WHISPER and SHOUT - mHealth interventions among Kenyan sex workers

Background/rationale for the study:

Reducing unmet need for contraception could prevent 54 million unintended pregnancies, result in 26 million fewer (often unsafe) abortions, and prevent 79,000 maternal and 600,000 newborn deaths globally each year. Female sex workers (FSW) in Africa carry a markedly disproportionate burden of reproductive health morbidities, experiencing considerable unmet need for family planning and high incidence of unintended pregnancy.

In Kenya, our previous longitudinal research showed over one quarter (27%) of FSWs have an unintended pregnancy each year. mHealth (mobile phone health) interventions are increasingly recognised for their enormous potential to reach large numbers of people across diverse populations segments and provide sustainable population-level platforms for preventive health in resource-constrained settings.

Our previous trials in Australia showed mHealth interventions significantly increased sexual and reproductive health knowledge and service uptake. Moreover, recent formative research among FSW in Kenya demonstrated high mobile phone use and ownership, and high levels of acceptability to receive SMS health messages.

Objectives:

Primary aim (WHISPER):

To assess the effectiveness of a 12-month mobile phone-based sexual and reproductive health promotion intervention to reduce the incidence of unintended pregnancy among FSWs in Kenya. The primary outcome is the incidence of unintended pregnancy over 12 months of follow-up.

Primary aim (SHOUT):

To assess the effectiveness of a 12-month mobile phone-based nutritional health promotion intervention on nutritional status among FSWs in Kenya. The primary outcome is the prevalence of anaemia (haemoglobin <10.0 g/dL) among study participants at month 12.

Hypotheses:

i) FSWs exposed to the sexual and reproductive health promotion intervention (WHISPER) will experience fewer unintended pregnancies compared to FSWs exposed to the nutrition intervention.
ii) FSWs exposed to the mobile phone-based nutrition intervention (SHOUT) will experience lower rates of anaemia than FSWs exposed to the SRH intervention.

Enrolment for the WHISPER trial is due to commence in July 2016, with follow up to be completed by November 2017

The study has two phases:

Phase 1 – Develop and pilot the mHealth intervention (due to be completed in May 2016):

The research team has been working with FSW in Mombasa, Kenya, to develop and test the mHealth intervention and control packages. Six participatory message development workshops have been conducted with FSWs for both SRH and nutrition messages, and the intervention modified accordingly. One-on-one interviews are being held with FSWs to test the near-final message content and usability of the mobile phone platform.

Phase 2 – Cluster Randomised Controlled Trial (due to commence in July 2016):

We will conduct a cluster randomised controlled trial to assess the effectiveness of our SMS-based mHealth interventions. Eligible women will be recruited from sex work venues (our clusters) by well-established peer outreach workers. FSWs will be randomised to the SRH or nutrition intervention (equal-attention control), with assessments done at baseline, six, and 12 months follow-up.

Semi-structured face-to-face interviews will be conducted by trained research assistants at 0, 6, and 12 months in a dedicated research space at two local drop-in centres linked to health facilities.

The primary study outcome for WHISPER is the incidence of unintended pregnancy over 12 months of follow-up. An unintended pregnancy is defined as one that is mistimed, unplanned, or unwanted at the time of conception. A psychometrically-validated 6-item questionnaire (London Measure of Unintended Pregnancy) is used to score pregnancy intention. Women will be asked about pregnancy intentions (self-reported and before any pregnancy occurred) at baseline, 6 and 12 months.

Secondary outcomes include the proportion of FSWs using modern contraceptive methods and condoms consistently (dual protection); proportion using long-acting reversible contraceptive methods or injectable contraceptives; incidence of HIV and self-reported abortion, and the median score in contraceptive knowledge.

The primary study outcome for SHOUT is the prevalence of anaemia at 12 months of follow-up. Secondary outcomes include mean haemoglobin levels, proportion of FSWs with malnutrition, either underweight (BMI < 18.5kg/m2) or overweight (BMI ≥25 kg/m2), and the proportion reporting nutritious diet, and median score in nutrition knowledge.

If shown to be effective in this trial, mHealth interventions could be incorporated into broader SRH and/or nutrition strategies for FSWs in Africa and elsewhere, and has the potential to be scaled up for use with other women at a population level at low cost.