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

Overview

Journal AIDS Res Hum Retroviruses

Publisher Mary Ann Liebert

Specialty Infectious Diseases

Date 2020 Mar 13

PMID 32160755

Citations 22

Authors

Karine Dube

Lara Hosey

Kate Starr

Liz Barr

David Evans

Erin Hoffman

Danielle M Campbell

Jane Simoni

Jeremy Sugarman

John Sauceda

Brandon Brown

Karen L Diepstra

Catherine Godfrey

Daniel R Kuritzkes

David A Wohl

Rajesh Gandhi

Eileen Scully

Affiliations

Soon will be listed here.

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.

Citing Articles

'It is scary to pause treatment': perspectives on HIV cure-related research and analytical treatment interruptions from women diagnosed during acute HIV in Durban, South Africa.

Mthimkhulu D, Dong K, Ngcobo M, Mindry D, Zulu A, Langa N HIV Res Clin Pract. 2025; 26(1):2455917.

PMID: 39862155 PMC: 11829625. DOI: 10.1080/25787489.2025.2455917.

Relatively high interest but limited active engagement in HIV cure research: Awareness, interest, and information-seeking among affected communities in the Netherlands.

Noorman M, de Wit J, Marcos T, Stutterheim S, Albers T, Jonas K J Virus Erad. 2025; 10(4):100570.

PMID: 39760121 PMC: 11697764. DOI: 10.1016/j.jve.2024.100570.

Participant experiences in a combination HIV cure-related trial with extended analytical treatment interruption in San Francisco, United States.

Dube K, Ndukwe S, Korolkova A, Dee L, Sugarman J, Sauceda J HIV Res Clin Pract. 2024; 25(1):2312318.

PMID: 38348830 PMC: 10951555.

Participant experiences in HIV cure-directed trial with an extended analytical treatment interruption in Philadelphia, United States.

Bilger A, Plenn E, Barg F, Rendle K, Carter W, Lamour-Harrington A HIV Res Clin Pract. 2023; 24(1):2267825.

PMID: 37837376 PMC: 10634456.

Increasing the meaningful involvement of women in HIV cure-related research: a qualitative interview study in the United States.

Dube K, Barr E, Philbin M, Perez-Brumer A, Minalga B, Peterson B HIV Res Clin Pract. 2023; 24(1):2246717.

PMID: 37608645 PMC: 10454980.

References

Rennie S, Day S, Mathews A, Gilbertson A, Luseno W, Tucker J . The Role of Inclusion Benefits in Ethics Committee Assessment of Research Studies. Ethics Hum Res. 2019; 41(3):13-22. PMC: 8162785. DOI: 10.1002/eahr.500015. View

Lantos J . The "inclusion benefit" in clinical trials. J Pediatr. 1999; 134(2):130-1. DOI: 10.1016/s0022-3476(99)70400-2. View

Dube K, Auerbach J, Stirratt M, Gaist P . Applying the Behavioural and Social Sciences Research (BSSR) Functional Framework to HIV Cure Research. J Int AIDS Soc. 2019; 22(10):e25404. PMC: 6820877. DOI: 10.1002/jia2.25404. View

Das B, Dobrowolski C, Luttge B, Valadkhan S, Chomont N, Johnston R . Estrogen receptor-1 is a key regulator of HIV-1 latency that imparts gender-specific restrictions on the latent reservoir. Proc Natl Acad Sci U S A. 2018; 115(33):E7795-E7804. PMC: 6099847. DOI: 10.1073/pnas.1803468115. View

Buchbinder S, Metch B, Holte S, Scheer S, Coletti A, Vittinghoff E . Determinants of enrollment in a preventive HIV vaccine trial: hypothetical versus actual willingness and barriers to participation. J Acquir Immune Defic Syndr. 2004; 36(1):604-12. DOI: 10.1097/00126334-200405010-00009. View

Verheggen F, Nieman F, Jonkers R . Determinants of patient participation in clinical studies requiring informed consent: why patients enter a clinical trial. Patient Educ Couns. 1999; 35(2):111-25. DOI: 10.1016/s0738-3991(98)00060-3. View

