Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa (AFFIRM-SA)

University of Cape Town (UCT)

Status: Completed

Conditions: Moderate Depression; Clinical Depression; Postpartum Depression

Treatments: Other: Enhanced usual care; Behavioral: basic counselling by lay-health workers

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01977326

5U19MH095699-02

1U19MH095699 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The objective of this randomised controlled trial (RCT) is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa(i.e. provided by non-specialist health workers)

Full description

Specific Objectives:

1. To determine the effectiveness and cost-effectiveness of task sharing care to community health workers (CHWs), compared to enhanced usual care in South Africa, on both primary outcome measures (severity of prenatal maternal depression symptoms) and on a series of secondary outcome measures (functional status, health care utilization, social support and postnatal infant growth).
2. To examine factors influencing the implementation of the task sharing intervention and future scale up, by assessing feasibility, sustainability, quality, and safety, and by qualitative exploration of the experience of task sharing from the perspectives of both CHWs and patients.

Enrollment: 4,205 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Living in Khayelitsha
3. 18 years or older
4. Screen positive for depression with a cut off of 13 or more on the EPDS
5. Able to give informed consent

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.
• Women who do not speak isiXhosa as a first language

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

4,205 participants in 2 patient groups

counseling intervention

Experimental group

Description:

Each woman recruited into the intervention arm will undergo 6 sessions of basic counselling by lay-health workers

Treatment:

Behavioral: basic counselling by lay-health workers

Enhanced usual care

Active Comparator group

Description:

usual antenatal care with additional 3 - 4 monthly phone calls.

Treatment:

Other: Enhanced usual care