Using a Theory-based SMS/VM Intervention to Improve Sexual and Reproductive Health of Female Entertainment Workers in Cambodia

NCT03117842 | Unknown

• 1 other identifier: mobilelinkcambodia
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

In Cambodia, HIV is prevalent in several high-risk groups including among female entertainment workers (FEWs) who work at entertainment venues such as karaoke bars and massage parlors and may engage in direct or indirect sex work. Reaching FEWs with sexual and reproductive health services such as testing and treatment for HIV and sexually transmitted infections (STIs) and contraception has been difficult because they are hidden and stigmatized. Mobile phone-based interventions may prove to be an effective way to reach this population and connect them with the existing services. This article describes study design and implementation of a two-arm randomized controlled trial of a mobile health intervention (the Mobile Link) aiming to improve sexual and reproductive health outcomes among FEWs in Cambodia. A two-armed randomized controlled trial (RCT) will be used to determine the effectiveness of a mobile phone-based text/voice messaging intervention. The intervention will be developed through a participatory process; 50 FEWs will work alongside researchers in focus groups to modify and tailor behavior change theory-based text and voice messages. Then, 600 FEWs will be recruited and randomly assigned into one of two arms: (1) a control group and (2) a mobile phone message group (either text messages or voice messages, delivery method chosen by participant). The primary outcome measures include HIV testing, condom use, STI testing and treatment and contraceptive use. If the Mobile Link trial is successful, an increase in condom use, screening and treatment for HIV and STI and contraception use is expected. These outcomes would lead to a reduction in the prevalence of HIV, STIs and unintended pregnancies. This trial is unique in a number of ways. First, the option of participation mode is offered to allow participants to choose the message medium that best links them to services. Second, this is the first RCT of a mobile phone-based behavior change intervention using SMS/VMs to support linkage to sexual and reproductive health services in Cambodia. Third, we are working with is a hidden, hard-to-reach and dynamic population with which traditional methods of outreach have not been fully successful.

Conditions

Reproductive Health; Sexual Health

Keywords

Female entertainment workers; mHealth; HIV testing; Cambodia

Outcome Measures

Primary Outcomes (9)

• Recent HIV Testing

  Having had an HIV test in the past 6 months

  past 6 months

• Condom Use with Clients

  Frequency of Condom Use with Clients in past month (always, sometime, rarely, never)

  Past 1 month

• Condom Use with boyfriend/husband/romantic partner

  Frequency of Condom Use with boyfriend/husband/romantic partner in past month (always, sometime, rarely, never)

  Past 1 month

• Contraceptive Prevalence Rate

  Currently using modern Contraceptive method if trying to prevent pregnancy

  Past 1 month

• Abortion Rate

  Abortion in last six months

  Past 6 months

• Workplace Alcohol Consumption

  Forced alcohol consumption at work in past six months

  Past 6 months

• Gender-Based harassment rate

  Experienced unwanted touching or groping in the past six months

  Past 6 months

• Gender-based violence rate

  Has experienced verbal abuse such as threats of violence, physical violence, rape/sexual assault in the past six months

  Past 6 months

• STI Screening

  Sought treatment when experiencing STI symptoms in past 6 months

  Past six months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive the 3 text or voice messages weekly. The messages will be designed to enhance and increase utilization of existing HIV and SRH services by reminding clients about safe sex methods available to them and providing a conduit for additional support.

Other: Automated text and voice messages

Control Group

NO INTERVENTION

Those in the control group will get one "check-in" text or voice message between baseline and midline and another between midline and endline.

Interventions

Automated text and voice messages OTHER

Participants will receive 3x weekly SMS or VM theory-based behavioral messages that will be designed to enhance and increase utilization of existing HIV and SRH services by reminding clients about safe sex methods available to them and providing a conduit for additional support. Participants will also be reminded in each message that they can talk to a peer counselor at any time by responding to the message. Participants who indicate they would like to talk to a counselor will receive a call from a Mobile Link community partner. The counselor will provide individualized information on HIV prevention and care and advice.

Intervention Group

Eligibility Criteria

• Gender Eligibility Details: They must be biologically female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants must:
• live and work at an entertainment venue in Cambodia;
• currently sexually active defined as engaged in oral, vaginal or anal sex in the past 3 months;
• own their own mobile phone;
• know how to retrieve VM or retrieve and read SMS on mobile phone (Khmer or Khmer with English alphabet);
• self-identify as a FEW;
• are willing to receive at most one SMS/VM per day for one year;
• provide written informed consent and
• agree to a follow-up visit after six months and 12 months.

Sponsors & Collaborators

• Touro University, California: lead
• KHANA Center for Population Health Research: collaborator

Study Sites (1)

KHANA

Phnom Penh, Cambodia

RECRUITING

Related Publications (36)

• Gisore P, Shipala E, Otieno K, Rono B, Marete I, Tenge C, Mabeya H, Bucher S, Moore J, Liechty E, Esamai F. Community based weighing of newborns and use of mobile phones by village elders in rural settings in Kenya: a decentralised approach to health care provision. BMC Pregnancy Childbirth. 2012 Mar 19;12:15. doi: 10.1186/1471-2393-12-15.

  PMID: 22429731 BACKGROUND

• Curran K, Mugo NR, Kurth A, Ngure K, Heffron R, Donnell D, Celum C, Baeten JM. Daily short message service surveys to measure sexual behavior and pre-exposure prophylaxis use among Kenyan men and women. AIDS Behav. 2013 Nov;17(9):2977-85. doi: 10.1007/s10461-013-0510-4.

  PMID: 23695519 BACKGROUND

• Hossain M, Mani KK, Sidik SM, Hayati KS, Rahman AK. Randomized controlled trial on drowning prevention for parents with children aged below five years in Bangladesh: a study protocol. BMC Public Health. 2015 May 11;15:484. doi: 10.1186/s12889-015-1823-1.

  PMID: 25957574 BACKGROUND

• Crawford J, Larsen-Cooper E, Jezman Z, Cunningham SC, Bancroft E. SMS versus voice messaging to deliver MNCH communication in rural Malawi: assessment of delivery success and user experience. Glob Health Sci Pract. 2014 Jan 28;2(1):35-46. doi: 10.9745/GHSP-D-13-00155. eCollection 2014 Feb.

  PMID: 25276561 BACKGROUND

• Dammert AC, Galdo JC, Galdo V. Preventing dengue through mobile phones: evidence from a field experiment in Peru. J Health Econ. 2014 May;35:147-61. doi: 10.1016/j.jhealeco.2014.02.002. Epub 2014 Mar 5.

  PMID: 24681813 BACKGROUND

• Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS Med. 2013;10(1):e1001362. doi: 10.1371/journal.pmed.1001362. Epub 2013 Jan 15.

  PMID: 23349621 BACKGROUND

• Deglise C, Suggs LS, Odermatt P. SMS for disease control in developing countries: a systematic review of mobile health applications. J Telemed Telecare. 2012 Jul;18(5):273-81. doi: 10.1258/jtt.2012.110810. Epub 2012 Jul 23.

  PMID: 22826375 BACKGROUND

• Mushamiri I, Luo C, Iiams-Hauser C, Ben Amor Y. Evaluation of the impact of a mobile health system on adherence to antenatal and postnatal care and prevention of mother-to-child transmission of HIV programs in Kenya. BMC Public Health. 2015 Feb 7;15:102. doi: 10.1186/s12889-015-1358-5.

  PMID: 25886279 BACKGROUND

• Raifman JR, Lanthorn HE, Rokicki S, Fink G. The impact of text message reminders on adherence to antimalarial treatment in northern Ghana: a randomized trial. PLoS One. 2014 Oct 28;9(10):e109032. doi: 10.1371/journal.pone.0109032. eCollection 2014.

  PMID: 25350546 BACKGROUND

• Sabin LL, Bachman DeSilva M, Gill CJ, Zhong L, Vian T, Xie W, Cheng F, Xu K, Lan G, Haberer JE, Bangsberg DR, Li Y, Lu H, Gifford AL. Improving Adherence to Antiretroviral Therapy With Triggered Real-time Text Message Reminders: The China Adherence Through Technology Study. J Acquir Immune Defic Syndr. 2015 Aug 15;69(5):551-9. doi: 10.1097/QAI.0000000000000651.

  PMID: 25886927 BACKGROUND

• Islam SM, Lechner A, Ferrari U, Froeschl G, Alam DS, Holle R, Seissler J, Niessen LW. Mobile phone intervention for increasing adherence to treatment for type 2 diabetes in an urban area of Bangladesh: protocol for a randomized controlled trial. BMC Health Serv Res. 2014 Nov 26;14:586. doi: 10.1186/s12913-014-0586-1.

  PMID: 25424425 BACKGROUND

• Vodopivec-Jamsek V, de Jongh T, Gurol-Urganci I, Atun R, Car J. Mobile phone messaging for preventive health care. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007457. doi: 10.1002/14651858.CD007457.pub2.

