Using a 2-Stage Strategy with Respondent-Driven Sampling to Recruit a Hard-to-Reach Population for a Placebo Microbicide Gel Clinical Trial in Nellore, Andhra Pradesh (India)

Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report duration of recruitment and lessons learned from a two-stage process to recruit female sex workers (FSWs) into a placebo microbicide trial, and exa...

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Published inAIDS and behavior Vol. 19; no. 2; pp. 369 - 379
Main Authors Tun, Waimar, Katzen, Lauren L., Abbott, Sharon A., Srikrishnan, Aylur K., Kelly, Christine A., Sarna, Avina, Friedland, Barbara A., Solomon, Suniti, Mensch, Barbara S.
Format Journal Article
LanguageEnglish
Published Boston Springer US 01.02.2015
Springer Nature B.V
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Abstract Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report duration of recruitment and lessons learned from a two-stage process to recruit female sex workers (FSWs) into a placebo microbicide trial, and examined characteristics associated with successful recruitment of peers who screened for and enrolled in the trial. FSWs were first recruited via respondent-driven sampling (RDS) to complete a survey and subsequently invited to screen for enrollment into a placebo microbicide trial taking place at a local clinic. It took 6 months to enroll 267 participants into the trial. Successful recruiters of peers who enrolled were more likely to have enrolled themselves (AOR 2.0, CI 1.3–2.9) and less likely to visit Nellore city (AOR 0.5, CI 0.3–0.9). Recruitment of FSWs via a two-stage recruitment strategy with RDS can be a good option for future clinical trials.
AbstractList Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report duration of recruitment and lessons learned from a two-stage process to recruit female sex workers (FSWs) into a placebo microbicide trial, and examined characteristics associated with successful recruitment of peers who screened for and enrolled in the trial. FSWs were first recruited via respondent-driven sampling (RDS) to complete a survey and subsequently invited to screen for enrollment into a placebo microbicide trial taking place at a local clinic. It took 6 months to enroll 267 participants into the trial. Successful recruiters of peers who enrolled were more likely to have enrolled themselves (AOR 2.0, CI 1.3–2.9) and less likely to visit Nellore city (AOR 0.5, CI 0.3–0.9). Recruitment of FSWs via a two-stage recruitment strategy with RDS can be a good option for future clinical trials.
Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report duration of recruitment and lessons learned from a two-stage process to recruit female sex workers (FSWs) into a placebo microbicide trial, and examined characteristics associated with successful recruitment of peers who screened for and enrolled in the trial. FSWs were first recruited via respondent-driven sampling (RDS) to complete a survey and subsequently invited to screen for enrollment into a placebo microbicide trial taking place at a local clinic. It took 6 months to enroll 267 participants into the trial. Successful recruiters of peers who enrolled were more likely to have enrolled themselves (AOR 2.0, CI 1.3-2.9) and less likely to visit Nellore city (AOR 0.5, CI 0.3-0.9). Recruitment of FSWs via a two-stage recruitment strategy with RDS can be a good option for future clinical trials.Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report duration of recruitment and lessons learned from a two-stage process to recruit female sex workers (FSWs) into a placebo microbicide trial, and examined characteristics associated with successful recruitment of peers who screened for and enrolled in the trial. FSWs were first recruited via respondent-driven sampling (RDS) to complete a survey and subsequently invited to screen for enrollment into a placebo microbicide trial taking place at a local clinic. It took 6 months to enroll 267 participants into the trial. Successful recruiters of peers who enrolled were more likely to have enrolled themselves (AOR 2.0, CI 1.3-2.9) and less likely to visit Nellore city (AOR 0.5, CI 0.3-0.9). Recruitment of FSWs via a two-stage recruitment strategy with RDS can be a good option for future clinical trials.
Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report duration of recruitment and lessons learned from a two-stage process to recruit female sex workers (FSWs) into a placebo microbicide trial, and examined characteristics associated with successful recruitment of peers who screened for and enrolled in the trial. FSWs were first recruited via respondent-driven sampling (RDS) to complete a survey and subsequently invited to screen for enrollment into a placebo microbicide trial taking place at a local clinic. It took 6 months to enroll 267 participants into the trial. Successful recruiters of peers who enrolled were more likely to have enrolled themselves (AOR 2.0, CI 1.3–2.9) and less likely to visit Nellore city (AOR 0.5, CI 0.3–0.9). Recruitment of FSWs via a two-stage recruitment strategy with RDS can be a good option for future clinical trials.
Author Srikrishnan, Aylur K.
Mensch, Barbara S.
Friedland, Barbara A.
Sarna, Avina
Tun, Waimar
Kelly, Christine A.
Katzen, Lauren L.
Abbott, Sharon A.
Solomon, Suniti
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Van DammeLGovindenRMirembeFMLack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmissionN Engl J Med2008359546347210.1056/NEJMoa070795718669425
ToerienMBrookesSTMetcalfeCA review of reporting of participant recruitment and retention in RCTs in six major journalsTrials2009105210.1186/1745-6215-10-52271795719591685
KanouseDBluthenthalRBogartLIguchiMPerrySSandKRecruiting drug-using men who have sex with men into behavioral interventions: a two-stage approachJ Urban Health200582i109i11910.1093/jurban/jti030345617115738314
MorrowKMFavaJLRosenRKChristensenALVargasSBarrosoCWillingness to use microbicides varies by race/ethnicity, experience with prevention products, and partner typeHealth Psychol200726677778610.1037/0278-6133.26.6.777262854718020851
AbbottSAFriedlandBASarnaAAn evaluation of methods to improve the reporting of adherence in a placebo gel trial in Andhra Pradesh, IndiaAIDS Behav20131762222223610.1007/s10461-012-0402-z367416023299877
van de Wijgert J, Coetzee N, de Kock A, Blanchard K, Jones H. Assessing selection bias in a microbicide trial. Paper presented at: Poster presentation at the International Congress of Sexually Transmitted Infections—ISSTDR/IUSTI, June 2001.
ScottG“They got their program, and I got mine”: a cautionary tale concerning the ethical implications of using respondent-driven sampling to study injection drug usersInt J Drug Policy2008191425110.1016/j.drugpo.2007.11.01418226516
MagnaniRSabinKSaidelTHeckathornDReview of sampling hard-to-reach and hidden populations for HIV surveillanceAids2005192S67S7210.1097/01.aids.0000172879.20628.e115930843
HeckathornDRespondent-driven sampling: a new approach to the study of hidden populationsSoc Probl199744217419910.2307/3096941
BroadheadRVolkanevskyVRydanovabTPeer-driven HIV interventions for drug injectors in Russia: first year impact results of a field experimentInt J Drug Policy20061737939210.1016/j.drugpo.2006.06.001
BiradavoluMRBurrisSGeorgeAJenaABlankenshipKMCan sex workers regulate police? Learning from an HIV prevention project for sex workers in southern IndiaSoc Sci Med20096881541154710.1016/j.socscimed.2009.01.04019261364
WattanaWvan GriensvenFRhucharoenpornpanichORespondent-driven sampling to assess characteristics and estimate the number of injection drug users in Bangkok, ThailandDrug Alcohol Depend2007902–322823310.1016/j.drugalcdep.2007.03.01317507180
YekaWMaibani-MichieGPrybylskiDColbyDApplication of respondent driven sampling to collect baseline data on FSWs and MSM for HIV risk reduction interventions in two urban centres in Papua New GuineaJ Urban Health2006836i60i7210.1007/s11524-006-9103-017066328
JoshiSJoglekarNGhateMPhase I safety & preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, IndiaIndian J Med Res20031171521571:CAS:528:DC%2BD3sXptFKrtLg%3D14604303
National AIDS Control Organization, Ministry of Health and Family Welfare, Government of India. Annual Report 2010–2011. New Delhi 2011.
