HIV InfectionsPhase 3NCT00710060
Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations
A Phase 3 study testing Community Popular Opinion Leader (C-POL) and HIV/STD educational materials in people with HIV Infections and Sexually Transmitted Diseases, run by RTI International at 5 sites in 5 countries.
Trial summary
This study will evaluate the effectiveness of a community-level HIV prevention program in promoting safer sexual behaviors and reducing the transmission of HIV/sexually transmitted diseases among at-risk populations in China, India, Peru, Russia, and Zimbabwe. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Community Popular Opinion Leader (C-POL) and HIV/STD educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,147 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Sep 2002to Aug 2007
- Phase
- Phase 3
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Either lives, works, or socializes in the selected venues
- Plans to remain in the venue for at least 1 year after study entry
Who cannot join
- Permanent disability that hinders participation (e.g. deaf, mental retardation)
- Reports no sex in the 6 months before study entry (China, Peru)
- No STDs present at study entry (China)
- Enrolled in final year of school at time of recruitment (Russia)
- Has lived in venue for less than 2 years (Zimbabwe)
- Lives in venue for less than 9 months out of a year (Zimbabwe)
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
India1 site
YRG Centre for AIDS Research and Education (YRGCARE)
Chennai, 600 113
Zimbabwe1 site
Zimbabwe Community Health Intervention Research (ZiCHIRe) - University of Zimbabwe
Harare
About this study
Official title: NIMH Collaborative HIV/STD Prevention Trial
This study will evaluate the effectiveness of a community-level HIV prevention program in promoting safer sexual behaviors and reducing the transmission of HIV/sexually transmitted diseases among at-risk populations in China, India, Peru, Russia, and Zimbabwe.
Read the detailed description
The HIV/AIDS epidemic remains largely out of control in many areas of the world, with an estimated 2.5 million new HIV infections worldwide in 2007. Developing countries with few economic resources and world regions undergoing difficult social transitions have been particularly impacted by large increases in HIV and sexually transmitted disease (STD) infections. To date, effective individual prevention approaches have not been rapid enough to avert the epidemic in these areas and may be too resource intensive to maintain. Behavioral HIV prevention interventions on the community level seek to reduce the prevalence of high-risk sexual behaviors by reaching large numbers of vulnerable people in a cost-effective and feasible manner, even in areas with limited resources. The Community Popular Opinion Leader (C-POL) program is an HIV prevention intervention that recruits and trains trusted opinion leaders in the community to promote safe sex behaviors through risk-reduction conversations with peers. Implementing the C-POL program in world regions facing significant HIV/AIDS epidemics may be the most effective means of encouraging behavior change among members of at-risk populations and strengthening social norms to maintain these changes. This study will evaluate the effectiveness of the C-POL program in promoting safer sexual behaviors and reducing the transmission of HIV/STDs among at-risk populations in China, India, Peru, Russia, and Zimbabwe.
Participation in this study will last 2 years. Initially, an ethnographic study will be conducted to determine the HIV/STD knowledge, attitudes, and behaviors among the population living in the target communities. Information collected via observation, focus groups, and interviews will be used to determine the social risk groups operating within the community and to identify and recruit the opinion leaders who are influential in these groups. Also, an epidemiological study will be conducted to collect information on sexual behaviors and HIV/STD rates.
A cohort of members from participating communities will first undergo baseline assessments that will include a survey about general health and knowledge of HIV/STDs and a biological sampling for HIV/STD testing. Participating communities will then be assigned randomly to receive the C-POL intervention and HIV/STD educational materials or HIV/STD educational materials alone. In communities receiving the C-POL intervention, the previously recruited opinion leaders will be taught skills for sharing HIV risk-reduction messages in daily conversation with peers. This training will occur over four to five weekly sessions. At least 15% of the community population will be trained as opinion leaders. After the initial training, opinion leaders will attend six to nine booster sessions over the next 2 years to reinforce and support continued conversation efforts. Communities assigned to receive the HIV/STD educational materials will receive informational materials on HIV/STDs to provide to community members and will provide treatment or treatment referral for people with nonviral STDs.
