Clinical trial NCT02130921: Enhancing the Role of Commune Health Workers in HIV and Drug Control: A Randomized Controlled Trial
Official title: Enhancing the Role of Commune Health Workers in HIV and Drug Control: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Dependence
Keywords: Stigma
HIV
CHWs
PLH
Injecting Drug Users
FM
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Hygiene and Epidemiology, Vietnam
First posted: 2014-05-06
Enrollment: 1800
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: This proposed study is an initiative for HIV prevention and care that integrates intervention efforts at multiple strata: Community Health Workers (CHWs), Injecting Drug Users (IDUs), and their Family Members (FMs). The proposed study will demonstrate the process of development, implementation, and evaluation of an intervention for CHWs, IDUs, and their FMs. One aim is to increase the CHWs' capacities to effectively interact with IDUs and FMs for HIV and drug use prevention and treatment. Using a combination of participatory action research and a randomized controlled trial design, this study has the potential to maximize PEPFAR impact in Vietnam and other PEPFAR-funded countries by identifying a sustainable mix of interventions and their implementation in different settings. The findings may benefit not only Vietnam but also a global audience by investigating enhanced methods for controlling the HIV epidemic.

Detailed description: Vietnam is currently facing an HIV epidemic that had affected approximately 280,000 people by the end of 2009. Injecting Drug Use (IDU) is principal driver of the HIV epidemic, contributing to between 32 % and 58 % of all HIV cases in various provinces. However, it has proven difficult to address the needs of IDUs, a high-risk group, given the prevalence of stigmatization and drug use in Vietnamese society. In addition, Vietnamese people are highly family oriented and most young IDUs have daily family contact of live in their parents' homes. Thus the burden on the family is substantial, and even greater if the IDU is HIV+.

The study will be implemented in two provinces in Vietnam: Phu Tho and Vinh Phuc. A randomized controlled trial will be conducted to evaluate the impact of the intervention in 60 commune health centers. From each center we will recruit 5 Community Health Workers (CHWs), 15 Injecting Drug Users (IDUs), and 10 Family Members (FMs) (totaling 300 CHWs, 900 IDUs, and 600 FMs). The outcomes will be evaluated at 3-, 6-, 9-, and 12- month follow-up assessments. The specific aims of the study are as follows:

1. To develop and implement an integrated intervention, CHW CARE, for CHWs, IDUs, and their FMS in Vietnam
2. To evaluate the feasibility and operational procedures of the intervention with an implementation pilot, including process evalution and monitoring, and participants feedback.
3. To assess the impact of the intervention by comparing outcome measures of CHWs, IDUs, and FMs in the intervention group to those in the control group.
4. To explore the relationships between the intervention outcomes of CHWs, IDUs, and FMs.

Eligibility criteria: Inclusion Criteria:

Injecting Drug Users:

* Age 18 or over
* Having a history of drug use
* Currently residing in the selected commune, and have no plan to move to other communes in the following year
* Voluntary informed consent

Family members of Injecting Drug Users:

* Age 18 or over
* Immediate or extended family member of the Injecting Drug User.
* Previous knowledge of the drug use of the IDU.
* Voluntary informed consent
* Currently residing in the selected commune, and have no plan to move to other communes in the following year

Community Health Workers:

* Age 18 or over
* Doctor, nurse, or other care provider working at the selected commune health centers
* Informed consent

Exclusion Criteria:

Injecting Drug Users:

* Those who have psychosis or neurological damage, or cannot understand the study purposes as judged by the interviewer in consultation with a clinic supervisor, will be excluded
* Does not meet other inclusion criteria

Family members of Injecting Drug Users:

* Those who have psychosis or neurological damage, or cannot understand the study purposes as judged by the interviewer in consultation with a clinic supervisor, will be excluded
* Does not meet other inclusion criteria

Community Health Workers:

* Inability to give informed consent
* Does not meet other inclusion criteria

Primary outcomes:
measure: Community Health Worker (CHW) Interaction with patients
timeFrame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up
measure: Injecting Drug User (IDU) drug use
timeFrame: baseline, 3-, 6-, 9- and 12- month follow-up
Secondary outcomes:
measure: Community Health Worker (CHW) job safety, support, and satisfaction
timeFrame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up
measure: Community Health Worker (CHW) knowledge and adherence to universal precautions
timeFrame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up
measure: Injecting Drug User (IDU) family and social support
timeFrame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up
measure: Family Member (FM) social support
timeFrame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up
measure: Community Health Worker (CHW) general prejudicial attitude
timeFrame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up
measure: Family Member (FM) Caregiver burden/coping
timeFrame: Changes from baseline to 3-,6-,9-, and 12-month follow-up
Other outcomes:
Locations:
city: Phú Thọ
country: Vietnam
facility: Phú Thọ commune health centers
city: Vĩnh Phúc
country: Vietnam
facility: Vĩnh Phúc commune health centers
Study officials:
affiliation: University of California, Los Angeles
name: Li Li, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: