Testing the Effectiveness and Cost-Effectiveness of a Combination HIV Prevention Intervention Among Young Cisgender Men Who Have Sex With Men and Transgender Women Who Sell or Exchange Sex in Thailand: Protocol for the Combination Prevention Effectiveness Study.
HIV
Thailand
cost-effectiveness
men who have sex with men
pre-exposure prophylaxis
prevention
sex work
transgender persons
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
27 Jan 2020
27 Jan 2020
Historique:
received:
03
07
2019
accepted:
20
10
2019
revised:
17
10
2019
entrez:
4
2
2020
pubmed:
6
2
2020
medline:
6
2
2020
Statut:
epublish
Résumé
Pre-exposure prophylaxis (PrEP) is highly effective in the prevention of HIV acquisition, particularly for men who have sex with men (MSM). Questions remain on the benefits of PrEP and implementation strategies for those at occupational risk of HIV acquisition in sex work, as well as on methods to support adherence among young people who initiate PrEP. The Combination Prevention Effectiveness study for young cisgender MSM and transgender women (TGW) aims to assess the effectiveness and cost-effectiveness of a combination intervention among HIV-uninfected young MSM and TGW engaged in sex work in Thailand. This open-label, nonrandomized assessment compares the relative effectiveness of a combination prevention intervention with and without daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada) PrEP with SMS-based adherence support. HIV-uninfected young MSM and TGW aged 18 to 26 years in Bangkok and Pattaya who self-report selling/exchanging sex at least once in the previous 12 months are recruited by convenience sampling and peer referral and are eligible regardless of their intent to initiate PrEP. At baseline, participants complete a standard assessment for PrEP eligibility and may initiate PrEP then or at any time during study participation. All participants complete a survey and HIV testing at baseline and every 3 months. Participants who initiate PrEP complete monthly pill pickups and may opt-in to SMS reminders. All participants are sent brief weekly SMS surveys to assess behavior with additional adherence questions for those who initiated PrEP. Adherence is defined as use of 4 or more pills within the last 7 days. The analytic plan uses a person-time approach to assess HIV incidence, comparing participant time on oral PrEP to participant time off oral PrEP for 12 to 24 months of follow-up, using a propensity score to control for confounders. Enrollment is based on the goal of observing 620 person-years (PY) on PrEP and 620 PY off PrEP. As of February 2019, 445 participants (417 MSM and 28 TGW) have contributed approximately 168 PY with 95% (73/77) retention at 12 months. 74.2% (330/445) of enrolled participants initiated PrEP at baseline, contributing to 134 PY of PrEP adherence, 1 PY nonadherence, and 33 PY PrEP nonuse/noninitiation. Some social harms, predominantly related to unintentional participant disclosure of PrEP use and peer stigmatization of PrEP and HIV, have been identified. The majority of cisgender MSM and TGW who exchange sex and participate in this study are interested in PrEP, report taking sufficient PrEP, and stay on PrEP, though additional efforts are needed to address community misinformation and stigma. This novel multilevel, open-label study design and person-time approach will allow evaluation of the effectiveness and cost-effectiveness of combination prevention intervention in the contexts of both organized sex work and exchanged sex. RR1-10.2196/15354.
Sections du résumé
BACKGROUND
BACKGROUND
Pre-exposure prophylaxis (PrEP) is highly effective in the prevention of HIV acquisition, particularly for men who have sex with men (MSM). Questions remain on the benefits of PrEP and implementation strategies for those at occupational risk of HIV acquisition in sex work, as well as on methods to support adherence among young people who initiate PrEP.
OBJECTIVE
OBJECTIVE
The Combination Prevention Effectiveness study for young cisgender MSM and transgender women (TGW) aims to assess the effectiveness and cost-effectiveness of a combination intervention among HIV-uninfected young MSM and TGW engaged in sex work in Thailand.
METHODS
METHODS
This open-label, nonrandomized assessment compares the relative effectiveness of a combination prevention intervention with and without daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada) PrEP with SMS-based adherence support. HIV-uninfected young MSM and TGW aged 18 to 26 years in Bangkok and Pattaya who self-report selling/exchanging sex at least once in the previous 12 months are recruited by convenience sampling and peer referral and are eligible regardless of their intent to initiate PrEP. At baseline, participants complete a standard assessment for PrEP eligibility and may initiate PrEP then or at any time during study participation. All participants complete a survey and HIV testing at baseline and every 3 months. Participants who initiate PrEP complete monthly pill pickups and may opt-in to SMS reminders. All participants are sent brief weekly SMS surveys to assess behavior with additional adherence questions for those who initiated PrEP. Adherence is defined as use of 4 or more pills within the last 7 days. The analytic plan uses a person-time approach to assess HIV incidence, comparing participant time on oral PrEP to participant time off oral PrEP for 12 to 24 months of follow-up, using a propensity score to control for confounders. Enrollment is based on the goal of observing 620 person-years (PY) on PrEP and 620 PY off PrEP.
