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

NCT05389358 | Unknown DMC

• 2 other identifiers: K01MH12118501; M2102165K01MH121185
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Partner Abuse; Depression; Adherence, Medication

Keywords

intimate partner violence; perinatal depression; ART adherence; HIV; antenatal care; prevention of mother-to-child transmission

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• ART adherence

  6 months postpartum

Other Outcomes (3)

• Viral suppression

  6 months postpartum

• Anxiety

  6 months postpartum

• PTSD

  6 months postpartum

Study Arms (2)

Intervention

EXPERIMENTAL

The Asiphephe (meaning "Let us stay safe") intervention is a problem-solving therapy manual delivered in a one-on-one setting by lay health workers during routine antenatal care. 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 includes illustrated job aids, participant workbook, intervention checklist, 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.

Behavioral: Asiphephe health worker training; Behavioral: Asiphephe therapeutic sessions; Other: IPV assessment; Other: Referral for IPV or Mental Health

Enhanced standard of care

ACTIVE COMPARATOR

The enhanced standard of care condition will entail a clinic-wide training (5 hours) on IPV, mental health, and HIV care in order to sensitize staff to the nature of the research. The clinic will receive access to established referral network to which participants can gain additional help with violence exposure or mental ill health. Participants in this arm will also be observed for adverse events and social harms, with referrals made appropriately by study staff.

Other: IPV assessment; Other: Referral for IPV or Mental Health

Interventions

Asiphephe health worker training BEHAVIORAL

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).

Intervention

Asiphephe therapeutic sessions BEHAVIORAL

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.

Intervention

IPV assessment OTHER

IPV intensity as measured by WHO Multicountry Study Instrument at a cut-off of any past-year physical/sexual/psychological violence exposure vs. none

Enhanced standard of care; Intervention

Referral for IPV or Mental Health OTHER

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.

Enhanced standard of care; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead
• University of North Carolina, Chapel Hill: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Malvern Clinic

Johannesburg, Gauteng, 2094, South Africa

RECRUITING

Yeoville Clinic

Johannesburg, Gauteng, 2198, South Africa

NOT YET RECRUITING

MeSH Terms

Conditions

Depression; Medication Adherence

Interventions

Referral and Consultation; Poliovirus Vaccine, Inactivated; Mental Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines; Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants at routine antenatal care will not know whether their clinic is the intervention or enhanced usual care arm, since both will offer support that is over-and-above standard care. Outcomes will be assessed using self-completed tablet computers, so there is no outcomes assessor.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 2 primary health clinics offering antenatal care services in inner-city Johannesburg, South Africa will be randomized to receive intervention or enhanced standard of care. Within each clinic n=40 participants will take part in baseline, midline, and endline assessments.

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 25, 2022
• Study Start: April 26, 2022
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)