The research component comprises two randomised control trials (RCTs), one each in Cape Town, South Africa, and the Butajira district, Ethiopia.
THE SOUTH AFRICAN TRIAL IN KHAYELITSHA, CAPE TOWN - URBAN AREA
Principal Investigator: Crick Lund
High rates of antenatal and postnatal depression have been reported in Khayelitsha, and maternal depression has been shown to negatively impact the mother and her baby's health. Our group is testing the efficacy of a counselling intervention for maternal depression in Khayelitsha in the form of a randomized controlled trial (RCT). What is special about this trial is that community health workers (CHWs) will be trained to deliver the intervention, as part of a task sharing strategy in primary health care.
With support from senior management in the Western Cape Government Department of Health, we are working with colleagues in the Michael Mapongwana Midwife Obstetric Unit and Site B Midwife Obstetric Unit.
The first phase of this five year study involved formative research to establish the feasibility and acceptability of the intervention. Pregnant women and mothers of young babies were interviewed to discover issues that would affect the research and counselling intervention. Women were also interviewed about their perceptions and descriptions of depression, and its various causes and symptoms.
Also included in the formative phase was the development of a 'Functional Assessment Instrument', which aims to assess in what way depression specifically affects pregnant women and mothers of young infants in Khayelitsha. This is guided by collaborators from Johns Hopkins University.
Official recruitment for the trial began in October 2013. This phase involves enrolling approximately 420 women into the RCT. As part of the RCT, the women will be randomly allocated to either receive the counselling intervention (6-8 sessions of a structured evidence-based programme delivered either in the clinic or at home by the CHWs), or receive enhanced usual care, which will comprise a monthly structured phone call from a CHW unassociated with the counselling CHWs.
Due to a slower than anticipated recruitment rate at Michael Mapongwana MOU, in January 2014 we included a second location for recruitment – Site B Community Centre MOU. The characteristics of the clinics and the women attending them are very similar, and recruitment increased, with the employment of two more field workers too. Recruitment was completed in October 2014, and the field workers are now concentrating on the follow up assessments, which occur at 1 month before birth, 3 months and 12 months after birth.
The third phase will involve conducting qualitative interviews with some of the participants and the counsellors in order to ascertain the successes and challenges of the intervention.
One of the major questions we seek to answer through the research is whether community health workers can effectively deliver counselling interventions, as this may inform their role in delivering mental health services. This vision is part of the national primary health care revitalization programme, where ward agents or CHWs are expected to play a major preventive and promotive role.
THE ETHIOPIAN TRIAL IN BUTAJIRA, GURAGE ZONE - RURAL AREA
Principal Investigator: Charlotte Hanlon
The Ethiopian trial focuses on task sharing care of stabilised persons with severe mental disorders with primary health care workers (PHWs). The participants are already diagnosed with severe mental disorders and have been receiving care from psychiatric nurses at Butajira hospital. These participants will be randomised into intervention and comparison groups, with the intervention group being those whose mental health management or care plan is transferred to the primary health care level and managed by primary health care workers. The comparison group will continue receiving hospital based mental health care. The aim is to determine whether the transfer to the primary health care level is as effective and not inferior to the management by psychiatric nurses.
The formative phase explored a range of issues to be addressed in the main trial, such as how potential participants understand randomisation, and how well the intervention will be accepted given the history of receiving the hospital based services. The complexity of these issues has required the formative phase to be expanded to include discussions with relevant stakeholders on issues such as randomisation.
As with the South African trial, the Ethiopia team is also developing and adapting outcome measures for the main RCT. This will create an indigenous scale to measure functional impairment and recovery in persons with severe mental disorders in the Butajira District. In addition, a measure of patient satisfaction with services is being adapted for the Ethiopian context. These culturally appropriate measures will be used primarily as secondary outcome measures, but will also provide important insights into the functional status or people with mental disorders. They will be an important contribution from the AFFIRM project, with potential application in both clinical and research settings.