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01-11-2017 | Original Paper

A Pilot Randomized Controlled Trial of an Integrated In-person and Mobile Phone Delivered Counseling and Text Messaging Intervention to Reduce HIV Transmission Risk among Male Sex Workers in Chennai, India

Authors: Matthew J. Mimiaga, Beena Thomas, Katie Biello, Blake E. Johnson, Soumya Swaminathan, Pandiyaraja Navakodi, S. Balaguru, A. Dhanalakshmi, Elizabeth F. Closson, Sunil Menon, Conall O’Cleirigh, Kenneth H. Mayer, Steven A. Safren

Published in: AIDS and Behavior | Issue 11/2017

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Abstract

Men who have sex with men (MSM) are at increased risk for HIV infection in India, particularly those who engage in transactional sex with other men (i.e., male sex workers; MSW). Despite the need, HIV prevention efforts for Indian MSW are lacking. As in other settings, MSW in India increasingly rely on the use of mobile phones for sex work solicitation. Integrating mobile phone technology into an HIV prevention intervention for Indian MSW may mitigate some of the challenges associated with face-to face approaches, such as implementation, lack of anonymity, and time consumption, while at the same time proving to be both feasible and useful. This is a pilot randomized controlled trial to examine participant acceptability, feasibility of study procedures, and preliminary efficacy for reducing sexual risk for HIV. MSW (N = 100) were equally randomized to: (1) a behavioral HIV prevention intervention integrating in-person and mobile phone delivered HIV risk reduction counseling, and daily, personalized text or voice messages as motivating “cognitive restructuring” cues for reducing condomless anal sex (CAS); or (2) a standard of care (SOC) comparison condition. Both groups received HIV counseling and testing at baseline and 6-months, and completed ACASI-based, behavioral and psychosocial assessments at baseline, 3, and 6 months. Mixed-effects regression procedures specifying a Poisson distribution and log link with a random intercept and slope for month of follow-up was estimated to assess the intervention effect on the primary outcomes: (1) CAS acts with male clients who paid them for sex, and (2) CAS acts with male non-paying sexual partners—both outcomes assessed over the past month. The intervention was both feasible (98% retention at 6-months) and acceptable (>96% of all intervention sessions attended); all intervention participants rated the intervention as “acceptable” or “very acceptable.” A reduction in the reported number of CAS acts with male clients who paid them for sex in the past month was seen in both study conditions. MSW in the intervention condition reported a faster rate of decline in the number of CAS acts with male clients in the past month from the baseline to both the 3-month (B = −1.20; 95% CI −1.68, −0.73; p < 0.0001) and 6-month (B = −2.44; 95% CI −3.35, −1.53; p < 0.00001) assessment visits compared to the SOC condition. Post-hoc contrasts indicated that, at 3 months, participants in the intervention condition reported 1.43 (SD = 0.29) CAS acts with male clients in the past month compared to 4.85 (SD = 0.87) in the control condition (p = 0.0003). Furthermore, at 6 months, the intervention condition participants reported 0.24 (SD = 0.09) CAS acts with male clients in the past month compared to 2.79 (SD = 0.79) in the control condition (p < 0.0001). Findings are encouraging and provide evidence of feasibility and acceptability, and demonstrate initial efficacy (for reducing sexual risk for HIV) of a behavioral HIV prevention intervention for Indian MSW that combines daily, personalized text or voice messages with mobile phone-delivered sexual risk reduction counseling and skills building. Future testing of the intervention in a fully powered randomized controlled efficacy trial is warranted.
Literature
1.
go back to reference Baral S, Sifakis F, Cleghorn F, Beyrer C. Elevated risk for HIV infection among men who have sex with men in low-and middle-income countries 2000–2006: a systematic review. PLoS Med. 2007;4(12):339.CrossRef Baral S, Sifakis F, Cleghorn F, Beyrer C. Elevated risk for HIV infection among men who have sex with men in low-and middle-income countries 2000–2006: a systematic review. PLoS Med. 2007;4(12):339.CrossRef
2.
