Considerations for Increasing Racial, Ethnic, Gender, and Sexual Diversity in HIV Cure-Related Research with Analytical Treatment Interruptions: A Qualitative Inquiry

Dubé, Karine; Kanazawa, John; Campbell, Chadwick K.; Boone, Cheriko A; Maragh-Bass, Allysha C.; Campbell, Danielle; Agosto-Rosario, Moisés; Stockman, Jamila K.; Diallo, Dázon Dixon; Poteat, Tonia; Johnson, Mallory O.; Saberi, Parya; Sauceda, John A

doi:10.1089/aid.2021.0023

Cited by 33 publications

(27 citation statements)

References 58 publications

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“…However, according to a recent landscape analysis of HIV cure research [46], our sample of study participants seem largely representative of community stakeholders currently involved in HIV cure research. Increased efforts would be needed to augment diversity in the field of HIV cure research [47]. We did not verify HIV status of self-reported PWH; however, we advertised the survey specifically among HIV cure research networks.…”

Section: Limitationsmentioning

confidence: 99%

Preliminary Acceptability of a Home-Based Peripheral Blood Collection Device for Viral Load Testing in the Context of Analytical Treatment Interruptions in HIV Cure Trials: Results from a Nationwide Survey in the United States

Dubé

Eskaf²,

Hastie

et al. 2022

JPM

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Frequent viral load testing is necessary during analytical treatment interruptions (ATIs) in HIV cure-directed clinical trials, though such may be burdensome and inconvenient to trial participants. We implemented a national, cross-sectional survey in the United States to examine the acceptability of a novel home-based peripheral blood collection device for HIV viral load testing. Between June and August 2021, we distributed an online survey to people with HIV (PWH) and community members, biomedical HIV cure researchers and HIV care providers. We performed descriptive analyses to summarize the results. We received 73 survey responses, with 51 from community members, 12 from biomedical HIV cure researchers and 10 from HIV care providers. Of those, 51 (70%) were cisgender men and 50 (68%) reported living with HIV. Most (>80% overall) indicated that the device would be helpful during ATI trials and they would feel comfortable using it themselves or recommending it to their patients/participants. Of the 50 PWH, 42 (84%) indicated they would use the device if they were participating in an ATI trial and 27 (54%) also expressed a willingness to use the device outside of HIV cure studies. Increasing sensitivity of viral load tests and pluri-potency of the device (CD4 count, chemistries) would augment acceptability. Survey findings provide evidence that viral load home testing would be an important adjunct to ongoing HIV cure-directed trials involving ATIs. Survey findings may help inform successful implementation and uptake of the device in the context of personalized HIV care.

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Section: Limitationsmentioning

confidence: 99%

Preliminary Acceptability of a Home-Based Peripheral Blood Collection Device for Viral Load Testing in the Context of Analytical Treatment Interruptions in HIV Cure Trials: Results from a Nationwide Survey in the United States

Dubé

Eskaf²,

Hastie

et al. 2022

JPM

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“…Key elements to inform new trials included intentional engagement with community stakeholders and advocates, including the establishment of a trial-specific community advisory and accountability group [ 25 – 29 ]. Recommendations also underscored judicious site selection by prioritizing study sites with culturally-sensitive investigators and staff, with prioritization for sites that have local community advisory boards and strong relationships with community-based organizations focused on HIV prevention in key populations [ 30 – 32 ]. Of particular importance, site investigators and/or staff should include individuals from the communities represented in the study [ 30 , 32 – 34 ].…”

Section: Resultsmentioning

confidence: 99%

“…Recommendations also underscored judicious site selection by prioritizing study sites with culturally-sensitive investigators and staff, with prioritization for sites that have local community advisory boards and strong relationships with community-based organizations focused on HIV prevention in key populations [ 30 – 32 ]. Of particular importance, site investigators and/or staff should include individuals from the communities represented in the study [ 30 , 32 – 34 ]. Lastly, findings from our review also emphasized the importance of culturally-relevant study design and implementation, including gender affirming practices [ 18 , 35 ].…”

Section: Resultsmentioning

confidence: 99%

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Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)

et al. 2022

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Introduction Black and Hispanic/Latinx cisgender men who have sex with men (MSM), transgender women, transgender men, and gender nonbinary (TGNB) individuals have been historically underrepresented in HIV pre-exposure prophylaxis (PrEP) clinical trials. There is an urgent need for ongoing engagement with communities that have been the most impacted by HIV and diverse representation in clinical trials. Here we describe strategic approaches undertaken in the PURPOSE 2 trial to optimize engagement of underrepresented individuals. Methods and results PURPOSE 2 is an ongoing Phase 3 trial evaluating the safety and efficacy of lenacapavir as PrEP in cisgender MSM and TGNB individuals. In PURPOSE 2, we used a multipronged approach aimed at enriching participation of underrepresented individuals. We conducted a review to identify evidence-informed recommendations from literature, engaged with stakeholders, and established the Global Community Advisory and Accountability Group (GCAG) to represent the needs of the community. Insights from stakeholders and GCAG members resulted in an expansion of the study population to include transgender men, gender nonbinary persons, and adolescents, and evaluation of population-specific outcomes. Feedback from stakeholders and GCAG members also informed investigator and site selection; these were selected based on prior experience working with persons from diverse racial, ethnic and gender identities, and estimates of local HIV incidence. Site selection was also expanded to include community-based clinics with services tailored towards Black, Hispanic/Latinx, and TGNB populations. We established a study-wide recruitment goal of 50% Black MSM and 20% Hispanic/Latinx MSM in US sites and 20% transgender women globally. Site-specific recruitment goals were also developed based on local demographics and HIV incidence. Mandatory trainings included Good Participatory Practice guidelines, gender inclusivity, and antiracism. Conclusion While further work is needed to achieve equitable representation, the strategies we describe may serve as a framework for future clinical trials. Trial registration Clinical Trial Number: NCT04925752.

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“… 14 , 15 In negotiating issues of disclosure and partner protections, attention must be paid upfront to gender and relationship power dynamics, equity, and GBV approaches in the design of these trials. 16 This can only be accomplished through the intentional and proactive collection, reporting, and incorporation of socio-behavioral research findings into the design of trials.…”

Section: Viewpointmentioning

confidence: 99%

Bringing social context into global biomedical HIV cure-related research: An urgent call to action

Miall

Mclellan

Dong

et al. 2022

Journal of Virus Eradication

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Advances in science have ushered in a wave of new potential curative and control strategies for HIV that could eliminate the current requirement for life-long antiretroviral therapy (ART) for people living with HIV (PLWH). In this article, we argue that it is critical to consider social contexts in the development of HIV cure trial protocols. The biological and behavioral risk factors for HIV acquisition by study participants are inseparable from the social context in which these participants live. The article discusses an example of a cohort established to further HIV cure research that included social context, called the FRESH Acute HIV study, which combines a sociostructural intervention while conducting HIV prevention, treatment and cure-related research in Durban, South Africa. We make an urgent call to action to include sociobehavioral components as instrumental in future HIV cure trials in global context.

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Considerations for Increasing Racial, Ethnic, Gender, and Sexual Diversity in HIV Cure-Related Research with Analytical Treatment Interruptions: A Qualitative Inquiry

Cited by 33 publications

References 58 publications

Preliminary Acceptability of a Home-Based Peripheral Blood Collection Device for Viral Load Testing in the Context of Analytical Treatment Interruptions in HIV Cure Trials: Results from a Nationwide Survey in the United States

Preliminary Acceptability of a Home-Based Peripheral Blood Collection Device for Viral Load Testing in the Context of Analytical Treatment Interruptions in HIV Cure Trials: Results from a Nationwide Survey in the United States

Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)

Bringing social context into global biomedical HIV cure-related research: An urgent call to action

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