Maltreatment by Spouse or PartnerMAISHANCT02592252
Impact of Microfinance and Participatory Gender Training for Women in Reducing Intimate Partner Violence
A study testing Participatory gender training and Microfinance in people with Maltreatment by Spouse or Partner, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
Trial summary
Violence against women and girls is increasingly recognized as a major global public health and development concern. However, evidence on what forms of intervention should be prioritised is severely lacking. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maltreatment by Spouse or Partner
- What is being tested?
- Participatory gender training and Microfinance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,640 participants
- Where
- 1 siteTanzania
- Study dates
- Sep 2014to Dec 2019
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Arms 1 and 2 - microfinance loan groups:
- there are between 15 and 30 active members in the group
- less than 25% of the women have been members for less than one year
- there is a good attendance (repayment) record
- a minimum of 70% of active members consent to take part in the study
- Arms 3 and 4, women who:
Show all 12Show fewer
- are aged 20-50 years
- are not formally employed, i.e. either self-employed or not currently working
- have been resident in Mwanza for at least two years
- have not been a member of a microfinance loan group in the past 12 months
- are fluent in Swahili
- have consented to take part in the study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Tanzania1 site, 1 recruiting
- Recruiting
Mawanza Intervention Trials Unit
Mwanza
Sheila E Harvey, Ph.D, +44 (0)20 612 7854, sheila.harvey@lshtm.ac.uk
Shelley Lees, Ph.D, +44 (0)20 7327 2586, shelley.lees@lshtm.ac.uk
About this study
Official title: Cluster Randomised Controlled Trial to Assess the Impact of Combined Microfinance and Gender Training for Women and Gender Training for Women and Their Male Partners in Reducing Intimate Partner Violence
Violence against women and girls is increasingly recognized as a major global public health and development concern. However, evidence on what forms of intervention should be prioritised is severely lacking. A cluster randomized controlled trial (The Intervention with Microfinance for AIDS \& Gender Equity - IMAGE Project) in rural South Africa combined a group-based microfinance intervention with a participatory gender and HIV training curriculum for loan participants and showed that, over a two-year period, levels of physical and/or sexual partner violence experienced by participants in the past year were reduced by 55%.
The overall goal of the current study is to design and implement a cluster randomized controlled trial to assess the impact on intimate partner violence of: 1) combining participatory gender training with microfinance for women in existing microfinance loan groups, and 2) a participatory gender training programme for women (not receiving microfinance) and their male partners.
- Conditions
- Maltreatment by Spouse or Partner
- Being tested
- Participatory gender training, Microfinance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory gender trainingBehavioural
10 sessions of participatory gender training
MicrofinanceOther
Microfinance loan
| Study group | Role | What they receive |
|---|---|---|
| Microfinance + gender training | Experimental | Microfinance + 10 sessions of participatory gender training Receives: Behavioral: Participatory gender training; Other: Microfinance |
| Microfinance only | Experimental | Receive microfinance only Receives: Other: Microfinance |
| Gender training only | Experimental | 10 sessions of participatory gender training for women and their male partners Receives: Behavioral: Participatory gender training |
| No intervention | No intervention | No microfinance or participatory gender training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Past 12 months exposure to intimate partner violence
Exposure to intimate partner violence will be assessed using the WHO Multi-country Study on Women's Health and Domestic Violence against Women questionnaire
Measured: 24 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 posted30 Oct 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Maltreatment by Spouse or PartnerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 2,640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Mwanza Intervention Trials Unit, National Institute for Medical Research, Tanzania, Bangladesh Rural Advancement Committee, EngenderHealth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592252
- Sponsor's protocol ID
- QA430
- Acronym
- MAISHA
- Status last verified
- Mar 2018
- First submitted
- 13 Aug 2015
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Abramsky T, Guadarrama DS, Kapiga S, Mtolela G, Madaha F, Lees S, Harvey S. Pathways to reduced physical intimate partner violence among women in north-western Tanzania: Evidence from two cluster randomised trials of the MAISHA intervention. PLOS Glob Public Health. 2023 Nov 13;3(11):e0002497. doi: 10.1371/journal.pgph.0002497. eCollection 2023.
