| Literature DB >> 34458390 |
Kathryn E Lancaster1, Katie R Mollan2,3, Brett S Hanscom4, Bonnie E Shook-Sa2,3, Tran V Ha3,5, Kostyantyn Dumchev6, Zubairi Djoerban7, Scott M Rose8, Carl A Latkin9, David S Metzger10, Vivian F Go3, Sergii Dvoriak11, Sarah A Reifeis2,3, Estelle M Piwowar-Manning12, Paul Richardson12, Michael G Hudgens2,3, Erica L Hamilton8, Susan H Eshleman12, Hepa Susami7, Viet Anh Chu5, Samsuridjal Djauzi7, Tetiana Kiriazova6, Do Thi Nhan13, David N Burns14, William C Miller1, Irving F Hoffman15.
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.Entities:
Keywords: HIV infection; antiretroviral therapy; injection drug use; methadone/therapeutic use; viral load
Year: 2021 PMID: 34458390 PMCID: PMC8391093 DOI: 10.1093/ofid/ofab281
Source DB: PubMed Journal: Open Forum Infect Dis ISSN: 2328-8957 Impact factor: 4.423
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.
Baseline Characteristics at the Time of Primary Trial Enrollment (N = 502)
| Characteristic | Overall | Intervention Reenrolled | Intervention Not Reenrolled | SOC Reenrolled | SOC Not Reenrolled | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| (N = 502) | (n = 89) | (n = 37) | (n = 238) | (n = 138) | ||||||
| Self-identified gender | ||||||||||
| Female | 75 | (15) | 13 | (15) | 3 | (8) | 47 | (20) | 12 | (9) |
| Male | 427 | (85) | 76 | (85) | 34 | (92) | 191 | (80) | 126 | (91) |
| Age, y | ||||||||||
| 18–19 | 1 | (<1) | 0 | (0) | 0 | (0) | 0 | (0) | 1 | (<1) |
| 20–29 | 81 | (16) | 12 | (13) | 9 | (24) | 37 | (16) | 23 | (17) |
| 30–39 | 328 | (65) | 60 | (67) | 25 | (68) | 159 | (67) | 84 | (61) |
| ≥40 | 92 | (18) | 17 | (19) | 3 | (8) | 42 | (18) | 30 | (22) |
| Highest education level | ||||||||||
| No schooling | 4 | (<1) | 0 | (0) | 1 | (3) | 1 | (<1) | 2 | (1) |
| At least some primary school | 55 | (11) | 6 | (7) | 6 | (16) | 20 | (8) | 23 | (17) |
| At least some secondary school | 256 | (51) | 41 | (46) | 20 | (54) | 120 | (50) | 75 | (54) |
| At least some technical training | 122 | (24) | 27 | (30) | 6 | (16) | 67 | (28) | 22 | (16) |
| At least some college or university | 65 | (13) | 15 | (17) | 4 | (11) | 30 | (13) | 16 | (12) |
| Relationship status | ||||||||||
| Married | 171 | (34) | 35 | (39) | 10 | (27) | 75 | (32) | 51 | (37) |
| Living with sexual partner, not married | 75 | (15) | 14 | (16) | 3 | (8) | 44 | (18) | 14 | (10) |
| Separated, divorced, widowed | 104 | (21) | 16 | (18) | 8 | (22) | 43 | (18) | 37 | (27) |
| Single | 152 | (30) | 24 | (27) | 16 | (43) | 76 | (32) | 36 | (26) |
| Unemployed (within past 3 mo) | ||||||||||
| Yes | 305 | (61) | 56 | (63) | 22 | (59) | 145 | (61) | 82 | (59) |
| No | 197 | (39) | 33 | (37) | 15 | (41) | 93 | (39) | 56 | (41) |
| Employment status | ||||||||||
| Employed full-time | 149 | (30) | 22 | (25) | 14 | (38) | 67 | (28) | 46 | (33) |
| Employed part-time | 134 | (27) | 25 | (28) | 9 | (24) | 58 | (24) | 42 | (30) |
| Unemployed, seeking work | 152 | (30) | 30 | (34) | 10 | (27) | 75 | (32) | 37 | (27) |
| Unemployed, not seeking work | 63 | (13) | 10 | (11) | 4 | (11) | 37 | (16) | 12 | (9) |
| Retired | 3 | (<1) | 1 | (1) | 0 | (0) | 1 | (<1) | 1 | (<1) |
| ART status (self-reported) | ||||||||||
| Currently on ART | 54 | (11) | 10 | (11) | 5 | (14) | 24 | (10) | 15 | (11) |
| Previously on ART | 46 | (9) | 8 | (9) | 1 | (3) | 27 | (11) | 10 | (7) |
| ART naive | 402 | (80) | 71 | (80) | 31 | (84) | 187 | (79) | 113 | (82) |
| On MOUD (self-reported) | ||||||||||
| Yes | 109 | (22) | 20 | (22) | 8 | (22) | 55 | (23) | 26 | (19) |
| No | 393 | (78) | 69 | (78) | 29 | (78) | 183 | (77) | 112 | (81) |
| Time since HIV diagnosis, y, median (IQR) | 1.4 | (0.07–6.4) | 3.0 | (0.13–8.5) | 0.10 | (0.06–5.5) | 1.1 | (0.06–5.9) | 0.60 | (0.08–5.9) |
| HIV-1 RNA, log10 copies/mL, median (IQR) | 4.6 | (4.0–5.0) | 4.6 | (3.9–4.9) | 4.8 | (4.4–5.0) | 4.5 | (3.9–4.9) | 4.7 | (4.1–5.1) |
| CD4 count, cells/μL, median (IQR) | 293 | (166–463) | 321 | (211–507) | 256 | (139–451) | 311 | (178–477) | 269 | (143–406) |
Data are presented as No. (%) unless otherwise indicated.
Abbreviations: ART, antiretroviral therapy; HIV, human immunodeficiency virus; IQR, interquartile range; MOUD, medication for opioid use disorder; SOC, standard of care.
aOne participant refused to answer (intervention reenrolled arm)
Antiretroviral Therapy, Medication for Opioid Use Disorder, Time Since HIV Diagnosis, and Viral Load at the Time of Study Extension Reenrollment
| Characteristic | Intervention Arm Reenrolled (Continuation) | SOC Arm Reenrolled and Started on Intervention | ||
|---|---|---|---|---|
| (n = 89) | (n = 94) | |||
| ART status (self-report) | ||||
| Currently on ART | 67 | (75) | 52 | (55) |
| Previously on ART | 17 | (19) | 13 | (14) |
| ART naive | 5 | (6) | 29 | (31) |
| Currently on MOUD (self-reported) | ||||
| Yes | 38 | (43) | 15 | (16) |
| No | 51 | (57) | 79 | (84) |
| Time since HIV diagnosis, y, median (IQR) | 5.0 | (2.3–10.4) | 2.4 | (2.0–6.4) |
| HIV-1 RNA | ||||
| Below 40 copies/mL | 38 | (43) | 38 | (40) |
| 40 to <1000 copies/mL | 8 | (9) | 9 | (10) |
| ≥1000 copies/mL | 43 | (48) | 47 | (50) |
Data are presented as No. (%) unless otherwise indicated.
Abbreviations: ART, antiretroviral therapy; HIV, human immunodeficiency virus; IQR, interquartile range; MOUD, medication for opioid use disorder; SOC, standard of care.
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.