NCT04853394

Tajik Migrant Health Education Study

Completed NA Results posted Last updated 6 December 2024

What this trial tests

NA trial testing MASLIHAT in HIV Infections in 420 participants. Completed in 28 May 2023.

Timeline

19 October 2021

Primary endpoint
4 May 2023

28 May 2023

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	420
Start date	19 October 2021
Primary completion	4 May 2023
Estimated completion	28 May 2023
Sites	1 location across Russia

Drugs / interventions tested

• MASLIHAT
• TANSIHAT

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Hepatitis C — all drugs for Hepatitis C →
• Risky Health Behavior — all drugs for Risky Health Behavior →
• Risk Reduction Behavior — all drugs for Risk Reduction Behavior →

Sponsor

University of Illinois at Chicago

Who can join

18 and older, male only, with HIV Infections or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Syringe Sharing Primary · 3 months

injected with a previously used syringe

3-month follow-up

Group	Value	95% CI
MASLIHAT Peer Education	16
TANSIHAT Health Education	167

6-month follow-up

Group	Value	95% CI
MASLIHAT Peer Education	15
TANSIHAT Health Education	175

9-month follow-up

Group	Value	95% CI
MASLIHAT Peer Education	22
TANSIHAT Health Education	163

12-month follow-up

Group	Value	95% CI
MASLIHAT Peer Education	36
TANSIHAT Health Education	163

Sex Without Condom Primary · 3 months

vaginal or anal sex without a condom in the past 3 months

3-months

Group	Value	95% CI
MASLIHAT Peer Education	27
TANSIHAT Health Education	77

6-months

Group	Value	95% CI
MASLIHAT Peer Education	25
TANSIHAT Health Education	91

9-months

Group	Value	95% CI
MASLIHAT Peer Education	25
TANSIHAT Health Education	86

12-months

Group	Value	95% CI
MASLIHAT Peer Education	26
TANSIHAT Health Education	93

Alcohol Use Primary · 30 days

Number of days drinking alcohol in past month

3-months

Group	Value	95% CI
MASLIHAT Peer Education	4.5	± 2.4
TANSIHAT Health Education	5.1	± 2.8

6-months

Group	Value	95% CI
MASLIHAT Peer Education	4.6	± 2.3
TANSIHAT Health Education	5.2	± 2.6

9-months

Group	Value	95% CI
MASLIHAT Peer Education	5.6	± 3.4
TANSIHAT Health Education	5.3	± 2.6

12-months

Group	Value	95% CI
MASLIHAT Peer Education	5.7	± 2.3
TANSIHAT Health Education	6.1	± 2.4

HIV Infection Secondary · 12 months

incident HIV infection

Group	Value	95% CI
MASLIHAT Peer Education	0
TANSIHAT Health Education	0

Hepatitis C Infection Secondary · 12 months

incident hepatitis C virus (HCV) infection

Group	Value	95% CI
MASLIHAT Peer Education	3
TANSIHAT Health Education	3

Injection Equipment Sharing Secondary · 3 months

used shared injection equipment

3-months

Group	Value	95% CI
MASLIHAT Peer Education	16
TANSIHAT Health Education	168

6-months

Group	Value	95% CI
MASLIHAT Peer Education	16
TANSIHAT Health Education	170

9-months

Group	Value	95% CI
MASLIHAT Peer Education	15
TANSIHAT Health Education	160

12-months

Group	Value	95% CI
MASLIHAT Peer Education	15
TANSIHAT Health Education	164

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MASLIHAT Peer Education

Serious: 0/210 (0%)

Deaths: 0/210

TANSIHAT Health Education

Serious: 0/210 (0%)

Deaths: 0/210

Other adverse events (1 terms — click to expand)

Reaction	System	MASLIHAT Peer Education	TANSIHAT Health Education
hepatitis C infection	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT04853394 adverse events section.

Sponsor's own description

This study will test the efficacy of a peer-education prevention intervention to reduce risky drug, alcohol, and sexual behaviors among male Tajik labor migrants who inject drugs (MWID) while working in Moscow. The peer educator intervention will be compared to a health education control intervention. Each intervention consists of 5 weekly 2-hour small group sessions. Follow-up assessments will be conducted at 3, 6, 9, and 12 months after the intervention. It is hypothesized that, compared to MWID who receive the health education control intervention, those who receive the peer educator intervention will have a greater reduction in the frequency of risk behaviors. Similar effects are expected for network members of intervention participants.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Changes in risk behaviour following a network peer education intervention for HIV prevention among male Tajik migrants who inject drugs in Moscow: a cluster-randomized controlled trial.
   Mackesy-Amiti ME, Bahromov M, Levy JA, Jonbekov J, et al · · 2024 · cited 5× · PMID 39030891 · DOI 10.1002/jia2.26310
2. MASLIHAT Peer Intervention Impact on HIV Testing Among Female Sex Partners of Male Tajik Migrants in Moscow Who Inject Drugs.
   Luc CM, Levy JA, Jonbekov J, Mackesy-Amiti ME. · · 2025 · PMID 40577396 · DOI 10.1521/aeap.2025.37.3.237
3. Peer education intervention reduced sexually transmitted infections among male Tajik labor migrants who inject drugs: results of a cluster-randomized controlled trial.
   Mackesy-Amiti ME, Levy JA, Luc CM, Jonbekov J. · · 2025 · PMID 40495129 · DOI 10.1186/s12889-025-23387-8
4. Peer Education Intervention Reduced Sexually Transmitted Infections Among Male Tajik Labor Migrants Who Inject Drugs: Results of a Cluster-randomized Controlled Trial
   Mackesy-Amiti ME, Levy JA, Luc CM, Jonbekov J. · · 2024 · DOI 10.1101/2024.08.15.24312070