HIV InfectionNCT01861431
Evaluating a Microfinance Intervention for High Risk Women in Mongolia
A study testing HIV Sexual Risk reduction and HIV Sexual Risk reduction plus Microfinance in people with HIV Infection, run by Columbia University at 1 site in Mongolia.
Trial summary
The proposed study aims to test the feasibility and preliminary efficacy of a combined 4-session HIV sexual risk reduction (HIVSRR) and microfinance intervention (including 34 training session and matched savings) to reduce unprotected sex and to increase proportion of income from sex work among women engaged in high… 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 Infection
- What is being tested?
- HIV Sexual Risk reduction and HIV Sexual Risk reduction plus Microfinance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteMongolia
- Study dates
- Apr 2010to Dec 2013
- 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
- She is at least 18 years of age;
- She reports having engaged in vaginal or anal sexual intercourse in the past 90 days in exchange for money, alcohol or other goods;
- She reports having engaged in unprotected vaginal or anal sexual intercourse in the past 90 days with a paying sexual partner; and
- She reports being interested in learning about and developing her own small business.
Who cannot join
- assessed to have a severe cognitive or psychiatric impairment that would interfere with the ability to provide informed consent or complete study instruments
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study aims to test the feasibility and preliminary efficacy of a combined 4-session HIV sexual risk reduction (HIVSRR) and microfinance intervention (including 34 training session and matched savings) to reduce unprotected sex and to increase proportion of income from sex work among women engaged in high risk sexual activity in Ulaanbaatar, Mongolia. Feasibility and preliminary efficacy will be tested using a randomized clinical trial (RCT) with 134 women sex workers meeting eligibility criteria. Following eligibility screening, eligible women will complete informed consent, a baseline assessment, and be randomized to one of 2 study conditions: 1) the combination HIV sexual risk reduction plus microfinance (HIVSRR+MF); or 2) a 4-session HIVSRR alone control condition.
The study design will permit us to:
- Examine and enhance the feasibility (i.e. recruitment, engagement, attendance, retention data collection) of a combination HIV sexual risk reduction and MF intervention with high risk women in Ulaanbaatar, Mongolia;
- Examine the preliminary outcomes of the interventions on decreasing unprotected acts of vaginal and anal intercourse; increasing the proportion of protected vaginal and/or anal acts using barrier protection and decreasing number of sexual partners with repeated measures at baseline, immediately post-intervention, and 3 and 6 month follow-up assessments.
- Use the results of the pilot study to inform the design of a future R01 application.
- Conditions
- HIV Infection
- Being tested
- HIV Sexual Risk reduction, HIV Sexual Risk reduction plus Microfinance
- Keywords
- HIV, prevention, microfinance, sex work, Mongolia
- Medical subject headings
- HIV Infections, Sex Work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Sexual Risk reductionBehavioural
4 sessions of HIV sexual risk reduction
HIV Sexual Risk reduction plus MicrofinanceBehavioural
4 sessions of sexual risk reduction plus 12 sessions of financial literacy, 12 sessions of business development training, 10 sessions of business mentorship; matched savings throughout course of intervention
| Study group | Role | What they receive |
|---|---|---|
| HIVSRR | Active comparator | 4 sessions of HIV sexual risk reduction Receives: Behavioral: HIV Sexual Risk reduction |
| HIVSRR + Microfinance | Experimental | 4 sessions of sexual risk reduction plus 12 sessions of financial literacy, 12 sessions of business development training, 10 sessions of business mentorship; matched savings throughout course of intervention Receives: Behavioral: HIV Sexual Risk reduction plus Microfinance |
What is being measured
The primary outcome is the main question the study is designed to answer.
unprotected acts of vaginal and anal intercourse;
The primary outcomes include: decreasing unprotected acts of vaginal and anal intercourse; increasing the proportion of protected vaginal and/or anal acts using barrier protection and decreasing number of sexual partners with repeated measures at baseline, immediately post-intervention, and 3 and 6 month follow-up assessments.
Measured: 6 months
Secondary outcomes (3)
proportion of protected vaginal and/or anal acts using barrier protection;
Measured: 6 months
number of sexual partners
Measured: 6 months
Proportion of income from sex work
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startApr 2010
- Primary completionAug 2013
- Study completionDec 2013
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 HIV InfectionStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Susan Witte, Columbia University
- Investigators
- Susan S Witte, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861431
- Sponsor's protocol ID
- AAAF4402
- Other IDs
- R34MH093227
- Status last verified
- Jul 2013
- First submitted
- 20 May 2013
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsai LC, Carlson CE, Aira T, Norcini Pala A, Riedel M, Witte SS. The impact of a microsavings intervention on reducing violence against women engaged in sex work: a randomized controlled study. BMC Int Health Hum Rights. 2016 Oct 28;16(1):27. doi: 10.1186/s12914-016-0101-3.
