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

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

Preventing blood-borne virus infection in people who inject drugs in the UK: systematic review, stakeholder interviews, psychosocial intervention development and feasibility randomised controlled trial

“…Go et al 82 conducted a multilevel intervention using a 2 × 2 (four-arm) factorial design consisting of (1) standard of care (i.e. HIV infection testing and counselling); (2) a structural-level community stigma reduction programme; (3) individual-level post-test counselling and skill-building support groups; and (4) both individual-and structural-level activities.…”

“…171 One manuscript published in Chinese was excluded. 172 In total, 42 manuscripts from 32 trials were eligible, 22,[68][69][70][71][72][73][74][75][76][77][81][82][83][84][85] 41 originating from the electronic database searches, and one from hand-searching recent reviews and review of reviews 178 was added as a result of this process. Twenty-four trials were included in the meta-analysis.…”

“…Twenty-four trials were included in the meta-analysis. 22,[68][69][70][71][72][73]75,76,81,82,173,175,179,180,182,186,188,189,[192][193][194][195]197 The reasons for excluding eight trials from the meta-analysis were not providing the number of PWID for control and intervention groups at follow-up, 84,174,176,177,196 only providing risk ratios, 178 outcome combined HIV infections with sexually transmitted infections 77 and data for 'unsafe injection practices' were presented only at baseline. 74 …”

“…In total, 12,840 participants (35% female, range 0-100%) were enrolled in the trials; the majority were PWID (84.5%) (the proportion of participants enrolled in the trials who were PWID ranged from 16% to 100%). The majority (n = 18) of trials were conducted in the USA, 22,68,[70][71][72]76,81,84,174,176,177,179,182,186,189,193,195,196 three were conducted in Russia, 74,75,194 two were conducted in Canada, 175,178 two were conducted in Vietnam, 82,180 one was conducted in Kazakhstan, 73 one was conducted in Georgia, 188 one was conducted in Australia, 197 one was conducted in the UK, 173 one was conducted in Mexico, 77 one was conducted in Puerto Rico 192 and one was conducted in both the USA and Thailand. 69 Trials included in the systematic review compared psychosocial interventions with usual care (n = 4), 22,68,178,195 education or information (n = 9), 70,76,77,175,176,180,188,…”

“…84,177 The remaining eight trials delivered interventions in more than one way (e.g. individual and couples sessions, 187,188 individual and group sessions, 69,76,186,190,194 Records identified from electronic database searches ( Samet 2015 194 Rotheram-Borus 2010 193 Robles 2004 192 Purcell 2007 189 Otiashvili 2012 188 McMahon 2013 84 Margolin 2003 Hoffman 2013 74 Go 2015 82 Go 2013 180 Gilbert 2010 73 Garfein 2007 179 Gagnon 2010 178 El-Bassell 2011 177 Dushay 2001 ) and one trial provided both individual-and structural-level activities. 82 For interventions with more than one session, retention or adherence to the intervention ranged from 50% 68 to 95%.…”