  PMID: 23235643 BACKGROUND

• Esbensen BA, Thomsen T, Hetland ML, Beyer N, Midtgaard J, Loppenthin K, Jennum P, Ostergaard M, Sorensen J, Christensen R, Aadahl M. The efficacy of motivational counseling and SMS-reminders on daily sitting time in patients with rheumatoid arthritis: protocol for a randomized controlled trial. Trials. 2015 Jan 27;16:23. doi: 10.1186/s13063-014-0540-x.

  PMID: 25623388 BACKGROUND

• Youl PH, Soyer HP, Baade PD, Marshall AL, Finch L, Janda M. Can skin cancer prevention and early detection be improved via mobile phone text messaging? A randomised, attention control trial. Prev Med. 2015 Feb;71:50-6. doi: 10.1016/j.ypmed.2014.12.009. Epub 2014 Dec 16.

  PMID: 25524612 BACKGROUND

• Smith C, Vannak U, Sokhey L, Ngo TD, Gold J, Free C. Mobile Technology for Improved Family Planning (MOTIF): the development of a mobile phone-based (mHealth) intervention to support post-abortion family planning (PAFP) in Cambodia. Reprod Health. 2016 Jan 5;13:1. doi: 10.1186/s12978-015-0112-x.

  PMID: 26728505 BACKGROUND

• Odeny TA, Bukusi EA, Cohen CR, Yuhas K, Camlin CS, McClelland RS. Texting improves testing: a randomized trial of two-way SMS to increase postpartum prevention of mother-to-child transmission retention and infant HIV testing. AIDS. 2014 Sep 24;28(15):2307-12. doi: 10.1097/QAD.0000000000000409.

  PMID: 25313586 BACKGROUND

• Swendeman D, Comulada WS, Ramanathan N, Lazar M, Estrin D. Reliability and validity of daily self-monitoring by smartphone application for health-related quality-of-life, antiretroviral adherence, substance use, and sexual behaviors among people living with HIV. AIDS Behav. 2015 Feb;19(2):330-40. doi: 10.1007/s10461-014-0923-8.

  PMID: 25331266 BACKGROUND

• Swendeman D. Are mobile phones the key to HIV prevention for mobile populations in India? Indian J Med Res. 2013 Jun;137(6):1024-6. No abstract available.

  PMID: 23852282 BACKGROUND

• Smith C, Vannak U, Sokhey L, Ngo TD, Gold J, Khut K, Edwards P, Rathavy T, Free C. MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial. Trials. 2013 Dec 12;14:427. doi: 10.1186/1745-6215-14-427.

  PMID: 24330763 BACKGROUND

• Baron S, Goutard F, Nguon K, Tarantola A. Use of a text message-based pharmacovigilance tool in Cambodia: pilot study. J Med Internet Res. 2013 Apr 16;15(4):e68. doi: 10.2196/jmir.2477.

  PMID: 23591700 BACKGROUND

• van Olmen J, Ku GM, van Pelt M, Kalobu JC, Hen H, Darras C, Van Acker K, Villaraza B, Schellevis F, Kegels G. The effectiveness of text messages support for diabetes self-management: protocol of the TEXT4DSM study in the democratic Republic of Congo, Cambodia and the Philippines. BMC Public Health. 2013 May 1;13:423. doi: 10.1186/1471-2458-13-423.

  PMID: 23635331 BACKGROUND

• Lorent N, Choun K, Thai S, Kim T, Huy S, Pe R, van Griensven J, Buyze J, Colebunders R, Rigouts L, Lynen L. Community-based active tuberculosis case finding in poor urban settlements of Phnom Penh, Cambodia: a feasible and effective strategy. PLoS One. 2014 Mar 27;9(3):e92754. doi: 10.1371/journal.pone.0092754. eCollection 2014.

  PMID: 24675985 BACKGROUND

• Brody C, Chhoun P, Tuot S, Pal K, Chhim K, Yi S. HIV risk and psychological distress among female entertainment workers in Cambodia: a cross-sectional study. BMC Public Health. 2016 Feb 9;16:133. doi: 10.1186/s12889-016-2814-6.

  PMID: 26861542 BACKGROUND

• Brody C, Tuot S, Chhea C, Saphonn V, Yi S. Factors associated with sex work among at-risk female youth in Cambodia: a cross-sectional study. AIDS Care. 2016;28(3):339-46. doi: 10.1080/09540121.2015.1096893. Epub 2015 Oct 19.

  PMID: 26477781 BACKGROUND

• Yi S, Tuot S, Chhoun P, Pal K, Tith K, Brody C. Factors associated with induced abortion among female entertainment workers: a cross-sectional study in Cambodia. BMJ Open. 2015 Jul 31;5(7):e007947. doi: 10.1136/bmjopen-2015-007947.

