HIV InfectionsNCT00021775
HIV Prevention Preparedness Study in Russia, China, and India
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.
Trial summary
The purpose of this study is to set up a system for doing research on HIV prevention in various parts of the world. In order to plan large, long-term studies on the prevention of HIV in different areas of the world, it is necessary to get certain information first. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 2,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2002to Feb 2004
- Phase
- Observational
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants may be eligible for this study if they:
- Are 16 (Saint Petersburg) or 18 (Xinjiang, Guangxi, and Chennai) years of age or older.
- Are HIV sero-negative.
- Are available for 12 months of study participation.
- Have written consent of parent or legal guardian if under age.
- Are able and willing to provide information on where they can be located or contacted.
- Meet specific risk-group requirements, for women at heterosexual risk, for men at heterosexual risk, and for injection drug users.
Who cannot join
- Participants will not be eligible for this study if they:
- Have any mental disorders that would cause a problem with the informed consent or study participation.
- Have any condition that, in the opinion of the doctor, would interfere with the study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
Guangxi Ctrs. for Disease Control & Prevention and for HIV/AIDS Prevention & Control CRS
Nanning, Guangxi, 530028
Xinjiang Uygar Autonomous Region Ctr. for Disease Control & Prevention, HPTN Project Office
Ürümqi, Xinjiang, 830011
About this study
Official title: HIV Prevention Preparedness Study
The purpose of this study is to set up a system for doing research on HIV prevention in various parts of the world.
In order to plan large, long-term studies on the prevention of HIV in different areas of the world, it is necessary to get certain information first. It is important to know about the rate of HIV infection and how to get people to enroll for any future studies. This study will be done at 4 study locations.
Read the detailed description
In order to realistically plan for future Phase III studies on HIV prevention, information must be obtained to characterize study population parameters at HTPN sites. Very different study designs may be required depending on these parameters, such as the ability of HPTN research centers to recruit study participants and the rate of HIV incidence observed in study populations. This study will be conducted at 4 HPTN sites to establish the necessary research knowledge and infrastructure.
This study enrolls participants from St. Petersburg, Russia; Xinjiang and Guangxi, China; and Chennai, India who are at high risk for HIV infection due to sexual and/or drug use behaviors. Participants who meet the screening criteria then complete an HIV risk assessment interview, receive HIV pre-test and risk reduction counseling, and undergo phlebotomy for HIV antibody testing. Participants who test positive are referred to available services and studies. Those who test HIV-negative and meet eligibility criteria are enrolled and maintained in follow-up over the next 12 months. Participants complete "locator contacts" at Months 3 and 9 and have follow-up visits at Months 6 and 12 for similar tests as performed at entry. In a substudy of this trial in China, participants will be interviewed about their drug use, social networks, needs, and perceptions about HIV/AIDS. These results will be used by HPTN to design more culturally sensitive and appropriate trials in the future.
- Conditions
- HIV Infections
- Keywords
- Risk Factors, Incidence, Patient Selection, HIV Seronegativity
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startApr 2002
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Observational
- Enrolment
- 2,000 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Robert Ryder, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021775
- Sponsor's protocol ID
- HPTN 033
- Other IDs
- 10611
- Status last verified
- Dec 2013
- First submitted
- 4 Aug 2001
- Last updated
- 3 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Prevention Preparedness Study
- ClinicalTrials.gov ID
- NCT00021775
- Acronym / sponsor ID
- HPTN 033
- Conditions
- HIV Infections
- Keywords
- Risk Factors, Incidence, Patient Selection, HIV Seronegativity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Apr 2002
- Study completion
- Feb 2004 (actual)
- First posted
- 31 Aug 2001 (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 purpose of this study is to set up a system for doing research on HIV prevention in various parts of the world.
In order to plan large, long-term studies on the prevention of HIV in different areas of the world, it is necessary to get certain information first. It is important to know about the rate of HIV infection and how to get people to enroll for any future studies. This study will be done at 4 study locations.
Detailed description
In order to realistically plan for future Phase III studies on HIV prevention, information must be obtained to characterize study population parameters at HTPN sites. Very different study designs may be required depending on these parameters, such as the ability of HPTN research centers to recruit study participants and the rate of HIV incidence observed in study populations. This study will be conducted at 4 HPTN sites to establish the necessary research knowledge and infrastructure.
This study enrolls participants from St. Petersburg, Russia; Xinjiang and Guangxi, China; and Chennai, India who are at high risk for HIV infection due to sexual and/or drug use behaviors. Participants who meet the screening criteria then complete an HIV risk assessment interview, receive HIV pre-test and risk reduction counseling, and undergo phlebotomy for HIV antibody testing. Participants who test positive are referred to available services and studies. Those who test HIV-negative and meet eligibility criteria are enrolled and maintained in follow-up over the next 12 months. Participants complete "locator contacts" at Months 3 and 9 and have follow-up visits at Months 6 and 12 for similar tests as performed at entry. In a substudy of this trial in China, participants will be interviewed about their drug use, social networks, needs, and perceptions about HIV/AIDS. These results will be used by HPTN to design more culturally sensitive and appropriate trials in the future.
Study design
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Are 16 (Saint Petersburg) or 18 (Xinjiang, Guangxi, and Chennai) years of age or older.
- Are HIV sero-negative.
- Are available for 12 months of study participation.
- Have written consent of parent or legal guardian if under age.
- Are able and willing to provide information on where they can be located or contacted.
Key exclusion criteria (3 listed)
- Have any mental disorders that would cause a problem with the informed consent or study participation.
- Have any condition that, in the opinion of the doctor, would interfere with the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 3 Jan 2014.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Robert Ryder study chair
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 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 7 inclusion and 3 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 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Russia. 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.
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 3 Jan 2014.