TY - JOUR
T1 - Retention in clinical trials after prison release
T2 - results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia
AU - Chandra, Divya K.
AU - Bazazi, Alexander R.
AU - Nahaboo Solim, Muzammil A.
AU - Kamarulzaman, Adeeba
AU - Altice, Frederick L.
AU - Culbert, Gabriel J.
N1 - Funding Information:
This work was supported by the National Institute on Drug Abuse under grants R01 DA025943 (FLA), R01 DA041271 (FLA), K23 DA041988 (GJC), and F30 DA039716 (ARB). We thank study participants for generously sharing of their time. We also thank study coordinators, research assistants, and data managers at CERiA and Yale University who helped to retain study participants and assemble the data set. Finally, we wish to thank the Malaysian Prison Department [Jabatan Penjara Malaysia] for their cooperation and assistance to conduct the study.
Publisher Copyright:
© 2019, © 2019 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2019/1/2
Y1 - 2019/1/2
N2 - Background: Study retention is a major challenge in HIV clinical trials conducted with persons recruited from correctional facilities. Objective: To examine study retention in a trial of within-prison methadone initiation and a behavioral intervention among incarcerated men with HIV and opioid dependence in Malaysia. Methods: In this 2x2 factorial trial, 296 incarcerated men with HIV and opioid dependence were allocated to (1) an HIV risk reduction intervention, the Holistic Health Recovery Program for Malaysia (HHRP-M), (2) pre-release methadone initiation, (3) both interventions, or (4) standard care (NCT02396979). Here we estimate effects of these interventions on linkage to the study after prison release and completion of post-release study visits. Results: Most participants (68.9%) completed at least one post-release study visit but few (18.6%) completed all 12. HHRP-M was associated with a 13.5% (95% confidence interval (CI): 3.8%, 23.2%) increased probability of completing at least one post-release study visit. Although not associated with initial linkage, methadone treatment was associated with an 11% (95% CI: 2.0%, 20.6%) increased probability of completing all twelve post-release study visits. Being subject to forced relocation outside Kuala Lumpur after prison release decreased retention by 43.3% (95% CI: −51.9%, −34.8%). Conclusion: Retaining study participants in HIV clinical trials following prison release is challenging and potentially related to the broader challenges that participants experience during community reentry. Researchers conducting clinical trials with this population may want to consider methadone and HHRP as means to improve post-release retention, even in clinical trials where these interventions are not being directly evaluated.
AB - Background: Study retention is a major challenge in HIV clinical trials conducted with persons recruited from correctional facilities. Objective: To examine study retention in a trial of within-prison methadone initiation and a behavioral intervention among incarcerated men with HIV and opioid dependence in Malaysia. Methods: In this 2x2 factorial trial, 296 incarcerated men with HIV and opioid dependence were allocated to (1) an HIV risk reduction intervention, the Holistic Health Recovery Program for Malaysia (HHRP-M), (2) pre-release methadone initiation, (3) both interventions, or (4) standard care (NCT02396979). Here we estimate effects of these interventions on linkage to the study after prison release and completion of post-release study visits. Results: Most participants (68.9%) completed at least one post-release study visit but few (18.6%) completed all 12. HHRP-M was associated with a 13.5% (95% confidence interval (CI): 3.8%, 23.2%) increased probability of completing at least one post-release study visit. Although not associated with initial linkage, methadone treatment was associated with an 11% (95% CI: 2.0%, 20.6%) increased probability of completing all twelve post-release study visits. Being subject to forced relocation outside Kuala Lumpur after prison release decreased retention by 43.3% (95% CI: −51.9%, −34.8%). Conclusion: Retaining study participants in HIV clinical trials following prison release is challenging and potentially related to the broader challenges that participants experience during community reentry. Researchers conducting clinical trials with this population may want to consider methadone and HHRP as means to improve post-release retention, even in clinical trials where these interventions are not being directly evaluated.
KW - Clinical trials
KW - criminal justice
KW - HIV
KW - prisoners
KW - study retention
KW - substance use
UR - http://www.scopus.com/inward/record.url?scp=85076356113&partnerID=8YFLogxK
U2 - 10.1080/15284336.2019.1603433
DO - 10.1080/15284336.2019.1603433
M3 - Article
C2 - 31303149
AN - SCOPUS:85076356113
SN - 2578-7489
VL - 20
SP - 12
EP - 23
JO - HIV Research & Clinical Practice
JF - HIV Research & Clinical Practice
IS - 1
ER -