MenschBSFriedlandBAAbbottSACharacteristics of female sex workers in southern india willing and unwilling to participate in a placebo gel trialAIDS Behav201317258559710.1007/s10461-012-0259-1362990322907287
TharawanKManopaiboonCEllertsonCWomen’s willingness to participate in microbide trials in northern ThailandJ Acquir Immune Defic Syndr Human Retrovirol200128218018610.1097/00126334-200110010-000111:STN:280:DC%2BD3MrktFeisA%3D%3D
MehendaleSMGhateMVKishore KumarBLow HIV-1 Incidence Among Married Serodiscordant Couples in Pune, IndiaJAIDS J Acquir Immune Defic Syndr200641337137310.1097/01.qai.0000209905.35620.481:STN:280:DC%2BD287ptFehsA%3D%3D
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BroadheadRHeckathornDWeakliemDHarnessing peer networks as an instrument for AIDS prevention: results from a peer-driven interventionPublic Health Rep19981131425713077269722809
CampbellMKSnowdonCFrancisDRecruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS studyHealth Technol Assess20071148iiiix10.3310/hta114801:STN:280:DC%2BD1c%2FlsFKrtQ%3D%3D
KendallCKerrLRFSGondimRCAn empirical comparison of respondent-driven sampling, time location sampling, and snowball sampling for behavioral surveillance in men who have sex with men, Fortaleza, BrazilAIDS Behav200812S97S10410.1007/s10461-008-9390-418389357
JoshiSNKattiUGodboleSPhase I safety study of Praneem polyherbal vaginal tablet use among HIV-uninfected women in Pune, IndiaTrans R Soc Trop Med Hyg2005991076977410.1016/j.trstmh.2005.01.00716084547
Parivartan P. Results of a Cross-sectional Survey of Female Sex Workers in Rajahmundry, Andhra Pradesh. A Summary Report.: Yale University, CARE India, Avahan; May 2007.
BarrosoPFde SouzaMBdo LagoRFBarriers to recruit female commercial sex workers for HIV vaccine trials: the Rio de Janeiro experienceJ Acquir Immune Defic Syndr200950111611710.1097/QAI.0b013e31818d5e3f19092453
GrovCBuxDJrParsonsJTMorgensternJRecruiting hard-to-reach drug-using men who have sex with men into an intervention study: lessons learned and implications for applied researchSubst Use Misuse200944131855187110.3109/10826080802501570287423820001284
HeckathornDSemaanSBroadheadRSHughesJExtensions of respondent-driven sampling: a new approach to the study of injection drug users aged 18–25AIDS Behav200261556710.1023/A:1014528612685
SarnaAFriedlandBASrikrishnanAKSexually transmitted infections and reproductive health morbidity in a cohort of female sex workers screened for a microbicide feasibility study in Nellore, IndiaGlob J Health Sci20135313914923618483
Van DammeLRamjeeGAlaryMEffectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trialLancet2002360933897197710.1016/S0140-6736(02)11079-812383665
ChatterjeePAIDS in India: police powers and public healthThe Lancet200636780580610.1016/S0140-6736(06)68319-0
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DuttaSJoglekarNJoshiSStevenJRExperience of conducting a phase I safety & acceptability clinical trial of a candidate vaginal microbicide & lessons learnedIndian J Med Res2008128221221319001688
JohnstonLGSabinKSampling hard-to-reach populations with respondent driven samplingMethodological Innovations Online2010523848
JoshiSSolomonSMayerKMehendaleSPreparing for efficacy trials of vaginal microbicides in Indian womenIndian J Med Res200512145025091:CAS:528:DC%2BD2MXltVSqtLs%3D15817959
BroadheadRHeckathornDAlticeFIncreasing drug users’ adherence to HIV treatment: results of a peer-driven intervention feasibility studySoc Sci Med200255223524610.1016/S0277-9536(01)00167-812144138
Dandona R, Dandona L, Gutierrez JP, et al. High risk of HIV in non-brothel based female sex workers in India. BMC Public Health. 2005;5(87): Available from: http://www.biomedcentral.com [Accessed October 2007].
