Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial.

Vivian F Go,Tran Thi Mo,Teerada Sripaipan,Carla Zelaya,David D Celentano,Tran Viet Ha,Constantine Frangakis,Pham The Vu,Wendy W Davis,Carl Latkin,Nguyen Le Minh,Vu Minh Quan

doi:10.1371/journal.pone.0125909

Abstract

IntroductionInjecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID) and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed.Methods455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled. We conducted a two-stage randomization: First, sub-districts were randomized to either a community video screening and house-to-house visits or standard of care educational pamphlets. Second, within each sub-district, participants were randomized to receive either enhanced individual level post-test counseling and group support sessions or standard of care HIV testing and counseling. This resulted in four arms: 1) standard of care; 2) community level intervention; 3) individual level intervention; and 4) community plus individual intervention. Follow-up was conducted at 6, 12, 18, and 24 months. Primary outcomes were self-reported HIV injecting and sexual risk behaviors. Secondary outcomes included HIV incidence among HIV negative network members.ResultsFewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms (77% to 4% and 24% to 5% respectively). There were no significant differences at the 24-month visit among the 4 arms (Wald = 3.40 (3 df); p = 0.33; Wald = 6.73 (3 df); p = 0.08). There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms.DiscussionUnderstanding the mechanisms through which all arms, particularly the control arm, demonstrated both low risk behaviors and low HIV incidence has important implications for policy and prevention programming.Trial RegistrationClinicalTrials.gov NCT01689545

Highlights

Injecting drug use is a primary driver of HIV epidemics in many countries
As in many other settings where injection drug use is the primary driver of a concentrated HIV epidemic, People who inject drugs (PWID) face severe social marginalization within families and communities [15, 16], may be subject to compulsory detoxification and incarceration, and are discriminated against in health care settings [17]
Despite evidence underscoring the need for multi-level interventions, to our knowledge, there has not been a multi-level study focusing on a key population such as PWID in a concentrated epidemic

Summary

Introduction

Injecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID) and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed

Methods

Results

Trial Registration

Ethics statement