go back to reference Department of AIDS Control—Ministry of Health & Family Welfare. Annual Report 2012-2013. India: Department of AIDS Control—National AIDS Control Organization; 2012. Department of AIDS Control—Ministry of Health & Family Welfare. Annual Report 2012-2013. India: Department of AIDS Control—National AIDS Control Organization; 2012.
3.
go back to reference Mimiaga MJ. Differential HIV transmission risk behaviors among MSM subgroups engaging in transactional sex in Chennai, India. Presentation presented at International AIDS Society Meeting—Vienna, Austria; 2010. Mimiaga MJ. Differential HIV transmission risk behaviors among MSM subgroups engaging in transactional sex in Chennai, India. Presentation presented at International AIDS Society Meeting—Vienna, Austria; 2010.
4.
go back to reference Shinde S, Setia MS, Row-Kavi A, Anand V, Jerajani H. Male sex workers: are we ignoring a risk group in Mumbai, India? Indian J Dermatol Venereol Leprol. 2009;75(1):41–6.CrossRefPubMed Shinde S, Setia MS, Row-Kavi A, Anand V, Jerajani H. Male sex workers: are we ignoring a risk group in Mumbai, India? Indian J Dermatol Venereol Leprol. 2009;75(1):41–6.CrossRefPubMed
5.
go back to reference Kumta S, Lurie M, Weitzen S, et al. Bisexuality, sexual risk taking, and HIV prevalence among men who have sex with men accessing voluntary counseling and testing services in Mumbai, India. J Acquir Immune Defic Syndr. 2010;53(2):227–33.CrossRefPubMedPubMedCentral Kumta S, Lurie M, Weitzen S, et al. Bisexuality, sexual risk taking, and HIV prevalence among men who have sex with men accessing voluntary counseling and testing services in Mumbai, India. J Acquir Immune Defic Syndr. 2010;53(2):227–33.CrossRefPubMedPubMedCentral
6.
go back to reference Newman PA, Chakrapani V, Cook C, Shunmugam M, Kakinami L. Correlates of paid sex among men who have sex with men in Chennai, India. Sex Transm Infect. 2008;84(6):434–8.CrossRefPubMed Newman PA, Chakrapani V, Cook C, Shunmugam M, Kakinami L. Correlates of paid sex among men who have sex with men in Chennai, India. Sex Transm Infect. 2008;84(6):434–8.CrossRefPubMed
7.
go back to reference Bharat S, Aggleton P, Tyrer P. India: HIV and AIDS-related discrimination stigmatization and denial. Geneva: UNAIDS; 2001. Bharat S, Aggleton P, Tyrer P. India: HIV and AIDS-related discrimination stigmatization and denial. Geneva: UNAIDS; 2001.
8.
go back to reference Avahan: India AIDS initiative: the business of HIV prevention at scale. New Delhi: Bill & Melinda Gates Foundation; 2008. Avahan: India AIDS initiative: the business of HIV prevention at scale. New Delhi: Bill & Melinda Gates Foundation; 2008.
9.
go back to reference Aral SO, St Lawrence J, Uusküla A. Sex work in Tallinn, Estonia: the sociospatial penetration of sex work into society. Sex Transm Infect. 2006;82(5):348–53.CrossRefPubMedPubMedCentral Aral SO, St Lawrence J, Uusküla A. Sex work in Tallinn, Estonia: the sociospatial penetration of sex work into society. Sex Transm Infect. 2006;82(5):348–53.CrossRefPubMedPubMedCentral
10.
go back to reference Mahapatra B, Saggurti N, Halli SS, Jain AK. HIV risk behaviors among female sex workers using cell phone for client solicitation in India. J AIDS Clin Res. 2012;1:176.CrossRef Mahapatra B, Saggurti N, Halli SS, Jain AK. HIV risk behaviors among female sex workers using cell phone for client solicitation in India. J AIDS Clin Res. 2012;1:176.CrossRef
11.
go back to reference Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009;36(2):165–73.CrossRefPubMed Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009;36(2):165–73.CrossRefPubMed
12.
go back to reference Biello KB, Thomas BE, Johnson BE, et al. Transactional sex and the challenges to safer sexual behaviors: a study among male sex workers in Chennai, India. AIDS Care. 2016;9:1–8. Biello KB, Thomas BE, Johnson BE, et al. Transactional sex and the challenges to safer sexual behaviors: a study among male sex workers in Chennai, India. AIDS Care. 2016;9:1–8.
13.
go back to reference Thomas B, Closson EF, Biello K, et al. Development and open pilot trial of an HIV-prevention intervention integrating mobile-phone technology for male sex workers in Chennai, India. Arch Sex Behav. 2015;29:1–2. Thomas B, Closson EF, Biello K, et al. Development and open pilot trial of an HIV-prevention intervention integrating mobile-phone technology for male sex workers in Chennai, India. Arch Sex Behav. 2015;29:1–2.
14.
go back to reference Tourangeau R, Smith TW. Collecting sensitive information with different modes of data collection. Computer assisted survey information collection. New York: Wiley; 1998. p. 431–54. Tourangeau R, Smith TW. Collecting sensitive information with different modes of data collection. Computer assisted survey information collection. New York: Wiley; 1998. p. 431–54.
