Enhancing the Role of Commune Health Workers in HIV and Drug Control: A Randomized Controlled Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02130921
• Date of registration: 01/05/2014
• Prospective Registration: Yes
• Primary sponsor: University of California, Los Angeles
• Public title: Enhancing the Role of Commune Health Workers in HIV and Drug Control: A Randomized Controlled Trial
• Scientific title: Enhancing the Role of Commune Health Workers in HIV and Drug Control: A Randomized Controlled Trial
• Date of first enrolment: July 2014
• Target sample size: 1800
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02130921
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Vietnam

Contacts

• Name: Li Li, Ph.D
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Drug Dependence

Intervention(s)

Behavioral: Intervention to Address Drug Use and HIV in Vietnam

Primary Outcome(s)

Community Health Worker (CHW) Interaction with patients [Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up]

Injecting Drug User (IDU) drug use [Time Frame: baseline, 3-, 6-, 9- and 12- month follow-up]

Secondary Outcome(s)

Injecting Drug User (IDU) family and social support [Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up]

Community Health Worker (CHW) general prejudicial attitude [Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up]

Community Health Worker (CHW) job safety, support, and satisfaction [Time Frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up]

Community Health Worker (CHW) knowledge and adherence to universal precautions [Time Frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up]

Family Member (FM) social support [Time Frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up]

Family Member (FM) Caregiver burden/coping [Time Frame: Changes from baseline to 3-,6-,9-, and 12-month follow-up]

Secondary ID(s)

R01DA033609-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Hygiene and Epidemiology, Vietnam