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Reported Participation Benefits in International HIV Prevention Research with People Who Inject Drugs.

ABSTRACT: Given ethical concerns about research involving people who inject drugs and those affected by HIV, identifying potential participation benefits is important. We evaluated participant-reported benefits in a trial conducted in Indonesia, Ukraine, and Vietnam that assessed an intervention combining psychosocial counseling and referral for antiretroviral therapy and substance use treatment for HIV-infected people who use drugs. Reported benefits were aggregated into three groups: clinical (antiretroviral therapy, reduced cravings, reduced drug use, lab testing, medical referral, mental health, physical health), social (employment, financial, relationships, reduced stigma), and general (gained knowledge, life improvement). Overall, 438 index participants (90.5%) and 642 injection partners (83.1%) reported at least one benefit. Significantly more index participants who received the study intervention reported at least one benefit versus those who received the standard of care. Clinical trial participation can provide broad direct and indirect benefits for stigmatized populations, which has implications for assessing the ethical appropriateness of studies with such populations.

SUBMITTER: Sugarman J

PROVIDER: S-EPMC8792865 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Reported Participation Benefits in International HIV Prevention Research with People Who Inject Drugs.

Sugarman Jeremy J Trumble Ilana I Hamilton Erica E Sarasvita Riza R Dumchev Kostyantyn K Viet Ha H Hoffman Irving I Miller William W Hanscom Brett B

Ethics & human research 20190901 5

Given ethical concerns about research involving people who inject drugs and those affected by HIV, identifying potential participation benefits is important. We evaluated participant-reported benefits in a trial conducted in Indonesia, Ukraine, and Vietnam that assessed an intervention combining psychosocial counseling and referral for antiretroviral therapy and substance use treatment for HIV-infected people who use drugs. Reported benefits were aggregated into three groups: clinical (antiretro ...[more]

PMID: 31541541

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Project description:BackgroundHIV disproportionately impacts people who experience incarceration. Incarceration represents an opportunity to engage in HIV prevention care for individuals who often experience a number of barriers accessing health services in the community. The development of evidence-based practices promoting pre-exposure prophylaxis for HIV prevention (PrEP) is crucial for ending the HIV epidemic within this highly marginalized population. However, PrEP research within carceral facilities has been limited and is hampered in part by the lack of ethical guidance on conducting HIV prevention research in this unique setting where incarcerated individuals are categorized as a vulnerable population requiring specific protections. This lack of knowledge is particularly striking when considering the lack of input from incarcerated individuals themselves on the responsible conduct of research, which is critical to understanding ways to ensure participant autonomy while avoiding coercive practices in research activities.MethodsIn order to gain a better understanding of ethical approaches to the conduct of HIV prevention research among incarcerated individuals, we conducted qualitative interviews with 21 incarcerated men who reported injecting drugs and met clinical criteria for PrEP use. The interview topics included HIV knowledge, PrEP knowledge, stigma, and perceptions related to ethical research practices.ResultsThemes identified included how forced abstinence during incarceration can negatively affect research participation, the importance of participant comfort as it relates to ensuring autonomy in decision making, a desire for person centred approaches in research activities, study staff characteristics impacting participant experience, and perceptions of carceral staff as members of research teams.ConclusionsThe results of this study indicate that conducting research focused on improving PrEP use in a carceral environment has support among those experiencing incarceration. However, researchers should place the participant experience at the center of research protocol development.

Project description:IntroductionPeople who inject drugs (PWID) experience high HIV incidence and face significant barriers to engagement in HIV care and substance use treatment. Strategies for HIV treatment as prevention and substance use treatment present unique challenges in PWID that may vary regionally. Understanding differences in the risk structure for HIV transmission and disease progression among PWID is essential in developing and effectively targeting intervention strategies of HIV treatment as prevention.MethodsWe present a baseline analysis of HIV Prevention Trials Network (HPTN) 074, a two-arm, randomized controlled trial among PWID in Indonesia (n = 258), Ukraine (n = 457) and Vietnam (n = 439). HPTN 074 was designed to determine the feasibility, barriers and uptake of an integrated intervention combining health systems navigation and psychosocial counselling for the early engagement of antiretroviral therapy (ART) and substance use treatment for PWID living with HIV. Discordant PWID networks were enrolled, consisting of an HIV-positive index and their HIV-negative network injection partner(s). Among the enrolled cohort of 1154 participants (502 index participants and 652 network partners), we examine regional differences in the baseline risk structure, including sociodemographics, HIV and substance use treatment history, and injection and sexual risk behaviours.ResultsThe majority of participants were male (87%), with 82% of the enrolled females coming from Ukraine. The overall mean age was 34 (IQR: 30, 38). Most commonly injected substances included illegally manufactured methadone in Ukraine (84.2%), and heroin in Indonesia (81.8%) and Vietnam (99.5%). Injection network sizes varied by region: median number of people with whom participants self-reported injecting drugs was 3 (IQR: 2, 5) in Indonesia, 5 (IQR: 3, 10) in Ukraine and 3 (IQR: 2, 4) in Vietnam. Hazardous alcohol use, assessed using the Alcohol Use Disorders Identification Test - Alcohol Consumption Questions (AUDIT-C), was prominent in Ukraine (54.7%) and Vietnam (26.4%). Reported sexual risk behaviours in the past month, including having two or more sex partners and giving/receiving money or drugs in exchange for sex, were uncommon among all participants and regions.ConclusionsWhile regional differences in risk structure exist, PWID particularly in Ukraine need immediate attention for risk reduction strategies. Substantial regional differences in risk structure will require flexible, tailored treatment as prevention interventions for distinct PWID populations.

Dataset Information

Reported Participation Benefits in International HIV Prevention Research with People Who Inject Drugs.

Publications

Reported Participation Benefits in International HIV Prevention Research with People Who Inject Drugs.

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