HIVPhase 3NCT00947271
Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic
A Phase 3 study testing DVD 1 and DVD 2 in people with HIV and Sexually Transmitted Diseases, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study will determine whether showing an educational DVD to people at sexually transmitted infection clinics can reduce incidence of new infections and risky sexual behaviors and improve overall health. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Diseases, HIV Infections
- What is being tested?
- DVD 1 and DVD 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2014
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Evidence of sexual risk behavior, defined as either signs, symptoms, or diagnosis indicative of an STD during the past 3 months; or unprotected vaginal or anal intercourse with two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug using partner, or a partner with an STD
Who cannot join
- Impaired mental status that would prevent participant from providing informed consent or participating meaningfully
- Inability to understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe County Health Department
Rochester, New York, 14611
About this study
Official title: HIV Prevention for STD Clinic Patients
This study will determine whether showing an educational DVD to people at sexually transmitted infection clinics can reduce incidence of new infections and risky sexual behaviors and improve overall health.
Read the detailed description
Sexually transmitted infections (STIs) can produce long-term health problems. They are often linked to HIV, which can also be sexually transmitted, because both occur in the same populations and because STIs and HIV interact biologically. Having an STI other than HIV can increase the risk of HIV acquisition and transmission as well as negatively impact HIV progression. The population of people who go to clinics specializing in STIs are particularly at risk of engaging in risky sexual behaviors and having poor health outcomes-like infection with an STI. This study will test the effectiveness of using an educational DVD to reduce incidence of risky sexual behaviors and STI acquisition, including risk of HIV, and to improve overall health.
Participation in this study will involve two phases. In Phase 1, participants will complete both computerized and paper surveys and watch an educational DVD. The educational DVD may include information on diet, physical activity, sleep, smoking, STIs, and stress. Participants will be recruited from among people who are already going to the clinic, and participation will add approximately 1.5 hours to their visits. In Phase 2, participants will be asked to complete four follow-up visits occurring 3, 6, 9, and 12 months after Phase 1. During these follow-up visits, participants will complete a 45-minute computerized survey similar to that in Phase 1 and provide urine and throat samples for STI testing. All surveys will assess health-related thoughts, feelings, and behaviors, including sexual behaviors. Participants will be compensated for completing Phase 1 and each visit in Phase 2.
- Conditions
- HIV, Sexually Transmitted Diseases, HIV Infections
- Being tested
- DVD 1, DVD 2
- Keywords
- STD, STI, Sexual Behavior, Prevention, HIV seronegativity
- Medical subject headings
- Sexually Transmitted Diseases, HIV Infections, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVD 1Behavioural
The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health
DVD 2Behavioural
The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health
| Study group | Role | What they receive |
|---|---|---|
| DVD 1 plus assessment 1 | Experimental | Participants will view educational DVD 1 and complete the first version of the study assessment. Receives: Behavioral: DVD 1 |
| DVD 1 plus assessment 2 | Experimental | Participants will view educational DVD 1 and complete the second version of the study assessment. Receives: Behavioral: DVD 1 |
| DVD 2 plus assessment 1 | Experimental | Participants will view educational DVD 2 and complete the first version of the study assessment. Receives: Behavioral: DVD 2 |
| DVD 2 plus assessment 2 | Experimental | Participants will view educational DVD 2 and complete the second version of the study assessment. Receives: Behavioral: DVD 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Sexual Partners, 3 Months Post Intervention
number of sexual partners in the past 3 months, assessed 3 months post intervention
Measured: Measured after 3 months
Number of Sexual Partners, 6 Months Post Intervention
number of sexual partners reported in the past 3 months, assessed 6 months post intervention.
