HIV Prevention and Assessment ReactivityNCT01580657
Experimental Analysis of HIV Risk Assessment Reactivity in South African Clinics
A study testing Detailed baseline interview, enhanced HIV intervention, General baseline interview, enhanced HIV intervention and No baseline interview, enhanced HIV intervention in people with HIV Prevention and Assessment Reactivity, run by Medical College of Wisconsin at 1 site in South Africa.
Trial summary
Randomized clinical trials of HIV prevention interventions typically include extensive baseline assessments of the risk behaviors that interventions target. Such pretests have the potential to direct participants' attention to the factors that put them at risk of HIV infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention and Assessment Reactivity
- What is being tested?
- Detailed baseline interview, enhanced HIV intervention, General baseline interview, enhanced HIV intervention and No baseline interview, enhanced HIV intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,728 participants
- Where
- 1 siteSouth Africa
- Study dates
- Sep 2006to Oct 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- presenting at the site B youth STD clinic for STD services, and
- residence within the clinic's catchment area.
Who cannot join
- The exclusion criteria will be a previous HIV-positive diagnosis or
- Testing HIV-positive on the day of recruitment.
Trial locations and contacts
1 site in 1 country.
About this study
Randomized clinical trials of HIV prevention interventions typically include extensive baseline assessments of the risk behaviors that interventions target. Such pretests have the potential to direct participants' attention to the factors that put them at risk of HIV infection. Evidence from intervention study control groups, the motivational enhancement and attitude change literature, and our preliminary studies suggest that assessments that lead people to think about behaviors with potentially negative outcomes lead to motivation for risk behavior reduction. As a consequence, HIV intervention research using baseline assessments may not accurately predict the impact of a given HIV prevention intervention outside of the research context, in particular when interventions are evaluated among high-risk, isolated individuals. However, the actual effects as well as public-health consequences and mechanisms of HIV assessment reactivity have never been systematically tested.
The proposed assessment reactivity study will be conducted in South Africa, a country with high levels of HIV prevalence, incidence, and stigma. The Republic of South Africa's HIV/AIDS epidemic has emerged recently relative to other sub-Saharan countries, and yet 21.5% of South Africans aged 15-49 -- more than 1 in 5 people -- are infected with HIV (UNAIDS, 2004). Despite the common presence of HIV in South Africa, it remains largely a hidden disease and HIV-related stigma interferes with peoples' ability to protect themselves through open discussion or spontaneous reflection on personal risk. Under these conditions, it is reasonable to expect a sizable effect from directing people's attention to their HIV relevant behaviors, an effect that could be incorrectly ascribed to brief interventions used in low-resource settings. The conditions in South Africa, therefore, heighten the clinical and public health significance of the assessment reactivity issue in that (a) it is vital to understand how reactivity may affect the results of behavioral intervention trials, and (b) it may be possible to capitalize on assessment reactivity through brief, assessment-based interventions.
Read more
This study will allow us to achieve our primary aim:
- To separate the effect of a brief HIV-risk reduction intervention from the potential effects of two types of baseline assessment commonly applied in HIV intervention research: a detailed, calendar-based assessment and a general frequency assessment. The detailed calendar-based assessment will potentially lead participants to observe themselves in specific risk-behavior situations, providing them with the opportunity to reassess the risk involved in those situations in light of their health goals and thus motivating them for behavior change. The general frequency assessment will merely prompt participants to estimate the overall frequency with which they engaged in several HIV-related behaviors. The effect of these assessments on participants' sexual behavior will be examined alone and in combination with the HIV-risk reduction intervention.
In addition, this project has two important secondary aims:
- To generate urgently needed additional efficacy data for a promising HIV risk reduction intervention culturally tailored for use and found to be effective in South Africa
- To determine potential HIV preventive effects of different types of HIV risk behavior assessments on risk behavior reduction in South Africa for future intervention development
To achieve the above aims, the investigators will:
- Recruit 1500 patients (50% women), age 18-44, from the Spencer Rd. STD Clinic, Cape Town, South Africa.
