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Benefits Related to Participating in an International HIV Prevention Trial (HPTN 074) Involving People Who Inject Drugs
Developed by Indonesia ITTC
Published on 9/1/2019
Introduction
Pendahuluan
Given concerns about the social risks and ethics of conducting research with people who inject drugs (PWID) who may be affected by HIV it is important to identify not only research-related risks, but also the benefits that may be realized by research participation. These can include direct benefits due to the study intervention and indirect benefits related to participation.
Mengingat kekhawatiran mengenai risiko etik dan sosial dalam melaksanakan penelitian yang melibatkan pengguna napza suntik (penasun) yang terinfeksi HIV menjadi hal yang penting, bukan hanya mengidentifikasi risiko terkait penelitian, namun juga manfaat yang diperoleh karena partisipasi dalam penelitian. Manfaat tersebut dapat mencakup manfaat tidak langsung akibat intervensi penelitian dan manfaat tidak langsung yang terkait dengan partisipasi.
Methods
Metode
Due to the high frequency of particular themes inductively observed among responses to the “Other” query, post-hoc codes were applied to responses consistent with these themes: related to initiation of ART; referral for lab testing; other medical referral; and other. To do so, reports of “Other” benefits were reviewed and coded with consensus among two authors (JS, IMT).
Akibat tingginya frekuensi tema-tema tertentu yang diamati secara induktif dari respons terhadap pertanyaan “Lainnya”, kode post-hoc diterapkan untuk respon yang konsisten dengan tema-tema berikut” berhubungan dengan inisiasi obat ARV; rujukan tes laboratorium; rujukan medis lainnya, dan lainnya. Untuk melakukan kode post-hoc, laporan mengenai manfaat “Lainnya” ditinjau dan diberi kode sesuai dengan konsensus dua penulis (JS, IMT).
Reported benefits were aggregated for analysis into three groups: clinical (initiation of ART, cravings/withdrawal, drug use, lab testing, medical referral, mental health, physical health); social (employment, financial, relationships, stigma); and general (gained knowledge, life[1]improvement).
Untuk tujuan analisa, manfaat yang dilaporkan dibagi ke dalam tiga kelompok: klinis (inisiasi obat ARV, craving/gejala putus obat, penggunaan NAPZA, tes laboratorium, rujukan medis, kesehatan jiwa, kesehatan fisik); sosial (pekerjaan, keuangan, hubungan, stigma); dan umum (pengetahuan yang diperoleh, perbaikan hidup).
Results
Hasil Penelitian
A substantial majority of trial participants reported at least one benefit from study participation. This included 438 (90.5%) index participants and 642 (83.1%) partner participants. Particularly, social benefits included improvement in: employment (13.6% of indexes, 14.2% of partners); financial (33.7% of indexes, 26.9% of partners); relationships (57.6% of indexes, 48.2% or partners); and reduced stigma (50.6% of indexes, 35.1% of partners). Overall, significantly more INT index participants reported benefits than SOC index participants. Specifically, INT and SOC index participants respectively reported: 93.4% vs 78.2% clinical benefits; 83.6% vs 68.2% social benefits; and 97.5% vs 87.6% general benefits. In contrast, reported benefits among partner participants did not differ substantially by study arm.
Sebagian besar partisipan penelitian melaporkan setidaknya satu manfaat akibat partisipasi dalam penelitian, yaitu 438 (90,5%) partisipan indeks dan 642 (83.1%) partisipan pasangan menyuntik. Khususnya, manfaat sosial mencakup peningkatan dalam: pekerjaan (13.6% indeks, 14.2% pasangan menyuntik); keuangan (33.7% indeks, 26.9% pasangan menyuntik); hubungan (57.6% indeks, 48.2% pasangan menyuntik); dan penurunan stigma (50.6% indeks, 35.1% pasangan menyuntik).
Discussion
Diskusi
Given that the trial involved an intervention to enhance linkage to care, including treatment of HIV infection, medication assisted treatment of drug use and harm reduction services, the high proportion of clinical benefits is not surprising.
Karena penelitian ini melibatkan intervensi untuk meningkatkan hubungan dengan perawatan, termasuk pengobatan infeksi HIV, pengobatan yang dibantu obat untuk penggunaan napza dan layanan pengurangan dampak buruk, proposi tinggi pada manfaat klinis bukanlah hal yang mengejutkan.
Participants in both study arms also realized substantial social and general benefits related to trial participation. The large proportion of social benefits included improvements related to employment, finances, relationships, and stigma. While the relationship to study participation and these reported benefits is unclear, a variety of factors may have played a role. These include social benefits that may result from linkage to care for HIV infection and drug use as well as being part a trial in which participants are treated with respect while engaged in an endeavor that is of important scientific and social value.
Partisipan di kedua kelompok penelitian juga menyadari adanya manfaat sosial dan umum yang terkait dengan partisipasi dalam penelitian. Sebagian besar manfaat sosial mencakup peningkatan terkait pekerjaan, keuangan, hubungan, dan stigma. Meskipun hubungan antara partisipasi dalam penelitian dan manfaat yang dilaporkan tidak jelas, sejumlah faktor memiliki peran dalam hal ini. Ini mencakup manfaat sosial yang mungkin dihasilkan dari keterkaitan ke perawatan infeksi HIV dan penyalahgunaan napza serta menjadi bagian dalam penelitian dimana partisipan diperlakukan dengan hormat saat terlibat dalam upaya yang memiliki nilai sosial dan ilmiah yang penting.
In conclusion, clinical trial participation can provide broad benefits to stigmatized populations such as PWID who may be affected by HIV, well beyond specific intervention targets. Going forward, such benefits should be measured systematically as efforts are also taken to minimize risks related to participation.
Kesimpulannya, partisipasi dalam uji klinis dapat memberikan manfaat yang luas bagi populasi yang terstigmatisasi seperti penasun yang terinfeksi HIV, jauh diluar target intervensi khusus. Selanjutnya, manfaat tersebut sebaiknya diukur secara sistematis karena upaya-upaya yang juga dilakukan untuk meminimalisasi risiko terkait partisipasi.
Resource Link
https://www.hptn.org/research/publications/940
Materials
- HPTN 074
Jeremy Sugarman, Ilana M. Trumble, Erica L. Hamilton, Riza Sarasvita, Kostyantyn Dumchev, Ha Tran Viet, Irving F. Hoffman, William C. Miller, Brett S. Hanscom
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).