Intimate Partner ViolenceTEVAWNCT02434796
Study of the Preliminary Effect of TEVAW: a Program to Address Intimate Partner Violence in Northern Tanzania
A study testing Male Peer Groups and Male Peer Groups and Community Dialogues in people with Intimate Partner Violence, run by Boston University.
Trial summary
Women in Tanzania suffer alarming rates of intimate partner violence (IPV) that has detrimental effects on mental and physical health including an increased risk of HIV infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Male Peer Groups and Male Peer Groups and Community Dialogues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Married women, aged 18 and older, who live in Karatu District in Northern Tanzania with their male partners, who participate in the LIMCA program, are willing to participate, and provide informed consent.
- Male partners of women LIMCA members named above, aged 18 and older who live in Karatu District in Northern Tanzania, are willing to participate, and provide informed consent.
Who cannot join
- Women who are not partnered, who do not live in the study catchment area, who do not participate in the LIMCA program, and who do not provide informed consent
- Men who are not married or partnered, who do not live in the study catchment area; whose wives/partners do not participate in the LIMCA program, and who do not provide informed consent.
About this study
Official title: A Mixed Methods Study to Test the Preliminary Effect of Together to End Violence Against Women (TEVAW): a Program to Address Intimate Partner Violence in Northern Tanzania
Women in Tanzania suffer alarming rates of intimate partner violence (IPV) that has detrimental effects on mental and physical health including an increased risk of HIV infection. The investigators will use a cluster randomized control study design to conduct a preliminary evaluation study of TEVAW, an intervention that aims to improve gender equitable attitudes and to decrease tolerance of IPV among men and women in rural Tanzania. Nine villages will be randomly assigned into one of three study arms, each comprised of 150 partnered women and their co-resident male partners. Women in the comparison arm are currently exposed to World Education's savings and lending group intervention (known as LIMCA), in which they receive training on business skills, literacy, child nutrition and health, child protection, intimate partner violence (IPV) and HIV prevention. Women in Intervention Arm 1 will be exposed to LIMCA, while their male partners will participate in male peer group workshops that explore gender norms, IPV and HIV prevention issues. In Intervention Arm 2, men and women will receive the same treatment as Intervention Arm 1 and participate in community dialogues with community leaders to explore similar topics as the male peer groups. Our hypothesis is that study participants in Arm 2 will report improved gender equitable attitudes and lower intolerance of intimate partner violence than participants in Arm 1 and participants in the control group. Data will be collected at baseline and endline using a structured questionnaire with questions from three validated instruments that measure gender equitable attitudes and attitudes about IPV.
Read the detailed description
Women in Tanzania suffer alarming rates of intimate partner violence (IPV) that has detrimental effects on mental and physical health including an increased risk of HIV infection. The investigators will use a cluster randomized control study design to conduct a preliminary evaluation study of TEVAW, an intervention that aims to improve gender equitable attitudes and to decrease tolerance of IPV among men and women in rural Tanzania. Nine villages will be randomly assigned into one of three study arms, each comprised of 150 partnered women and their co-resident male partners. A total of 450 women and their partners will be recruited for the study. Women in the comparison arm are currently exposed to World Education's savings and lending group intervention (known as LIMCA), in which they receive training on business skills, literacy, child nutrition and health, child protection, intimate partner violence (IPV) and HIV prevention. Women in Intervention Arm 1 will be exposed to LIMCA, while their male partners will participate in male peer group workshops that explore gender norms, IPV and HIV prevention issues. In Intervention Arm 2, men and women will receive the same treatment as Intervention Arm 1 and participate in community dialogues with community leaders to explore similar topics as the male peer groups. Our hypothesis is that study participants in Arm 2 will report improved gender equitable attitudes and lower intolerance of intimate partner violence than participants in Arm 1 and participants in the control group. Data will be collected at baseline and endline using a structured questionnaire with questions from three validated instruments that measure gender equitable attitudes and attitudes about IPV. The following are the specific aims of the study:
- To test the feasibility, acceptability and proof of concept of two interventions (women's savings groups combined with male peer groups vs. women's savings groups combined with male peer groups and community dialogues) compared to a control group participating only in women's savings groups in Karatu District, Northern Tanzania.
