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: pactr.samrc.ac.za
Trial no.: PACTR201802003124149 Date of Approval: 20/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Tathmini GBV Study
Official scientific title Tathmini GBV: Evaluation of the Outcomes of Comprehensive Gender-based Violence Programming in Tanzania
Brief summary describing the background and objectives of the trial The purpose of the study is to assess the effectiveness of a comprehensive GBV prevention and response program delivered at facility and community levels through the HIV program platform in Mbeya region of Tanzania. The study compares the effectiveness of this comprehensive programming over time with standard practice in control facilities and communities. The GBV program and this study focus on intimate partner violence in the forms of sexual, physical, and emotional violence; and on sexual violence among both adults and children, irrespective of the relationship between perpetrator and survivor.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied gender-based violence
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 14/05/2013
Actual trial start date 14/05/2013
Anticipated date of last follow up 13/05/2016
Actual Last follow-up date 13/05/2016
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants) 1250
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NIMR/HQ/R.8a/Vol. IX/1502 Tanzania National Institute for Medical Research
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 Simple randomization of 12 clusters using coin toss Name of cluster was witheld (blinded) from person tossing the coin Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group WRP/HJFMRI GBV Program Multi-component porgram delivered at individual, community, and facility levels; exposure to the intervention varied within the population 28 months Multi-component program that included GBV service delivery improvements at public health facilities, Community sensitization and dialogues, group education, couples skills building, and building linkages among services 6
Control Group Control Standard practice 28 months Standard practice 6 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligibility for household survey: Female 15-49 years of age Residing in study area Under age 15 or older than age 50 Resident outside the study area 15 Year(s) 49 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 05/03/2013 Tanzania National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
PO Box 9653 Dar es Salaam Tanzania
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 04/02/2013 Muhimbili University of Health and Allied Sciences
Ethics Committee Address
Street address City Postal code Country
PO Box 65001 Dar es Salaam Tanzania
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 15/03/2013 Mbeya Medical Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 419 Mbeya Tanzania
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 12/09/2012 Population Council
Ethics Committee Address
Street address City Postal code Country
1230 York Avenue New York, NY 10065 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Recent experience of IPV (sexual, physical, or emotional) among females ages 15¿49 years May/June 2013 April/May 2016
Primary Outcome ¿ Utilization of GBV services at Health Centers and Hospitals (by females and males, all ages) January 1, 2015 April 30, 2016
Primary Outcome ¿ Delivery of comprehensive sexula violence services at Health Centers and Hospitals January 1, 2014 April 30, 2016
Secondary Outcome Experience of controlling behaviors by partner in the past 12 months May/June 2013 April/May 2016
Secondary Outcome Acceptance of intimate partner violence May/June 2013 April/May 2016
Secondary Outcome Knowledge about gender-based violence May/June 2013 January-March 2015 April/May 2016
Secondary Outcome Gender norms (as measured by GEM Scale) May/June 2013 April/May 2016
Secondary Outcome Community actions to address gender-based violence May/June 2013 January-March 2015 April/May 2016
Secondary Outcome Utilization of HIV-related services May/June 2013 April/May 2016
Primary Outcome Recent experience of IPV (sexual, physical, or emotional) among females ages 15-49 years May/June 2013 April/May 2016
Primary Outcome Utilization of GBV services at Health Centers and Hospitals January 2014 through April 2016 (monthly)
Primary Outcome Delivery of comprehensive sexual violence services at Health Centers and Hospitals January 2015 through April 2016 (monthly)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kyela District Hospital Kyela Tanzania
Chunya District Hospital Chunya Tanzania
Vwawa District Hospital Vwawa Tanzania
Mbarali District Hospital Mbarali Tanzania
Itumba District Hospital Itumba Tanzania
Iyula Health Centre Iyulu Tanzania
Inyala Health Centre Inyala Tanzania
Mbuyuni Health Centre Mbuyuni Tanzania
Ilembo Health Centre Ilembo Tanzania
Ibaba Health Centre Ibaba Tanzania
Mwakaleli Health Centre Mwakalelei Tanzania
Tukuyu District Hospital Tukuyu Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
U.S. President's Emergency Plan for AIDS Relief 1800 G Street NW Washington, DC 20006 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Palladium 1331 Pennsylvania Avenue NW, Suite 600 Washington, DC 20004 United States of America Commercial Sector/Industry
Primary Sponsor U.S. Agency for International Development Ronald Reagan Building Washington, DC 20523-1000 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Jessie Kilonzo Mbwambo Muhimbili University of Health and Allied Sciences Dar es Salaam PO Box 65001 Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Susan Settergren susan.settergren@thepalladiumgroup.com +1 404 875 2941 1331 Pennsylvania Avenue NW, Suite 600
City Postal code Country Position/Affiliation
Washington, DC 20004 United States of America Techical Director; Data, Informatics, and Analytical Solutions; Palladium
Role Name Email Phone Street address
Public Enquiries Susan Settergren susan.settergren@thepalladiumgroup.com +1 404 875 2941 1331 Pennsylvania Avenue NW, Suite 600
City Postal code Country Position/Affiliation
Washington, DC 20004 United States of America Technical Director; Data, Informatics, and Analytical Solutions; Palladium
Role Name Email Phone Street address
Scientific Enquiries Susan Settergren susan.settergren@thepalladiumgroup.com +1 404 875 2941 1331 Pennsylvania Avenue NW, Suite 600
City Postal code Country Position/Affiliation
Washington, DC 20004 United States of America Technical Director; Data, Informatics, and Analytical Solutions; Palladium
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