- Randomly assign participants within gender to one of 6 study arms in a modified Solomon Four-Group (SFG) design. The 2 (intervention: standard of care vs. an efficacious theory based HIV prevention intervention) x 3 (baseline face-to-face interview: none vs. basic single-item frequency questions vs. detailed partner-by-partner calendar-based interview) factorial design is depicted below:
- Conditions
- HIV Prevention and Assessment Reactivity
- Being tested
- Detailed baseline interview, enhanced HIV intervention, General baseline interview, enhanced HIV intervention, No baseline interview, enhanced HIV intervention, Detailed baseline interview, standard of care intervention, General baseline interview, standard of care intervention
- Keywords
- HIV, Prevention, Methods, Assessment reactivity, South Africa, Youth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detailed baseline interview, enhanced HIV interventionBehavioural
Participants in this group will receive a detailed sexual behavior interview, similar to measures used in major intervention trials. This measure will identify the instances in which participants engaged in sexual behaviors with specific partners during a 90 day retrospective reporting period. Participants will then complete an empirically validated 60-minute session HIV-risk reduction intervention (Simbayi, Kalichman, Skinner et al., 2004) consisting of exercises to increase HIV/AIDS knowledge, motivation to reduce risk, behavior self-management skills, and sexual communication skills and reduce HIV-related stigma.
General baseline interview, enhanced HIV interventionBehavioural
Participants in this group will receive the same procedures as in (A) except that the behavioral measure will consist of single-item frequency questions regarding sexual behaviors during the prior 90 days, questions that do not lead the participant to focus on specific instances of behavior.
No baseline interview, enhanced HIV interventionBehavioural
This group will receive the same enhanced intervention procedures as in (A) and (B), but they will not be interviewed at baseline.
Detailed baseline interview, standard of care interventionBehavioural
Participants in this group will receive the same interview procedure as in (A) but instead of the enhanced intervention, They will undergo the standard clinical exam and health education that at the Spencer Rd. Clinic.
General baseline interview, standard of care interventionBehavioural
Participants in this group will complete the general baseline interview described in (B) and then receive the standard care at the clinic.
No baseline interview, standard of care interventionBehavioural
Participants assigned to this group will be consented on the day they are recruited, but will not receive further study contact on that day other than being scheduled to return for follow up assessments.
| Study group | Role | What they receive |
|---|---|---|
| Detailed baseline interview, enhanced HIV intervention | Experimental | Participants in this group will receive a detailed sexual behavior interview, similar to measures used in major intervention trials. This measure will identify the instances in which participants engaged in sexual behaviors with specific partners during a 90 day retrospective reporting period. Participants will then complete an empirically validated 60-minute session HIV-risk reduction intervention (Simbayi, Kalichman, Skinner et al., 2004) consisting of exercises to increase HIV/AIDS knowledge, motivation to reduce risk, behavior self-management skills, and sexual communication skills and reduce HIV-related stigma. Receives: Behavioral: Detailed baseline interview, enhanced HIV intervention |
| General baseline interview, enhanced HIV intervention | Experimental | Participants in this group will receive the same procedures as in (A) except that the behavioral measure will consist of single-item frequency questions regarding sexual behaviors during the prior 90 days, questions that do not lead the participant to focus on specific instances of behavior. Receives: Behavioral: General baseline interview, enhanced HIV intervention |
| No baseline interview, enhanced HIV intervention | Experimental | This group will receive the same enhanced intervention procedures as in (A) and (B), but they will not be interviewed at baseline. Receives: Behavioral: No baseline interview, enhanced HIV intervention |
| D. Detailed baseline interview, standard of care intervention | Active comparator | Participants in this group will receive the same interview procedure as in (A) but instead of the enhanced intervention, They will undergo the standard clinical exam and health education that at the Spencer Rd. Clinic. Receives: Behavioral: Detailed baseline interview, standard of care intervention |
| E. General baseline interview, standard of care intervention | Active comparator | Participants in this group will complete the general baseline interview described in (B) and then receive the standard care at the clinic. Receives: Behavioral: General baseline interview, standard of care intervention |
| F. No baseline interview, standard of care intervention | Active comparator | Participants assigned to this group will be consented on the day they are recruited, but will not receive further study contact on that day other than being scheduled to return for follow up assessments. Receives: Behavioral: No baseline interview, standard of care intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactivity assessment
Using the analytic strategy for the SFG design, we will use the follow-up data point to test our hypotheses that there will be a significant interaction between assessment conditions x intervention conditions.
