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  1. Fulltext Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia
    Chandra DK, Bazazi AR, Nahaboo Solim MA, Kamarulzaman A, Altice FL, Culbert GJ
    HIV Res Clin Pract, 2019 Feb;20(1):12-23.
    PMID: 31303149 DOI: 10.1080/15284336.2019.1603433
    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.
  2. Adaption of an ongoing clinical trial to quickly respond to gaps in changing international recommendations: the experience of D2EFT
    Papot E, Jacoby S, Arlinda D, Avihingsanon A, Azwa I, Borok M, et al.
    HIV Res Clin Pract, 2022 Jul 19;23(1):37-46.
    PMID: 35938597
    A rapidly changing landscape of antiretrovirals and their procurement at scale has permitted the evaluation of new optimised second-line antiretroviral therapy (ART) in low- and middle-income countries. D2EFT is an open-label randomised controlled non-inferiority phase IIIB/IV trial in people living with HIV-1 (PWH) whose first-line non-nucleoside reverse transcriptase inhibitor (NNRTI)-based ART is failing. At inception, it compared a standard of care of boosted darunavir with two nucleos(t)ide reverse transcriptase inhibitors (NRTIs) to the novel NRTI-sparing regimen of boosted darunavir with dolutegravir. Implemented in 2017, participating sites were across Africa, Asia and Latin America. Around the time of implementation, the World Health Organization updated its treatment guidelines and recommended scaling up tenofovir disoproxil fumarate-lamivudine-dolutegravir (TLD). This situation pushed D2EFT investigators to consider the impact of the roll-out of TLD on the D2EFT research question. The protocol team agreed it was important to study TLD in second-line when an NNRTI regimen was failing, and focused on options to expedite the work by studying the question within the existing trial and network. All key issues (statistical, programmatic and financial) were reviewed to assess the benefits and risks of adding a third arm to the ongoing study, as opposed to developing a new randomised clinical trial with the same control arm and within the same network. The development of a new trial was deemed to be longer than adding a third arm, and to create a challenging situation with two competing clinical trials at the same sites which would slow down recruitment and impair both trials. On the other hand, adding a third arm would be demanding in terms of operationalisation, increased sample size and statistical biases to control. The optimal strategy was deemed to be the addition of a third arm, arriving retrospectively at a simplified multi-arm multi-stage clinical trial design to achieve statistical validity. The D2EFT study maintains additional value in a quickly evolving second-line ART strategy allowed by the progress in global access to ART.
  3. Evaluating knowledge, practice, and attitude of Syrian population on sexually transmitted infections and human immunodeficiency virus
    Swed S, Alibrahim H, Albakri K, Rais MA, Al-Rassas S, Hafez W, et al.
    HIV Res Clin Pract, 2024 Dec;25(1):2356409.
    PMID: 39001878 DOI: 10.1080/25787489.2024.2356409
    BACKGROUND: Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) can cause severe and fatal complications; knowledge about these diseases is essential for promoting safe sex practices and modifying behaviours that are harmful to one's health. This study investigates Syrian people's understanding, attitudes, and behaviors towards HIV/AIDS and STIs, aiming to identify factors promoting safe sex practices and modifying harmful behaviors.

    METHODS: This online cross-sectional study was conducted in Syria between 3 September and 23 November 2022, involving all 18+ individuals. The questionnaire was adapted from a previous study containing 74 questions from five sections: socio-demographic information, knowledge and practice regarding STIs, knowledge and practice regarding HIV/AIDS, attitude towards HIV/AIDS, and attitude regarding STIs and analyzed using descriptive and multivariate logistic regression.

    RESULTS: The study involved 1073 participants mostly aged between 18-30, with 55.3% females. Over half had good awareness of STIs and HIV/AIDS, with 55% and 63% respectively. Specifically, the overall knowledge level of STI type, signs/symptoms, risks of transmission, preventive methods, and complications for untreated STIs were (45.7%), (52.9%), (58.1%), (66.1%), and (59.6%), respectively. Medical field respondents had higher knowledge of HIV (P-value < 0.05, OR = 2).

    CONCLUSION: Our results show that Syrian people have a knowledge level of STIs and HIV was moderate. However, the attitude toward STIs was negative, as less than half of the participants had a good attitude. It is essential to solve these knowledge gaps, especially in low-income countries such as Syria.

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