Intimate Partner ViolenceNCT06811922
The Primary Prevention of Intimate Partner Violence
A study testing GBE (Ghya Bharaari Ekatra) intervention in people with Intimate Partner Violence, run by Emory University at 2 sites in India.
Trial summary
This is a cluster randomized trial for newly married dyads, that seeks to quantify the impact of GBE's (Ghya Bharaari Ekatra's) intervention on intimate partner violence (IPV) and downstream outcomes, mental health and reproductive autonomy, examine its mechanism of action, contexts in which it may need modification… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- GBE (Ghya Bharaari Ekatra) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 2 sitesIndia
- Study dates
- Oct 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- couples wherein both members are age ≥18 years,
- married ≤ 1 year, in their first marriage, married to only one individual, cohabiting in a slum in Mumbai or Pune India, and
- fluent in Marathi and/or Hindi
- Both members of the couple must meet eligibility criteria and be present at the session for the couple to participate.
Who cannot join
- As GBE was designed for primary IPV prevention, couples in which the female member screens positive for physical and/or sexual IPV (using the modified Conflict Tactics Scale (CTS-2)) at baseline will be excluded (and referred to support services)
- those in the 3rd trimester of pregnancy (as women traditionally return to their natal home during this perinatal period).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites
Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health (ICMR-NIRRCH),
Mumbai, Maharashtra, 400012
Indian Council of Medical Research - National Institute of Translational Virology and AIDS Research (ICMR-NITVAR)
Pune, Maharashtra, 411026
About this study
Official title: Primary Prevention of Intimate Partner Violence
This is a cluster randomized trial for newly married dyads, that seeks to quantify the impact of GBE's (Ghya Bharaari Ekatra's) intervention on intimate partner violence (IPV) and downstream outcomes, mental health and reproductive autonomy, examine its mechanism of action, contexts in which it may need modification, and factors associated with its future successful adoption and implementation.
Read the detailed description
Intimate partner violence (IPV) is experienced by one-fourth of women in India and associated with poor mental, physical, sexual and reproductive health, leading many experts including the World Health Organization to call for the urgent development of effective primary IPV prevention. The investigators previously developed an evidence-based, theory-driven, dyadic intervention, Ghya Bharaari Ekatra (GBE, "Take a Flight Together," NIH/FIC K01 TW009664) for the primary prevention of IPV among newly married couples residing in slums in India. GBE is delivered over six weekly sessions by a team of lay peer educators to groups of five couples and makes use of engaging culturally tailored delivery methods to challenge norms and build knowledge and skills to address six key IPV determinants: limited relationship quality time, poor self-esteem, resilience, communication and conflict management, sexual communication and sexual/reproductive health knowledge, and conservative IPV norms and definitions. In a pilot study of 40 couples married < 1 year, it was found that GBE demonstrated high acceptance (with 85% of participants retained across all 6 sessions), feasibility, safety (no reported adverse events), and preliminary efficacy in preventing IPV and improving mental health in the female partner. The investigators now seek to quantify GBE's impact on IPV and downstream outcomes, mental health and reproductive autonomy, examine its mechanism of action, contexts in which it may need modification, and factors associated with its future successful adoption and implementation.
The research team hypothesizes that (1) GBE prevents IPV experience and enhances reproductive autonomy among women,(2) GBE improves mental health among both dyadic members, and (3) GBE's effects are mediated by the IPV determinants it was designed to address. The team, with 15 years of IPV research experience in India, proposes a cluster randomized trial of 850 newly married dyads (500 to GBE and 350 controls) in Maharashtra, India to execute the following aims: 1) to quantify the impact of the GBE intervention compared to the ethical standard of care (information on IPV and mental and reproductive/sexual health resources) in preventing IPV experience (primary outcome), enhancing reproductive autonomy among newly married women (secondary outcome) and mental health among the both members of the dyad (secondary outcome) at 12 months; 2) to conduct mediation and moderation analyses for the efficacy of the GBE intervention; and 3) to identify barriers, facilitators, and strategies for future, successful adoption and implementation of GBE through exit interviews with GBE participants and qualitative interviews, guided by Consolidated Framework for Implementation Research, with interventionists, adopters, and other stakeholders who have influence over implementation outcomes. Study findings will provide the information necessary to facilitate scale-up of GBE across India and similar resource-limited, high-burden settings globally upon study completion.