Measured: 6 months post intervention
Number of Sexual Partners, 9 Months Post Intervention
number of sexual partners in the past 3 months, assessed 9 months post intervention
Measured: 9 months post intervention
Number of Sexual Partners, 12 Months Post Intervention
number of sexual partners in the past 3 months, assessed 12 months post intervention
Measured: 12 months post intervention
Secondary outcomes (1)
Sexually Transmitted Infection Incidence
number of participants diagnosed with a new STI (CT, Gc, trichomoniasis, syphilis, or HIV) throughout the entire year of follow-up; includes participants who provided a study urine sample for STI testing at 3, 6, 9, and/or 12 months post intervention and participants who received STI testing through the clinic during the year of follow up
Measured: Measured throughout the 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2014
- Study completionJun 2014
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 (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Rochester, Brown University, Syracuse University
- Responsible party
- Principal investigator, Michael P. Carey, The Miriam Hospital
- Investigators
- Michael P. Carey, Ph.D., Principal investigator, The Miriam Hospital and Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947271
- Sponsor's protocol ID
- R01MH068171-06
- Other IDs
- R01MH068171-06, PCC: DAHBR 9A-ASPQ
- Status last verified
- Sep 2014
- First submitted
- 27 Jul 2009
- Last updated
- 17 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Carey MP, Senn TE, Coury-Doniger P, Urban MA, Vanable PA, Carey KB. Optimizing the scientific yield from a randomized controlled trial (RCT): evaluating two behavioral interventions and assessment reactivity with a single trial. Contemp Clin Trials. 2013 Sep;36(1):135-46. doi: 10.1016/j.cct.2013.06.019. Epub 2013 Jun 29.
PubMed 23816489Carey KB, Senn TE, Walsh JL, Scott-Sheldon LA, Carey MP. Alcohol Use Predicts Number of Sexual Partners for Female but not Male STI Clinic Patients. AIDS Behav. 2016 Jan;20 Suppl 1(0 1):S52-9. doi: 10.1007/s10461-015-1177-9.
PubMed 26310596Carey MP, Senn TE, Walsh JL, Coury-Doniger P, Urban MA, Fortune T, Vanable PA, Carey KB. Evaluating a Brief, Video-Based Sexual Risk Reduction Intervention and Assessment Reactivity with STI Clinic Patients: Results from a Randomized Controlled Trial. AIDS Behav. 2015 Jul;19(7):1228-46. doi: 10.1007/s10461-014-0960-3.
PubMed 25433653
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Prevention for STD Clinic Patients
- ClinicalTrials.gov ID
- NCT00947271
- Acronym / sponsor ID
- R01MH068171-06
- Conditions
- HIV, Sexually Transmitted Diseases, HIV Infections
- Keywords
- STD, STI, Sexual Behavior, Prevention, HIV seronegativity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Rochester, Brown University, Syracuse University
- Study start
- Oct 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Posted 17 Sep 2014
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 determine whether showing an educational DVD to people at sexually transmitted infection clinics can reduce incidence of new infections and risky sexual behaviors and improve overall health.
Detailed description
Sexually transmitted infections (STIs) can produce long-term health problems. They are often linked to HIV, which can also be sexually transmitted, because both occur in the same populations and because STIs and HIV interact biologically. Having an STI other than HIV can increase the risk of HIV acquisition and transmission as well as negatively impact HIV progression. The population of people who go to clinics specializing in STIs are particularly at risk of engaging in risky sexual behaviors and having poor health outcomes-like infection with an STI. This study will test the effectiveness of using an educational DVD to reduce incidence of risky sexual behaviors and STI acquisition, including risk of HIV, and to improve overall health.
