NCT03293355

Brief Summary

There is an urgent need for treatment service integration for People Living with HIV (PLH) because many PLH have comorbid conditions, including substance use disorders and psychiatric disorders, among others. Although providing integrated services to PLH who use drugs (PLHWUD) has been proven to produce positive outcomes, multilevel challenges must be addressed, including barriers at the policy, structural, and provider levels. Many countries, including Vietnam, face challenges in the pursuit of multilevel integration of combination treatment services and care. In Vietnam, injecting drug use accounts for nearly two-thirds of HIV infection, and methadone maintenance therapy (MMT) services have rapidly expanded to 135 clinics with over 25,000 clients since 2008. There is a timely call as well as an opportunity to identify, implement and evaluate new strategies to provide MMT and HIV treatment as an integrated service system for PLHWUD. The study will take advantage of this window of opportunity to explore and pilot integration strategies to address the multilevel challenges associated with service integration in Vietnam.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

July 23, 2020

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

September 20, 2017

Last Update Submit

July 21, 2020

Conditions

Keywords

People Living with HIV Who Use Drugs (PLHWUD)Community Health Workers (CHW)Multilevel Service IntegrationHIV/AIDSVietnam

Outcome Measures

Primary Outcomes (2)

  • PLHWUD's service utilization

    This will be measured by PLHWUD's utilization of health services including OPC and MMT. Both their access and adherence to treatments will be assessed.

    Changes from baseline to 3-, 6-, 9- and 12- month follow-ups

  • CHW interaction with providers of other treatment agencies

    This will be measured by a multi-item scale on interaction with other treatment providers

    Changes from baseline to 3-, 6-, 9- and 12- month follow-ups

Secondary Outcomes (3)

  • PLHWUD's service satisfaction

    Changes from baseline to 3-, 6-, 9- and 12- month follow-ups

  • CHW's patient-provider interaction with PLHWUD

    Changes from baseline to 3-, 6-, 9- and 12- month follow-ups

  • CHW's service provision

    Changes from baseline to 3-, 6-, 9- and 12- month follow-ups

Study Arms (2)

Control

NO INTERVENTION

Standard of care

Intervention

EXPERIMENTAL

The VPN intervention has 2 in-person sessions: 1\) Providing training on service integration and team building for CHW and tools for them to network more effectively with OPC and MMT treatment providers as well as reach out to their patients; and 2) Learning to use effective communication tools such as motivational ruler and decision balance sheet to work more effectively with their patients and use Facebook group to facilitate collaboration among providers and e-chat for patient engagements. Sessions will occur once a week for two weeks, with each session featuring a different set of themes and relevant activities.

Behavioral: VPN

Interventions

VPNBEHAVIORAL

Two in-person sessions will take place one week apart for the VPN intervention targeting CHW. The intervention contents aim to utilize traditional communications tools and the latest technology to tackle challenges faced by service providers working in commune health centers and the impact of these challenges on their patients' treatment initiation, retention, and adherence. In addition, booster sessions will be offered once every month during the first three months and once every three months thereafter. The booster sessions will focus on participants' reports of their experiences, reinforcement of efforts, and continued skill building for problem solving.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CHW:
  • Age 18 or over
  • Be a service provider to PLHWUD attending commune health centers in one of the 40 communes selected selected for the study
  • Voluntary written informed consent
  • PLHWUD:
  • Age 18 or over
  • HIV positive (self-report)
  • Currently using opiates or has a history of opiate use (self-report) and seeking services at the commune health centers in one of 40 communes selected from the study
  • Has not received treatment services from OPC or MMT clinics (i.e., is treatment naive).
  • Voluntary written informed consent

You may not qualify if:

  • CHW:
  • Inability to give informed consent
  • PLHWUD:
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Commune Health Centers

Hải Dương, Hải Dương, Vietnam

Location

Commune Health Centers

Nghi An, Nghệ An Province, Vietnam

Location

Commune Health Centers

Bắc Giang, Vietnam

Location

Commune Health Centers

Nam Định, Vietnam

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Li Li, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Residence

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 26, 2017

Study Start

March 1, 2018

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

July 23, 2020

Record last verified: 2018-10

Locations