HCV test result available at W24 a/or W52

HIV incidence was calculated by 100person/year. With zero conversion, we choose 2.5% unilateral confidence interval.

Outcome measures

Measure	PWID Cohort n=180 Participants 250 participants selected among 603 RDS participants
HIV Incidence	0 infections per 100 person-years Interval 0.0 to 1.8

Adverse Events

PWID Cohort

Serious events: 9 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Measure	PWID Cohort n=250 participants at risk 250 participants
General disorders Overdose	0.80% 2/250 • Number of events 2 • 52 weeks Adverse events reported for cohort participants (n=250)
Immune system disorders AIDS	2.0% 5/250 • Number of events 5 • 52 weeks Adverse events reported for cohort participants (n=250)
Psychiatric disorders Suicide	0.80% 2/250 • Number of events 2 • 52 weeks Adverse events reported for cohort participants (n=250)

Other adverse events

Adverse event data not reported

Additional Information

NAGOT NICOLAS

UMR 1058 (Inserm/University of Montpellier/EFS)

Phone: +33 4 34 35 91 09

Email: n-nagot@chu-montpellier.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place