Multilevel Integration Strategies to Enhance Service Provider Networks in Vietnam

Linkage to Care Clinical Trial

Official title:

Multilevel Integration Strategies to Enhance Service Provider Networks in Vietnam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293355
• Other study ID #: R01DA041008
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: October 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Linkage to Care

Intervention

Behavioral:
• VPN
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.

Locations

Country	Name	City	State
Vietnam	Commune Health Centers	B?c Giang
Vietnam	Commune Health Centers	Nam Ð?nh
Vietnam	Commune Health Centers	Nghi An	Nghe An
Vietnam	Commune Health Centers	Thành Ph? H?i Duong	H?i Duong

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Hygiene and Epidemiology, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	PLHWUD's service satisfaction	PLHWUD's service satisfaction will be measured using a 12-item scale to evaluate patients' service satisfaction with MMT and OPC treatment based on the Texas Christian University Client Evaluation of Self and Treatment (TCU-CEST) forms.	Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Secondary	CHW's patient-provider interaction with PLHWUD	CHW's communication and interaction with PLHWUD will be measured by a self-reported scale and the provider-patient communication logs.	Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Secondary	CHW's service provision	Service provision such as patient referrals will be captured by the reported frequency and type of service referrals made in the past three months to other treatment clinics will also be documented.	Changes from baseline to 3-, 6-, 9- and 12- month follow-ups