All participants in the baseline cohort will be asked to repeat the baseline testing 1 and 2 years later. Participants who are not able to visit a clinic for testing will be contacted by phone to complete the baseline survey. After the 2-year assessments, the C-POL intervention will be conducted in the communities that received educational materials only.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Community Popular Opinion Leader (C-POL), HIV/STD educational materials
- Keywords
- HIV, Popular Opinion Leader, POL, Behavioral Intervention, STD, STI, Community, Prevention, International, Global
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Popular Opinion Leader (C-POL)Behavioural
Also called Popular Opinion Leader (POL), Diffusion of Innovations
The C-POL intervention will teach identified opinion leaders to share personalized HIV prevention messages in conversations with peers in an effort to change community norms. Opinion leaders will be taught skills for sharing HIV risk-reduction messages during four to five weekly training sessions. At least 15% of the community population will be trained as opinion leaders. After the initial training, opinion leaders will attend six to nine booster sessions over the next 2 years to reinforce and support continued conversation efforts.
HIV/STD educational materialsBehavioural
Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participating communities will receive the Community Popular Opinion Leader intervention and HIV/STD educational materials. Receives: Behavioral: Community Popular Opinion Leader (C-POL); Behavioral: HIV/STD educational materials |
| 2 | Active comparator | Participating communities will receive HIV/STD educational materials only. Receives: Behavioral: HIV/STD educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of unprotected sexual acts with nonspousal partners
Measured: Measured at baseline and Years 1 and 2
Overall observed incidence of sexually transmitted diseases (STDs) (e.g., chlamydia, gonorrhea, syphilis, trichomonas, HIV, or herpes simplex virus-2), as detected by biological specimens
Measured: Measured at baseline and Years 1 and 2
Secondary outcomes (1)
Increased exposure to HIV prevention messages, more STD treatment seeking, lower stigma regarding HIV and STDs, and lower substance abuse associated with sexual behavior in intervention group as compared to control group
Measured: Measured at Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startSep 2002
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18,147 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Carlos F. Caceres, PhD, Principal investigator, Universidad Peruana Cayetano HerediaDavid D. Celentano, ScD, Principal investigator, The Johns Hopkins University, Baltimore, Maryland (India)Thomas J. Coates, PhD, Principal investigator, University of California at Los Angeles, Los Angeles, California (Peru)Tyler D. Hartwell, PhD, Principal investigator, RTI International, Research Triangle Park, North Carolina (DCC)Danuta Kasprzyk, PhD, Principal investigator, Battelle Center for Public Health Research and Evaluation, Seattle, Washington (Zimbabwe)Jeffrey A. Kelly, PhD, Principal investigator, Medical College of Wisconsin, Milwaukee, Wisconsin (Russia)Andrei P. Kozlov, PhD, Principal investigator, Biomedical Center, St. Petersburg State University, St. Petersburg, RussiaWillo Pequegnat, PhD, Principal investigator, National Institute of Mental Health, Bethesda, Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710060
- Sponsor's protocol ID
- U10MH061537
- Other IDs
- U10MH061537, U10MH061499, U10MH061513, U10MH061536, U10MH061543, U10MH061544, DAHBR 9A-ASGT
- Status last verified
- Jul 2008
- First submitted
- 30 Jun 2008
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
NIMH Collaborative HIV/STD Prevention Trial Group. Methodological overview of a five-country community-level HIV/sexually transmitted disease prevention trial. AIDS. 2007 Apr;21 Suppl 2:S3-18. doi: 10.1097/01.aids.0000266453.18644.27.
PubMed 17413262NIMH Collaborative HIV/STD Prevention Trial Group. Selection of populations represented in the NIMH Collaborative HIV/STD Prevention Trial. AIDS. 2007 Apr;21 Suppl 2:S19-28. doi: 10.1097/01.aids.0000266454.26268.90.