15.
go back to reference Moum T. Mode of administration and interviewer effects in self-reported symptoms of anxiety and depression. Soc Indic Res. 1998;45(1–3):279–318.CrossRef Moum T. Mode of administration and interviewer effects in self-reported symptoms of anxiety and depression. Soc Indic Res. 1998;45(1–3):279–318.CrossRef
16.
go back to reference Hernandez AL, et al. The prevalence of sexual behaviors with other men among men who attend sexually transmitted infection clinics in Mumbai, India. Presentation presented at NACO National Conference on Research in HIV and AIDS—Delhi, India; 2006. Hernandez AL, et al. The prevalence of sexual behaviors with other men among men who attend sexually transmitted infection clinics in Mumbai, India. Presentation presented at NACO National Conference on Research in HIV and AIDS—Delhi, India; 2006.
17.
go back to reference Hernandez AL, Lindan CP, Mathur M, et al. Sexual behavior among men who have sex with women, men, and Hijras in Mumbai, India—multiple sexual risks. AIDS Behav. 2006;10(1):5–16.CrossRef Hernandez AL, Lindan CP, Mathur M, et al. Sexual behavior among men who have sex with women, men, and Hijras in Mumbai, India—multiple sexual risks. AIDS Behav. 2006;10(1):5–16.CrossRef
18.
go back to reference Hernandez AL, et al. Men in India have sex with women as well as other men and Hijras-multiple sexual risks. Presentation presented at 15th International AIDS Conference—Bangkok, Thailand; 2004. Hernandez AL, et al. Men in India have sex with women as well as other men and Hijras-multiple sexual risks. Presentation presented at 15th International AIDS Conference—Bangkok, Thailand; 2004.
19.
go back to reference Kumta S, et al. Men who have sex with men (MSM) and male-to-female transgender (TG) in Mumbai: A critical emerging risk group for HIV and sexually transmitted infections (STI) in India. Presentation presented at 14th International AIDS Conference—Barcelona, Spain; 2002. Kumta S, et al. Men who have sex with men (MSM) and male-to-female transgender (TG) in Mumbai: A critical emerging risk group for HIV and sexually transmitted infections (STI) in India. Presentation presented at 14th International AIDS Conference—Barcelona, Spain; 2002.
20.
go back to reference Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013;66(2):197–201.CrossRefPubMed Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013;66(2):197–201.CrossRefPubMed
21.
go back to reference Feeley N, Cossette S, Cote J, et al. The importance of piloting an RCT intervention. Can J Nurs Res. 2009;41(2):85–99.PubMed Feeley N, Cossette S, Cote J, et al. The importance of piloting an RCT intervention. Can J Nurs Res. 2009;41(2):85–99.PubMed
22.
go back to reference Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006;63(5):484–9.CrossRefPubMed Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006;63(5):484–9.CrossRefPubMed
23.
go back to reference Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.CrossRefPubMed Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.CrossRefPubMed
24.
go back to reference Shanyinde M, Pickering RM, Weatherall M. Questions asked and answered in pilot and feasibility randomized controlled trials. BMC Med Res Methodol. 2011;11:117.CrossRefPubMedPubMedCentral Shanyinde M, Pickering RM, Weatherall M. Questions asked and answered in pilot and feasibility randomized controlled trials. BMC Med Res Methodol. 2011;11:117.CrossRefPubMedPubMedCentral
27.
go back to reference Vickers AJ. Underpowering in randomized trials reporting a sample size calculation. J Clin Epidemiol. 2003;56(8):717–20.CrossRefPubMed Vickers AJ. Underpowering in randomized trials reporting a sample size calculation. J Clin Epidemiol. 2003;56(8):717–20.CrossRefPubMed
Metadata
Title
A Pilot Randomized Controlled Trial of an Integrated In-person and Mobile Phone Delivered Counseling and Text Messaging Intervention to Reduce HIV Transmission Risk among Male Sex Workers in Chennai, India
Authors
Matthew J. Mimiaga
Beena Thomas
Katie Biello
Blake E. Johnson
Soumya Swaminathan
Pandiyaraja Navakodi
S. Balaguru
A. Dhanalakshmi
Elizabeth F. Closson
Sunil Menon
Conall O’Cleirigh
Kenneth H. Mayer
Steven A. Safren
Publication date
01-11-2017
Publisher
Springer US
Published in
AIDS and Behavior / Issue 11/2017
Print ISSN: 1090-7165
Electronic ISSN: 1573-3254
DOI
https://doi.org/10.1007/s10461-017-1884-5