Understanding women's motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence.
Administration, Intravaginal
Adult
Clinical Trials, Phase II as Topic
Female
HIV Infections
/ prevention & control
Humans
Medication Adherence
/ psychology
Middle Aged
Motivation
Patient Acceptance of Health Care
/ psychology
Patient Preference
Pre-Exposure Prophylaxis
/ methods
Qualitative Research
Retrospective Studies
Self Report
Surveys and Questionnaires
Vaginal Creams, Foams, and Jellies
/ administration & dosage
Clinical trials
HIV prevention
Microbicides
Motivation to participate
Oral PrEP
VOICE trial
Journal
BMC women's health
ISSN: 1472-6874
Titre abrégé: BMC Womens Health
Pays: England
ID NLM: 101088690
Informations de publication
Date de publication:
25 01 2019
25 01 2019
Historique:
received:
19
04
2018
accepted:
11
01
2019
entrez:
27
1
2019
pubmed:
27
1
2019
medline:
27
6
2019
Statut:
epublish
Résumé
In biomedical prevention trials, correct and consistent use of the investigational product is crucial to determine efficacy. Product adherence in VOICE, a phase 2B randomized trial of a vaginal gel and oral tablets for HIV prevention, was low (~ 34%), yet self-reported adherence and retention was high (> 90%). This analysis from VOICE-D, a post-trial qualitative ancillary study, explores motivations to participate in VOICE, and possible sources of misalignment between the stated priorities of the trial and the participants. VOICE-D enrolled 171 former VOICE participants to investigate, among other things, reasons for joining and remaining in the trial. Local language in-depth interviews and focus groups were transcribed and translated into English and coded and analyzed using NVivo. Data on motivation to join obtained from a VOICE termination visit survey of 106 participants were also analyzed to corroborate the VOICE-D findings. Participants primarily participated for personal health benefits (e.g. free healthcare and HIV testing) and reported remaining enrolled from a sense of commitment to the trial. Altruistic motivations were the most commonly stated motivation on the termination visit survey; qualitatively, many of those stating altruistic reasons also desired personal health benefits. Joining for financial reimbursement was not commonly mentioned. Social networks influenced recruitment and spread therapeutic misconception. Women's participation for personal health benefits highlighted their desire to monitor their HIV risk and overall health. Helping participants view use of investigational products as improving social capital and reminding participants of their study responsibilities may improve trial outcomes. Understanding the reasons for participating in studies will help to ensure alignment between priorities of researchers and participants. NCT02358616 ; Posted February 9, 2015, retrospectively registered.
Sections du résumé
BACKGROUND
In biomedical prevention trials, correct and consistent use of the investigational product is crucial to determine efficacy. Product adherence in VOICE, a phase 2B randomized trial of a vaginal gel and oral tablets for HIV prevention, was low (~ 34%), yet self-reported adherence and retention was high (> 90%). This analysis from VOICE-D, a post-trial qualitative ancillary study, explores motivations to participate in VOICE, and possible sources of misalignment between the stated priorities of the trial and the participants.
METHODS
VOICE-D enrolled 171 former VOICE participants to investigate, among other things, reasons for joining and remaining in the trial. Local language in-depth interviews and focus groups were transcribed and translated into English and coded and analyzed using NVivo. Data on motivation to join obtained from a VOICE termination visit survey of 106 participants were also analyzed to corroborate the VOICE-D findings.
RESULTS
Participants primarily participated for personal health benefits (e.g. free healthcare and HIV testing) and reported remaining enrolled from a sense of commitment to the trial. Altruistic motivations were the most commonly stated motivation on the termination visit survey; qualitatively, many of those stating altruistic reasons also desired personal health benefits. Joining for financial reimbursement was not commonly mentioned. Social networks influenced recruitment and spread therapeutic misconception.
CONCLUSIONS
Women's participation for personal health benefits highlighted their desire to monitor their HIV risk and overall health. Helping participants view use of investigational products as improving social capital and reminding participants of their study responsibilities may improve trial outcomes. Understanding the reasons for participating in studies will help to ensure alignment between priorities of researchers and participants.
TRIAL REGISTRATION
NCT02358616 ; Posted February 9, 2015, retrospectively registered.
