HIVNCT02263391
HIV Risk and Prevention in Women
A study testing Opt-in or Opt-out testing and Focus Group in people with HIV, run by University of Oklahoma at 2 sites in 2 countries.
Trial summary
This study gathers information about HIV testing utilization and influences on HIV testing decisions among young, general population Russian women at-risk of HIV exposure. The study compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in vs. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- HIV
- What is being tested?
- Opt-in or Opt-out testing and Focus Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2014to Jan 2016
- 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 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The participant's sexual risk behaviors (i.e., a) two or more partners in the last 12 months, or her partner's HIV risk (e.g., HIV positive, no HIV testing and a diagnosis of sexually transmitted diseases in last 12 months, multiple partners, blood transmission, male partners, served in prison, or drug use) and no or inconsistent condom use in the last 3 months, and no HIV testing in the last 12 months, or b) any sexually-transmitted disease and no HIV testing in the last 12 months).
Who cannot join
- Does not speak Russian, are currently pregnant, have a condition that might preclude a finger-stick procedure, or have tested HIV positive in the past.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Oklahoma
Oklahoma City, Oklahoma, 73104
About this study
Official title: Collaborative Biosocial Research on HIV Risk and Prevention in Women
This study gathers information about HIV testing utilization and influences on HIV testing decisions among young, general population Russian women at-risk of HIV exposure. The study compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in vs. opt-out) and conducts one of the first randomized experimental comparisons of these strategies. The overarching goal is to gain knowledge that can be used to increase utilization of HIV testing among at-risk young women and offer gender-specific strategies for improving prevention.
Read the detailed description
The study uses an adaptive design. That is, the procedures and phases of the study experienced by a participant depend to some extent on their responses to earlier phases. Ultimately, this design yields a number of practice relevant pathways and endpoints, each of which has a testing rate associated with it.
Phase-I is initial screening for risk status, collecting background data, and ascertaining whether there has been recent independent HIV testing. If there has been independent testing, information about the independent testing is collected and the participant's involvement is complete.
Those who are not independent testers enter Phase-II. Phase II will include: randomization to opt-in vs. opt-out conditions; a survey asking about reasons for acceptance or non-acceptance; participating in a focus group in which participants who have not accepted HIV testing (non-accepters) and those who accepted (accepters) will be asked to discuss their health beliefs related to HIV prevention, barriers and reasons for testing/not testing; then (5) after the focus group is complete, privately offer another testing opportunity to non-accepters, under the same opt-in or opt-out strategy to which they previously were randomized. The design was selected in order simultaneously answer a number of questions that we believe will be important for engineering a testing and prevention strategy suitable for testing in a subsequent study: (1) identify key attitudes, beliefs and knowledge (survey); (2) contrast opt-in and opt-out strategies (randomized trial); (3) generate qualitative data about reasons for decisions in the women's own words (focus group); and (4) identify any incremental benefit related to peer discussion.
- Conditions
- HIV
- Being tested
- Opt-in or Opt-out testing, Focus Group
- Keywords
- transmission, prevention, women, childbearing age, HIV testing, testing strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opt-in or Opt-out testingBehavioural
Study participants will be offered a health screening onsite.
Focus GroupBehavioural
Study participants will be invited to participate in a focus group discussion.
| Study group | Role | What they receive |
|---|---|---|
| Opt-in testing | Experimental | 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). The research assistant will say: "There is voluntary HIV testing available to all study participants if you wish to do it. It is free, private, it is only a finger stick, and you will learn your HIV results in just minutes." 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. Receives: Behavioral: Opt-in or Opt-out testing; Behavioral: Focus Group |
| Opt-out testing | Experimental | Participants will be informed that a routine health test bundle is available on a voluntary basis to study participants, and the participant may elect to decline all or any individual part of the testing. The assistant will say: "We are offering a voluntary panel of routine health screening test today for study participants. It includes blood sugar, cholesterol, and HIV. We recommend all of them for everyone, but you can choose to decline any or all of them. This is free, private, it is only a finger stick, and you will learn your results for all the tests in just minutes." 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. Receives: Behavioral: Opt-in or Opt-out testing; Behavioral: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At first visit, an expected average of 1 hour
Number of participants who accepted the health screening/HIV test after a focus group
participating in a focus group in which participants who have not accepted HIV testing (non-accepters) and those who accepted (accepters) will be asked to discuss their health beliefs related to HIV prevention, barriers and reasons for testing/not testing; then (5) after the focus group is complete, privately offer another testing opportunity to non-accepters, under the same opt-in or opt-out strategy to which they previously were randomized.
Measured: After completing a focus group discussion, an expected average of 4 weeks
Secondary outcomes (1)
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.
Measured: At first visit, an expected average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2016
- Study completionJan 2016
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 HIVStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), Russian Foundation for Basic Research (RFBR), Saint Petersburg State University, Russia
- Responsible party
- Sponsor
- Investigators
- Tatiana Balachova, PhD, Principal investigator, University of OklahomaAlla Shaboltas, PhD, Principal investigator, Facility: St. Petersburg State University St. Peterburg, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263391
- Sponsor's protocol ID
- 3878
- Other IDs
- 1R21AA022596-01
- Status last verified
- Feb 2017
- First submitted
- 26 Sep 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balachova TN, Batluk JV, Bryant KJ, Shaboltas AV. International collaboration in HIV prevention research: evidence from a research seminar in Russia. AIDS Res Hum Retroviruses. 2015 Feb;31(2):163-72. doi: 10.1089/AID.2014.0078. Epub 2014 Dec 31.
