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A Scalable, Integrated Intervention To Engage People Who Inject Drugs In HIV Care And Medication-Assisted Treatment (HPTN 074): A Randomised, Controlled Phase 3 Feasibility And Efficacy Study

Developed by Indonesia ITTC

Published on 9/1/2018

Summary



The study was conducted in three countries with high prevalence of addiction cases: Indonesia, Vietnam, and Ukraine. The aim of the study is to assess the feasibility of a future controlled trial based on the incidence of HIV, enrolment, retention, and uptake of the intervention, and the efficacy of an integrated and flexible intervention on ART use, viral suppression, and (Medication-Assisted Treatment) MAT use.



Studi HPTN 074 dilaksanakan di tiga negara yang memiliki kasus adiksi dengan prevalensi tinggi: Indonesia, Vietnam, dan Ukraina. Tujuan dari studi ini adalah untuk menilai kelayakan dari uji klinis terkendali di masa depan berdasarkan pada insidens HIV, enrolmen, retensi, dan serapan intervensi, serta efikasi dari intervensi yang fleksibel dan terintegrasi untuk penggunaan obat ARV, supresi virus, dan penggunaan obat MAT.



 



This randomised, controlled vanguard study was run in Kyiv, Ukraine (one community site), Thai Nguyen, Vietnam (two district health centre sites), and Jakarta, Indonesia (one hospital site). PWID who were HIV infected (index participants) and non-infected injection partners were recruited as PWID network units and were eligible for screening if they were aged 18–45 years (updated to 18–60 years 8 months into study), and active injection drug users. Further eligibility criteria for index participants included a viral load of 1000 copies per mL or higher, willingness and ability to recruit at least one injection partner who would be willing to participate. Index participants were randomly assigned via a computer generated sequence accessed through a secure web portal (3:1) to standard of care or intervention, stratified by site. Masking of assignment was not possible due to the nature of intervention. The intervention comprised systems navigation, psychosocial counselling, and ART at any CD4 count. Local ART and MAT services were used. Participants were followed up for 12–24 months.



Uji klinis ini bersifat terkontrol dan random serta dilaksanakan di Kyiv, Ukraine (satu pusat komunitas), Thai Nguyen, Vietnam (dua puskesmas), dan Jakarta Indonesia (satu rumah sakit). Penasun dengan HIV (partisipan indeks) dan pasangan menyuntiknya yang HIV negatif direkrut sebagai unit jejaring penasun dan layak untuk diskrining jika mereka berusia 18-45 tahun (diperbaharui menjadi 18-60 tahun, 8 bulan setelah studi berjalan) serta merupakan penasun yang aktif. Kriteria kelayakan lainnya bagi partisipan indeks meliputi angka viral load 1.000 kopi/mL atau lebih, keinginan dan kemampuan untuk merekrut setidaknya satu orang pasangan menyuntik yang mau berpartisipasi dalam studi. Partisipan indeks ditetapkan secara acak melalui sekuensi komputerisasi yang diakses melalui portal web yang aman (3:1) ke dalam kelompok layanan standar atau intervensi, distratifikasi berdasarkan site. Penutupan penetapan kelompok tidak dapat dilakukan karena sifat intervensi. Paket intervensi terdiri dari: navigasi system, konseling psikososial, dan ART tanpa melihat angka CD4. Layanan MAT dan ART lokal menjadi tempat rujukan. Partisipan ditindaklanjuti selama 12-24 bulan.



 



Across all sites, between Feb 5, 2015, and June 3, 2016, 3343 potential index participants were screened, of whom 504 (15%) HIV-infected PWID were enrolled as index participants; two subsequently excluded for ineligibility reasons. Of the remaining 502 eligible index participants, 194 (39%) were enrolled in Thai Nguyen, Vietnam, 187 (37%) in Kyiv, Ukraine, and 121 (24%) in Jakarta, Indonesia. 1171 injection partners were referred, of whom 810 (69%) were enrolled; 4 were subsequently excluded due to ineligibility reasons. Thus, 806 partners were included in analysis.



