Pallitto 2016.

Study name	Testing a counselling intervention in antenatal care for women experiencing partner violence
Methods	Study design: RCT Country: South Africa
Participants	Pregnant women Inclusion criteria:  a. pregnant women who are at least 18 years old and less than 33 weeks gestation (to allow enough time for the second intervention session); b. able to communicate in one of the most common local languages (English, Sotho, or Zulu); c. reporting that they have experienced physical or sexual violence by their current or most recent partner in the past 12 months. Exclusion criteria: a. reported risk of imminent lethal violence by a partner; b. fear that a child in the home is at immediate risk of lethal violence by the partner; c. at suicidal risk (as determined by having ideation with a plan to commit suicide). Stated purpose: 1) to test a nurse‐led counselling intervention for abused pregnant women receiving antenatal care in South Africa that could be incorporated into the routine antenatal care package; 2) To determine whether the counselling intervention being tested during pregnancy can reduce the recurrence of intimate partner violence and the frequency and severity of this violence; 3) To determine whether the counselling intervention being tested is effective in improving safety, empowerment, mental health, and help‐ and health‐seeking behaviour of abused pregnant women; 4) To assess whether, at baseline, women experiencing intimate partner violence differ from women who do not experience intimate partner violence in regard to mental health, self‐efficacy, and HIV risk behaviours; 5) To assess whether HIV‐positive women who have experienced intimate partner violence differ from HIV‐positive women who have not experienced intimate partner violence with regard to PMTCT uptake and adherence as measured at follow‐up
Interventions	Intervention: Safe & Sound intervention The Safe & Sound intervention is based on a nurse‐led "empowerment counselling model"; and it consists of two 30‐min counselling sessions. This model promoted by Dutton includes two complementary components – (a) improving women's safety and protection, including negotiating safer sex with a partner, while (b) enhancing her decision‐making and problem‐solving ability in her relationship. Safe & Sound covers a combination of the following elements that will be individually tailored depending on women’s experience and her readiness to change: empathetic listening, cyclical nature of partner violence, evaluating danger and discussing option, developing safety strategies, pregnancy changes, legal steps, available resources. Control: Enhanced usual care (a referral list to local resources)
Outcomes	Participants'outcomes of interest for this review Mental health symptoms – Hospital Anxiety and Depression Scale (HADS) Economic outcomes Nil Time points: baseline, post‐intervention (6 weeks postpartum)
Starting date	1 March 2014 Completed (29 July 2016)
Contact information	Christina Pallitto, pallittoc@who.int
Notes	Source of funding: grant from Flanders International Cooperation Agency, WHO Initiative for Health Pregnancy in Southern Africa, 2010–2016, and the UNDP‐UNFPA‐UNICEF‐WHO‐World Bank Special Programme of Re‐ search, Development and Research Training in Human Reproduction (HRP) Prospective trial registration number: ISRCTN35969343 and DOH‐27‐0414‐4720