Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03293355
Study type Interventional
Source University of California, Los Angeles
Contact
Status Completed
Phase N/A
Start date March 1, 2018
Completion date May 31, 2020

See also
  Status Clinical Trial Phase
Completed NCT02964897 - Improving Linkage to Health and Other Services for Veterans Leaving Incarceration N/A
Completed NCT01637324 - Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM N/A
Completed NCT05388084 - Peer Led Outreach to Engage Male Partners of Pregnant Women in Uganda (Okutuuka Study) N/A
Completed NCT03484533 - HIV Self Testing of Male Partners of Women in PMTCT N/A
Recruiting NCT03757104 - Home-based Intervention to Test and Start N/A
Enrolling by invitation NCT05194085 - Impact of Male Provider Phone Calls to Increase Men's Clinic Linkage After HIVST N/A
Completed NCT05092997 - Kingasa Pilot Study N/A