- Conditions
- Intimate Partner Violence
- Being tested
- GBE (Ghya Bharaari Ekatra) intervention, Ethical standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBE (Ghya Bharaari Ekatra) interventionBehavioural
Also called Ghya Bharaari Ekatra intervention, Take a flight together intervention, IPV Intervention
Ghya Bharaari Ekatra (Marathi for "Take a flight together") intervention
The intervention consists of six sessions. Each session will cover one of 6 major modules to enhance transformation of motivation: 1) You, Me, and Us: Spending Meaningful Time Together, 2) I'm a Champion: I Can't Be Broken and I don't Accept Defeat! 3) Building Communication and conflict management strategies, and 4) Empowerment of the Couple: Planning Ahead, 5) Sexual communication and the sexual relationships, and 6) A Lens into Domestic Violence. The sessions will be audio-recorded and include a combination of didactics, interactive discussions, media use, and role play. The expected durations of sessions are 2 hours.
GBE will be delivered to a total of 500 dyads.
Ethical standard of careBehavioural
Ethical standard of care includes information on IPV and mental and reproductive/sexual health resources) to prevent IPV experience. This intervention will be delivered to a total of 350 dyads.
| Study group | Role | What they receive |
|---|---|---|
| GBE (Ghya Bharaari Ekatra) Group | Experimental | * Dyads assigned to the GBE arm will be sequentially assigned into a group composed of 5 newly married (married ≤ 1 yr) couples.
* GBE will be delivered to groups of 5 newly married couples (husband-wife dyads) in weekly 2-hour sessions over a 6-week period, plus ethical standard of care (information about IPV resources).
* GBE will be facilitated by a male/female pair of trained peer educators and held at a community-based venue, in the slum communities in which the couples reside.
* The intervention is highly participatory. Receives: Behavioral: GBE (Ghya Bharaari Ekatra) intervention; Behavioral: Ethical standard of care |
| Control Group | Active comparator | Control groups will solely receive the ethical standard of care (information about IPV resources). Receives: Behavioral: Ethical standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intimate Partner Violence (IPV) Experience
IPV experience is defined as a woman experiencing one or more act of physical, sexual, and/or psychological IPV.
Measured: 12 months post intervention
Secondary outcomes (2)
Change in General Health Questionnaire-12 (GHQ-12) Score
Mental health is assessed using the General Health Questionnaire-12 (GHQ-12). The GHQ-12 is scored using a 4-point Likert scale, where each item is assigned a value from 0 to 3, resulting in a total score ranging from 0 to 36, with higher scores indicating greater psychological distress.
Measured: Baseline, 6 and 12 months post intervention
Change in Reproductive Autonomy Scale (RAS) Score
Reproductive autonomy among women is measured using a culturally-tailored version of the Reproductive Autonomy Scale (RAS). The RAS is a 14-item self-reported measure of individual experiences of ability to achieve reproductive goals, comprising of three domains: Decision-making, Freedom from Coercion, and Communication. The Decision-making subscale uses a 3-point Likert scale, where each item is assigned a value of 1 to 3. The Freedom from Coercion and Communication Subscales use a 4-point Likert scale, where each item is assigned a value of 1 to 4. Item scores are averaged to calculate subscale and total measure scores. Higher scores indicate greater levels of autonomy.
Measured: Baseline, 6 and 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible dyads will be sequentially enrolled and randomly assigned within each geographic strata (slum community) of Mumbai and Pune (equal numbers in both cities) using a computer-generated randomization scheme to the GBE intervention (n=500 dyads) or control arm (n=350 dyads); total n=1,700 participants.