- To contribute to a better understanding of the attitudes, behaviors and social factors related to intimate partner violence through the exploration of cultural gender norms in Karatu District, Northern Tanzania.
- Conditions
- Intimate Partner Violence
- Being tested
- Male Peer Groups, Male Peer Groups and Community Dialogues
- Keywords
- Intimate Partner Violence, Gender-Based Violence, Gender, HIV
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male Peer GroupsBehavioural
In Intervention Arm 1, male partners participate in male peer group workshops on gender norms, IPV and HIV prevention. Men's peer groups address gender inequality and transformation of gender power relations, positive masculinities and accountability of men in the perpetration of violence against women. This intervention aims to improve knowledge and attitudes among men about the harms of IPV on women, men and children; the confidence to internalize positive masculine ideals and to challenge gender stereotypes; and the ability to formulate positive outcome expectations regarding IPV and healthy relationships with their spouses and communities. Male peer group workshops will be conducted as a series of four workshops for a total of 24 hours spread out over a 5-month period.
Male Peer Groups and Community DialoguesBehavioural
Men participate in male peer group workshops as in Intervention Arm 1. In addition, village level community leaders engage in community mobilization/sensitization activities that include women members of savings groups and their male partners who participate male peer groups. Community dialogues focus on gender norms, IPV and HIV prevention. First, a one-day workshop for community leaders on topics similar to those raised in male peer group sessions. Second, trained community leaders facilitate community dialogues on IPV, HIV prevention, and gender norms with savings groups members and their male partners who participate in male peer groups. Each workshop will be a day-long event.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Male Peer Groups (MPG) | Experimental | Women participate in savings groups and male partners participate in male peer group workshops on gender norms, IPV and HIV prevention. This intervention aims to improve knowledge and attitudes about the harms of IPV on women, men and children; the confidence to internalize positive masculine ideals (e.g. caring for one's family) and to challenge gender stereotypes (e.g. women are not equal to men); and the ability to formulate positive outcome expectations regarding IPV (intolerance of violence perpetrated by themselves or others) and healthy relationships with their spouses and communities. Receives: Behavioral: Male Peer Groups |
| Arm 2 MPG & Community Dialogues | Experimental | This arm will include women participants in savings groups, male peer groups and community dialogues. Village community leaders will engage in community dialogues on gender norms, IPV and HIV prevention. Receives: Behavioral: Male Peer Groups and Community Dialogues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportion of men who report a husband is justified in beating his wife
For attitudes on IPV, men get the value of 1, if they agree that a husband is justified in hitting or beating his wife if she (a) burns the food; (b) argues with him; (c) goes out without telling him; (d) neglects the children; or (e) refuses to have sexual intercourse with him; men get a 0 if they do not agree with any of these statements.
Measured: 4 months
Secondary outcomes (1)
Difference in proportion of men who report gender-inequitable attitudes
We will measure men's gender-inequitable attitudes using an 18-item scale on attitudes toward gender norms in intimate relationships, known as the GEM (Gender Equitable Men). For each item listed on the GEM scale, men will report their level of agreement with Strongly Agree [=3], Agree [=2], Disagree [=1], and Strongly Disagree [=0]. Men will get a score ranging between 0 and 54, where 0 indicates that a man reports to maintain the most inequitable attitudes on gender and 54 indicates that he maintains the most equitable gender attitudes.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionJan 2017
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 Boston 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
- Single group
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- World Education, Inc.
- Responsible party
- Principal investigator, Lisa J. Messersmith, Boston University
- Investigators
- Lisa Messersmith, PhD, MPH, Principal investigator, Boston University Center for Global Health and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434796
- Sponsor's protocol ID
- SVRI49-WEI2014
- Acronym
- TEVAW
- Status last verified
- Mar 2017
- First submitted
- 30 Apr 2015
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Halim N, Steven Mzilangwe E, Reich N, Badi L, Simmons E, Servidone M, Bingham Holmes N 2nd, Kawemama P, Messersmith LJ. Together to end violence against women in Tanzania: Results of a pilot cluster randomized controlled trial to evaluate preliminary effectiveness of interpersonal and community level interventions to address intimate partner violence. Glob Public Health. 2019 Dec;14(12):1653-1668. doi: 10.1080/17441692.2019.1609062. Epub 2019 May 13.
