Linkage to CareNCT03293355
Multilevel Integration Strategies to Enhance Service Provider Networks in Vietnam
A study testing VPN in people with Linkage to Care, run by University of California, Los Angeles at 4 sites in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Linkage to Care
- What is being tested?
- VPN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 4 sitesVietnam
- Study dates
- 1 Mar 2018to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- CHW:
- Inability to give informed consent
- PLHWUD:
- Inability to give informed consent
Trial locations and contacts
4 sites in 1 country.
Vietnam4 sites
Commune Health Centers
Bắc Giang
Commune Health Centers
Hải Dương, Hải Dương
Commune Health Centers
Nam Định
Commune Health Centers
Nghi An, Nghệ An Province
About this study
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.
Read the 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.
- Conditions
- Linkage to Care
- Being tested
- VPN
- Keywords
- People Living with HIV Who Use Drugs (PLHWUD), Community Health Workers (CHW), Multilevel Service Integration, HIV/AIDS, Vietnam
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPNBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: VPN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Secondary outcomes (3)
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.
Measured: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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.
Measured: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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.
Measured: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Mar 2018
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Linkage to CareStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam
- Responsible party
- Principal investigator, Li Li, University of California, Los Angeles
- Investigators
- Li Li, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293355
- Sponsor's protocol ID
- R01DA041008
- Status last verified
- Oct 2018
- First submitted
- 20 Sep 2017
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Integration Strategies to Enhance Service Provider Networks in Vietnam
- ClinicalTrials.gov ID
- NCT03293355
- Acronym / sponsor ID
- R01DA041008
- Conditions
- Linkage to Care
- Keywords
- People Living with HIV Who Use Drugs (PLHWUD), Community Health Workers (CHW), Multilevel Service Integration, HIV/AIDS, Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care |
| Intervention | Experimental | Behavioral: VPNThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Age 18 or over
- HIV positive (self-report)
Key exclusion criteria (4 listed)
- Inability to give informed consent
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPNTwo 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. | Behavioural | Intervention |
Primary outcome
PLHWUD's service utilization
Time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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.
CHW interaction with providers of other treatment agencies
Time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
This will be measured by a multi-item scale on interaction with other treatment providers
3 secondary outcomes
PLHWUD's service satisfaction
Time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
CHW's patient-provider interaction with PLHWUD
Time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
CHW's service provision
Time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Li, PhD principal investigator
University of California, Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VPN in people with Linkage to Care, run by University of California, Los Angeles at 4 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PLHWUD's service utilization (time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.