HIVPhase 3NCT00771537
HIV Testing & Womens Attitudes on HIV Vaccine Trials
A Phase 3 study testing Message Sidedness in people with HIV, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of different persuasive informational messages on rates of rapid HIV testing and willingness to participate in a HIV vaccine clinical trial. Adult African-American, non-Latina White, and Latina women will be recruited. Women will initially be randomized to 4 groups: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Message Sidedness
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,031 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jan 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- 18 years of age or older
- Able to understand English or Spanish
- Able to give informed consent
Who cannot join
- Not female
- Under 18 years of age
- Not able to understand English and Spanish
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Medical Group Clinics
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to test the effects of different persuasive informational messages on rates of rapid HIV testing and willingness to participate in a HIV vaccine clinical trial. Adult African-American, non-Latina White, and Latina women will be recruited. Women will initially be randomized to 4 groups: 1. no message control; 2. 1-sided message that mentions benefits of HIV testing; 3. 2-sided message that acknowledges minor opposition to testing, then refutes the opposition; and 4. 2-sided message that acknowledge stronger opposition to testing, then refutes the opposition. Women will be offered HIV testing, then re-randomized to a similar set of 4 messages related to HIV vaccine trials. There will therefore be 16 groups in total (4 X 4).
Read the detailed description
This 5-year proposal responds to PAS-03-168, "Enrolling Women and Minorities in HIV/AIDS Research Trials." This study seeks to evaluate persuasive message interventions to increase HIV testing rates and improve acceptability of participation in a phase 3 HIV vaccine clinical trial among African-American, Latina, and White women. We plan to evaluate 1-sided messages, which mention only the benefits of an action, versus 2-sided messages, which mention negative aspects of the action, followed by positive counterarguments. The Health Belief Model, Inoculation and Attribution Theories will guide the research. Participants will be women attending urban community health clinics in Indianapolis, IN. Specific Aim 1 is to identify obstacles to HIV testing and to participation in a HIV vaccine clinical trial. This aim will be accomplished in years 1 and 2 through individual semi-structured interviews. We will analyze data via thematic content analysis and will use interview findings to assist in the development of measures and interventions employed in the intervention phase (years 3-5). Specific Aim 2 is to evaluate the effects of 2-sided versus 1-sided persuasive messages on rates of acceptance of rapid HIV testing. Demographic, behavioral, and attitudinal measures will be administered via audio computer-assisted self-interview (A-CASI). Participants will be randomized to the intervention groups via A-CASI as well. The outcome will be acceptance/rejection of free rapid HIV testing. This Aim will be evaluated via binary logistic regression. Specific Aim 3 is to evaluate the effects of 2-sided versus 1-sided messages on willingness to participate in phase 3 clinical trials for a preventive HIV vaccine. Participants will complete this 2nd A-CASI survey and will again be randomized to intervention groups. The outcome will be a scale measuring acceptability of clinical trial participation. This Aim will be evaluated via one-way Analysis of Variance. This study is relevant to public health in that the results may help us to understand how to improve enrollment of women and minorities into preventive HIV vaccine clinical trials and how to encourage women and minorities to get tested for HIV.
- Conditions
- HIV
- Being tested
- Message Sidedness
- Keywords
- HIV Testing, Persuasion, Health Communication, Clinical Trials Participation, Attitudes toward Health, Diagnostic Tests, Behavioral Research, Intervention Studies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Message SidednessBehavioural
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1. Control PLUS Control | No intervention | Not described |
| Arm 2. Control PLUS 1-Sided | Experimental | No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 3. Control PLUS 2-Sided Trivial | Experimental | No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 4. Control PLUS 2-Sided Major | Experimental | No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 5. 1-Sided PLUS Control | Experimental | 1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 6. 1-Sided PLUS 1-Sided | Experimental | 1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 7. 1-Sided PLUS 2-Sided Trivial | Experimental | 1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Aim 8. 1-Sided PLUS 2-Sided Major | Experimental | 1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 9. 2-Sided Trivial PLUS Control | Experimental | 2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 10. 2-Sided Trivial PLUS 1-Sided | Experimental | 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 11. 2-Sided Trivial PLUS 2-Sided Trivial | Experimental | 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 12. 2-Sided Trivial PLUS 2-Sided Major | Experimental | 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 13. 2-Sided Major PLUS Control | Experimental | 2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 14. 2-Sided Major PLUS 1-Sided | Experimental | 2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 15. 2-Sided Major PLUS 2-Sided Trivial | Experimental | 2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
| Arm 16. 2-Sided Major PLUS 2-Sided Major | Experimental | 2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation. Receives: Behavioral: Message Sidedness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Accepted Rapid HIV Testing.
