Expansion to Interdisciplinary HIV Prevention in Women
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01994603 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Last Update Posted : January 14, 2016
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Condition or disease | Intervention/treatment | Phase |
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HIV AIDS Fetal Alcohol Syndrome Alcohol Related Neurodevelopmental Disorder | Behavioral: Opt-in or Opt-out testing Behavioral: Focus Group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |
Arm | Intervention/treatment |
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Experimental: Opt-in testing
Participants 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. "
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Behavioral: Opt-in or Opt-out testing
Study participants will be offered a health screening onsite. Behavioral: Focus Group Study participants will be invited to participate in a focus group discussion. |
Experimental: Opt-out testing
Participants 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.
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Behavioral: Opt-in or Opt-out testing
Study participants will be offered a health screening onsite. Behavioral: Focus Group Study participants will be invited to participate in a focus group discussion. |
- Number of participants who completed HIV test [ Time Frame: First 1: at initial contact, an expected average of 15 minutes ]A brief survey completed over the phone. Participants asked when the last HIV test was completed and her reasons for taking the test.
- Number of participants who accepted a rapid health screening/HIV test [ Time Frame: Phase 2: an expected average of 2 hours ]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.
- Brief survey to assess reasons for being tested [ Time Frame: Phase 2: at time of completing HIV testing ]Participants who accepted a rapid health screening/HIV test are asked about reasons for taking the test at this time

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 44 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- A parent study participants who declined to be contacted for participating in future research studies

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994603
United States, Oklahoma | |
University of Oklahoma | |
Oklahoma City, Oklahoma, United States, 73104 | |
Russian Federation | |
St. Petersburg State University | |
St. Peterburg, Russian Federation, 199034 |
Principal Investigator: | Tatiana Balachova | University of Oklahoma | |
Principal Investigator: | Alla Shaboltas, PhD | Saint Petersburg State University, Russia |
Responsible Party: | University of Oklahoma |
ClinicalTrials.gov Identifier: | NCT01994603 |
Other Study ID Numbers: |
1590 3R01AA016234-05S1 ( U.S. NIH Grant/Contract ) |
First Posted: | November 26, 2013 Key Record Dates |
Last Update Posted: | January 14, 2016 |
Last Verified: | January 2016 |
Prevention HIV AIDS Fetal Alcohol Syndrome (FAS) Alcohol Related Neurodevelopmental Disorder (ARND) |
Fetal Alcohol Spectrum Disorders Neurodevelopmental Disorders Mental Disorders Fetal Diseases Pregnancy Complications |
Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |