WHISPER or SHOUT study: Efficacy of a mobile phone text messaging intervention for improving the health of female sex workers in Mombasa, Kenya.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000852459
• Date of registration: 29/06/2016
• Prospective Registration: Yes
• Primary sponsor: Burnet Institute
• Public title: WHISPER or SHOUT study: Efficacy of a mobile phone text messaging intervention for improving the health of female sex workers in Mombasa, Kenya.
• Scientific title: Women’s Health Intervention using SMS for Preventing Unintended Pregnancy (WHISPER), or SMS intervention to improve nutritional Heath OUTcomes (SHOUT): A cluster randomised controlled trial assessing mHealth interventions among female sex workers in Mombasa, Kenya
• Date of first enrolment: 15/09/2016
• Target sample size: 860
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000852459.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Assignment: Parallel;Type of endpoint: Efficacy;

Countries of recruitment

Kenya

Contacts

• Name: A/Prof Stanley Luchters

• Name: A/Prof Stanley Luchters

Key inclusion & exclusion criteria

Inclusion criteria: - Self-report engaging in paid sex work in the last six months
- Have a personal mobile phone with Safaricom or Airtel subscription, and be willing to provide the number to the researchers
- Self-report being ‘SMS literate’
- Not currently pregnant or planning pregnancy within 12 months
- Reside, and plan to continue to reside, within the site-specific catchment area for the next 12 months
- Willing to provide reliable contact information (e.g. home address) to be contacted by a member of the research team in the community
- Able and willing to give written informed consent for enrolment in the study.

Exclusion criteria: - Planning to travel or relocate from the study areas
- Participating in another mHealth intervention study
- Having a medical or non-medical issue incapacitating participation in the research, as decided by the local Principal Investigator.


Age minimum: 16 Years
Age maximum: 34 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Blood - Anaemia

Infection - Acquired immune deficiency syndrome (AIDS / HIV)

Unintended pregnancy;HIV;Anaemia;Nutrition;Sexually transmitted infections;
Unintended pregnancy
HIV
Anaemia
Nutrition
Sexually transmitted infections

Reproductive Health and Childbirth - Contraception

Intervention(s)

Mobile phone delivered health promotion intervention (mHealth intervention), addressing contraceptive options and their effectiveness and safety, and improvements in sexual and reproductive health self-efficacy, particularly through the promotion of long-acting reversible contraceptive methods (non user-dependent) methods.

The intervention consists of three components:
- Health messages sent through a series of SMS;
- Theory-guided role model stories sent in text message instalments, promoting positive norms and attitudes, and increased self-efficacy for healthier behaviour;
- On-demand system in which participants reply to texts free of charge to obtain more detailed information via SMS,

Messages will be delivered from an online platform and sent 2-3 times per week for one year. The messages sent and received by participants will be tracked to ensure the system is functioning as planned, and to monitor participant engagement with the system.

Primary Outcome(s)

Incidence of unintended pregnancy.
Pregnancy will be measured by urine pregnancy test at baseline and 6- and 12- months' follow-up, as well as self-reported during the interval since last test.
Intention will be assessed using the London Measure of Unintended Pregnancy (validated questionnaire scale) for any pregnancy that occurs during the trial.[6 and 12 months]

Prevalence of anaemia
This will be measured by laboratory-based full haemogram at baseline and 12 months.[12 months]

Secondary Outcome(s)

Use of modern contraceptive methods and condoms consistently (dual protection) in past month with all partner types.
This will be assessed by self-report during study questionnaire at baseline and 6- and 12-month follow-up visits.[6 and 12 months]

Prevalence of malnutrition: either underweight (BMI < 18.5kg/m2) or overweight (BMI greater than or equal to 25 kg/m2).[12 months]

HIV incidence
HIV will be measured by rapid diagnostic tests (Determine (Registered Trademark) HIV-1 and First response (Registered Trademark) HIV-1 rapid tests) at baseline and 6- and 12-month follow-up visits.[6 and 12 months]

Prevalence of healthy eating behaviour.
This will be assessed by study questionnaire at baseline and 6- and 12-month follow-up visits, containing self-reported dietary intake in previous 7 days.[6 and 12 months]

Mean haemoglobin level (g/dL).
This will be measured by laboratory-based full haemogram at baseline and 12 months.[12 months]

Incidence of induced abortion
This will be assessed by self-report during study questionnaire at 12-months. Participants who have become pregnant during the study will be asked about the outcome of the pregnancy, including induced abortion.[12 months]

Syphilis incidence
This will be assessed by syphilis screening using rapid plasma reagin test at baseline and 6- and 12-month follow-up visits.[6 and 12 months]

Current use of long-acting reversible contraceptive methods (contraceptive implant or intra-uterine device).
This will be assessed by self-report during study questionnaire at baseline and 6- and 12-month follow-up visits.[6 and 12 months]

Median score in nutrition knowledge.
This will be assessed by study questionnaire at baseline and 6- and 12-month follow-up visits, containing nutrition-related true/false knowledge statements. [6 and 12 months]

Secondary ID(s)

None

Source(s) of Monetary Support

National health and medical research council

Ethics review

Status: Approved
Approval date:
Contact:

Kenyatta National Hospital ethics and research committee

Status: Approved
Approval date:
Contact:

Monash University Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 29/01/2019
• Date Completed: 31/07/2018