PubMed 17413260NIMH Collaborative HIV/STD Prevention Trial Group. Challenges and processes of selecting outcome measures for the NIMH Collaborative HIV/STD Prevention Trial. AIDS. 2007 Apr;21 Suppl 2:S29-36. doi: 10.1097/01.aids.0000266455.03397.08.
PubMed 17413261NIMH Collaborative HIV/STD Prevention Trial Group. Design and integration of ethnography within an international behavior change HIV/sexually transmitted disease prevention trial. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S37-48. doi: 10.1097/01.aids.0000266456.03397.d3.
PubMed 17413263NIMH Collaborative HIV/STD Prevention Trial Group. The feasibility of audio computer-assisted self-interviewing in international settings. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S49-58. doi: 10.1097/01.aids.0000266457.11020.f0.
PubMed 17413264NIMH Collaborative HIV/STD Prevention Trial Group. The community popular opinion leader HIV prevention programme: conceptual basis and intervention procedures. AIDS. 2007 Apr;21 Suppl 2:S59-68. doi: 10.1097/01.aids.0000266458.49138.fa.
PubMed 17413265NIMH Collaborative HIV/STD Prevention Trial Group. Ethical issues in the NIMH Collaborative HIV/STD Prevention Trial. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S69-80. doi: 10.1097/01.aids.0000266459.49138.b3.
PubMed 17413266NIMH Collaborative HIV/STD Prevention Trial Group. Sexually transmitted disease and HIV prevalence and risk factors in concentrated and generalized HIV epidemic settings. AIDS. 2007 Apr;21 Suppl 2:S81-90. doi: 10.1097/01.aids.0000266460.56762.84.
PubMed 17413267NIMH Collaborative HIV/STD Prevention Trial Group. Formative study conducted in five countries to adapt the community popular opinion leader intervention. AIDS. 2007 Apr;21 Suppl 2:S91-8. doi: 10.1097/01.aids.0000266461.33891.d0.
PubMed 17413268NIMH Collaborative HIV/STD Prevention Trial. Role of the data safety and monitoring board in an international trial. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S99-102. doi: 10.1097/01.aids.0000266462.33891.0b.
PubMed 17413269Rotheram-Borus MJ, Wu Z, Liang LJ, Li L, Detels R, Guan J, Yin Y, Swendeman D; NIMH Collaborative HIV/STD Prevention Trial Group. Reductions in sexually transmitted infections associated with popular opinion leaders in China in a randomised controlled trial. Sex Transm Infect. 2011 Jun;87(4):337-43. doi: 10.1136/sti.2010.046243. Epub 2011 Jan 29.
PubMed 21278400
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIMH Collaborative HIV/STD Prevention Trial
- ClinicalTrials.gov ID
- NCT00710060
- Acronym / sponsor ID
- U10MH061537
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- HIV, Popular Opinion Leader, POL, Behavioral Intervention, STD, STI, Community, Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,147 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2002
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 3 Jul 2008 (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 will evaluate the effectiveness of a community-level HIV prevention program in promoting safer sexual behaviors and reducing the transmission of HIV/sexually transmitted diseases among at-risk populations in China, India, Peru, Russia, and Zimbabwe.
Detailed description
The HIV/AIDS epidemic remains largely out of control in many areas of the world, with an estimated 2.5 million new HIV infections worldwide in 2007. Developing countries with few economic resources and world regions undergoing difficult social transitions have been particularly impacted by large increases in HIV and sexually transmitted disease (STD) infections. To date, effective individual prevention approaches have not been rapid enough to avert the epidemic in these areas and may be too resource intensive to maintain. Behavioral HIV prevention interventions on the community level seek to reduce the prevalence of high-risk sexual behaviors by reaching large numbers of vulnerable people in a cost-effective and feasible manner, even in areas with limited resources. The Community Popular Opinion Leader (C-POL) program is an HIV prevention intervention that recruits and trains trusted opinion leaders in the community to promote safe sex behaviors through risk-reduction conversations with peers. Implementing the C-POL program in world regions facing significant HIV/AIDS epidemics may be the most effective means of encouraging behavior change among members of at-risk populations and strengthening social norms to maintain these changes. This study will evaluate the effectiveness of the C-POL program in promoting safer sexual behaviors and reducing the transmission of HIV/STDs among at-risk populations in China, India, Peru, Russia, and Zimbabwe.
