HIVNCT02606344
Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV
A study testing Mico-finance based intervention in people with HIV and AIDS, run by NMP Medical Research Institute at 3 sites in India.
Trial summary
The high rates of HIV infection in women have brought into sharp focus the problem of violence against women. There is a growing recognition that women and girls' risk of and vulnerability to HIV infection is shaped by deep-rooted and pervasive gender inequalities violence against them in particular. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, AIDS, Domestic Violence
- What is being tested?
- Mico-finance based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 561 participants
- Where
- 3 sitesIndia
- Study dates
- Sep 2014to Nov 2015
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years old;
- Must plan to reside in study areas for the next 12 months
- Must visit camp at least 1 time per week
- Must provide contact information of friend or family member
Who cannot join
- Unwilling to provide local information
- Psychological disturbance, cognitive impairment or threatening behavior
Trial locations and contacts
3 sites in 1 country.
India3 sites
NMP Medical Research Institute
Deharadun, Uttarakhand
Vinita Nursing Home
Hindaun, Rajasthan
Sonal Foundation
Mahesāna, Gujarat, 384001
About this study
Official title: Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV: a Multi-centric Randomized Trial
The high rates of HIV infection in women have brought into sharp focus the problem of violence against women. There is a growing recognition that women and girls' risk of and vulnerability to HIV infection is shaped by deep-rooted and pervasive gender inequalities violence against them in particular. The links between intimate partner violence and HIV/AIDS are explained by biological as well as sociocultural and economic factors.
- Conditions
- HIV, AIDS, Domestic Violence
- Being tested
- Mico-finance based intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mico-finance based interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (IG) | Experimental | Loans were provided to poor women who enrolled in the intervention group. A participatory learning and action curriculum was integrated into loan meetings, which took place every 2 weeks. Receives: Other: Mico-finance based intervention |
| Control Group (CG) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of New Sexually Transmitted Infections
Measured: 12 months
Secondary outcomes (2)
Proportion of women Reporting Physical, Sexual, or Psychological Partner Violence
Measured: 12 Months
Proportion of unprotected sexual acts with partner
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sonal Foundation, India, Vinita Nursing Home, India, Macmillan Research Group UK
- Responsible party
- Sponsor
- Investigators
- Kalvinder Kour, MBA, Principal investigator, NMP Medical Research Institute, IndiaNeha Sharma, PhD, Study director, Macmillan Research Group UKVinita Makkad, MD, Principal investigator, Vinita Nursing Home, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606344
- Sponsor's protocol ID
- nmp/22186
- Status last verified
- Nov 2015
- First submitted
- 13 Nov 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV: a Multi-centric Randomized Trial
- ClinicalTrials.gov ID
- NCT02606344
- Acronym / sponsor ID
- nmp/22186
- Conditions
- HIV, AIDS, Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Sonal Foundation, India, Vinita Nursing Home, India, Macmillan Research Group UK
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Nov 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.
The high rates of HIV infection in women have brought into sharp focus the problem of violence against women. There is a growing recognition that women and girls' risk of and vulnerability to HIV infection is shaped by deep-rooted and pervasive gender inequalities violence against them in particular. The links between intimate partner violence and HIV/AIDS are explained by biological as well as sociocultural and economic factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Other: Mico-finance based interventionLoans were provided to poor women who enrolled in the intervention group. A participatory learning and action curriculum was integrated into loan meetings, which took place every 2 weeks. |
| Control Group (CG) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years old;
- Must plan to reside in study areas for the next 12 months
- Must visit camp at least 1 time per week
- Must provide contact information of friend or family member
Key exclusion criteria (2 listed)
- Unwilling to provide local information
- Psychological disturbance, cognitive impairment or threatening behavior
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 |
|---|---|---|
| Mico-finance based intervention | Other | Intervention Group (IG) |
Primary outcome
Incidence of New Sexually Transmitted Infections
Time frame: 12 months
2 secondary outcomes
Proportion of women Reporting Physical, Sexual, or Psychological Partner Violence
Time frame: 12 Months
Proportion of unprotected sexual acts with partner
Time frame: 12 month
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 Nov 2015.
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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.
Kalvinder Kour, MBA principal investigator
NMP Medical Research Institute, India
Neha Sharma, PhD study director
Macmillan Research Group UK
Vinita Makkad, MD principal investigator
Vinita Nursing Home, India
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mico-finance based intervention in people with HIV and AIDS, run by NMP Medical Research Institute at 3 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: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Incidence of New Sexually Transmitted Infections (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2015.