Cluster randomised trial to evaluate an intervention for depressed HIV-positive women in the perinatal period, to enhance child development and reduce maternal depressio

Not Applicable

Completed

• Conditions: Perinatal depression in women with HIV infection; Mental and Behavioural Disorders

• Registration Number: ISRCTN11284870
• Lead Sponsor: The University of Oxford

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39097310/ (added 09/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-14
• Study Completion: 2024-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

Current inclusion criteria as of 14/12/2022:
1. Pregnant women, 23-33 weeks gestation at the time of enrolment
2. Participant is willing and able to give informed consent for participation in the trial
3. Aged 16 years and above
4. Diagnosed HIV-positive
5. Mother meets criteria for antenatal depression as defined by 9 and greater on the EPDS
6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period)
7. Mother conversant in isiZulu or English

Current inclusion criteria as of 25/01/2019 to 14/12/2022:
1. Pregnant women, <33 weeks gestation at time of enrolment
2. Participant is willing and able to give informed consent for participation in the trial
3. Aged 16 years and above
4. Diagnosed HIV-positive
5. Mother meets criteria for antenatal depression as defined by 9 and greater on the EPDS
6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period)
7. Mother conversant in isiZulu or English

Previous inclusion criteria:
1. Pregnant women, <33 weeks gestation at time of enrolment
2. Participant is willing and able to give informed consent for participation in the trial
3. Aged 16 years and above
4. Diagnosed HIV-positive
5. Mother meets criteria for antenatal depression as defined by 13 and greater on the EPDS
6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period)
7. Mother conversant in isiZulu or English

Exclusion Criteria

1. Any significant disease, disorder or disability which, in the opinion of the Principal Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. This includes hospitalisation for at least three days for severe psychiatric illness (specifically bipolar disorder, schizophrenia and any other psychoses), or a life-threatening or other serious physical illness (excluding HIV and tuberculosis)
2. Current suicidal ideation/thoughts with specific plans and means identified
3. Substance or alcohol use disorder
4. Currently receiving a psychological treatment for mental health problems
5. Participant planning to move away from the study area before 9 months postnatal
6. Mother not planning to cohabit with the infant

Study & Design

• Study Type: Interventional
• Study Design: Not specified