Analyses will explore the effects of assessment and intervention on the factors presumed to mediate the effect of assessment reactivity (increases in perceived risk and safer sex intentions). Moderator analyses will observe if type of assessment interacts with the level of reported risk behavior (dichotomized as low and high).
Measured: Three month follow up
Secondary outcomes (1)
Risk Behavior Frequency
- To separate the effect of a brief HIV-risk reduction intervention from the potential effects of two types of baseline assessment commonly applied in HIV intervention research: a detailed, calendar-based assessment and a general frequency assessment.
Measured: Baseline and three month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startSep 2006
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV Prevention and Assessment ReactivityStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lance S Weinhardt, PhD, Principal investigator, Medical College of Wisconsin and UW Milwaukee Zilber School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580657
- Sponsor's protocol ID
- PRO00005529
- Other IDs
- 5R01MH077515-04
- Status last verified
- Apr 2012
- First submitted
- 12 Apr 2012
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Kalichman SC, Cain D, Weinhardt L, Benotsch E, Presser K, Zweben A, Bjodstrup B, Swain GR. Experimental components analysis of brief theory-based HIV/AIDS risk-reduction counseling for sexually transmitted infection patients. Health Psychol. 2005 Mar;24(2):198-208. doi: 10.1037/0278-6133.24.2.198.
PubMed 15755234Kalichman SC, Rompa D, Coley B. Experimental component analysis of a behavioral HIV-AIDS prevention intervention for inner-city women. J Consult Clin Psychol. 1996 Aug;64(4):687-93. doi: 10.1037//0022-006x.64.4.687.
PubMed 8803358Weinhardt LS, Carey KB, Carey MP. HIV risk sensitization following a detailed sexual behavior interview: a preliminary investigation. J Behav Med. 2000 Aug;23(4):393-8. doi: 10.1023/a:1005505018784.
PubMed 10984867Weinhardt LS. Effects of a detailed sexual behavior interview on perceived risk of HIV infection: preliminary experimental analysis in a high risk sample. J Behav Med. 2002 Apr;25(2):195-203. doi: 10.1023/a:1014888905882.
PubMed 11977438Weinhardt LS, Forsyth AD, Carey MP, Jaworski BC, Durant LE. Reliability and validity of self-report measures of HIV-related sexual behavior: progress since 1990 and recommendations for research and practice. Arch Sex Behav. 1998 Apr;27(2):155-80. doi: 10.1023/a:1018682530519.
PubMed 9562899
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Analysis of HIV Risk Assessment Reactivity in South African Clinics
- ClinicalTrials.gov ID
- NCT01580657
- Acronym / sponsor ID
- PRO00005529
- Conditions
- HIV Prevention and Assessment Reactivity
- Keywords
- HIV, Prevention, Methods, Assessment reactivity, South Africa, Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,728 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Apr 2012 (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.
Randomized clinical trials of HIV prevention interventions typically include extensive baseline assessments of the risk behaviors that interventions target. Such pretests have the potential to direct participants' attention to the factors that put them at risk of HIV infection. Evidence from intervention study control groups, the motivational enhancement and attitude change literature, and our preliminary studies suggest that assessments that lead people to think about behaviors with potentially negative outcomes lead to motivation for risk behavior reduction. As a consequence, HIV intervention research using baseline assessments may not accurately predict the impact of a given HIV prevention intervention outside of the research context, in particular when interventions are evaluated among high-risk, isolated individuals. However, the actual effects as well as public-health consequences and mechanisms of HIV assessment reactivity have never been systematically tested.
The proposed assessment reactivity study will be conducted in South Africa, a country with high levels of HIV prevalence, incidence, and stigma. The Republic of South Africa's HIV/AIDS epidemic has emerged recently relative to other sub-Saharan countries, and yet 21.5% of South Africans aged 15-49 -- more than 1 in 5 people -- are infected with HIV (UNAIDS, 2004). Despite the common presence of HIV in South Africa, it remains largely a hidden disease and HIV-related stigma interferes with peoples' ability to protect themselves through open discussion or spontaneous reflection on personal risk. Under these conditions, it is reasonable to expect a sizable effect from directing people's attention to their HIV relevant behaviors, an effect that could be incorrectly ascribed to brief interventions used in low-resource settings. The conditions in South Africa, therefore, heighten the clinical and public health significance of the assessment reactivity issue in that (a) it is vital to understand how reactivity may affect the results of behavioral intervention trials, and (b) it may be possible to capitalize on assessment reactivity through brief, assessment-based interventions.
