| CTRI Number |
CTRI/2018/01/011596 [Registered on: 30/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
30/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Primary Prevention of Intimate Partner Violence in India |
|
Scientific Title of Study
|
Primary Prevention of Intimate Partner Violence in India |
| Trial Acronym |
IPV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seema Sahay |
| Designation |
Scientist - F |
| Affiliation |
National AIDS Research Institute (ICMR) |
| Address |
National AIDS Research Institute (ICMR)
SBR Dept, Plot No.73 G-Block MIDC Pune
Pune
MAHARASHTRA
411026
India |
| Phone |
02027331200 |
| Fax |
|
| Email |
ssahay@nariindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Sahay |
| Designation |
Scientist - F |
| Affiliation |
National AIDS Research Institute (ICMR) |
| Address |
National AIDS Research Institute (ICMR)
SBR Dept, Plot No.73 G-Block MIDC Pune
Pune
MAHARASHTRA
411026
India |
| Phone |
02027331200 |
| Fax |
|
| Email |
ssahay@nariindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Sahay |
| Designation |
Scientist - F |
| Affiliation |
National AIDS Research Institute (ICMR) |
| Address |
National AIDS Research Institute (ICMR)
SBR Dept, Plot No.73 G-Block MIDC Pune
Pune
MAHARASHTRA
411026
India |
| Phone |
02027331200 |
| Fax |
|
| Email |
ssahay@nariindia.org |
|
|
Source of Monetary or Material Support
|
| National Institutes of Health Fogarty International Center |
|
|
Primary Sponsor
|
| Name |
National Institutes of Health Fogarty International Center |
| Address |
National Institutes of Health, Fogarty International Center, Building 31
31 Center Drive MSC 2220
Bethesda MD 20892 2220
USA |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ICMR National AIDS Research Institute |
ICMR - National AIDS Research Institute, Plot No.73, G-Block, MIDC, Bhosari, Pune 411026 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Seema Sahay |
Pune, Maharashtra, India |
National AIDS Research Institute (ICMR)
Plot No.73 G-Block MIDC Pune - 411026
Pune
MAHARASHTRA |
02027331200
ssahay@nariindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National AIDS Research Institute (NARI), Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All human volunteers fulfilling the inclusion/exclusion criteria can participate |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
"Ghya Bharaari Ekatra" |
Intervention for newly married couples |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Couples who have been married for 0-12 months are eligible.
2.This should be the couples first marriage.
3.They should be living together.
4.They should live in Pune, PCMC for the next 6 months. |
|
| ExclusionCriteria |
| Details |
1.Couples in which the women report experience of violence will be excluded.
2.Couples who have participated in a previous research study or Aim 1 and Aim 2 of our study will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate safety of the developed intervention for primary prevention of intimate partner violence in India |
August 2018 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preliminarily evaluate acceptances, feasibility and efficacy of the developed intervention for primary prevention of intimate partner violence in India |
August 2018 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/01/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim is to develop an evidence based intervention for primary prevention of intimate partner violence in India. The 6-session pilot intervention will be administered to 20 recently-married, individual, low income husband-wife dyads over 6 weeks with one module per week. Each of the 6 sessions will be followed by semi-structured interviews with the couple and intervention administrator to gauge acceptance and feasibility. A control group of 20 recently-married husband-wife dyads (who will not receive any intervention) will also be asked to individually complete the survey at two time points . There will be assessment for feasibility, acceptability, safety and preliminary efficacy of the intervention.
|