Clinical trial NCT03293355: Multilevel Integration Strategies to Enhance Service Provider Networks in Vietnam
Official title: Multilevel Integration Strategies to Enhance Service Provider Networks in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Linkage to Care
Keywords: People Living with HIV Who Use Drugs (PLHWUD)
Community Health Workers (CHW)
Multilevel Service Integration
HIV/AIDS
Vietnam
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Hygiene and Epidemiology, Vietnam
First posted: 2017-09-26
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The purpose of this study is to develop and pilot test intervention strategies at the provincial level (Aim 1), treatment agency level (Aim2), and community level (Aim 3). These strategies aim to strengthen both horizontal and vertical collaboration and networking among providers to better serve people living with HIV who use drugs (PLHWUD), including those who are already in treatment and those who need to be linked to service. Commune health workers (CHW) have great potentials to be mobilized to engage PLHWUD living in the community and to work with providers at treatment clinics to support PLHWUD treatment retention and adherence. E-technologies such as Facebook and e-chat will also be utilized to enhance provider-provider coordination and provider-patient interaction.

The Specific Aims of the study are as follows:

Aim 1: Develop and implement structural-level strategies by establishing a provincial coordination team to improve coordination and service integration.

Aim 2: Assess agency-level intervention outcomes on treatment-provider collaboration and service integration of OPC services and MMT programs.

Aim 3: Assess community provider-level intervention outcomes by evaluating whether: 1) CHW in the intervention group, compared to those in the control group, demonstrate improved levels of collaboration with other clinical agencies, communication with patients, and service referrals, and 2) PLHWUD in the intervention group, compared to those in the control group, demonstrate improvements in treatment initiation, retention and adherence, and other mental and biological outcomes.

Based on the findings from Aims 1 and 2 activities, this intervention will be conducted in four provinces of Vietnam(Bac Giang, Hai Duong, Nam Dinh, and Nghe An). Randomization will occur at the community level (20 communes assigned to the intervention group; 20 communes assigned to the control group).

CONTROL COMMUNE ACTIVITIES:

A total of 40 CHW from 20 communes assigned to the control group will be invited to participate in a one-time didactic lecture/meeting with other co-workers from their commune health centers to learn about the importance of service integration.

CHW(n=40) and PLHWUD(n=120) from the control commune health centers will participate in a baseline assessment and follow-up assessments at 3, 6, 9, 12-months.

INTERVENTION COMMUNE ACTIVITIES:

A total of 40 CHW from 20 communes assigned to the intervention group will be invited to participate in the intervention that will consist of two in-person sessions lasting approximately 90 minutes over two weeks with 8-10 CHW in each session.

Booster sessions of the intervention training will be offered to CHW once every month during the first three months and once every three months thereafter. The booster session will focus on CHW' reports of their experiences, reinforcement of efforts, and continued skill building for problem solving. CHW(n=40) and PLHWUD(n=120) from the intervention commune health centers will participate in a baseline assessment and follow-up assessments at 3, 6, 9, 12-months.

The efficacy of the intervention will be assessed at baseline, 3, 6, 9, and 12-month follow-ups.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

CHW:

* Inability to give informed consent

PLHWUD:

* Inability to give informed consent

Primary outcomes:
measure: PLHWUD's service utilization
timeFrame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
measure: CHW interaction with providers of other treatment agencies
timeFrame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Secondary outcomes:
measure: PLHWUD's service satisfaction
timeFrame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
measure: CHW's patient-provider interaction with PLHWUD
timeFrame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
measure: CHW's service provision
timeFrame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Other outcomes:
Locations:
city: Thành Phố Hải Dương
country: Vietnam
facility: Commune Health Centers
state: Hải Dương
city: Nghi An
country: Vietnam
facility: Commune Health Centers
state: Nghe An
city: Bắc Giang
country: Vietnam
facility: Commune Health Centers
city: Nam Định
country: Vietnam
facility: Commune Health Centers
Study officials:
affiliation: University of California, Los Angeles
name: Li Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: