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Participant Perspectives in an HIV Cure-Related Trial Conducted Exclusively in Women in the United States: Results from AIDS Clinical Trials Group 5366.

ABSTRACT: Women remain underrepresented in HIV research. The AIDS Clinical Trials Group (ACTG) 5366 study was the first HIV cure-related trial conducted exclusively in women. Our multidisciplinary team integrated participant-centered reports into the ACTG 5366 protocol to elicit their perspectives. We nested mixed-methods surveys at the enrollment and final study visits to assess ACTG 5366 participants' perceptions and experiences. Of 31 participants enrolled in the ACTG 5366, 29 study agreed to complete the entry questionnaire and 27 completed the exit survey. The majority of study participants were nonwhite. We identified societal and personal motivators for participation, understanding of risks and benefits, and minor misconceptions among some trial participants. Stigma was pervasive for several women who joined the study, and served as a motivator for study participation. Reimbursements to defray costs of study participation were reported to facilitate involvement in the trial by about one-third of participants. Almost all respondents reported positive experiences participating in the ACTG 5366 trial. The ACTG 5366 study showed that it is possible to recruit and retain women in HIV cure-related research and to embed participant-centered outcomes at strategic time points during the study. The findings could help in the design, implementation, recruitment, and retention of women in HIV cure-related research and highlight the value of assessing psychosocial factors in HIV cure-related research participation.

SUBMITTER: Dube K

PROVIDER: S-EPMC7185351 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Participant Perspectives in an HIV Cure-Related Trial Conducted Exclusively in Women in the United States: Results from AIDS Clinical Trials Group 5366.

Dubé Karine K Hosey Lara L Starr Kate K Barr Liz L Evans David D Hoffman Erin E Campbell Danielle M DM Simoni Jane J Sugarman Jeremy J Sauceda John J Brown Brandon B Diepstra Karen L KL Godfrey Catherine C Kuritzkes Daniel R DR Wohl David A DA Gandhi Rajesh R Scully Eileen E

AIDS research and human retroviruses 20200401 4

Women remain underrepresented in HIV research. The AIDS Clinical Trials Group (ACTG) 5366 study was the first HIV cure-related trial conducted exclusively in women. Our multidisciplinary team integrated participant-centered reports into the ACTG 5366 protocol to elicit their perspectives. We nested mixed-methods surveys at the enrollment and final study visits to assess ACTG 5366 participants' perceptions and experiences. Of 31 participants enrolled in the ACTG 5366, 29 study agreed to complete ...[more]

PMID: 32160755

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Project description:BackgroundTo test efficacy, HIV cure-related trials often require a period of intensively monitored interruption of antiretroviral therapy (ART) (analytical treatment interruption or ATI). As individuals who started ART during primary HIV-1 infection (PHI) are often recruited, we have asked people already enrolled into an observational PHI study about their willingness and concerns around participating in cure-related studies involving ATIs.MethodsPeople who were diagnosed with PHI and started ART, attending two London HIV clinics, provided informed consent to complete a digital survey in clinic between 21/07/21 to October 31, 2023. Questions comprised sociodemographics, motivations, concerns and practical considerations influencing willingness to participate in studies involving ATIs. Hierarchical clustering of responses was performed using the 'pheatmap' R statistical package and ranked from most to least concerned. Responses were cross-referenced with enrolment into an ATI study which recruited from this cohort.ResultsOf 352 eligible participants, 75 completed the survey. The majority were white, cisgender men who have sex with men, 34/75 (45 %) were born outside the UK. 29 (39 %) expressed interest in joining ATI studies. Participants who were interested or unsure in joining ATI studies were primarily motivated (53/65, 82 % very or moderately interested) by an altruistic desire to help scientific research. Across all participants, onward HIV transmission was the predominant concern (67/75, 89 % very or moderately concerned), and similar levels of concerns reported if the HIV-1 viral load threshold to restarting ART was increased from 500 to 50 000 copies/mL. Most participants preferred weekly (23/65, 35 %) or fortnightly (11/65, 17 %) viral load monitoring during an ATI. Before taking part in a study involving an ATI, participants stated they would prefer to discuss this with their HIV doctor (55/65, 85 %).ConclusionIn this small survey, 39 % of respondents expressed interest in joining studies involving ATIs, primarily for altruistic reasons. Participants were more interested in joining a potential ATI study if a novel intervention was included than simply an ATI alone. The main concern expressed was risk of viral transmission. To inform practical and study design considerations for future ATI studies, unrestricted access for mitigation of transmission risk should be included, and regular, frequent viral load monitoring is preferred.

Project description:Background and aimsWomen have historically been under-represented in clinical research, but the extent to which this is true for substance use disorder (SUD) trials is unknown. We aimed to determine the ratio of female:male participation in clinical trials for SUDs and describe the reporting of sex-specific outcomes from 2010 to 2019.DesignA retrospective cohort review of clinical trials involving people with SUD.SettingUnited States.ParticipantsClinical trials including people with SUD registered in clinicaltrials.gov and completed between 1 January 2010 and 31 December 2019 were reviewed. Trials were excluded if they had < 30 participants, focused on SUD prevention, were conducted outside the United States and/or did not report data on participant sex or gender.MeasurementsThe following were extracted for each trial: primary outcome, number of participants enrolled, analytical sample size, percentage of participants who were female, inclusion of transgender participants, whether sex-based analyses were performed, funding source, type of SUD and type of intervention. Relative representation in trials was examined using the female:male ratio, reported using median ratios and by year of trial completion. The proportion of females participating was adjusted using the underlying disease prevalence among females using National Survey on Drug Use and Health data.FindingsA total of 316 trials met inclusion criteria: 274 were mixed-sex, 12 enrolled only males and 30 only females. In 274 mixed-sex trials, 40% of 57 544 participants were female. Only 22 trials (8%) reported any sex-specific analyses; four studies (1.5%) reported inclusion of transgender participants. Females represented 35% of participants in trials targeting illicit drug use disorder, 52% in nicotine use disorder and 29% in alcohol use disorder. Accounting for underlying disease prevalence revealed that women had the lowest relative enrollment in alcohol use disorder trials (median participation to prevalence ratio in 2017: 0.58; 95% confidence interval: 0.13, 0.91).ConclusionsA review of 316 US clinical trials for alcohol, nicotine and illicit substance use disorders completed between 2010 and 2019 showed that females were enrolled at lower rates than males overall. Only 8% of the trials reviewed reported sex-specific analyses and 1.5% reported transgender participants.

Project description:BackgroundAn increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered.MethodsWe used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning.ResultsWe interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research.ConclusionThe increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance.

Dataset Information

Participant Perspectives in an HIV Cure-Related Trial Conducted Exclusively in Women in the United States: Results from AIDS Clinical Trials Group 5366.

Publications

Participant Perspectives in an HIV Cure-Related Trial Conducted Exclusively in Women in the United States: Results from AIDS Clinical Trials Group 5366.

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