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Expansion to Interdisciplinary HIV Prevention in Women

Primary Purpose

HIV, AIDS, Fetal Alcohol Syndrome

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Opt-in or Opt-out testing
Focus Group
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring Prevention, HIV, AIDS, Fetal Alcohol Syndrome (FAS), Alcohol Related Neurodevelopmental Disorder (ARND)

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Oklahoma
  • St. Petersburg State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Opt-in testing

Opt-out testing

Arm Description

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. "

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Brief survey to assess reasons for being tested
Participants who accepted a rapid health screening/HIV test are asked about reasons for taking the test at this time

Full Information

First Posted
October 23, 2013
Last Updated
January 13, 2016
Sponsor
University of Oklahoma
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01994603
Brief Title
Expansion to Interdisciplinary HIV Prevention in Women
Official Title
Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
A mixed methods research design combining qualitative and quantitative data collection methods will be used to increase the understanding of barriers to HIV testing, identify promising strategies to increase testing, generate research hypotheses, and design a future randomized clinical trial to evaluate HIV prevention targeted to at-risk women in the general population in Russia. The qualitative methods include structured interviews and a focus group participation to assess women's reasons for being the tested and possible prevention strategies. The quantitative methods include observation/recording of women's testing behaviors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, AIDS, Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental Disorder
Keywords
Prevention, HIV, AIDS, Fetal Alcohol Syndrome (FAS), Alcohol Related Neurodevelopmental Disorder (ARND)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opt-in testing
Arm Type
Experimental
Arm Description
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. "
Arm Title
Opt-out testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Opt-in or Opt-out testing
Intervention Description
Study participants will be offered a health screening onsite.
Intervention Type
Behavioral
Intervention Name(s)
Focus Group
Intervention Description
Study participants will be invited to participate in a focus group discussion.
Primary Outcome Measure Information:
Title
Number of participants who completed HIV test
Description
A brief survey completed over the phone. Participants asked when the last HIV test was completed and her reasons for taking the test.
Time Frame
First 1: at initial contact, an expected average of 15 minutes
Title
Number of participants who accepted a rapid health screening/HIV test
Description
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.
Time Frame
Phase 2: an expected average of 2 hours
Secondary Outcome Measure Information:
Title
Brief survey to assess reasons for being tested
Description
Participants who accepted a rapid health screening/HIV test are asked about reasons for taking the test at this time
Time Frame
Phase 2: at time of completing HIV testing

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Balachova
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alla Shaboltas, PhD
Organizational Affiliation
Saint Petersburg State University, Russia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
St. Petersburg State University
City
St. Peterburg
ZIP/Postal Code
199034
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Expansion to Interdisciplinary HIV Prevention in Women

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