This study will allow us to achieve our primary aim:
- To separate the effect of a brief HIV-risk reduction intervention from the potential effects of two types of baseline assessment commonly applied in HIV intervention research: a detailed, calendar-based assessment and a general frequency assessment. The detailed calendar-based assessment will potentially lead participants to observe themselves in specific risk-behavior situations, providing them with the opportunity to reassess the risk involved in those situations in light of their health goals and thus motivating them for behavior change. The general frequency assessment will merely prompt participants to estimate the overall frequency with which they engaged in several HIV-related behaviors. The effect of these assessments on participants' sexual behavior will be examined alone and in combination with the HIV-risk reduction intervention.
In addition, this project has two important secondary aims:
- To generate urgently needed additional efficacy data for a promising HIV risk reduction intervention culturally tailored for use and found to be effective in South Africa
- To determine potential HIV preventive effects of different types of HIV risk behavior assessments on risk behavior reduction in South Africa for future intervention development
To achieve the above aims, the investigators will:
- Recruit 1500 patients (50% women), age 18-44, from the Spencer Rd. STD Clinic, Cape Town, South Africa.
- Randomly assign participants within gender to one of 6 study arms in a modified Solomon Four-Group (SFG) design. The 2 (intervention: standard of care vs. an efficacious theory based HIV prevention intervention) x 3 (baseline face-to-face interview: none vs. basic single-item frequency questions vs. detailed partner-by-partner calendar-based interview) factorial design is depicted below:
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Detailed baseline interview, enhanced HIV intervention | Experimental | Behavioral: Detailed baseline interview, enhanced HIV interventionParticipants in this group will receive a detailed sexual behavior interview, similar to measures used in major intervention trials. This measure will identify the instances in which participants engaged in sexual behaviors with specific partners during a 90 day retrospective reporting period. Participants will then complete an empirically validated 60-minute session HIV-risk reduction intervention (Simbayi, Kalichman, Skinner et al., 2004) consisting of exercises to increase HIV/AIDS knowledge, motivation to reduce risk, behavior self-management skills, and sexual communication skills and reduce HIV-related stigma. |
| General baseline interview, enhanced HIV intervention | Experimental | Behavioral: General baseline interview, enhanced HIV interventionParticipants in this group will receive the same procedures as in (A) except that the behavioral measure will consist of single-item frequency questions regarding sexual behaviors during the prior 90 days, questions that do not lead the participant to focus on specific instances of behavior. |
| No baseline interview, enhanced HIV intervention | Experimental | Behavioral: No baseline interview, enhanced HIV interventionThis group will receive the same enhanced intervention procedures as in (A) and (B), but they will not be interviewed at baseline. |
| D. Detailed baseline interview, standard of care intervention | Active comparator | Behavioral: Detailed baseline interview, standard of care interventionParticipants in this group will receive the same interview procedure as in (A) but instead of the enhanced intervention, They will undergo the standard clinical exam and health education that at the Spencer Rd. Clinic. |
| E. General baseline interview, standard of care intervention | Active comparator | Behavioral: General baseline interview, standard of care interventionParticipants in this group will complete the general baseline interview described in (B) and then receive the standard care at the clinic. |
| F. No baseline interview, standard of care intervention | Active comparator | Behavioral: No baseline interview, standard of care interventionParticipants assigned to this group will be consented on the day they are recruited, but will not receive further study contact on that day other than being scheduled to return for follow up assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older,
- presenting at the site B youth STD clinic for STD services, and
- residence within the clinic's catchment area.
Key exclusion criteria (2 listed)
- The exclusion criteria will be a previous HIV-positive diagnosis or
- Testing HIV-positive on the day of recruitment.