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SolomonSSSolomonSMasseBRRisk reduction counseling is associated with decreased hiv transmission-associated behaviors in high-risk indian heterosexualsJAIDS J Acquir Immune Defic Syndr200642447848310.1097/01.qai.0000221684.83057.2f
MauckCJoshiSSchwartzJCallahanMWalshTReddy female condom: functional performance of a 90-mm shaft length in two clinical studiesContraception201183546647110.1016/j.contraception.2010.09.01521477691
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ErausquinJTReedEBlankenshipKMPolice-related experiences and HIV risk among female sex workers in Andhra Pradesh, IndiaJ Infect Dis20112045S1223S122810.1093/infdis/jir53922043036
GuestGSeveryLvon MollendorfCVan DammeLOvercoming recruitment challenges: lessons learned from a safety and feasibility study of a diaphragm/microbicide combination in South AfricaJ Acquir Immune Defic Syndr200745448148210.1097/QAI.0b013e318093de8a17622839
Van DammeLChandeyingVRamjeeGSafety of multiple daily applications of COL-1492, a nonoxynol-9 vaginal gel, among female sex workers. COL-1492 Phase II Study GroupAIDS2000141858810.1097/00002030-200001070-0001010714571
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MalekinejadMJohnstonLGKendallCKerrLRRifkinMRRutherfordGWUsing respondent-driven sampling methodology for HIV biological and behavioral surveillance in international settings: a systematic reviewAIDS Behav2008124S105S13010.1007/s10461-008-9421-118561018
National
LG Johnston (938_CR17) 2010; 5
K Tharawan (938_CR50) 2001; 28
LG Johnston (938_CR14) 2006; 83
SA Abbott (938_CR22) 2013; 17
D Heckathorn (938_CR11) 2002; 6
P Chatterjee (938_CR7) 2006; 367
J Wijgert van De (938_CR40) 2001; 26
D Heckathorn (938_CR9) 1997; 44
KM Morrow (938_CR44) 2007; 26
A Sarna (938_CR26) 2013; 5
S Joshi (938_CR2) 2005; 121
W Wattana (938_CR15) 2007; 90
M Malekinejad (938_CR19) 2008; 12
N Joglekar (938_CR29) 2007; 19
S Mehendale (938_CR35) 2012; 4
C Grov (938_CR43) 2009; 44
D Kanouse (938_CR42) 2005; 82
R Broadhead (938_CR48) 2002; 55
GK Medhi (938_CR21) 2012; 24
R Jenkins (938_CR20) 2012; 16
938_CR3
C Kendall (938_CR18) 2008; 12
938_CR1
C Mauck (938_CR34) 2011; 83
G Scott (938_CR10) 2008; 19
G Guest (938_CR6) 2007; 45
R Magnani (938_CR12) 2005; 19
L Damme Van (938_CR37) 2000; 14
R Broadhead (938_CR47) 1995; 25
938_CR24
L Damme Van (938_CR39) 2002; 360
938_CR25
M Toerien (938_CR4) 2009; 10
PF Barroso (938_CR27) 2009; 50
JT Erausquin (938_CR13) 2011; 204
R Broadhead (938_CR45) 1998; 113
M Gross (938_CR49) 1998; 25
SS Solomon (938_CR36) 2006; 42
938_CR51
R Broadhead (938_CR46) 2006; 17
MR Biradavolu (938_CR8) 2009; 68
BS Mensch (938_CR23) 2013; 17
NS Joglekar (938_CR30) 2006; 123
S Dutta (938_CR28) 2008; 128
NS Joglekar (938_CR31) 2010; 104
L Damme Van (938_CR38) 2008; 359
SM Mehendale (938_CR41) 2006; 41
W Yeka (938_CR16) 2006; 83
S Joshi (938_CR32) 2003; 117
SN Joshi (938_CR33) 2005; 99
MK Campbell (938_CR5) 2007; 11
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References_xml – reference: WattanaWvan GriensvenFRhucharoenpornpanichORespondent-driven sampling to assess characteristics and estimate the number of injection drug users in Bangkok, ThailandDrug Alcohol Depend2007902–322823310.1016/j.drugalcdep.2007.03.01317507180
– reference: SolomonSSSolomonSMasseBRRisk reduction counseling is associated with decreased hiv transmission-associated behaviors in high-risk indian heterosexualsJAIDS J Acquir Immune Defic Syndr200642447848310.1097/01.qai.0000221684.83057.2f
– reference: van De WijgertJFullemAKellyCPhase 1 trial of the topical microbicide BufferGel: safety results from four international sitesJ Acquir Immune Defic Syndr2001261212710.1097/00126334-200101010-00003
– reference: van de Wijgert J, Coetzee N, de Kock A, Blanchard K, Jones H. Assessing selection bias in a microbicide trial. Paper presented at: Poster presentation at the International Congress of Sexually Transmitted Infections—ISSTDR/IUSTI, June 2001.