Acceptance of rapid HIV testing. Acceptance was assessed by actual administration of rapid oral HIV test by research staff.
Measured: During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.
Willingness to Participate in a HIV Vaccine Clinical Trial
Willingness to Participate in a HIV Vaccine Clinical Trial. Assessed via participant self-report with 6 items on Part 2 of the questionnaire. Item responses measured on 5-point Likert-type scale ranging from Strongly Disagree (value = 1) to Strongly Agree (value = 5).
Measured: Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startNov 2006
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,031 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Gregory Zimet, Indiana University
- Investigators
- Gregory D Zimet, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771537
- Sponsor's protocol ID
- 0601-09
- Other IDs
- R01NR010004
- Status last verified
- Jun 2013
- First submitted
- 10 Oct 2008
- Last updated
- 9 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Burrage JW, Zimet GD, Cox DS, Cox AD, Mays RM, Fife RS, Fife KH. The Centers for Disease Control and Prevention revised recommendations for HIV testing: reactions of women attending community health clinics. J Assoc Nurses AIDS Care. 2008 Jan-Feb;19(1):66-74. doi: 10.1016/j.jana.2007.11.003.
PubMed 18191770Kasting ML, Cox AD, Cox D, Fife KH, Katz BP, Zimet GD. The effects of HIV testing advocacy messages on test acceptance: a randomized clinical trial. BMC Med. 2014 Nov 6;12:204. doi: 10.1186/s12916-014-0204-4.
PubMed 25374047
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Testing & Womens Attitudes on HIV Vaccine Trials
- ClinicalTrials.gov ID
- NCT00771537
- Acronym / sponsor ID
- 0601-09
- Conditions
- HIV
- Keywords
- HIV Testing, Persuasion, Health Communication, Clinical Trials Participation, Attitudes toward Health, Diagnostic Tests, Behavioral Research, Intervention Studies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,031 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- Nov 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Posted 9 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effects of different persuasive informational messages on rates of rapid HIV testing and willingness to participate in a HIV vaccine clinical trial. Adult African-American, non-Latina White, and Latina women will be recruited. Women will initially be randomized to 4 groups: 1. no message control; 2. 1-sided message that mentions benefits of HIV testing; 3. 2-sided message that acknowledges minor opposition to testing, then refutes the opposition; and 4. 2-sided message that acknowledge stronger opposition to testing, then refutes the opposition. Women will be offered HIV testing, then re-randomized to a similar set of 4 messages related to HIV vaccine trials. There will therefore be 16 groups in total (4 X 4).
Detailed description
This 5-year proposal responds to PAS-03-168, "Enrolling Women and Minorities in HIV/AIDS Research Trials." This study seeks to evaluate persuasive message interventions to increase HIV testing rates and improve acceptability of participation in a phase 3 HIV vaccine clinical trial among African-American, Latina, and White women. We plan to evaluate 1-sided messages, which mention only the benefits of an action, versus 2-sided messages, which mention negative aspects of the action, followed by positive counterarguments. The Health Belief Model, Inoculation and Attribution Theories will guide the research. Participants will be women attending urban community health clinics in Indianapolis, IN. Specific Aim 1 is to identify obstacles to HIV testing and to participation in a HIV vaccine clinical trial. This aim will be accomplished in years 1 and 2 through individual semi-structured interviews. We will analyze data via thematic content analysis and will use interview findings to assist in the development of measures and interventions employed in the intervention phase (years 3-5). Specific Aim 2 is to evaluate the effects of 2-sided versus 1-sided persuasive messages on rates of acceptance of rapid HIV testing. Demographic, behavioral, and attitudinal measures will be administered via audio computer-assisted self-interview (A-CASI). Participants will be randomized to the intervention groups via A-CASI as well. The outcome will be acceptance/rejection of free rapid HIV testing. This Aim will be evaluated via binary logistic regression. Specific Aim 3 is to evaluate the effects of 2-sided versus 1-sided messages on willingness to participate in phase 3 clinical trials for a preventive HIV vaccine. Participants will complete this 2nd A-CASI survey and will again be randomized to intervention groups. The outcome will be a scale measuring acceptability of clinical trial participation. This Aim will be evaluated via one-way Analysis of Variance. This study is relevant to public health in that the results may help us to understand how to improve enrollment of women and minorities into preventive HIV vaccine clinical trials and how to encourage women and minorities to get tested for HIV.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Arm 1. Control PLUS Control | No intervention | – |