Di ketiga site, periode skrining dimulai tanggal 5 Februari 2015 sampai dengan 3 Juni 2016, sebanyak 3.343 partisipan indeks yang potensial berhasil diskrining, dan 504 penasun dengan HIV (15%) berhasil dienrol sebagai partisipan indeks; dua orang dikeluarkan karena alasan tidak memenuhi kriteria kelayakan. Dari 502 partisipan indeks tersebut, 194 penasun (39%) dienrol di site Thai Nguyen, Vietnam, 187 orang (37%) di site Kyiv, Ukraina, dan 121 orang (24%) di site Jakarta, Indonesia. Sebanyak 1.171 pasangan menyuntik dirujuk. Dari jumlah tersebut, sebanyak 810 (69%) berhasil dienrol; sebanyak 4 orang pasangan menyuntik dikeluarkan dari studi karena alasan tidak memenuhi kriteria kelayakan. Oleh karenanya, hanya 806 pasangan menyuntik yang termasuk dalam analisa data.



 



Index participants were randomly assigned to intervention (126 [25%]) and standard of care (376 [75%]) groups. At week 52, most living index participants (389 [86%] of 451) and partners (567 [80%] of 710) were retained, and self-reported ART use was higher among index participants in the intervention group than those in the standard of care group (probability ratio [PR] 1·7, 95% CI 1·4–1·9). Viral suppression was also higher in the intervention group than in the standard of care group (PR 1·7, 95% CI 1·3–2·2). Index participants in the intervention group reported more MAT use at 52 weeks than those in the standard of care group (PR 1·7, 95% CI 1·3–2·2). Seven incident HIV infections occurred, and all in injection partners in the standard of care group (intervention incidence 0·0 per 100 person-years, 95% CI 0·0–1·7; standard of care incidence 1·0 per 100 person-years, 95% CI 0·4–2·1; incidence rate difference –1·0 per 100 person-years, 95% CI –2·1 to 1·1). No severe adverse events due to the intervention were recorded.



Partisipan indeks dikelompokkan secara acak ke kelompok intervensi (126 [25%]) dan kelompok layanan standar (376 [75%]). Pada minggu ke-52, sebagian besar partisipan indeks yang hidup (389 [86%] dari 451) dan pasangan menyuntik (567 [80%] dari 710) tetap mengikuti penelitian. Penggunaan obat ARV yang dilaporkan secara mandiri juga tinggi pada partisipan indeks dari kelompok intervensi dibandingkan pada kelompok layanan standar (probability ratio [PR] 1·7, 95% CI 1·4–1·9). Penggunaan obat MAT di minggu ke-52 pada partisipan indeks di kelompok intervensi dilaporkan lebih banyak dibandingkan pada kelompok layanan standar (PR 1·7, 95% CI 1·3–2·2). Sebanyak 7 insidens infeksi HIV terjadi sepanjang studi berlangsung; seluruh kasus insidens tejadi pada pasangan menyuntik di kelompok layanan standar (insidens pada kelompok intervensi 0·0 per 100 orang-tahun, 95% CI 0·0–1·7; insidens pada kelompok layanan standar 1·0 per 100 orang-tahun, 95% CI 0·4–2·1; perbedaan angka insidens –1·0 per 100 orang-tahun, 95% CI –2·1 to 1·1). Tidak terdapat kasus kejadian yang tidak diinginkan terjadi akibat intervensi yang dilakukan.


https://www.hptn.org/research/publications/832

Materials

 

Related Topics

  • Evidence Based Practices
  • HIV/AIDS

This product was developed by this Center under previous funding as part of the Addiction Technology Transfer Center Network through the President's Emergency Plan For AIDS Relief (PEPFAR)/Substance Abuse Mental Health Administration (SAMHSA).