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Trial record 98 of 662 for:    SMS

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

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ClinicalTrials.gov Identifier: NCT03117842
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
KHANA Center for Population Health Research
Information provided by (Responsible Party):
Touro University, California

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.

Condition or disease Intervention/treatment Phase
Reproductive Health Sexual Health Other: Automated text and voice messages Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: Statistical Analysis will be conducted without knowledge of the assignment of the groups.
Primary Purpose: Health Services Research
Official Title: Using a Theory-based SMS/VM Intervention to Improve Sexual and Reproductive Health of Female Entertainment Workers in Cambodia: Study Protocol of a Randomized Controlled Trial
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention Group
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
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.

No Intervention: Control Group
Those in the control group will get one "check-in" text or voice message between baseline and midline and another between midline and endline.



Primary Outcome Measures :
  1. Recent HIV Testing [ Time Frame: past 6 months ]
    Having had an HIV test in the past 6 months

  2. Condom Use with Clients [ Time Frame: Past 1 month ]
    Frequency of Condom Use with Clients in past month (always, sometime, rarely, never)

  3. Condom Use with boyfriend/husband/romantic partner [ Time Frame: Past 1 month ]
    Frequency of Condom Use with boyfriend/husband/romantic partner in past month (always, sometime, rarely, never)

  4. Contraceptive Prevalence Rate [ Time Frame: Past 1 month ]
    Currently using modern Contraceptive method if trying to prevent pregnancy

  5. Abortion Rate [ Time Frame: Past 6 months ]
    Abortion in last six months

  6. Workplace Alcohol Consumption [ Time Frame: Past 6 months ]
    Forced alcohol consumption at work in past six months

  7. Gender-Based harassment rate [ Time Frame: Past 6 months ]
    Experienced unwanted touching or groping in the past six months

  8. Gender-based violence rate [ Time Frame: Past 6 months ]
    Has experienced verbal abuse such as threats of violence, physical violence, rape/sexual assault in the past six months

  9. STI Screening [ Time Frame: Past six months ]
    Sought treatment when experiencing STI symptoms in past 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   They must be biologically female.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117842


Contacts
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Contact: Carinne D Brody, DrPH 7076385833 carinne.brody@tu.edu

Locations
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Cambodia
KHANA Recruiting
Phnom Penh, Cambodia
Contact: Siyan Yi, MD    +855-12-417-170      
Contact: Sovannary Tuot    855-23-211505      
Sponsors and Collaborators
Touro University, California
KHANA Center for Population Health Research

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Touro University, California
ClinicalTrials.gov Identifier: NCT03117842     History of Changes
Other Study ID Numbers: mobilelinkcambodia
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Touro University, California:
Female entertainment workers
mHealth
HIV testing
Cambodia