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– reference: Dandona R, Dandona L, Gutierrez JP, et al. High risk of HIV in non-brothel based female sex workers in India. BMC Public Health. 2005;5(87): Available from: http://www.biomedcentral.com [Accessed October 2007].
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– reference: GuestGSeveryLvon MollendorfCVan DammeLOvercoming recruitment challenges: lessons learned from a safety and feasibility study of a diaphragm/microbicide combination in South AfricaJ Acquir Immune Defic Syndr200745448148210.1097/QAI.0b013e318093de8a17622839
– reference: MauckCJoshiSSchwartzJCallahanMWalshTReddy female condom: functional performance of a 90-mm shaft length in two clinical studiesContraception201183546647110.1016/j.contraception.2010.09.01521477691
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– reference: JoglekarNSJoshiSNDeshpandeSSParkheANKattiURMehendaleSMAcceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, ‘Praneem polyherbal tablet’, in Pune, IndiaTrans R Soc Trop Med Hyg2010104641241510.1016/j.trstmh.2009.12.0071:STN:280:DC%2BC3czitl2lsw%3D%3D20096909
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– reference: JohnstonLGSabinKMaiTHPhamTHAssessment of respondent driven sampling for recruiting female sex workers in two Vietnamese cities: reaching the unseen sex workerJ Urban Health2006836 Suppli16i2810.1007/s11524-006-9099-517031567
– reference: BroadheadRHeckathornDAlticeFIncreasing drug users’ adherence to HIV treatment: results of a peer-driven intervention feasibility studySoc Sci Med200255223524610.1016/S0277-9536(01)00167-812144138
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– volume: 360
  start-page: 971
  issue: 9338
  year: 2002
  ident: 938_CR39
  publication-title: Lancet
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Snippet Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report...
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StartPage 369
SubjectTerms Adolescent
Adult
Anti-Infective Agents, Local - administration & dosage
Clinical trials
Female
Females
Health Psychology
Health Surveys - methods
HIV
HIV Infections - prevention & control
HIV Infections - psychology
Human immunodeficiency virus
Humans
India - epidemiology
Infectious Diseases
Medical research
Medicine
Medicine & Public Health
Middle Aged
Original Paper
Patient Selection
Peers
Pharmaceuticals
Preventive medicine
Prostitution
Public Health
Randomized Controlled Trials as Topic
Recruitment
Risk
Risk groups
Sampling
Sampling Studies
Sex Work
Sex Workers - psychology
Sex Workers - statistics & numerical data
Time Factors
Vaginal Creams, Foams, and Jellies - administration & dosage
Workers
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Title Using a 2-Stage Strategy with Respondent-Driven Sampling to Recruit a Hard-to-Reach Population for a Placebo Microbicide Gel Clinical Trial in Nellore, Andhra Pradesh (India)
URI https://link.springer.com/article/10.1007/s10461-014-0938-1
https://www.ncbi.nlm.nih.gov/pubmed/25384905
https://www.proquest.com/docview/1658371198
https://www.proquest.com/docview/1659768575
https://www.proquest.com/docview/1664214332
https://pubmed.ncbi.nlm.nih.gov/PMC5103172
Volume 19
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