Pilot Intervention for Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Intimate partner violence
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
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.
干预措施: Asiphephe health worker training (Behavioral)
Intervention
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.
干预措施: Asiphephe therapeutic sessions (Behavioral)
Intervention
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.
干预措施: IPV assessment (Other)
Intervention
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.
干预措施: Referral for IPV or Mental Health (Other)
Enhanced standard of care
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.
干预措施: IPV assessment (Other)
Enhanced standard of care
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.
干预措施: Referral for IPV or Mental Health (Other)
结局指标
主要结局
Intimate partner violence
时间窗: 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).
Depression
时间窗: 6 months postpartum
Depressive symptoms using Patient Health Questionnaire-9 will be assessed as a continuous marker of symptomology (with ≥13 indicating probable depression)
次要结局
- ART adherence(6 months postpartum)
研究者
Abigail Hatcher
Assistant Professor
University of North Carolina, Chapel Hill