PubMed 37956111Abramsky T, Harvey S, Mosha N, Mtolela G, Gibbs A, Mshana G, Lees S, Kapiga S, Stockl H. Longitudinal inconsistencies in women's self-reports of lifetime experience of physical and sexual IPV: evidence from the MAISHA trial and follow-on study in North-western Tanzania. BMC Womens Health. 2022 Apr 15;22(1):120. doi: 10.1186/s12905-022-01697-y.
PubMed 35428296Harvey S, Abramsky T, Mshana G, Hansen CH, Mtolela GJ, Madaha F, Hashim R, Kapinga I, Watts C, Lees S, Kapiga S. A cluster randomised controlled trial to evaluate the impact of a gender transformative intervention on intimate partner violence against women in newly formed neighbourhood groups in Tanzania. BMJ Glob Health. 2021 Jul;6(7):e004555. doi: 10.1136/bmjgh-2020-004555.
PubMed 34301673Kapiga S, Harvey S, Mshana G, Hansen CH, Mtolela GJ, Madaha F, Hashim R, Kapinga I, Mosha N, Abramsky T, Lees S, Watts C. A social empowerment intervention to prevent intimate partner violence against women in a microfinance scheme in Tanzania: findings from the MAISHA cluster randomised controlled trial. Lancet Glob Health. 2019 Oct;7(10):e1423-e1434. doi: 10.1016/S2214-109X(19)30316-X.
PubMed 31537372Abramsky T, Lees S, Stockl H, Harvey S, Kapinga I, Ranganathan M, Mshana G, Kapiga S. Women's income and risk of intimate partner violence: secondary findings from the MAISHA cluster randomised trial in North-Western Tanzania. BMC Public Health. 2019 Aug 14;19(1):1108. doi: 10.1186/s12889-019-7454-1.
PubMed 31412825Harvey S, Lees S, Mshana G, Pilger D, Hansen C, Kapiga S, Watts C. A cluster randomized controlled trial to assess the impact on intimate partner violence of a 10-session participatory gender training curriculum delivered to women taking part in a group-based microfinance loan scheme in Tanzania (MAISHA CRT01): study protocol. BMC Womens Health. 2018 Apr 2;18(1):55. doi: 10.1186/s12905-018-0546-8.
PubMed 29609568Kapiga S, Harvey S, Muhammad AK, Stockl H, Mshana G, Hashim R, Hansen C, Lees S, Watts C. Prevalence of intimate partner violence and abuse and associated factors among women enrolled into a cluster randomised trial in northwestern Tanzania. BMC Public Health. 2017 Feb 14;17(1):190. doi: 10.1186/s12889-017-4119-9.
PubMed 28193198
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomised Controlled Trial to Assess the Impact of Combined Microfinance and Gender Training for Women and Gender Training for Women and Their Male Partners in Reducing Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT02592252
- Acronym / sponsor ID
- MAISHA / QA430
- Conditions
- Maltreatment by Spouse or Partner
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,640 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Mwanza Intervention Trials Unit, National Institute for Medical Research, Tanzania, Bangladesh Rural Advancement Committee, EngenderHealth
- Study start
- Sep 2014 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Oct 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.
Violence against women and girls is increasingly recognized as a major global public health and development concern. However, evidence on what forms of intervention should be prioritised is severely lacking. A cluster randomized controlled trial (The Intervention with Microfinance for AIDS \& Gender Equity - IMAGE Project) in rural South Africa combined a group-based microfinance intervention with a participatory gender and HIV training curriculum for loan participants and showed that, over a two-year period, levels of physical and/or sexual partner violence experienced by participants in the past year were reduced by 55%.