RESULTS
RESULTS
As of February 2019, 445 participants (417 MSM and 28 TGW) have contributed approximately 168 PY with 95% (73/77) retention at 12 months. 74.2% (330/445) of enrolled participants initiated PrEP at baseline, contributing to 134 PY of PrEP adherence, 1 PY nonadherence, and 33 PY PrEP nonuse/noninitiation. Some social harms, predominantly related to unintentional participant disclosure of PrEP use and peer stigmatization of PrEP and HIV, have been identified.
CONCLUSIONS
CONCLUSIONS
The majority of cisgender MSM and TGW who exchange sex and participate in this study are interested in PrEP, report taking sufficient PrEP, and stay on PrEP, though additional efforts are needed to address community misinformation and stigma. This novel multilevel, open-label study design and person-time approach will allow evaluation of the effectiveness and cost-effectiveness of combination prevention intervention in the contexts of both organized sex work and exchanged sex.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
RR1-10.2196/15354.
Identifiants
pubmed: 32012113
pii: v9i1e15354
doi: 10.2196/15354
pmc: PMC7011123
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e15354Subventions
Organisme : NIAID NIH HHS
ID : P30 AI094189
Pays : United States
Organisme : NIAID NIH HHS
ID : R01 AI118505
Pays : United States
Informations de copyright
©Andrea L Wirtz, Brian Wilson Weir, Sandra Hsu Hnin Mon, Pachara Sirivongrangson, Tareerat Chemnasiri, Eileen F Dunne, Anchalee Varangrat, Andrew C Hickey, Michele R Decker, Stefan Baral, Kamolnetr Okanurak, Patrick Sullivan, Rachel Valencia, Michael C Thigpen, Timothy H Holtz, Philip A Mock, Betsy Cadwell, Adeola Adeyeye, James F Rooney, Chris Beyrer, Combination Prevention Effectiveness (COPE) Study Team. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 27.01.2020.
Références
N Engl J Med. 2010 Dec 30;363(27):2587-99
pubmed: 21091279
AIDS. 2013 Mar 13;27(5):825-32
pubmed: 23169330
Lancet. 2012 Jul 28;380(9839):424-38
pubmed: 22819663
J Acquir Immune Defic Syndr. 2016 Aug 15;72 Suppl 3:S210-9
pubmed: 27429185
AIDS Behav. 2011 Apr;15(3):650-8
pubmed: 21104008
Lancet. 2015 Jan 17;385(9964):287-301
pubmed: 25059950
PLoS One. 2018 Aug 30;13(8):e0203294
pubmed: 30161226
PLoS One. 2014 Feb 05;9(2):e88166
pubmed: 24505411
Lancet. 2012 Jul 28;380(9839):388-99
pubmed: 22819659
Lancet Infect Dis. 2014 Sep;14(9):820-9
pubmed: 25065857
Lancet. 2015 Jan 17;385(9964):274-86
pubmed: 25059941
AIDS. 2017 Oct 23;31(16):2179-2191
pubmed: 28991023
J Acquir Immune Defic Syndr. 2005 Dec 1;40(4):434-44
pubmed: 16280698
Cult Health Sex. 2012;14(5):563-75
pubmed: 22468793
Lancet. 2015 Jan 17;385(9964):260-73
pubmed: 25059939
Sex Transm Infect. 2012 Jun;88(4):258-63
pubmed: 22290327
PLoS One. 2013 Oct 08;8(10):e76650
pubmed: 24116132
J Med Assoc Thai. 2008 Jun;91 Suppl 2:S126-38
pubmed: 19253494
BMC Public Health. 2013 May 17;13:482
pubmed: 23679953
Med Care. 2009 Jul;47(7 Suppl 1):S76-81
pubmed: 19536026
J Public Health Manag Pract. 2012 May-Jun;18(3):259-67
pubmed: 22473119
Int J STD AIDS. 2019 Mar;30(3):212-222
pubmed: 30360682
AIDS Patient Care STDS. 2005 Feb;19(2):89-99
pubmed: 15716640
Stat Med. 1990 Dec;9(12):1501-15
pubmed: 2281238
Epidemiology. 2000 Sep;11(5):550-60
pubmed: 10955408
Cost Eff Resour Alloc. 2013 Aug 08;11(1):18
pubmed: 23927817
Pharmacoepidemiol Drug Saf. 2014 Jun;23(6):560-71
pubmed: 24458364
Health Policy Plan. 2001 Sep;16(3):326-31
pubmed: 11527874
Lancet. 2012 Jul 28;380(9839):367-77
pubmed: 22819660
PLoS One. 2015 Apr 24;10(4):e0124310
pubmed: 25909508
PLoS One. 2013 May 17;8(5):e64038
pubmed: 23691143
Lancet Infect Dis. 2013 Mar;13(3):214-22
pubmed: 23260128
Epidemiol Rev. 2010;32:137-51
pubmed: 20573756
AIDS. 2013 Nov 13;27(17):2665-78
pubmed: 23842129