A Pilot Study of Improving Outcomes in Teenage Pregnancy Using a Combined Tailored M- Health Program and Motivational Interviewing Intervention

Mortality among pregnant teenagers in South Africa (SA) is very high: institutional Maternal Mortality Ratio (iMMR) of 67.1 deaths per 100,000 live births in teenagers; with 71.7% of deaths resulting from four causes: hypertension (22.8%); non-pregnancy related infections (21.1%) (HIV/AIDS-related, such as TB or pneumonia); obstetric haemorrhage (14.2%); and medical and surgical disorders (13.6%). Risk factors for these include poor antenatal clinic (ANC) attendance, lack of adherence to antiretroviral therapy, poor compliance to treatment for tuberculosis, inadequate management of preeclampsia, and slow referral of high risk pregnancies to secondary and tertiary centres. Changing the health-related behaviour of pregnant teenagers, using an m-health intervention combined with motivational interviewing (MI), could reduce the prevalence of these risk factors and, thus reduce mortality. This pilot study will test the feasibility, user acceptability and preliminary efficacy of an enhanced version of MomConnect - an m-Health program developed by our partners, the Praekelt Foundation and the SA National Department of Health (NDOH).The enhancements include adding tailored content to the SMS messaging platform; and an MI counselling intervention (4 sessions) delivered face to face by trained healthcare workers. The SMS messages will be tailored by age (13 - 19 years), motivational variables, appointment adherence, language and culture. Messages will be designed, pretested, and refined through formative evaluation procedures, under direction of our health communications expert. The revised program, Teen-MomConnect, will integrate both the enhanced SMS messages and the MI counselling for each pregnant teenager. For example, the MI counsellors will have access to the survey question responses, as well as ANC appointment-keeping status obtained via the cell phone. The MI clinical behavioural counselling training and implementation will be designed by, and pilot tested with health workers, who will deliver the counselling. Starting from week 12 of their pregnancy, the teenagers will receive 4 MI sessions delivered face to face (or via cell phone) at the ANC by a healthcare worker. The study has two phases. Phase 1 aims to develop, test, refine, and then pilot the major program enhancements (SMS and MI) to MomConnect. Phase II is the pilot field test and its aims are:1) to demonstrate whether pregnant teenagers can be recruited and retained in the study; 2) whether the causes of 71.7% of mortality in pregnant teenagers can be measured, 3) to establish uptake rates (both SMS use and completion of MI visit) for the enhanced Teen-MomConnect intervention; 4) evaluate if the integrated motivational behavioural face to face counselling, and the tailored health SMS intervention, impact pregnant teenagers ANC attendance (primary outcome), and the other risk factors for teenage maternal mortality. For the Phase II field pilot study, 200 pregnant teenagers will be recruited through clinics, schools and community organisations - 100 will be randomised to the behavioural intervention of Teen-MomConnect plus MI; and 100 will be given "usual care" with MomConnect alone. The study will take 18 months to complete at a cost of ?150,000.The results of the pilot will be used to design a randomised controlled trial (RCT) to test the effectiveness of the Teen-MomConnect in a fully powered cohort of pregnant teenagers. The RCT will also include a cost effectiveness analysis. The products from this grant will include the Teen-MomConnect App and SMS messages; an MI training program for health workers; research instruments that have been designed and validated for the larger RCT; recruitment and retention protocols and a partnership between an international collaboration of scientists, Praekelt Foundation and the NDOH. This grant application has received the support of the NDOH who have issued a letter of support.

Technical Summary

Objectives: 1) Develop the Teen-MomConnect intervention, which enhances the existing MomConnect SMS messaging content and adds MI counselling, delivered by trained healthcare workers to the pregnant teenagers, 2) Test the feasibility and user acceptability of Teen- MomConnect in a pilot study. Methodology: Phase I: Formative research for intervention development comprises design, pretesting and refinement of intervention content. Development of tailored SMS content: 1) focus groups of 8-10 eligible pregnant teenagers to determine behavioural drivers, 2) develop SMS messages tailored by age, motivational variables, appointment adherence, language, culture, 3) pretest messages in one on one interviews with a new set of teenagers, 4) message refinement. Development of the MI content delivered by health workers to teenagers comprises similar 4-stage procedures to the development of SMS content. Phase II: Piloting. Pregnant teenagers will be recruited and screened for eligibility from clinics, communities and schools. Eligibility criteria: 13-19 years, ?20 weeks pregnant, speak Afrikaans, English or Xhosa, registered on the MomConnect system. 200 enrolled participants will be randomised to receive either usual care MomConnect (control) or Teen- MomConnect with MI (intervention). The intervention group will receive tailored messages and counselling based on characteristics established from baseline assessment. Questionnaires and clinic records will measure pre and post test. Outcome measures: ANC attendance, uptake rates of SMS use and MI, HIV testing, treatment compliance for those with TB and HIV, preeclampsia identified and treated, and referral of high risk pregnancies to specialist centres. The pilot will inform a large scale RCT to test the effectiveness of the Teen-MomConnect. Products include the Teen-MomConnect intervention, MI training program for health workers, and designed and validated research instruments for the larger RCT.