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 |
|---|---|---|
| Detailed baseline interview, enhanced HIV interventionParticipants in this group will receive a detailed sexual behavior interview, similar to measures used in major intervention trials. This measure will identify the instances in which participants engaged in sexual behaviors with specific partners during a 90 day retrospective reporting period. Participants will then complete an empirically validated 60-minute session HIV-risk reduction intervention (Simbayi, Kalichman, Skinner et al., 2004) consisting of exercises to increase HIV/AIDS knowledge, motivation to reduce risk, behavior self-management skills, and sexual communication skills and reduce HIV-related stigma. | Behavioural | Detailed baseline interview, enhanced HIV intervention |
| General baseline interview, enhanced HIV interventionParticipants in this group will receive the same procedures as in (A) except that the behavioral measure will consist of single-item frequency questions regarding sexual behaviors during the prior 90 days, questions that do not lead the participant to focus on specific instances of behavior. | Behavioural | General baseline interview, enhanced HIV intervention |
| No baseline interview, enhanced HIV interventionThis group will receive the same enhanced intervention procedures as in (A) and (B), but they will not be interviewed at baseline. | Behavioural | No baseline interview, enhanced HIV intervention |
| Detailed baseline interview, standard of care interventionParticipants in this group will receive the same interview procedure as in (A) but instead of the enhanced intervention, They will undergo the standard clinical exam and health education that at the Spencer Rd. Clinic. | Behavioural | D. Detailed baseline interview, standard of care intervention |
| General baseline interview, standard of care interventionParticipants in this group will complete the general baseline interview described in (B) and then receive the standard care at the clinic. | Behavioural | E. General baseline interview, standard of care intervention |
| No baseline interview, standard of care interventionParticipants assigned to this group will be consented on the day they are recruited, but will not receive further study contact on that day other than being scheduled to return for follow up assessments. | Behavioural | F. No baseline interview, standard of care intervention |
Primary outcome
Reactivity assessment
Time frame: Three month follow up
Using the analytic strategy for the SFG design, we will use the follow-up data point to test our hypotheses that there will be a significant interaction between assessment conditions x intervention conditions. Analyses will explore the effects of assessment and intervention on the factors presumed to mediate the effect of assessment reactivity (increases in perceived risk and safer sex intentions). Moderator analyses will observe if type of assessment interacts with the level of reported risk behavior (dichotomized as low and high).
1 secondary outcome
Risk Behavior Frequency
Time frame: Baseline and three month follow up
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 18 Aug 2023.
- Background: PubMed 15755234Kalichman SC, Cain D, Weinhardt L, Benotsch E, Presser K, Zweben A, Bjodstrup B, Swain GR. Experimental components analysis of brief theory-based HIV/AIDS risk-reduction counseling for sexually transmitted infection patients. Health Psychol. 2005 Mar;24(2):198-208. doi: 10.1037/0278-6133.24.2.198.
- Background: PubMed 8803358Kalichman SC, Rompa D, Coley B. Experimental component analysis of a behavioral HIV-AIDS prevention intervention for inner-city women. J Consult Clin Psychol. 1996 Aug;64(4):687-93. doi: 10.1037//0022-006x.64.4.687.
- Background: PubMed 10984867Weinhardt LS, Carey KB, Carey MP. HIV risk sensitization following a detailed sexual behavior interview: a preliminary investigation. J Behav Med. 2000 Aug;23(4):393-8. doi: 10.1023/a:1005505018784.
- Background: PubMed 11977438Weinhardt LS. Effects of a detailed sexual behavior interview on perceived risk of HIV infection: preliminary experimental analysis in a high risk sample. J Behav Med. 2002 Apr;25(2):195-203. doi: 10.1023/a:1014888905882.
- Background: PubMed 9562899Weinhardt LS, Forsyth AD, Carey MP, Jaworski BC, Durant LE. Reliability and validity of self-report measures of HIV-related sexual behavior: progress since 1990 and recommendations for research and practice. Arch Sex Behav. 1998 Apr;27(2):155-80. doi: 10.1023/a:1018682530519.
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.
Lance S Weinhardt, PhD principal investigator
Medical College of Wisconsin and UW Milwaukee Zilber School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detailed baseline interview, enhanced HIV intervention, General baseline interview, enhanced HIV intervention and No baseline interview, enhanced HIV intervention in people with HIV Prevention and Assessment Reactivity, run by Medical College of Wisconsin at 1 site in South Africa.
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 2 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 18 Aug 2023. 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 South Africa. 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?
Reactivity assessment (time frame: Three month follow up). 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 NCT01580657, which also lists 5 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 18 Aug 2023.