PubMed 31084264
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Study to Test the Preliminary Effect of Together to End Violence Against Women (TEVAW): a Program to Address Intimate Partner Violence in Northern Tanzania
- ClinicalTrials.gov ID
- NCT02434796
- Acronym / sponsor ID
- TEVAW / SVRI49-WEI2014
- Conditions
- Intimate Partner Violence
- Keywords
- Intimate Partner Violence, Gender-Based Violence, Gender, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- World Education, Inc.
- Study start
- May 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 May 2015 (estimated)
- 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.
Women in Tanzania suffer alarming rates of intimate partner violence (IPV) that has detrimental effects on mental and physical health including an increased risk of HIV infection. The investigators will use a cluster randomized control study design to conduct a preliminary evaluation study of TEVAW, an intervention that aims to improve gender equitable attitudes and to decrease tolerance of IPV among men and women in rural Tanzania. Nine villages will be randomly assigned into one of three study arms, each comprised of 150 partnered women and their co-resident male partners. Women in the comparison arm are currently exposed to World Education's savings and lending group intervention (known as LIMCA), in which they receive training on business skills, literacy, child nutrition and health, child protection, intimate partner violence (IPV) and HIV prevention. Women in Intervention Arm 1 will be exposed to LIMCA, while their male partners will participate in male peer group workshops that explore gender norms, IPV and HIV prevention issues. In Intervention Arm 2, men and women will receive the same treatment as Intervention Arm 1 and participate in community dialogues with community leaders to explore similar topics as the male peer groups. Our hypothesis is that study participants in Arm 2 will report improved gender equitable attitudes and lower intolerance of intimate partner violence than participants in Arm 1 and participants in the control group. Data will be collected at baseline and endline using a structured questionnaire with questions from three validated instruments that measure gender equitable attitudes and attitudes about IPV.
Detailed description
Women in Tanzania suffer alarming rates of intimate partner violence (IPV) that has detrimental effects on mental and physical health including an increased risk of HIV infection. The investigators will use a cluster randomized control study design to conduct a preliminary evaluation study of TEVAW, an intervention that aims to improve gender equitable attitudes and to decrease tolerance of IPV among men and women in rural Tanzania. Nine villages will be randomly assigned into one of three study arms, each comprised of 150 partnered women and their co-resident male partners. A total of 450 women and their partners will be recruited for the study. Women in the comparison arm are currently exposed to World Education's savings and lending group intervention (known as LIMCA), in which they receive training on business skills, literacy, child nutrition and health, child protection, intimate partner violence (IPV) and HIV prevention. Women in Intervention Arm 1 will be exposed to LIMCA, while their male partners will participate in male peer group workshops that explore gender norms, IPV and HIV prevention issues. In Intervention Arm 2, men and women will receive the same treatment as Intervention Arm 1 and participate in community dialogues with community leaders to explore similar topics as the male peer groups. Our hypothesis is that study participants in Arm 2 will report improved gender equitable attitudes and lower intolerance of intimate partner violence than participants in Arm 1 and participants in the control group. Data will be collected at baseline and endline using a structured questionnaire with questions from three validated instruments that measure gender equitable attitudes and attitudes about IPV. The following are the specific aims of the study:
- To test the feasibility, acceptability and proof of concept of two interventions (women's savings groups combined with male peer groups vs. women's savings groups combined with male peer groups and community dialogues) compared to a control group participating only in women's savings groups in Karatu District, Northern Tanzania.
