Partner AbuseNCT05389358
Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care
A study testing Asiphephe health worker training, Asiphephe therapeutic sessions and IPV assessment in people with Partner Abuse and Depression, run by University of Witwatersrand, South Africa at 2 sites in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Partner Abuse, Depression, Adherence, Medication
- What is being tested?
- Asiphephe health worker training, Asiphephe therapeutic sessions and IPV assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 26 Apr 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites, 2 recruiting
- Recruiting
Malvern Clinic
Johannesburg, Gauteng, 2094
Lele van Eck, BA, +27813844179, lelevaneck@gmail.com
Nataly Woollett, PhD, woollettn@gmail.com
- Not yet recruiting
Yeoville Clinic
Johannesburg, Gauteng, 2198
Lele van Eck, BA, lelevaneck@gmail.com
About this study
Official title: Pilot Intervention for Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care
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).
Read the detailed 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.
- Conditions
- Partner Abuse, Depression, Adherence, Medication
- Being tested
- Asiphephe health worker training, Asiphephe therapeutic sessions, IPV assessment, Referral for IPV or Mental Health
- Keywords
- intimate partner violence, perinatal depression, ART adherence, HIV, antenatal care, prevention of mother-to-child transmission
- Medical subject headings
- Depression, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asiphephe health worker trainingBehavioural
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 sessionsBehavioural
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.
IPV assessmentOther
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 HealthOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: IPV assessment; Other: Referral for IPV or Mental Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Depressive symptoms using Patient Health Questionnaire-9 will be assessed as a continuous marker of symptomology (with ≥13 indicating probable depression)
Measured: 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).
Measured: 6 months postpartum
Secondary outcomes (1)
ART adherence
Self-reported ART adherence will be collected using a multi-item measure (Wilson et al, 2014).
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start26 Apr 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partner AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abigail Hatcher, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389358
- Sponsor's protocol ID
- K01MH12118501; M210216
- Other IDs
- 5K01MH121185
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The pilot nature of this study and small sample mean we will not make IDP available to researchers outside of our investigative team.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Intervention for Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care
- ClinicalTrials.gov ID
- NCT05389358
- Acronym / sponsor ID
- K01MH12118501; M210216
- Conditions
- Partner Abuse, Depression, Adherence, Medication
- Keywords
- intimate partner violence, perinatal depression, ART adherence, HIV, antenatal care, prevention of mother-to-child transmission
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, National Institute of Mental Health (NIMH)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Asiphephe health worker training, Behavioral: Asiphephe therapeutic sessions, Other: IPV assessment, Other: Referral for IPV or Mental HealthThe 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. |
| Enhanced standard of care | Active comparator | Other: IPV assessment, Other: Referral for IPV or Mental HealthThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asiphephe health worker trainingLay 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). | Behavioural | Intervention |
| Asiphephe therapeutic sessionsAsiphephe 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. | Behavioural | Intervention |
| IPV assessmentIPV intensity as measured by WHO Multicountry Study Instrument at a cut-off of any past-year physical/sexual/psychological violence exposure vs. none | Other | Enhanced standard of care, Intervention |
| Referral for IPV or Mental HealthStudy 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. | Other | Enhanced standard of care, Intervention |
Primary outcome
Depression
Time frame: 6 months postpartum
Depressive symptoms using Patient Health Questionnaire-9 will be assessed as a continuous marker of symptomology (with ≥13 indicating probable depression)
Intimate partner violence
Time frame: 6 months postpartum
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).
1 secondary outcome
ART adherence
Time frame: 6 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No. The pilot nature of this study and small sample mean we will not make IDP available to researchers outside of our investigative team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asiphephe health worker training, Asiphephe therapeutic sessions and IPV assessment in people with Partner Abuse and Depression, run by University of Witwatersrand, South Africa at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 6 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.