  PMID: 26231754 BACKGROUND

• Page K, Stein E, Sansothy N, Evans J, Couture MC, Sichan K, Cockroft M, Mooney-Somers J, Phlong P, Kaldor J, Maher L; Young Women's Health Study Collaborative*. Sex work and HIV in Cambodia: trajectories of risk and disease in two cohorts of high-risk young women in Phnom Penh, Cambodia. BMJ Open. 2013 Sep 10;3(9):e003095. doi: 10.1136/bmjopen-2013-003095.

  PMID: 24022389 BACKGROUND

• Couture MC, Sansothy N, Sapphon V, Phal S, Sichan K, Stein E, Evans J, Maher L, Kaldor J, Vun MC, Page K. Young women engaged in sex work in Phnom Penh, Cambodia, have high incidence of HIV and sexually transmitted infections, and amphetamine-type stimulant use: new challenges to HIV prevention and risk. Sex Transm Dis. 2011 Jan;38(1):33-9. doi: 10.1097/OLQ.0b013e3182000e47.

  PMID: 21085056 BACKGROUND

• Couture MC, Page K, Stein ES, Sansothy N, Sichan K, Kaldor J, Evans JL, Maher L, Palefsky J. Cervical human papillomavirus infection among young women engaged in sex work in Phnom Penh, Cambodia: prevalence, genotypes, risk factors and association with HIV infection. BMC Infect Dis. 2012 Jul 28;12:166. doi: 10.1186/1471-2334-12-166.

  PMID: 22839728 BACKGROUND

• Yi S, Tuot S, Chhoun P, Brody C, Tith K, Oum S. The impact of a community-based HIV and sexual reproductive health program on sexual and healthcare-seeking behaviors of female entertainment workers in Cambodia. BMC Infect Dis. 2015 Jun 6;15:221. doi: 10.1186/s12879-015-0954-4.

  PMID: 26047818 BACKGROUND

• Maher L, Mooney-Somers J, Phlong P, Couture MC, Kien SP, Stein E, Bates AJ, Sansothy N, Page K; Young Women's Health Study Collaborative. Condom negotiation across different relationship types by young women engaged in sex work in Phnom Penh, Cambodia. Glob Public Health. 2013;8(3):270-83. doi: 10.1080/17441692.2013.767930. Epub 2013 Feb 22.

  PMID: 23432108 BACKGROUND

• Bui TC, Markham CM, Tran LT, Beasley RP, Ross MW. Condom negotiation and use among female sex workers in Phnom Penh, Cambodia. AIDS Behav. 2013 Feb;17(2):612-22. doi: 10.1007/s10461-012-0369-9.

  PMID: 23196858 BACKGROUND

• Brody C, Tatomir B, Sovannary T, Pal K, Mengsrun S, Dionosio J, Luong MA, Yi S. Mobile phone use among female entertainment workers in Cambodia: an observation study. Mhealth. 2017 Jan 30;3:3. doi: 10.21037/mhealth.2017.01.01. eCollection 2017.

  PMID: 28293620 BACKGROUND

• Avancena ALV, Brody C, Chhoun P, Tuot S, Yi S. Connecting Female Entertainment Workers in Cambodia to Health Care Services Using mHealth: Economic Evaluation of Mobile Link. JMIR Form Res. 2024 Jul 25;8:e52734. doi: 10.2196/52734.

  PMID: 39052328 DERIVED

• Brody C, Chhoun P, Tuot S, Fehrenbacher AE, Moran A, Swendeman D, Yi S. A Mobile Intervention to Link Young Female Entertainment Workers in Cambodia to Health and Gender-Based Violence Services: Randomized Controlled Trial. J Med Internet Res. 2022 Jan 4;24(1):e27696. doi: 10.2196/27696.

  PMID: 34982716 DERIVED

• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

  PMID: 32779730 DERIVED

• Brody C, Tuot S, Chhoun P, Swendeman D, Kaplan KC, Yi S. Mobile Link - a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial. Trials. 2018 Apr 19;19(1):235. doi: 10.1186/s13063-018-2614-7.

  PMID: 29673381 DERIVED

Central Study Contacts

Carinne D Brody, DrPH

CONTACT

7076385833; carinne.brody@tu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistical Analysis will be conducted without knowledge of the assignment of the groups.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 12-month randomized controlled trial (RCT) will be conducted to evaluate the Mobile Link intervention, with two arms of 300 FEWs each. FEWs will be equally randomized into one of two groups: (1) no intervention and (2) SMS or VM theory-based behavioral messages.

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 18, 2017
• Study Start: April 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: April 1, 2019
• Last Updated: April 20, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)