Participation in this study will last 2 years. Initially, an ethnographic study will be conducted to determine the HIV/STD knowledge, attitudes, and behaviors among the population living in the target communities. Information collected via observation, focus groups, and interviews will be used to determine the social risk groups operating within the community and to identify and recruit the opinion leaders who are influential in these groups. Also, an epidemiological study will be conducted to collect information on sexual behaviors and HIV/STD rates.
A cohort of members from participating communities will first undergo baseline assessments that will include a survey about general health and knowledge of HIV/STDs and a biological sampling for HIV/STD testing. Participating communities will then be assigned randomly to receive the C-POL intervention and HIV/STD educational materials or HIV/STD educational materials alone. In communities receiving the C-POL intervention, the previously recruited opinion leaders will be taught skills for sharing HIV risk-reduction messages in daily conversation with peers. This training will occur over four to five weekly sessions. At least 15% of the community population will be trained as opinion leaders. After the initial training, opinion leaders will attend six to nine booster sessions over the next 2 years to reinforce and support continued conversation efforts. Communities assigned to receive the HIV/STD educational materials will receive informational materials on HIV/STDs to provide to community members and will provide treatment or treatment referral for people with nonviral STDs.
All participants in the baseline cohort will be asked to repeat the baseline testing 1 and 2 years later. Participants who are not able to visit a clinic for testing will be contacted by phone to complete the baseline survey. After the 2-year assessments, the C-POL intervention will be conducted in the communities that received educational materials only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Community Popular Opinion Leader (C-POL), Behavioral: HIV/STD educational materialsParticipating communities will receive the Community Popular Opinion Leader intervention and HIV/STD educational materials. |
| 2 | Active comparator | Behavioral: HIV/STD educational materialsParticipating communities will receive HIV/STD educational materials only. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Either lives, works, or socializes in the selected venues
- Plans to remain in the venue for at least 1 year after study entry
Key exclusion criteria (6 listed)
- Permanent disability that hinders participation (e.g. deaf, mental retardation)
- Reports no sex in the 6 months before study entry (China, Peru)
- No STDs present at study entry (China)
- Enrolled in final year of school at time of recruitment (Russia)
- Has lived in venue for less than 2 years (Zimbabwe)
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 |
|---|---|---|
| Community Popular Opinion Leader (C-POL)Also: Popular Opinion Leader (POL), Diffusion of InnovationsThe C-POL intervention will teach identified opinion leaders to share personalized HIV prevention messages in conversations with peers in an effort to change community norms. Opinion leaders will be taught skills for sharing HIV risk-reduction messages during four to five weekly training sessions. At least 15% of the community population will be trained as opinion leaders. After the initial training, opinion leaders will attend six to nine booster sessions over the next 2 years to reinforce and support continued conversation efforts. | Behavioural | 1 |
| HIV/STD educational materialsCommunities will receive HIV/STD educational materials and treatment referral information to distribute to community members. | Behavioural | 1, 2 |
Primary outcome
Frequency of unprotected sexual acts with nonspousal partners
Time frame: Measured at baseline and Years 1 and 2
Overall observed incidence of sexually transmitted diseases (STDs) (e.g., chlamydia, gonorrhea, syphilis, trichomonas, HIV, or herpes simplex virus-2), as detected by biological specimens
Time frame: Measured at baseline and Years 1 and 2
1 secondary outcome
Increased exposure to HIV prevention messages, more STD treatment seeking, lower stigma regarding HIV and STDs, and lower substance abuse associated with sexual behavior in intervention group as compared to control group
Time frame: Measured at Year 2
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 4 Nov 2013.
- Background: PubMed 17413262NIMH Collaborative HIV/STD Prevention Trial Group. Methodological overview of a five-country community-level HIV/sexually transmitted disease prevention trial. AIDS. 2007 Apr;21 Suppl 2:S3-18. doi: 10.1097/01.aids.0000266453.18644.27.