The overall goal of the current study is to design and implement a cluster randomized controlled trial to assess the impact on intimate partner violence of: 1) combining participatory gender training with microfinance for women in existing microfinance loan groups, and 2) a participatory gender training programme for women (not receiving microfinance) and their male partners.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Microfinance + gender training | Experimental | Behavioral: Participatory gender training, Other: MicrofinanceMicrofinance + 10 sessions of participatory gender training |
| Microfinance only | Experimental | Other: MicrofinanceReceive microfinance only |
| Gender training only | Experimental | Behavioral: Participatory gender training10 sessions of participatory gender training for women and their male partners |
| No intervention | No intervention | –No microfinance or participatory gender training |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- there are between 15 and 30 active members in the group
- less than 25% of the women have been members for less than one year
- there is a good attendance (repayment) record
- a minimum of 70% of active members consent to take part in the study
- are aged 20-50 years
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Participatory gender training10 sessions of participatory gender training | Behavioural | Gender training only, Microfinance + gender training |
| MicrofinanceMicrofinance loan | Other | Microfinance + gender training, Microfinance only |
Primary outcome
Past 12 months exposure to intimate partner violence
Time frame: 24 months post-intervention
Exposure to intimate partner violence will be assessed using the WHO Multi-country Study on Women's Health and Domestic Violence against Women questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Derived from this study: PubMed 37956111Abramsky T, Guadarrama DS, Kapiga S, Mtolela G, Madaha F, Lees S, Harvey S. Pathways to reduced physical intimate partner violence among women in north-western Tanzania: Evidence from two cluster randomised trials of the MAISHA intervention. PLOS Glob Public Health. 2023 Nov 13;3(11):e0002497. doi: 10.1371/journal.pgph.0002497. eCollection 2023.
- Derived from this study: PubMed 35428296Abramsky T, Harvey S, Mosha N, Mtolela G, Gibbs A, Mshana G, Lees S, Kapiga S, Stockl H. Longitudinal inconsistencies in women's self-reports of lifetime experience of physical and sexual IPV: evidence from the MAISHA trial and follow-on study in North-western Tanzania. BMC Womens Health. 2022 Apr 15;22(1):120. doi: 10.1186/s12905-022-01697-y.
- Derived from this study: PubMed 34301673Harvey S, Abramsky T, Mshana G, Hansen CH, Mtolela GJ, Madaha F, Hashim R, Kapinga I, Watts C, Lees S, Kapiga S. A cluster randomised controlled trial to evaluate the impact of a gender transformative intervention on intimate partner violence against women in newly formed neighbourhood groups in Tanzania. BMJ Glob Health. 2021 Jul;6(7):e004555. doi: 10.1136/bmjgh-2020-004555.
- Derived from this study: PubMed 31537372Kapiga S, Harvey S, Mshana G, Hansen CH, Mtolela GJ, Madaha F, Hashim R, Kapinga I, Mosha N, Abramsky T, Lees S, Watts C. A social empowerment intervention to prevent intimate partner violence against women in a microfinance scheme in Tanzania: findings from the MAISHA cluster randomised controlled trial. Lancet Glob Health. 2019 Oct;7(10):e1423-e1434. doi: 10.1016/S2214-109X(19)30316-X.
- Derived from this study: PubMed 31412825Abramsky T, Lees S, Stockl H, Harvey S, Kapinga I, Ranganathan M, Mshana G, Kapiga S. Women's income and risk of intimate partner violence: secondary findings from the MAISHA cluster randomised trial in North-Western Tanzania. BMC Public Health. 2019 Aug 14;19(1):1108. doi: 10.1186/s12889-019-7454-1.
- Derived from this study: PubMed 29609568Harvey S, Lees S, Mshana G, Pilger D, Hansen C, Kapiga S, Watts C. A cluster randomized controlled trial to assess the impact on intimate partner violence of a 10-session participatory gender training curriculum delivered to women taking part in a group-based microfinance loan scheme in Tanzania (MAISHA CRT01): study protocol. BMC Womens Health. 2018 Apr 2;18(1):55. doi: 10.1186/s12905-018-0546-8.
- Derived from this study: PubMed 28193198Kapiga S, Harvey S, Muhammad AK, Stockl H, Mshana G, Hashim R, Hansen C, Lees S, Watts C. Prevalence of intimate partner violence and abuse and associated factors among women enrolled into a cluster randomised trial in northwestern Tanzania. BMC Public Health. 2017 Feb 14;17(1):190. doi: 10.1186/s12889-017-4119-9.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory gender training and Microfinance in people with Maltreatment by Spouse or Partner, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
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 12 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheila E Harvey, Ph.D (+44 (0)207 612 7854, sheila.harvey@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Past 12 months exposure to intimate partner violence (time frame: 24 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 NCT02592252, which also lists 7 linked publications.
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 26 Mar 2018.