Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care

Depression Clinical Trial

Official title:

Pilot Intervention for Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389358
• Other study ID #: K01MH12118501; M210216
• Secondary ID: 5K01MH121185
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2022
• Source: University of Witwatersrand, South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This quasi-experimental feasibility study recruit n=40 participants from each of two public antenatal clinics in Johannesburg, South Africa. Using the Bowen et al. approach, key feasibility study questions will be those around acceptability, implementation, and promising effects on intermediate variable. While this pilot trial is not powered to determine efficacy, it can help establish whether intervention targets the appropriate intermediate mechanisms (i.e. primary endpoints of IPV exposure and depressive symptoms) and moves intended outcomes in the right direction (i.e. towards better adherence as measured by self-reported adherence).

Description:

Prevention of mother-to-child transmission (PMTCT) programs are effective if women take medication regularly, yet many perinatal women in sub-Saharan Africa have sup-optimal adherence. Intimate partner violence (IPV) worsens women's ability to adhere to antiretroviral therapy (ART), and leads to higher rates of depression. In a quasi-experimental feasibility study in South Africa, 2 inner-city Johannesburg clinics will be assigned to intervention or enhanced standard of care conditions. Intervention consists of training health workers to deliver one-on-one sessions in pregnancy (4 sessions) and postpartum (2 sessions) using problem-solving therapy and safety planning. Following n=80 women in a prospective cohort will allow for preliminarily assessment of intervention effects on: perinatal depression, IPV exposure, and ART adherence at 6 months postpartum. Additional qualitative research with 10 providers and 15 beneficiaries will help us qualitatively assess acceptability of intervention content, measures, and study conditions. This pilot trial can establish acceptability of intervention and control conditions and provide preliminary point estimates to inform future trial design.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older (the age of research consent in South Africa)

• currently pregnant and less than 30 weeks gestation (from antenatal green card)

• speak a study language (English, isiZulu, Sesotho)

• living with HIV (self-reported and confirmed on green card)

• report past-year IPV (score of =1 on WHO multicountry study instrument)

• are willing to provide informed consent

Exclusion Criteria:

• fail to meet all of the inclusion criteria

• at risk of immediate danger (current suicidality, homicidality, or risk to child safety)

• planning to terminate the pregnancy

Related Conditions & MeSH terms

• Adherence, Medication
• Depression
• Partner Abuse

Intervention

Behavioral:
• Asiphephe health worker training
Lay health workers are already employed by the Department of Health and are trained in-service (30 hours) and receive monthly supervision (total of approximately 6 one-on-one hours; 15 group hours).
• Asiphephe therapeutic sessions
Asiphephe sessions are manualized using illustrated job aids, a participant workbook, session checklists, and an intervention manual. The model is informed by problem-solving therapy (Lund, 2018), trauma-informed coping (Sikkema, 2018) and safety planning (Garcia-Moreno, forthcoming) and was piloted with 12 health workers with input from 3 global mental health experts.

Other:
• IPV assessment
IPV intensity as measured by WHO Multicountry Study Instrument at a cut-off of any past-year physical/sexual/psychological violence exposure vs. none
• Referral for IPV or Mental Health
Study staff are trained to recognize signs or symptoms of distress and to make appropriate referrals to appropriate community-based services, if necessary. Experienced mental health professionals on the investigative can be consulted or referred to should a participant exhibit severe symptom of mental distress.

Locations

Country	Name	City	State
South Africa	Malvern Clinic	Johannesburg	Gauteng
South Africa	Yeoville Clinic	Johannesburg	Gauteng

Sponsors (3)

Lead Sponsor	Collaborator
University of Witwatersrand, South Africa	National Institute of Mental Health (NIMH), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Viral suppression	Log10 viral load (VL) will be abstracted from medical records.	6 months postpartum
Other	Anxiety	Anxiety symptoms will measured by Generalized Anxiety Disorder scale-7 with a cut-off of 8 suggesting probable generalized anxiety.	6 months postpartum
Other	PTSD	Post traumatic stress symptoms will be measured by the Harvard Trauma Questionnaire with symptom severity assessed as continuous scale.	6 months postpartum
Primary	Depression	Depressive symptoms using Patient Health Questionnaire-9 will be assessed as a continuous marker of symptomology (with =13 indicating probable depression)	6 months postpartum
Primary	Intimate partner violence	IPV exposure will be measured using the World Health Organization multicountry study instrument of behaviorally-specific likert-type items about frequency of physical, sexual, or psychological violence from a partner. Any IPV will be defined as an affirmative response to any physical, sexual, or psychological violence question. For primary outcome assessment, the WHO instrument will be examined as a continuous measure summing all standardized response items as a marker of IPV intensity (Tsai, 2016).	6 months postpartum
Secondary	ART adherence	Self-reported ART adherence will be collected using a multi-item measure (Wilson et al, 2014).	6 months postpartum