Draper 2020.

Study name	Pilot implementation of Bukhali: a preconception health trial in South Africa
Methods	Study design: cluster‐RCT Country: South Africa
Participants	18‐ to 25‐year‐old women Inclusion criteria:  a. women aged 18‐25 years at baseline measurement Exclusion criteria: a. women with type‐I diabetes, cancer or epilepsy; b. intellectual disability; c. not able or willing to provide consent. Stated purpose: to describe the findings and learnings from the pilot implementation of the HeLTI trial in SA, including a description of intervention strategies and adaptations to the trial design
Interventions	Intervention: Bukhali The intervention arm was designed to be delivered by CHWs (26–40 years old) who would (1) dispense multiple‐micronutrient supplements and resource material, (2) provide health feedback (body mass index (BMI), blood pressure, anaemia and lifestyle) and free services (HIV and pregnancy testing) through monthly individual sessions and (3) facilitate monthly peer sessions on Saturdays. The materials were designed for use in monthly peer sessions with approximately 15 women, facilitated by a Health Helper, over 18 months. Peer sessions were structured to encourage group discussion and also had take‐home activities. Control: Standard of care plus (standard access to healthcare plus additional input on life skills: materials are developed for a call centre intervention that covers practical life skills. Information will be provided via email, SMS and telephonic conversation. The call centre team will offer centre‐based HIV and pregnancy testing and counselling).
Outcomes	Participants'outcomes of interest for this review Mental health symptoms/depression – Patient Health Questionnaire 9 (PHQ‐9) Mental health symptoms/anxiety – Generalized Anxiety Disorder 7 (GAD‐7) Economic outcomes Nil Time points: baseline, post‐intervention (2 years postpartum)
Starting date	1 April 2019
Contact information	CE Draper, catherine.draper@wits.ac.za
Notes	Source of funding: South African Medical Research Council and the Canadian Institutes of Health Research Prospective trial registration number: PACTR201903750173871