| Arm 2. Control PLUS 1-Sided | Experimental | Behavioral: Message SidednessNo message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation. |
| Arm 3. Control PLUS 2-Sided Trivial | Experimental | Behavioral: Message SidednessNo message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation. |
| Arm 4. Control PLUS 2-Sided Major | Experimental | Behavioral: Message SidednessNo message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation. |
| Arm 5. 1-Sided PLUS Control | Experimental | Behavioral: Message Sidedness1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation. |
| Arm 6. 1-Sided PLUS 1-Sided | Experimental | Behavioral: Message Sidedness1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation. |
| Arm 7. 1-Sided PLUS 2-Sided Trivial | Experimental | Behavioral: Message Sidedness1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation. |
| Aim 8. 1-Sided PLUS 2-Sided Major | Experimental | Behavioral: Message Sidedness1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation. |
| Arm 9. 2-Sided Trivial PLUS Control | Experimental | Behavioral: Message Sidedness2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation. |
| Arm 10. 2-Sided Trivial PLUS 1-Sided | Experimental | Behavioral: Message Sidedness2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation. |
| Arm 11. 2-Sided Trivial PLUS 2-Sided Trivial | Experimental | Behavioral: Message Sidedness2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation. |
| Arm 12. 2-Sided Trivial PLUS 2-Sided Major | Experimental | Behavioral: Message Sidedness2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation. |
| Arm 13. 2-Sided Major PLUS Control | Experimental | Behavioral: Message Sidedness2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation. |
| Arm 14. 2-Sided Major PLUS 1-Sided | Experimental | Behavioral: Message Sidedness2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation. |
| Arm 15. 2-Sided Major PLUS 2-Sided Trivial | Experimental | Behavioral: Message Sidedness2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation. |
| Arm 16. 2-Sided Major PLUS 2-Sided Major | Experimental | Behavioral: Message Sidedness2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- 18 years of age or older
- Able to understand English or Spanish
- Able to give informed consent
Key exclusion criteria (4 listed)
- Not female
- Under 18 years of age
- Not able to understand English and Spanish
- Unable to give informed consent
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 |
|---|---|---|
| Message SidednessThere are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message. | Behavioural | Aim 8. 1-Sided PLUS 2-Sided Major, Arm 10. 2-Sided Trivial PLUS 1-Sided, Arm 11. 2-Sided Trivial PLUS 2-Sided Trivial, Arm 12. 2-Sided Trivial PLUS 2-Sided Major, Arm 13. 2-Sided Major PLUS Control, Arm 14. 2-Sided Major PLUS 1-Sided, Arm 15. 2-Sided Major PLUS 2-Sided Trivial, Arm 16. 2-Sided Major PLUS 2-Sided Major, Arm 2. Control PLUS 1-Sided, Arm 3. Control PLUS 2-Sided Trivial, Arm 4. Control PLUS 2-Sided Major, Arm 5. 1-Sided PLUS Control, Arm 6. 1-Sided PLUS 1-Sided, Arm 7. 1-Sided PLUS 2-Sided Trivial, Arm 9. 2-Sided Trivial PLUS Control |
Primary outcome
Number of Participants Who Accepted Rapid HIV Testing.
Time frame: During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.
Acceptance of rapid HIV testing. Acceptance was assessed by actual administration of rapid oral HIV test by research staff.
Willingness to Participate in a HIV Vaccine Clinical Trial
Time frame: Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.
Willingness to Participate in a HIV Vaccine Clinical Trial. Assessed via participant self-report with 6 items on Part 2 of the questionnaire. Item responses measured on 5-point Likert-type scale ranging from Strongly Disagree (value = 1) to Strongly Agree (value = 5).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18191770Burrage JW, Zimet GD, Cox DS, Cox AD, Mays RM, Fife RS, Fife KH. The Centers for Disease Control and Prevention revised recommendations for HIV testing: reactions of women attending community health clinics. J Assoc Nurses AIDS Care. 2008 Jan-Feb;19(1):66-74. doi: 10.1016/j.jana.2007.11.003.
- Derived from this study: PubMed 25374047Kasting ML, Cox AD, Cox D, Fife KH, Katz BP, Zimet GD. The effects of HIV testing advocacy messages on test acceptance: a randomized clinical trial. BMC Med. 2014 Nov 6;12:204. doi: 10.1186/s12916-014-0204-4.
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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.
Gregory D Zimet, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Message Sidedness in people with HIV, run by Indiana University at 1 site in United States.
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 4 inclusion and 4 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 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Rapid HIV Testing. (time frame: During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.). 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 NCT00771537, which also lists 2 linked publications.
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 9 Jul 2013.