- Background: PubMed 17413260NIMH Collaborative HIV/STD Prevention Trial Group. Selection of populations represented in the NIMH Collaborative HIV/STD Prevention Trial. AIDS. 2007 Apr;21 Suppl 2:S19-28. doi: 10.1097/01.aids.0000266454.26268.90.
- Background: PubMed 17413261NIMH Collaborative HIV/STD Prevention Trial Group. Challenges and processes of selecting outcome measures for the NIMH Collaborative HIV/STD Prevention Trial. AIDS. 2007 Apr;21 Suppl 2:S29-36. doi: 10.1097/01.aids.0000266455.03397.08.
- Background: PubMed 17413263NIMH Collaborative HIV/STD Prevention Trial Group. Design and integration of ethnography within an international behavior change HIV/sexually transmitted disease prevention trial. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S37-48. doi: 10.1097/01.aids.0000266456.03397.d3.
- Background: PubMed 17413264NIMH Collaborative HIV/STD Prevention Trial Group. The feasibility of audio computer-assisted self-interviewing in international settings. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S49-58. doi: 10.1097/01.aids.0000266457.11020.f0.
- Background: PubMed 17413265NIMH Collaborative HIV/STD Prevention Trial Group. The community popular opinion leader HIV prevention programme: conceptual basis and intervention procedures. AIDS. 2007 Apr;21 Suppl 2:S59-68. doi: 10.1097/01.aids.0000266458.49138.fa.
- Background: PubMed 17413266NIMH Collaborative HIV/STD Prevention Trial Group. Ethical issues in the NIMH Collaborative HIV/STD Prevention Trial. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S69-80. doi: 10.1097/01.aids.0000266459.49138.b3.
- Background: PubMed 17413267NIMH Collaborative HIV/STD Prevention Trial Group. Sexually transmitted disease and HIV prevalence and risk factors in concentrated and generalized HIV epidemic settings. AIDS. 2007 Apr;21 Suppl 2:S81-90. doi: 10.1097/01.aids.0000266460.56762.84.
- Background: PubMed 17413268NIMH Collaborative HIV/STD Prevention Trial Group. Formative study conducted in five countries to adapt the community popular opinion leader intervention. AIDS. 2007 Apr;21 Suppl 2:S91-8. doi: 10.1097/01.aids.0000266461.33891.d0.
- Background: PubMed 17413269NIMH Collaborative HIV/STD Prevention Trial. Role of the data safety and monitoring board in an international trial. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S99-102. doi: 10.1097/01.aids.0000266462.33891.0b.
- Derived from this study: PubMed 21278400Rotheram-Borus MJ, Wu Z, Liang LJ, Li L, Detels R, Guan J, Yin Y, Swendeman D; NIMH Collaborative HIV/STD Prevention Trial Group. Reductions in sexually transmitted infections associated with popular opinion leaders in China in a randomised controlled trial. Sex Transm Infect. 2011 Jun;87(4):337-43. doi: 10.1136/sti.2010.046243. Epub 2011 Jan 29.
- Click here for more information on this study at the NIMH Collaborative HIV/STD Prevention Trial Web siteLink provided by the sponsor.
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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.
Carlos F. Caceres, PhD principal investigator
Universidad Peruana Cayetano Heredia
David D. Celentano, ScD principal investigator
The Johns Hopkins University, Baltimore, Maryland (India)
Thomas J. Coates, PhD principal investigator
University of California at Los Angeles, Los Angeles, California (Peru)
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Community Popular Opinion Leader (C-POL) and HIV/STD educational materials in people with HIV Infections and Sexually Transmitted Diseases, run by RTI International at 5 sites in 5 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 2 inclusion and 6 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 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China, India, Peru, Russia, Zimbabwe. 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?
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?
Frequency of unprotected sexual acts with nonspousal partners (time frame: Measured at baseline and Years 1 and 2). 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 NCT00710060, which also lists 11 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 4 Nov 2013.