An interventional study of HIV Sexual Risk reduction and HIV Sexual Risk reduction plus Microfinance in HIV Infection, sponsored by Columbia University. Completed at 1 site in Mongolia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Columbia University · Not applicable, Interventional, and Prevention
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:
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 107 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4 sessions of HIV sexual risk reduction
Behavioral: HIV Sexual Risk reduction
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
Behavioral: HIV Sexual Risk reduction plus Microfinance
4 sessions of HIV sexual risk reduction
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
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.
Time frame: 6 months
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
The record gives a start of Apr 2010, a primary completion of Aug 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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