Sexually Transmitted InfectionNCT00170534
Intervention for Male STDs in India
A study testing Behavior in people with Sexually Transmitted Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in India.
Trial summary
The specific aim of this study is to complete an ongoing randomized controlled trial of the efficacy of behavioral intervention compared to STI treatment/HIV counseling alone in decreasing risk behavior and incident HIV/STI infections in Mumbai, India. Read more about this study
- Who is it for?
- Ages 16 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infection
- What is being tested?
- Behavior
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,892 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2004to Apr 2007
- 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 16 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males, over 16 years of age
- Hindu or Marathi speakers
- Have no plan to move permanently out of Mumbia in the following 12 months
- have a symptom of an STI or have had a sexual exposure in the past 6 months. A sexual exposure is defined as having sex with a commercial sex worker (FSW), having unprotected sex with anyone, male or female, or if the patient came to the clinic seeking an HIV test.
- Patients will be required to provide an address that can be located by a tracer.
Who cannot join
- 1. HIV positive subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Intervention for Male STD Patients in India
The specific aim of this study is to complete an ongoing randomized controlled trial of the efficacy of behavioral intervention compared to STI treatment/HIV counseling alone in decreasing risk behavior and incident HIV/STI infections in Mumbai, India.
Read the detailed description
India has the second highest number of HIV infections of any country in the world, and the epidemic continues unabated. This trial is focused on high risk men attending public STI clinics. A proposed 2 and a half year study, this trial will utilize the continuation of a randomized controlled trial of a behavioral intervention compared to HIV C\&T and STI treatment alone targeting HIV uninfected male STI patients. The specific aims are to complete the current behavioral intervention trial and to expand the current investigations to include: the evaluation of men who have sex with men as well as women and evaluate the use of alcohol to the entire sample of recruited men. STI patients will be recruited from three sites and if randomized will agree to a 12 month participation commitment. Strategies employed in both arms of the trial are simple and the fundamental components of an HIV prevention strategy. By demonstrating their effectiveness in India the hope is to encourage the public health leadership to adopt them and continue to change drug treatment availability.
- Conditions
- Sexually Transmitted Infection
- Being tested
- Behavior
- Keywords
- India, male, sexually transmitted infection, STI, STD
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehaviorBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1,892 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170534
- Sponsor's protocol ID
- 02-106
- Status last verified
- Apr 2009
- First submitted
- 12 Sep 2005
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention for Male STD Patients in India
- ClinicalTrials.gov ID
- NCT00170534
- Acronym / sponsor ID
- 02-106
- Conditions
- Sexually Transmitted Infection
- Keywords
- India, male, sexually transmitted infection, STI, STD
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1,892 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2004
- Study completion
- Apr 2007
- First posted
- 15 Sep 2005 (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.
The specific aim of this study is to complete an ongoing randomized controlled trial of the efficacy of behavioral intervention compared to STI treatment/HIV counseling alone in decreasing risk behavior and incident HIV/STI infections in Mumbai, India.
Detailed description
India has the second highest number of HIV infections of any country in the world, and the epidemic continues unabated. This trial is focused on high risk men attending public STI clinics. A proposed 2 and a half year study, this trial will utilize the continuation of a randomized controlled trial of a behavioral intervention compared to HIV C\&T and STI treatment alone targeting HIV uninfected male STI patients. The specific aims are to complete the current behavioral intervention trial and to expand the current investigations to include: the evaluation of men who have sex with men as well as women and evaluate the use of alcohol to the entire sample of recruited men. STI patients will be recruited from three sites and if randomized will agree to a 12 month participation commitment. Strategies employed in both arms of the trial are simple and the fundamental components of an HIV prevention strategy. By demonstrating their effectiveness in India the hope is to encourage the public health leadership to adopt them and continue to change drug treatment availability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Males, over 16 years of age
- Hindu or Marathi speakers
- Have no plan to move permanently out of Mumbia in the following 12 months
- have a symptom of an STI or have had a sexual exposure in the past 6 months. A sexual exposure is defined as having sex with a commercial sex worker (FSW), having unprotected sex with anyone, male or female, or if the patient came to the clinic seeking an HIV test.
- Patients will be required to provide an address that can be located by a tracer.
Key exclusion criteria (1 listed)
- 1. HIV positive subjects.
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 |
|---|---|---|
| Behavior | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior in people with Sexually Transmitted Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in India.
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 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2010. 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 India. 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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010.