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AFFIRM-SA trial

The effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201403000676264
Enrollment
420
Registered
2013-10-11
Start date
2013-10-07
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth perinatal depression

Interventions

Enhanced usual care
Basic manual based counselling for 6 sessions by trained community health workers
Basic manual based counselling for 6 sessions by trained lay counsellors

Sponsors

Alan J Flisher Centre for Public Mental Health, Psychiatry and Mental Health, University of Cape Town
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: ¿ Women attending antenatal clinics at the Michael Mapongwana Community Health Centre in Khayelitsha, presenting for their first booking appointment, no later than 28 weeks gestation ¿ Living in Khayelitsha ¿ 18 years or older ¿ Screen positive for depression with a cut off of 13 or more on the EPDS ¿ Able to give informed consent

Exclusion criteria

Exclusion criteria: ¿ Require urgent medical attention or have severe mental health problems, defined as a diagnosis of schizophrenia, bipolar mood disorder, or currently experiencing an episode of psychosis. ¿ Individuals assessed as being suicidal and requiring immediate referral to a mental health specialist (as indicated by a score of 17 or higher on the Suicide module of the Mini International Neuropsychiatric Interview 6.0.0 (MINI). ¿ Women who do not speak isiXhosa as a first language

Design outcomes

Primary

MeasureTime frame
scores on Hamilton depression rating scale

Secondary

MeasureTime frame
Edinburgh Postnatal depression scale (EPDS);Mini International Psychiatric Interview 2.0.0 (MINI) Major depression ;Mini International Psychiatric Interview 2.0.0 (MINI) Suicidality;Multidimensional Scale of Perceived Social Support (MSPSS);WHO-DAS 2.0 12 item version;Health services utilisation questionnaire;Cape Town Functional Assessment Instrument for Maternal Depression;Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisation

Countries

South Africa

Contacts

Public ContactMarguerite Schneider

AFFIRM Project Manager

marguerite.schneider@uct.ac.za+27214066308

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026