- Masking
- None (open label)
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Ameeta Kalokhe, Emory University
- Investigators
- Ameeta Kalokhe, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811922
- Sponsor's protocol ID
- STUDY00007022
- Other IDs
- 1R01HD114862-01
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant survey data collected during the trial that underlie the results reported, after deidentification.
Publications
Kalokhe AS, Begum S, Bangar S, Bhise M, Freeman MC, Katendra T, Rahane G, Ravi U, Patel SA, Prusty R, Sales JM, Wirtz S, Sahay S. 'Ghya Bharaari Ekatra': study protocol for a cluster randomized trial to evaluate a couples-based intervention for the primary prevention of intimate partner violence in India. BMC Public Health. 2026 Mar 24;26(1):1705. doi: 10.1186/s12889-026-26803-9.
PubMed 41872785
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT06811922
- Acronym / sponsor ID
- STUDY00007022
- Conditions
- Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cluster randomized trial for newly married dyads, that seeks to quantify the impact of GBE's (Ghya Bharaari Ekatra's) intervention on intimate partner violence (IPV) and downstream outcomes, mental health and reproductive autonomy, examine its mechanism of action, contexts in which it may need modification, and factors associated with its future successful adoption and implementation.
Detailed description
Intimate partner violence (IPV) is experienced by one-fourth of women in India and associated with poor mental, physical, sexual and reproductive health, leading many experts including the World Health Organization to call for the urgent development of effective primary IPV prevention. The investigators previously developed an evidence-based, theory-driven, dyadic intervention, Ghya Bharaari Ekatra (GBE, "Take a Flight Together," NIH/FIC K01 TW009664) for the primary prevention of IPV among newly married couples residing in slums in India. GBE is delivered over six weekly sessions by a team of lay peer educators to groups of five couples and makes use of engaging culturally tailored delivery methods to challenge norms and build knowledge and skills to address six key IPV determinants: limited relationship quality time, poor self-esteem, resilience, communication and conflict management, sexual communication and sexual/reproductive health knowledge, and conservative IPV norms and definitions. In a pilot study of 40 couples married < 1 year, it was found that GBE demonstrated high acceptance (with 85% of participants retained across all 6 sessions), feasibility, safety (no reported adverse events), and preliminary efficacy in preventing IPV and improving mental health in the female partner. The investigators now seek to quantify GBE's impact on IPV and downstream outcomes, mental health and reproductive autonomy, examine its mechanism of action, contexts in which it may need modification, and factors associated with its future successful adoption and implementation.
The research team hypothesizes that (1) GBE prevents IPV experience and enhances reproductive autonomy among women,(2) GBE improves mental health among both dyadic members, and (3) GBE's effects are mediated by the IPV determinants it was designed to address. The team, with 15 years of IPV research experience in India, proposes a cluster randomized trial of 850 newly married dyads (500 to GBE and 350 controls) in Maharashtra, India to execute the following aims: 1) to quantify the impact of the GBE intervention compared to the ethical standard of care (information on IPV and mental and reproductive/sexual health resources) in preventing IPV experience (primary outcome), enhancing reproductive autonomy among newly married women (secondary outcome) and mental health among the both members of the dyad (secondary outcome) at 12 months; 2) to conduct mediation and moderation analyses for the efficacy of the GBE intervention; and 3) to identify barriers, facilitators, and strategies for future, successful adoption and implementation of GBE through exit interviews with GBE participants and qualitative interviews, guided by Consolidated Framework for Implementation Research, with interventionists, adopters, and other stakeholders who have influence over implementation outcomes. Study findings will provide the information necessary to facilitate scale-up of GBE across India and similar resource-limited, high-burden settings globally upon study completion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible dyads will be sequentially enrolled and randomly assigned within each geographic strata (slum community) of Mumbai and Pune (equal numbers in both cities) using a computer-generated randomization scheme to the GBE intervention (n=500 dyads) or control arm (n=350 dyads); total n=1,700 participants.
