Scaling an intervention for the engagement of people with HIV who inject drugs into care in Viet Nam: an implementation-effectiveness, cluster-randomised trial.

backgroundGovernmental agencies often implement evidence-based interventions with a one-size-fits-all approach, which ignores site differences. We compared a tailored approach, accounting for sites' needs, to a standard approach to implement systems navigation and psychosocial counselling (SNaP) to improve HIV outcomes for people who inject drugs (PWID).

methodsWe conducted a hybrid type 3 implementation-effectiveness, cluster-randomised trial at HIV testing sites in ten provinces in Viet Nam. SNaP comprised two systems navigation sessions, in person or by telephone, and at least one psychosocial counselling session. Sites were randomised (1:1) to a standard approach (a package of 15 implementation strategies) or a tailored approach (standard strategies plus a menu of ten additional strategies). Study participants included navigators and counsellors of SNaP, site directors, other staff, and PWID with HIV. Sites were chosen based on the number of HIV tests performed, HIV positivity rate, and the size of the PWID population covered by the site. PWID with HIV were aged 18 years or older, not on antiretroviral therapy (ART) at enrolment, and had used injection drugs in the previous 6 months. The primary outcomes were fidelity (implementation outcome) and ART initiation (effectiveness outcome); secondary effectiveness outcomes were the current use of ART and medications for opioid use disorder and viral suppression. Analyses were conducted with generalised linear models or generalised estimating equations. The study was registered with ClinicalTrials.gov (NCT03952520) and is complete.

findingsOn Feb 27, 2020, 42 testing sites were randomised to two approaches (tailored: n=21; standard: n=21), and participants were recruited to the trial between May 8, 2020, and Aug 17, 2022, resulting in the inclusion of 277 staff (tailored: n=141; standard: n=136) and 723 PWID with HIV (tailored: n=364; standard: n=359). Clinic fidelity scores (range 0-200) were higher with the tailored approach (mean 151·4 [SD 21·4]) than the standard approach (114·1 [13·5]; adjusted mean difference 37·3 points [95% CI 26·5-48·1]). Nearly all follow-up participants receiving SNaP initiated ART (tailored: 345 [99%] of 347; standard: 334 [99%] of 338; adjusted risk difference 1·3 percentage points [95% CI 0·7-1·9]; intraclass correlation coefficient -0·01). Viral suppression among PWID was substantially higher in the tailored approach arm (adjusted prevalence difference 15·8% [95% CI 5·0-26·5]); no other secondary effectiveness outcomes were significant. There were 63 (9%) deaths among 685 follow-up participants, with 14 (2%) dying before baseline assessment.

interpretationA tailored approach with rapid needs assessment before and during implementation to address local testing site barriers in Viet Nam improved fidelity of SNaP delivery. The tailored approach had a small effect on ART initiation; viral suppression improved substantially.

fundingUS National Institutes of Health, US National Institute of Drug Abuse, and US National Institute for Allergy and Infectious Diseases.