Engaging People Who Inject Drugs Living With HIV in Antiretroviral Treatment and Medication for Opioid Use Disorder: Extended Follow-up of HIV Prevention Trials Network (HPTN) 074

Abstract

Background: People who inject drugs (PWID) living with HIV experience inadequate access to antiretroviral treatment (ART) and medication for opioid use disorders (MOUD). HPTN 074 showed that an integrated intervention increased ART use and viral suppression over 52 weeks. To examine durability of ART, MOUD, and HIV viral suppression, participants could re-enroll for an extended follow-up period, during which standard-of-care (SOC) participants in need of support were offered the intervention.

Methods: Participants were recruited from Ukraine, Indonesia and Vietnam and randomly allocated 3:1 to SOC or intervention. Eligibility criteria included: HIV-positive; active injection drug use; 18-60 years of age; ≥1 HIV-uninfected injection partner; and viral load ≥1,000 copies/mL. Re-enrollment was offered to all available intervention and SOC arm participants, and SOC participants in need of support (off-ART or off-MOUD) were offered the intervention.

Results: The intervention continuation group re-enrolled 89 participants, and from week 52 to 104, viral suppression (<40 copies/mL) declined from 41% to 29% (estimated 9.4% decrease per year, 95% CI -17.0%; -1.8%). The in need of support group re-enrolled 94 participants and had increased ART (re-enrollment: 55%, week 26: 69%) and MOUD (re-enrollment: 16%, week 26: 25%) use, and viral suppression (re-enrollment: 40%, week 26: 49%).

Conclusions: Viral suppression declined in year 2 for those who initially received the HPTN 074 intervention and improved maintenance support is warranted. Viral suppression and MOUD increased among in need participants who received intervention during the study extension. Continued efforts are needed for widespread implementation of this scalable, integrated intervention.

Keywords: HIV infection; antiretroviral therapy; injection drug use; methadone/therapeutic use; viral load.

Figure 1.

Consolidated Standards of Reporting Trials (CONSORT) diagram. Enrollment and reenrollment participation, with primary trial intervention group on left and standard of care (SOC) group on right. *Participants originally randomized to SOC were recommended to receive intervention during the extension if they reported being off antiretroviral therapy and/or off medication for opioid use disorder at their last main study follow-up before the extension, or by site personnel discretion during the extension. †Retention denominator excludes participants who were deceased and nonrequired visits where the study closed before the participant’s targeted visit date. The denominator includes participants who missed the visit or exited study prematurely due to incarceration or compulsory rehabilitation, refusal to participate, unable to contact, or participant relocation. Extension visit e1 was the time of enrollment in the extension. Visit e1 is the extension enrollment. Visit e2 is extension week 13. Visit e3 is extension week 26.

Figure 2.

Proportion of intervention continuation participants on treatment (A) and virally suppressed (B) by study week (n = 126). Weeks since primary study enrollment is displayed on the x-axis, with year 2 of follow-up in the shaded region. The proportion of participants who were alive and on treatment is shown on the y-axis with a corresponding 95% confidence interval at each follow-up. Abbreviations: ART, antiretroviral therapy; CI, confidence interval; MOUD, medication for opioid use disorder.

Figure 3.

Proportion of in need of support participants on treatment (A) and virally suppressed (B) by study week (n = 94). Standard of care (SOC) randomization arm participants who enrolled in the extension and received the intervention during the extension. Weeks since extension enrollment is displayed on the x-axis, and week –65 to week –13 outcomes occurred during the primary SOC study period before the extension. The proportion of participants who were alive and on treatment is shown on the y-axis with a corresponding 95% confidence interval at each follow-up. By definition, participants were alive at the time of their extension enrollment (week 0) and typically, these participants were off antiretroviral therapy (ART) or off medication for opioid use disorder (MOUD) at extension enrollment. The sample size at the visit prior to the extension (–13 weeks) reflects the time gap between the end of the primary study and the opening of extension enrollment.