PubMed 27793147
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Microfinance Intervention for High Risk Women in Mongolia
- ClinicalTrials.gov ID
- NCT01861431
- Acronym / sponsor ID
- AAAF4402
- Conditions
- HIV Infection
- Keywords
- HIV, prevention, microfinance, sex work, Mongolia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 May 2013 (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 proposed study aims to test the feasibility and preliminary efficacy of a combined 4-session HIV sexual risk reduction (HIVSRR) and microfinance intervention (including 34 training session and matched savings) to reduce unprotected sex and to increase proportion of income from sex work among women engaged in high risk sexual activity in Ulaanbaatar, Mongolia. Feasibility and preliminary efficacy will be tested using a randomized clinical trial (RCT) with 134 women sex workers meeting eligibility criteria. Following eligibility screening, eligible women will complete informed consent, a baseline assessment, and be randomized to one of 2 study conditions: 1) the combination HIV sexual risk reduction plus microfinance (HIVSRR+MF); or 2) a 4-session HIVSRR alone control condition.
The study design will permit us to:
- Examine and enhance the feasibility (i.e. recruitment, engagement, attendance, retention data collection) of a combination HIV sexual risk reduction and MF intervention with high risk women in Ulaanbaatar, Mongolia;
- Examine the preliminary outcomes of the interventions on decreasing unprotected acts of vaginal and anal intercourse; increasing the proportion of protected vaginal and/or anal acts using barrier protection and decreasing number of sexual partners with repeated measures at baseline, immediately post-intervention, and 3 and 6 month follow-up assessments.
- Use the results of the pilot study to inform the design of a future R01 application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIVSRR | Active comparator | Behavioral: HIV Sexual Risk reduction4 sessions of HIV sexual risk reduction |
| HIVSRR + Microfinance | Experimental | Behavioral: HIV Sexual Risk reduction plus Microfinance4 sessions of sexual risk reduction plus 12 sessions of financial literacy, 12 sessions of business development training, 10 sessions of business mentorship; matched savings throughout course of 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)
- She is at least 18 years of age;
- She reports having engaged in vaginal or anal sexual intercourse in the past 90 days in exchange for money, alcohol or other goods;
- She reports having engaged in unprotected vaginal or anal sexual intercourse in the past 90 days with a paying sexual partner; and
- She reports being interested in learning about and developing her own small business.
Key exclusion criteria (1 listed)
- assessed to have a severe cognitive or psychiatric impairment that would interfere with the ability to provide informed consent or complete study instruments
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 |
|---|---|---|
| HIV Sexual Risk reduction4 sessions of HIV sexual risk reduction | Behavioural | HIVSRR |
| HIV Sexual Risk reduction plus Microfinance4 sessions of sexual risk reduction plus 12 sessions of financial literacy, 12 sessions of business development training, 10 sessions of business mentorship; matched savings throughout course of intervention | Behavioural | HIVSRR + Microfinance |
Primary outcome
unprotected acts of vaginal and anal intercourse;
Time frame: 6 months
The primary outcomes include: decreasing unprotected acts of vaginal and anal intercourse; increasing the proportion of protected vaginal and/or anal acts using barrier protection and decreasing number of sexual partners with repeated measures at baseline, immediately post-intervention, and 3 and 6 month follow-up assessments.
3 secondary outcomes
proportion of protected vaginal and/or anal acts using barrier protection;
Time frame: 6 months
number of sexual partners
Time frame: 6 months
Proportion of income from sex work
Time frame: 6 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 18 Mar 2015.
- Derived from this study: PubMed 27793147Tsai LC, Carlson CE, Aira T, Norcini Pala A, Riedel M, Witte SS. The impact of a microsavings intervention on reducing violence against women engaged in sex work: a randomized controlled study. BMC Int Health Hum Rights. 2016 Oct 28;16(1):27. doi: 10.1186/s12914-016-0101-3.
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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.
Susan S Witte, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV Sexual Risk reduction and HIV Sexual Risk reduction plus Microfinance in people with HIV Infection, run by Columbia University at 1 site in Mongolia.
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 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: finished, as of the sponsor's last update on 18 Mar 2015. 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 Mongolia. 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?
unprotected acts of vaginal and anal intercourse; (time frame: 6 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 NCT01861431, 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 18 Mar 2015.