Participation in this study will involve two phases. In Phase 1, participants will complete both computerized and paper surveys and watch an educational DVD. The educational DVD may include information on diet, physical activity, sleep, smoking, STIs, and stress. Participants will be recruited from among people who are already going to the clinic, and participation will add approximately 1.5 hours to their visits. In Phase 2, participants will be asked to complete four follow-up visits occurring 3, 6, 9, and 12 months after Phase 1. During these follow-up visits, participants will complete a 45-minute computerized survey similar to that in Phase 1 and provide urine and throat samples for STI testing. All surveys will assess health-related thoughts, feelings, and behaviors, including sexual behaviors. Participants will be compensated for completing Phase 1 and each visit in Phase 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DVD 1 plus assessment 1 | Experimental | Behavioral: DVD 1Participants will view educational DVD 1 and complete the first version of the study assessment. |
| DVD 1 plus assessment 2 | Experimental | Behavioral: DVD 1Participants will view educational DVD 1 and complete the second version of the study assessment. |
| DVD 2 plus assessment 1 | Experimental | Behavioral: DVD 2Participants will view educational DVD 2 and complete the first version of the study assessment. |
| DVD 2 plus assessment 2 | Experimental | Behavioral: DVD 2Participants will view educational DVD 2 and complete the second version of the study assessment. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Evidence of sexual risk behavior, defined as either signs, symptoms, or diagnosis indicative of an STD during the past 3 months; or unprotected vaginal or anal intercourse with two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug using partner, or a partner with an STD
Key exclusion criteria (2 listed)
- Impaired mental status that would prevent participant from providing informed consent or participating meaningfully
- Inability to understand English
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 |
|---|---|---|
| DVD 1The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health | Behavioural | DVD 1 plus assessment 1, DVD 1 plus assessment 2 |
| DVD 2The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health | Behavioural | DVD 2 plus assessment 1, DVD 2 plus assessment 2 |
Primary outcome
Number of Sexual Partners, 3 Months Post Intervention
Time frame: Measured after 3 months
number of sexual partners in the past 3 months, assessed 3 months post intervention
Number of Sexual Partners, 6 Months Post Intervention
Time frame: 6 months post intervention
number of sexual partners reported in the past 3 months, assessed 6 months post intervention.
Number of Sexual Partners, 9 Months Post Intervention
Time frame: 9 months post intervention
number of sexual partners in the past 3 months, assessed 9 months post intervention
Number of Sexual Partners, 12 Months Post Intervention
Time frame: 12 months post intervention
number of sexual partners in the past 3 months, assessed 12 months post intervention
1 secondary outcome
Sexually Transmitted Infection Incidence
Time frame: Measured throughout the 12 months post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23816489Carey MP, Senn TE, Coury-Doniger P, Urban MA, Vanable PA, Carey KB. Optimizing the scientific yield from a randomized controlled trial (RCT): evaluating two behavioral interventions and assessment reactivity with a single trial. Contemp Clin Trials. 2013 Sep;36(1):135-46. doi: 10.1016/j.cct.2013.06.019. Epub 2013 Jun 29.
- Derived from this study: PubMed 26310596Carey KB, Senn TE, Walsh JL, Scott-Sheldon LA, Carey MP. Alcohol Use Predicts Number of Sexual Partners for Female but not Male STI Clinic Patients. AIDS Behav. 2016 Jan;20 Suppl 1(0 1):S52-9. doi: 10.1007/s10461-015-1177-9.
- Derived from this study: PubMed 25433653Carey MP, Senn TE, Walsh JL, Coury-Doniger P, Urban MA, Fortune T, Vanable PA, Carey KB. Evaluating a Brief, Video-Based Sexual Risk Reduction Intervention and Assessment Reactivity with STI Clinic Patients: Results from a Randomized Controlled Trial. AIDS Behav. 2015 Jul;19(7):1228-46. doi: 10.1007/s10461-014-0960-3.
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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.
Michael P. Carey, Ph.D. principal investigator
The Miriam Hospital and Brown 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 DVD 1 and DVD 2 in people with HIV and Sexually Transmitted Diseases, run by The Miriam Hospital 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 1 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 17 Sep 2014. 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 17 Sep 2014). 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 Sexual Partners, 3 Months Post Intervention (time frame: Measured after 3 months). The study lists 4 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 NCT00947271, which also lists 3 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 17 Sep 2014.