Identifiants
pubmed: 30683103
doi: 10.1186/s12905-019-0713-6
pii: 10.1186/s12905-019-0713-6
pmc: PMC6347781
doi:
Substances chimiques
Vaginal Creams, Foams, and Jellies
0
Banques de données
ClinicalTrials.gov
['NCT02358616']
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
18Subventions
Organisme : NIAID NIH HHS
ID : UM1 AI068633
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069422
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI106707
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI069436
Pays : United States
Organisme : NIMH NIH HHS
ID : P30 MH062246
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068615
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069530
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069436
Pays : United States
Références
Curr HIV/AIDS Rep. 2008 Nov;5(4):186-92
pubmed: 18838058
N Engl J Med. 2014 Oct 2;371(14):1344-53
pubmed: 25265493
AIDS Behav. 2016 Jul;20(7):1541-8
pubmed: 25969178
AIDS Behav. 2014 Feb;18(2):263-77
pubmed: 23736885
AIDS. 2012 Apr 24;26(7):F13-9
pubmed: 22333749
J Int AIDS Soc. 2016 May 30;19(1):20875
pubmed: 27247202
AIDS Care. 2014;26(11):1359-69
pubmed: 24797186
Cult Health Sex. 2016;18(1):30-44
pubmed: 26223703
Hum Resour Health. 2013 Mar 22;11:13
pubmed: 23521859
AIDS Behav. 2017 Feb;21(2):481-491
pubmed: 27858268
Afr J AIDS Res. 2014;13(4):393-8
pubmed: 25555105
Health Policy Plan. 2006 Nov;21(6):459-68
pubmed: 17030551
BMC Public Health. 2015 Apr 15;15:382
pubmed: 25886513
J Med Ethics. 2012 Dec;38(12):746-50
pubmed: 22822200
J Med Ethics. 2004 Apr;30(2):190-3
pubmed: 15082816
AIDS Behav. 2016 Apr;20(4):754-62
pubmed: 26126586
N Engl J Med. 2015 Feb 5;372(6):509-18
pubmed: 25651245
BJOG. 2014 Oct;121 Suppl 5:53-61
pubmed: 25335841
N Engl J Med. 2012 Aug 2;367(5):411-22
pubmed: 22784040
N Engl J Med. 2010 Dec 30;363(27):2587-99
pubmed: 21091279
AIDS Res Hum Retroviruses. 2017 Mar 2;33(8):778-783
pubmed: 28253024
AIDS. 2015 Oct 23;29(16):2161-71
pubmed: 26544581
Arch Intern Med. 2008 Jun 23;168(12):1294-9
pubmed: 18574086
N Engl J Med. 2016 Dec;375(22):2121-2132
pubmed: 26900902
AIDS Educ Prev. 2009 Jun;21(3):233-50
pubmed: 19519238
J Acquir Immune Defic Syndr. 2001 Oct 1;28(2):180-6
pubmed: 11588513
Patient Prefer Adherence. 2012;6:579-88
pubmed: 22936844
AIDS Behav. 2016 Nov;20(11):2654-2661
pubmed: 26906023
Soc Sci Med. 2008 Jan;66(1):189-200
pubmed: 17904718
World J AIDS. 2013 Sep;3(3):
pubmed: 24324918
J Acquir Immune Defic Syndr. 2013 Jul;63 Suppl 2:S122-9
pubmed: 23764623
PLoS One. 2013;8(1):e55013
pubmed: 23383037
Curr Opin Infect Dis. 2012 Feb;25(1):51-7
pubmed: 22156901
J Antimicrob Chemother. 2011 Feb;66(2):240-50
pubmed: 21118913
AIDS Behav. 2018 Mar;22(3):877-886
pubmed: 28110473
Trials. 2010 Mar 22;11:31
pubmed: 20307273
BMC Public Health. 2013 Mar 11;13:220
pubmed: 23497196
AIDS Behav. 2013 Feb;17(2):585-97
pubmed: 22907287
N Engl J Med. 2012 Aug 2;367(5):399-410
pubmed: 22784037
Health Hum Rights. 2015 Jun 11;17(1):E31-42
pubmed: 26204581
Emerg Themes Epidemiol. 2009 Oct 09;6:5
pubmed: 19818138
AIDS. 2017 May 15;31(8):1159-1167
pubmed: 28441175
AIDS Behav. 2017 May;21(5):1361-1375
pubmed: 27317411