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Trial registered on ANZCTR

Registration number

ACTRN12616000852459

Ethics application status

Approved

Date submitted

23/05/2016

Date registered

29/06/2016

Date last updated

29/01/2019

Date data sharing statement initially provided

29/01/2019

Type of registration

Prospectively registered

Titles & IDs

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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Unintended pregnancy

HIV

Anaemia

Nutrition

Sexually transmitted infections

Condition category

Condition code

Reproductive Health and Childbirth

Contraception

Infection

Acquired immune deficiency syndrome (AIDS / HIV)

Blood

Anaemia

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Prevention

Intervention code [2]

Behaviour

Comparator / control treatment

Equal-attention control consisting of a parallel mHealth intervention addressing positive knowledge, attitudes and practices regarding locally applicable actions, which could improve nutritional status of women of childbearing age.

The parallel nutrition intervention will have the same three mobile phone-based components, with identical structure, duration, and message number and frequency.

Control group

Active

Outcomes

Primary outcome [1]

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.

Timepoint [1]

6 and 12 months

Primary outcome [2]

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

Timepoint [2]

12 months

Secondary outcome [1]

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.

Timepoint [1]

6 and 12 months

Secondary outcome [2]

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.

Timepoint [2]

6 and 12 months

Secondary outcome [3]

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.

Timepoint [3]

12 months

Secondary outcome [4]

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

Timepoint [4]

12 months

Secondary outcome [5]

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

Timepoint [5]

12 months

Secondary outcome [6]

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.

Timepoint [6]

6 and 12 months

Secondary outcome [7]

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.

Timepoint [7]

6 and 12 months

Secondary outcome [8]

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.

Timepoint [8]

6 and 12 months

Secondary outcome [9]

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

Timepoint [9]

6 and 12 months

Eligibility

Key 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.

Minimum age

16 Years

Maximum age

34 Years

Sex

Females

Can healthy volunteers participate?

Key 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.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation of clusters to intervention arms will be done by central randomisation by computer. Allocation will be concealed from the study team and participants until after cluster enrolment is completed and all baseline questionnaires administered for that cluster.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Cluster-randomised: each sex work venue constitutes one cluster, with up to 10 participants per cluster.

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Primary analysis will compare the primary endpoints (either unintended pregnancy incidence, or anaemia prevalence) between groups at 12 months and secondary analysis will compare groups at 6 months.
The sample size was calculated to obtain sufficient power to detect a 37% relative reduction in annual unintended pregnancy incidence, based on estimated pregnancy incidence in this population of 27%. This results in a sample size of 860 participants from a minimum of 86 clusters – 430 participants per arm. This estimate is calculated with 80% power and 5% significance level), and is adjusted for an expected 10% attrition rate and estimated inflation in standard error due to cluster randomisation.
Given the interval-censored nature of unintended pregnancy incidence, discrete-time survival models using generalised linear modelling will be used to compare unintended pregnancy incidence between FSW exposed to SRH intervention and those exposed to nutrition intervention messages.
These analyses will provide estimates with robust standard errors for FSW venue clustering. Standardised probability weighting will be applied in population-averaged analyses to account for any sampling bias where achieved sample cluster sizes vary. Where randomisation is not effective in removing allocation bias, adjusted models will be specified. In all analyses, associations will be considered statistically significant at the 5% level. The statistician will conduct the analysis blind to the intervention group.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

18/07/2016

Actual

15/09/2016

Date of last participant enrolment

Anticipated

Actual

18/05/2017

Date of last data collection

Anticipated

Actual

31/07/2018

Sample size

Target

860

Accrual to date

Final

882

Recruitment outside Australia

Country [1]

Kenya

State/province [1]

Mombasa, Coast Province

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National health and medical research council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Other

Name

Burnet Institute

Address

85 Commercial Road
Melbourne VIC 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/05/2016

Approval date [1]

11/07/2016

Ethics approval number [1]

CF16/1552 - 2016000812

Ethics committee name [2]

Kenyatta National Hospital ethics and research committee

Ethics committee address [2]

Ethics committee country [2]

Kenya

Date submitted for ethics approval [2]

02/05/2016

Approval date [2]

18/07/2016

Ethics approval number [2]

P354/05/2016

Summary

Brief summary

WHISPER is a mobile phone-based health promotion (mHealth) intervention in which text messages will be sent to female sex workers in Mombasa, Kenya. The messages address pregnancy prevention and other sexual and reproductive health (SRH) topics, including HIV/ STI prevention and gender based violence, to improve participants’ knowledge and encourage them to adopt healthier behaviours. The intervention will be tested in a randomised controlled trial to determine whether it results in fewer unintended pregnancies.

The participants receiving the WHISPER messages will be a compared to a second group receiving messages about nutritional health (the SHOUT intervention). Topics include nutritional needs, particularly iron and other micronutrients, locally appropriate food preparation and purchasing tips, water sanitation and hygiene, and food safety. The aim is to improve nutrition and reduce iron deficiency anaemia, and the rate of anaemia will be compared between the SHOUT and WHISPER groups. In other words, each intervention acts as the control group for the other.

The messages for both groups are based on health promotion theory and consultation with FSWs in Mombasa to make them relevant, engaging and effective. As well as simple stand-alone texts, participants will receive stories about sex workers in similar circumstances, overcoming familiar challenges and barriers in order to change their behaviour – for example by using more effective long term contraceptive methods or eating a greater diversity of freshly foods. Participants will also be able to text into the system to request further information via automated response codes, without bearing the cost.

The project is a collaboration between the International Centre for Reproductive Health (ICRH, Kenya) and the Burnet Institute, along with collaborating investigators from other institutions. ICRH is a local NGO with a long history of providing services and support to FSWs via outreach and drop-in clinics in Mombasa, including STI/HIV testing, pregnancy testing, counselling, and support for sexual and gender-based violence. ICRH has a respected role in the sex work community in Mombasa, and close links with other local community-based organisations working with FSWs.

Trial website

http://www.burnet.edu.au/projects/261_whisper_women_s_health_intervention_using_sms_to_prevent_pregnancy_and_shout_sms_intervention_to_improve_nutritional_health_outcomes_a_cluster_randomised_controlled_trial_assessing_mhealth_interventions_among_female_sex_workers_in_mombasa_kenya

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Stanley Luchters

Address

Burnet Institute
85 Commercial Rd
Melbourne VIC 3004

Country

Australia

Phone

+61385062378

Fax

sluchters@burnet.edu.au

Contact person for public queries

Name

Stanley Luchters

Address

Burnet Institute
85 Commercial Rd
Melbourne VIC 3004

Country

Australia

Phone

+61385062378

Fax

sluchters@burnet.edu.au

Contact person for scientific queries

Name

Stanley Luchters

Address

Burnet Institute
85 Commercial Rd
Melbourne VIC 3004

Country

Australia

Phone

+61385062378

Fax

sluchters@burnet.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1164	Study protocol				https://bmjopen.bmj.com/content/7/8/e017388

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	WHISPER or SHOUT study: Protocol of a cluster-randomised controlled trial assessing mHealth sexual reproductive health and nutrition interventions among female sex workers in Mombasa, Kenya.	2017	https://dx.doi.org/10.1136/bmjopen-2017-017388
Embase	Use of long-acting reversible contraception in a cluster-random sample of female sex workers in Kenya.	2019	https://dx.doi.org/10.1002/ijgo.12862
Embase	Effect of a mobile phone intervention for female sex workers on unintended pregnancy in Kenya (WHISPER or SHOUT): a cluster-randomised controlled trial.	2020	https://dx.doi.org/10.1016/S2214-109X%2820%2930389-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

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