Expansion to Interdisciplinary HIV Prevention in Women
Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women
2 other identifiers
interventional
41
2 countries
2
Brief Summary
This trial will pilot test intervention strategies to increase utilization of HIV testing and gain knowledge for designing a clinical trial to evaluate prevention strategies to reduce HIV sexual transmission in the general population in Russia. The study will assess whether external (cost, convenience) or internal factors (low perception of own risk, reluctance to identify a partner as at-risk, fear of stigma) drive Russian women's reluctance to be tested and if peer support impacts their decision. A randomized experimental manipulation, comparing opt-in vs. bundled opt-out testing approaches, followed by focus group discussions, followed by a second-chance testing offer will be used to inform these questions. The answers will enable the international research team to engineer and then test an HIV testing promotion strategy in Russia. The project will collect preliminary data for a larger study to develop an evidence-based program to reduce the HIV transmission in this high risk population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Dec 2012
Typical duration for not_applicable hiv
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 23, 2013
CompletedFirst Posted
Study publicly available on registry
November 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJanuary 14, 2016
January 1, 2016
2.8 years
October 23, 2013
January 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants who completed HIV test
A brief survey completed over the phone. Participants asked when the last HIV test was completed and her reasons for taking the test.
First 1: at initial contact, an expected average of 15 minutes
Number of participants who accepted a rapid health screening/HIV test
Women's decision to take/not take a health screening test/HIV test is recorded. If a woman chooses to be tested, she will be asked a few questions to assess her reasons for being tested. She will be provided with the results of the testing. If a woman's test is positive for HIV (or other health risks in the bundled opt-out condition), counseling with a trained study nurse, physician or psychologist will be available on-site and a referral for additional testing, counseling, and appropriate medical care will be provided.
Phase 2: an expected average of 2 hours
Secondary Outcomes (1)
Brief survey to assess reasons for being tested
Phase 2: at time of completing HIV testing
Study Arms (2)
Opt-in testing
EXPERIMENTALParticipants will be scheduled for a two-hour appointment to complete the written consent procedure, enroll in the study, and participate in the study activities, testing and a focus group. Opt-in: Common barriers to HIV screening testing will be removed as much as possible (i.e., providing rapid testing, results shortly available, testing on-site, confidentiality). "There is voluntary HIV testing available to all study participants if you wish to do it. "
Opt-out testing
EXPERIMENTALParticipants will be scheduled for a two-hour appointment to complete the written consent procedure, enroll in the study, and participate in the study activities, testing and a focus group. Opt-out multicomponent testing. Participants will be informed that a bundled routine health test is available on a voluntary basis to study participants, and the participant may elect to decline all or part of the testing.
Interventions
Study participants will be offered a health screening onsite.
Study participants will be invited to participate in a focus group discussion.
Eligibility Criteria
You may qualify if:
- A parent study participants who completed HIV risk survey and
- Reported two or more partners in the last 12 months and no or inconsistent condom use in the last 3 months and no HIV testing in the last 12 months
- Or reported any sexually-transmitted disease and no HIV testing in the last 12 months
You may not qualify if:
- A parent study participants who declined to be contacted for participating in future research studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
St. Petersburg State University
Saint Peterburg, 199034, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tatiana Balachova
University of Oklahoma
- PRINCIPAL INVESTIGATOR
Alla Shaboltas, PhD
Saint Petersburg State University, Russia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2013
First Posted
November 26, 2013
Study Start
December 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
January 14, 2016
Record last verified: 2016-01