PubMed 25430518
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Biosocial Research on HIV Risk and Prevention in Women
- ClinicalTrials.gov ID
- NCT02263391
- Acronym / sponsor ID
- 3878
- Conditions
- HIV
- Keywords
- transmission, prevention, women, childbearing age, HIV testing, testing strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), Russian Foundation for Basic Research (RFBR), Saint Petersburg State University, Russia
- Study start
- Mar 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Oct 2014 (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.
This study gathers information about HIV testing utilization and influences on HIV testing decisions among young, general population Russian women at-risk of HIV exposure. The study compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in vs. opt-out) and conducts one of the first randomized experimental comparisons of these strategies. The overarching goal is to gain knowledge that can be used to increase utilization of HIV testing among at-risk young women and offer gender-specific strategies for improving prevention.
Detailed description
The study uses an adaptive design. That is, the procedures and phases of the study experienced by a participant depend to some extent on their responses to earlier phases. Ultimately, this design yields a number of practice relevant pathways and endpoints, each of which has a testing rate associated with it.
Phase-I is initial screening for risk status, collecting background data, and ascertaining whether there has been recent independent HIV testing. If there has been independent testing, information about the independent testing is collected and the participant's involvement is complete.
Those who are not independent testers enter Phase-II. Phase II will include: randomization to opt-in vs. opt-out conditions; a survey asking about reasons for acceptance or non-acceptance; participating in a focus group in which participants who have not accepted HIV testing (non-accepters) and those who accepted (accepters) will be asked to discuss their health beliefs related to HIV prevention, barriers and reasons for testing/not testing; then (5) after the focus group is complete, privately offer another testing opportunity to non-accepters, under the same opt-in or opt-out strategy to which they previously were randomized. The design was selected in order simultaneously answer a number of questions that we believe will be important for engineering a testing and prevention strategy suitable for testing in a subsequent study: (1) identify key attitudes, beliefs and knowledge (survey); (2) contrast opt-in and opt-out strategies (randomized trial); (3) generate qualitative data about reasons for decisions in the women's own words (focus group); and (4) identify any incremental benefit related to peer discussion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opt-in testing | Experimental | Behavioral: Opt-in or Opt-out testing, Behavioral: Focus GroupCommon barriers to HIV screening testing will be removed as much as possible (i.e., providing rapid testing, results shortly available, testing on-site, confidentiality). The research assistant will say: "There is voluntary HIV testing available to all study participants if you wish to do it. It is free, private, it is only a finger stick, and you will learn your HIV results in just minutes." 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 testing | Experimental | Behavioral: Opt-in or Opt-out testing, Behavioral: Focus GroupParticipants will be informed that a routine health test bundle is available on a voluntary basis to study participants, and the participant may elect to decline all or any individual part of the testing. The assistant will say: "We are offering a voluntary panel of routine health screening test today for study participants. It includes blood sugar, cholesterol, and HIV. We recommend all of them for everyone, but you can choose to decline any or all of them. This is free, private, it is only a finger stick, and you will learn your results for all the tests in just minutes." 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The participant's sexual risk behaviors (i.e., a) two or more partners in the last 12 months, or her partner's HIV risk (e.g., HIV positive, no HIV testing and a diagnosis of sexually transmitted diseases in last 12 months, multiple partners, blood transmission, male partners, served in prison, or drug use) and no or inconsistent condom use in the last 3 months, and no HIV testing in the last 12 months, or b) any sexually-transmitted disease and no HIV testing in the last 12 months).
Key exclusion criteria (1 listed)
- Does not speak Russian, are currently pregnant, have a condition that might preclude a finger-stick procedure, or have tested HIV positive in the past.
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 |
|---|---|---|
| Opt-in or Opt-out testingStudy participants will be offered a health screening onsite. | Behavioural | Opt-in testing, Opt-out testing |
| Focus GroupStudy participants will be invited to participate in a focus group discussion. | Behavioural | Opt-in testing, Opt-out testing |
Primary outcome
Number of participants who accepted a rapid health screening/HIV test
Time frame: At first visit, an expected average of 1 hour
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.
Number of participants who accepted the health screening/HIV test after a focus group
Time frame: After completing a focus group discussion, an expected average of 4 weeks
participating in a focus group in which participants who have not accepted HIV testing (non-accepters) and those who accepted (accepters) will be asked to discuss their health beliefs related to HIV prevention, barriers and reasons for testing/not testing; then (5) after the focus group is complete, privately offer another testing opportunity to non-accepters, under the same opt-in or opt-out strategy to which they previously were randomized.
1 secondary outcome
Brief survey to assess reasons for being tested
Time frame: At first visit, an expected average of 1 hour
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 23 Feb 2017.
- Background: PubMed 25430518Balachova TN, Batluk JV, Bryant KJ, Shaboltas AV. International collaboration in HIV prevention research: evidence from a research seminar in Russia. AIDS Res Hum Retroviruses. 2015 Feb;31(2):163-72. doi: 10.1089/AID.2014.0078. Epub 2014 Dec 31.
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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.
Tatiana Balachova, PhD principal investigator
University of Oklahoma
Alla Shaboltas, PhD principal investigator
Facility: St. Petersburg State University St. Peterburg, Russian Federation
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opt-in or Opt-out testing and Focus Group in people with HIV, run by University of Oklahoma at 2 sites in 2 countries.
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 1 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Russia. 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?
Number of participants who accepted a rapid health screening/HIV test (time frame: At first visit, an expected average of 1 hour). The study lists 2 primary outcomes in all. 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 NCT02263391, 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 23 Feb 2017.