| Arm | Type | Receives |
|---|---|---|
| GBE (Ghya Bharaari Ekatra) Group | Experimental | Behavioral: GBE (Ghya Bharaari Ekatra) intervention, Behavioral: Ethical standard of care* Dyads assigned to the GBE arm will be sequentially assigned into a group composed of 5 newly married (married ≤ 1 yr) couples. * GBE will be delivered to groups of 5 newly married couples (husband-wife dyads) in weekly 2-hour sessions over a 6-week period, plus ethical standard of care (information about IPV resources). * GBE will be facilitated by a male/female pair of trained peer educators and held at a community-based venue, in the slum communities in which the couples reside. * The intervention is highly participatory. |
| Control Group | Active comparator | Behavioral: Ethical standard of careControl groups will solely receive the ethical standard of care (information about IPV resources). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- couples wherein both members are age ≥18 years,
- married ≤ 1 year, in their first marriage, married to only one individual, cohabiting in a slum in Mumbai or Pune India, and
- fluent in Marathi and/or Hindi
- Both members of the couple must meet eligibility criteria and be present at the session for the couple to participate.
Key exclusion criteria (2 listed)
- As GBE was designed for primary IPV prevention, couples in which the female member screens positive for physical and/or sexual IPV (using the modified Conflict Tactics Scale (CTS-2)) at baseline will be excluded (and referred to support services)
- those in the 3rd trimester of pregnancy (as women traditionally return to their natal home during this perinatal period).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBE (Ghya Bharaari Ekatra) interventionAlso: Ghya Bharaari Ekatra intervention, Take a flight together intervention, IPV InterventionGhya Bharaari Ekatra (Marathi for "Take a flight together") intervention The intervention consists of six sessions. Each session will cover one of 6 major modules to enhance transformation of motivation: 1) You, Me, and Us: Spending Meaningful Time Together, 2) I'm a Champion: I Can't Be Broken and I don't Accept Defeat! 3) Building Communication and conflict management strategies, and 4) Empowerment of the Couple: Planning Ahead, 5) Sexual communication and the sexual relationships, and 6) A Lens into Domestic Violence. The sessions will be audio-recorded and include a combination of didactics, interactive discussions, media use, and role play. The expected durations of sessions are 2 hours. GBE will be delivered to a total of 500 dyads. | Behavioural | GBE (Ghya Bharaari Ekatra) Group |
| Ethical standard of careEthical standard of care includes information on IPV and mental and reproductive/sexual health resources) to prevent IPV experience. This intervention will be delivered to a total of 350 dyads. | Behavioural | Control Group, GBE (Ghya Bharaari Ekatra) Group |
Primary outcome
Intimate Partner Violence (IPV) Experience
Time frame: 12 months post intervention
IPV experience is defined as a woman experiencing one or more act of physical, sexual, and/or psychological IPV.
2 secondary outcomes
Change in General Health Questionnaire-12 (GHQ-12) Score
Time frame: Baseline, 6 and 12 months post intervention
Change in Reproductive Autonomy Scale (RAS) Score
Time frame: Baseline, 6 and 12 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 41872785Kalokhe AS, Begum S, Bangar S, Bhise M, Freeman MC, Katendra T, Rahane G, Ravi U, Patel SA, Prusty R, Sales JM, Wirtz S, Sahay S. 'Ghya Bharaari Ekatra': study protocol for a cluster randomized trial to evaluate a couples-based intervention for the primary prevention of intimate partner violence in India. BMC Public Health. 2026 Mar 24;26(1):1705. doi: 10.1186/s12889-026-26803-9.
- Individual participant dataSharing planned: Yes. Individual participant survey data collected during the trial that underlie the results reported, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ameeta Kalokhe, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GBE (Ghya Bharaari Ekatra) intervention in people with Intimate Partner Violence, run by Emory University at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ameeta Kalokhe, MD (404-712-1924, akalokh@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intimate Partner Violence (IPV) Experience (time frame: 12 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06811922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.