Luschin G, Habersack M, Gerlich I . Reasons for and against participation in studies of medicinal therapies for women with breast cancer: a debate. BMC Med Res Methodol. 2012; 12:25. PMC: 3329416. DOI: 10.1186/1471-2288-12-25. View

Verheggen F, Jonkers R, Kok G . Patients' perceptions on informed consent and the quality of information disclosure in clinical trials. Patient Educ Couns. 1996; 29(2):137-53. DOI: 10.1016/0738-3991(96)00859-2. View

Gilbertson A, Kelly E, Rennie S, Henderson G, Kuruc J, Tucker J . Indirect Benefits in HIV Cure Clinical Research: A Qualitative Analysis. AIDS Res Hum Retroviruses. 2018; 35(1):100-107. PMC: 6343180. DOI: 10.1089/AID.2017.0224. View

10.

Cox K, Avis M . Ethical and practical problems of early anti-cancer drug trials: a review of the literature. Eur J Cancer Care (Engl). 1996; 5(2):90-5. DOI: 10.1111/j.1365-2354.1996.tb00214.x. View

11.

Klein S, Jedlicka A, Pekosz A . The Xs and Y of immune responses to viral vaccines. Lancet Infect Dis. 2010; 10(5):338-49. PMC: 6467501. DOI: 10.1016/S1473-3099(10)70049-9. View

12.

Grossman C, Ross A, Auerbach J, Ananworanich J, Dube K, Tucker J . Towards Multidisciplinary HIV-Cure Research: Integrating Social Science with Biomedical Research. Trends Microbiol. 2015; 24(1):5-11. PMC: 4698010. DOI: 10.1016/j.tim.2015.10.011. View

13.

Smeaton L, Kacanek D, Mykhalchenko K, Coughlin K, Klingman K, Koletar S . Screening and Enrollment by Sex in Human Immunodeficiency Virus Clinical Trials in the United States. Clin Infect Dis. 2019; 71(5):1300-1305. PMC: 7442845. DOI: 10.1093/cid/ciz959. View

14.

Barr L, Jefferys R . A landscape analysis of HIV cure-related clinical trials and observational studies in 2018. J Virus Erad. 2019; 5(4):212-219. PMC: 6844401. View

15.

Rennie S, Siedner M, Tucker J, Moodley K . The ethics of talking about 'HIV cure'. BMC Med Ethics. 2015; 16:18. PMC: 4377195. DOI: 10.1186/s12910-015-0013-0. View

16.

Henderson G, Peay H, Kroon E, Cadigan R, Meagher K, Jupimai T . Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment. J Med Ethics. 2017; 44(4):270-276. PMC: 5869463. DOI: 10.1136/medethics-2017-104433. View

17.

Dube K, Dee L, Evans D, Sylla L, Taylor J, Brown B . Perceptions of Equipoise, Risk-Benefit Ratios, and "Otherwise Healthy Volunteers" in the Context of Early-Phase HIV Cure Research in the United States: A Qualitative Inquiry. J Empir Res Hum Res Ethics. 2017; 13(1):3-17. PMC: 5768449. DOI: 10.1177/1556264617734061. View

18.

Moodley K, Staunton C, Rossouw T, de Roubaix M, Duby Z, Skinner D . The psychology of "cure" - unique challenges to consent processes in HIV cure research in South Africa. BMC Med Ethics. 2019; 20(1):9. PMC: 6346569. DOI: 10.1186/s12910-019-0348-z. View

19.

Julg B, Dee L, Ananworanich J, Barouch D, Bar K, Caskey M . Recommendations for analytical antiretroviral treatment interruptions in HIV research trials-report of a consensus meeting. Lancet HIV. 2019; 6(4):e259-e268. PMC: 6688772. DOI: 10.1016/S2352-3018(19)30052-9. View

20.

Brown B, Galea J, Dube K, Davidson P, Khoshnood K, Holtzman L . The Need to Track Payment Incentives to Participate in HIV Research. IRB. 2018; 40(4):8-12. View