HIVNCT01994603
Expansion to Interdisciplinary HIV Prevention in Women
A study testing Opt-in or Opt-out testing and Focus Group in people with HIV and AIDS, run by University of Oklahoma at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- HIV, AIDS, Fetal Alcohol Syndrome
- 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
- 41 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2012to Sep 2015
- 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
- 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
Who cannot join
- A parent study participants who declined to be contacted for participating in future research studies
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: Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women
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.
Read the 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.
- Being tested
- Opt-in or Opt-out testing, Focus Group
- Keywords
- Prevention, HIV, AIDS, Fetal Alcohol Syndrome (FAS), Alcohol Related Neurodevelopmental Disorder (ARND)
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Fetal Alcohol Spectrum Disorders
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 | 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. " Receives: Behavioral: Opt-in or Opt-out testing; Behavioral: Focus Group |
| Opt-out testing | Experimental | 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. 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 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.
Measured: 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.
Measured: Phase 2: an expected average of 2 hours
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: Phase 2: at time of completing HIV testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Tatiana Balachova, Principal investigator, University of OklahomaAlla Shaboltas, PhD, Principal investigator, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994603
- Sponsor's protocol ID
- 1590
- Other IDs
- 3R01AA016234-05S1
- Status last verified
- Jan 2016
- First submitted
- 23 Oct 2013
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women
- ClinicalTrials.gov ID
- NCT01994603
- Acronym / sponsor ID
- 1590
- Keywords
- Prevention, HIV, AIDS, Fetal Alcohol Syndrome (FAS), Alcohol Related Neurodevelopmental Disorder (ARND)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Dec 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Nov 2013 (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 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.
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 GroupParticipants 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 | Experimental | Behavioral: Opt-in or Opt-out testing, Behavioral: Focus GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- A parent study participants who declined to be contacted for participating in future research studies
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 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.
1 secondary outcome
Brief survey to assess reasons for being tested
Time frame: Phase 2: at time of completing HIV testing
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 14 Jan 2016.
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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 principal investigator
University of Oklahoma
Alla Shaboltas, PhD principal investigator
Saint Petersburg State University, Russia
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 and AIDS, 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 3 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 14 Jan 2016. 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 completed HIV test (time frame: First 1: at initial contact, an expected average of 15 minutes). 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?
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 14 Jan 2016.