- To contribute to a better understanding of the attitudes, behaviors and social factors related to intimate partner violence through the exploration of cultural gender norms in Karatu District, Northern Tanzania.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Male Peer Groups (MPG) | Experimental | Behavioral: Male Peer GroupsWomen participate in savings groups and male partners participate in male peer group workshops on gender norms, IPV and HIV prevention. This intervention aims to improve knowledge and attitudes about the harms of IPV on women, men and children; the confidence to internalize positive masculine ideals (e.g. caring for one's family) and to challenge gender stereotypes (e.g. women are not equal to men); and the ability to formulate positive outcome expectations regarding IPV (intolerance of violence perpetrated by themselves or others) and healthy relationships with their spouses and communities. |
| Arm 2 MPG & Community Dialogues | Experimental | Behavioral: Male Peer Groups and Community DialoguesThis arm will include women participants in savings groups, male peer groups and community dialogues. Village community leaders will engage in community dialogues on gender norms, IPV and HIV prevention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Married women, aged 18 and older, who live in Karatu District in Northern Tanzania with their male partners, who participate in the LIMCA program, are willing to participate, and provide informed consent.
- Male partners of women LIMCA members named above, aged 18 and older who live in Karatu District in Northern Tanzania, are willing to participate, and provide informed consent.
Key exclusion criteria (2 listed)
- Women who are not partnered, who do not live in the study catchment area, who do not participate in the LIMCA program, and who do not provide informed consent
- Men who are not married or partnered, who do not live in the study catchment area; whose wives/partners do not participate in the LIMCA program, and who do not provide informed consent.
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 |
|---|---|---|
| Male Peer GroupsIn Intervention Arm 1, male partners participate in male peer group workshops on gender norms, IPV and HIV prevention. Men's peer groups address gender inequality and transformation of gender power relations, positive masculinities and accountability of men in the perpetration of violence against women. This intervention aims to improve knowledge and attitudes among men about the harms of IPV on women, men and children; the confidence to internalize positive masculine ideals and to challenge gender stereotypes; and the ability to formulate positive outcome expectations regarding IPV and healthy relationships with their spouses and communities. Male peer group workshops will be conducted as a series of four workshops for a total of 24 hours spread out over a 5-month period. | Behavioural | Arm 1 Male Peer Groups (MPG) |
| Male Peer Groups and Community DialoguesMen participate in male peer group workshops as in Intervention Arm 1. In addition, village level community leaders engage in community mobilization/sensitization activities that include women members of savings groups and their male partners who participate male peer groups. Community dialogues focus on gender norms, IPV and HIV prevention. First, a one-day workshop for community leaders on topics similar to those raised in male peer group sessions. Second, trained community leaders facilitate community dialogues on IPV, HIV prevention, and gender norms with savings groups members and their male partners who participate in male peer groups. Each workshop will be a day-long event. | Behavioural | Arm 2 MPG & Community Dialogues |
Primary outcome
Difference in proportion of men who report a husband is justified in beating his wife
Time frame: 4 months
For attitudes on IPV, men get the value of 1, if they agree that a husband is justified in hitting or beating his wife if she (a) burns the food; (b) argues with him; (c) goes out without telling him; (d) neglects the children; or (e) refuses to have sexual intercourse with him; men get a 0 if they do not agree with any of these statements.
1 secondary outcome
Difference in proportion of men who report gender-inequitable attitudes
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Derived from this study: PubMed 31084264Halim N, Steven Mzilangwe E, Reich N, Badi L, Simmons E, Servidone M, Bingham Holmes N 2nd, Kawemama P, Messersmith LJ. Together to end violence against women in Tanzania: Results of a pilot cluster randomized controlled trial to evaluate preliminary effectiveness of interpersonal and community level interventions to address intimate partner violence. Glob Public Health. 2019 Dec;14(12):1653-1668. doi: 10.1080/17441692.2019.1609062. Epub 2019 May 13.
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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. This study is not recruiting at the moment.
Lisa Messersmith, PhD, MPH principal investigator
Boston University Center for Global Health and Development
Questions about this trial
What is this clinical trial studying?
A study testing Male Peer Groups and Male Peer Groups and Community Dialogues in people with Intimate Partner Violence, run by Boston University.
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 2 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: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in proportion of men who report a husband is justified in beating his wife (time frame: 4 months). 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 NCT02434796, 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 17 Mar 2017.