Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR201804003321122 Date of Approval: 11/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title MyPlan4SexualSafety: synergising eHealth and behavioral science to promote safety for women
Official scientific title MyPlan4SexualSafety: synergizing eHealth & behavioral science to promote safety for women
Brief summary describing the background and objectives of the trial This is a two-phased research study designed to better understand and address sexual safety and safety planning surrounding sexual coercion and intimate partner violence (IPV). During Phase 1, we conducted formative research to inform content and piloted a preliminary mHealth ¿app¿ intervention. We are now in Phase 2; implementing an mHealth ¿app¿ intervention (myPlanKenya) to reduce women¿s experiences of IPV and sexual coercion, and increase safety behaviors. The intervention, delivered via app, provides assessment, safety planning, and support, and helps women address decisional conflict. Phase 2 will consist of a RCT, where individuals will be randomized to receive the myPlanKenya app or standard of care, and undergo short baseline, exit interview, and follow-up surveys. Data collected will be used to describe patterns of sexual and reproductive coercion, IPV, safety planning strategies, decisional conflict, and related physical, sexual and mental health outcomes, and evaluate the efficacy of the myPlanKenya app to reduce sexual and reproductive coercion, IPV, and decisional conflict, and enhance safety behavior and health at follow-up relative to control condition. The study aim is to: Implement the myPlanKenya app and evaluate its efficacy relative to a control condition on outcomes assessed at 3-month follow-up
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Intimate partner violence and sexual violence
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 12/04/2018
Actual trial start date
Anticipated date of last follow up 08/10/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 450
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
IRB00008440 Johns Hopkins Institutional Review Board
IRB00008440 Johns Hopkins Institutional Review Board
IRB00008440 Johns Hopkins Institutional Review Board
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Randomization occurs within the app and will be stratified by violence experience and study site (1:1 allocation) Allocation is determined within the app, therefore all women will be blind to their intervention status and all study staff, besides those who are working through the app with the women will also be blind to intervention status. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group myPlanKenya One visit with the participant's having the option to return to the study center to review their safety plan and referral list 30 minutes The intervention, delivered via app, provides assessment, safety planning, and support, and helps women address decisional conflict. 225
Control Group Control One visit with the participant's having the option to return to the study center to review the control content 10-20 minutes Comparable to the standard of care, the control condition is consists of a minimal standard set of safety strategies with an emphasis on referral resources. The content is delivered in the form of an app for comparability with the intervention 225 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Female ¿ Age 18-35 ¿ Is currently in a relationship where physical or sexual partner violence has been experienced, or fears for safety have occurred in the past 3 months ¿ Lives in Korogocho/Kariobangi, Dandora, or Huruma/Mathare settlements in Nairobi with no plans to move within the next 6 months ¿ Speaks English or Swahili ¿ Male ¿ Under age 18 ¿ Have not experienced intimate partner violence or sexual coercion or partner-related fears within the last 3 months ¿ Lives outside of the study area or plans to move within the next 6 months ¿ Does not speak English or Swahili 18 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/04/2018 Johns Hopkins Bloomberg School of Public Health Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
615 N. Wolfe St Baltimore 21205 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reducing sexual and reproductive coercion 3-month follow-up
Primary Outcome reducing IPV 3-month follow-up
Primary Outcome reducing decisional conflict 3-month follow-up
Primary Outcome enhancing safety behavior and health 3-month follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ujamaa 5th Floor, Landmark Plaza, Opposite Harvest Mission Deaf Church, Kamunde Rd Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Ideas42 Floor 30, 80 Broad St New York 10004 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Johns Hopkins Bloomberg School of Public Health 615 N. Wolfe St Baltimore 21205 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Michele R. Decker 615 N. Wolfe St Baltimore 21205 United States of America
Zaynab Hameeduddin 615 N. Wolfe St Baltimore 21205 United States of America
Shannon Wood 615 N. Wolfe St Baltimore 21205 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michele Decker mdecker@jhu.edu 410.502.2747 615 N. Wolfe St
City Postal code Country Position/Affiliation
Baltimore 21205 United States of America Associate Professor, Department of Population, Family & Reproductive Health
Role Name Email Phone Street address
Public Enquiries Zaynab Hameeduddin zhameed1@jhu.edu 410.502.9097 615 N. Wolfe St
City Postal code Country Position/Affiliation
Baltimore 21205 United States of America Sr. Research Program Coordinator
Role Name Email Phone Street address
Scientific Enquiries Zaynab Hameeduddin zhameed1@jhu.edu 410.502.9097 615 N. Wolfe St
City Postal code Country Position/Affiliation
Baltimore 21205 United States of America Sr. Research Program Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 18/04/2018 New information. In our previous submission the intervention assignment was indicated to be single group, however in this study we will have two groups to which participants will be randomly allocated: the control group (no intervention) and the intervention group. Single group: all participants receive same intervention throughout study Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously
Section Name Field Name Date Reason Old Value Updated Value
Ethics IsApprovedByEC 26/04/2018 edit true true
Section Name Field Name Date Reason Old Value Updated Value
Ethics IsApprovedByEC 18/04/2018 New information true true
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 26/02/2019 edit MyPlan4SexualSafety: synergizing eHealth & behavioral science to promote safety for women MyPlan4SexualSafety: synergising eHealth and behavioral science to promote safety for women
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 26/02/2019 edit Not Applicable