HIV InfectionsNCT00028119
HIV Incidence and Participation Retention in Pune, India
An observational study of HIV Infections and HIV Seronegativity, run by HIV Prevention Trials Network at 1 site in India.
Trial summary
The purpose of this study is to ensure that the HIV Prevention Trials Unit (HPTU) in Pune will be able to enroll and retain participants for 2 upcoming HPTN clinical trials. Specifically, this study seeks to find the rate of HIV infection and follow-up among a group of high-risk, HIV-negative non-sexworker women in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HIV Seronegativity
- How many people
- 1,070 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2002to Aug 2005
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-uninfected non-sex worker women and HIV-discordant heterosexual couples attending STD clinics in Pune, India
Who may be able to join
- HIV-uninfected women may be eligible if they are:
- At least 18 years old.
- Able and willing to provide written informed consent for HIV testing and to take part in this study.
- Willing to receive their HIV test results.
- HIV-negative.
- Available for at least 17.5 months of study follow-up.
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- HIV-infected partners (index partner) in the HIV-discordant couples may be eligible if they are:
- At least 18 years old.
- Able and willing to provide written consent for HIV testing and to take part in this study.
- Willing to receive their HIV test results.
- HIV-positive.
- Available for at least 17.5 months of study follow-up.
- Presently in a sexual relationship with the same partner for at least 3 months.
- Intending to remain with this partner for the duration of the study.
- Willing to identify his/her sexual partner and disclose his/her HIV status to partner.
- Willing to attempt to recruit their partner.
- Partners of HIV-infected index partners in the HIV-discordant couples may be eligible if they are:
- At least 18 years old.
- Able and willing to provide written consent for HIV testing.
- Willing to receive their HIV test results.
- HIV-negative.
- HIV-discordant couples may be eligible if they first meet the criteria in 2 and 3 above and also if:
- Each partner agrees to participate in the study together.
- Each partner is able and willing to provide written informed consent to take part in the study.
- The partners have been in a sexual relationship for at least the prior 3 months.
- Each partner is available for at least 17.5 months of study follow-up.
- Each couple has stated intention to continue their relationship for at least 17.5 months.
- Each partner is willing and able to attend each scheduled follow-up study visit.
Who cannot join
- Persons may not be eligible for this study if they:
- Are HIV-uninfected women who report a history of prior commercial sex work. However, HIV-infected female commercial sex workers can be enrolled in the HIV-discordant partners study with their HIV-uninfected male sexual partner.
- Have mental problems that would interfere with study participation.
- Have any other condition that, in the opinion of the investigator, would interfere with the study.
- Are an HIV-discordant couple that reports a history of domestic violence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HPTN HIV Incidence and Participant Retention Protocol, Pune, India
The purpose of this study is to ensure that the HIV Prevention Trials Unit (HPTU) in Pune will be able to enroll and retain participants for 2 upcoming HPTN clinical trials. Specifically, this study seeks to find the rate of HIV infection and follow-up among a group of high-risk, HIV-negative non-sexworker women in Pune, as well as among HIV-discordant couples (couples where 1 partner is HIV-infected and the other is not).
Phase III studies of HIV prevention require the participation of a large number of people at high risk for HIV infection. It is also important that these participants continue and follow through with the study through the extended period of follow-up. A measurement of HIV incidence and retention rate among high-risk women and HIV-discordant couples is necessary for upcoming HPTN trials. Taken together with the need for estimates of HIV incidence and the need for data to ensure high retention rates, this protocol is important for the HPTN generally and for HPTU in Pune in particular.
Read the detailed description
Previous prevention-trial planning efforts have indicated that Phase III studies of HIV prevention interventions will require the participation of large numbers of persons at high risk for HIV infection. In addition to accruing large numbers of participants, research centers conducting Phase III HIV prevention studies must retain participants in extended periods of follow-up in order to accurately reflect the impact of the intervention in the target population. A current measurement of HIV incidence, the risk factors associated with HIV infection, and the retention rate of newly enrolled high-risk women is necessary for an upcoming HPTN trial. In addition, HPTN requires an assessment of its ability to enroll and retain HIV-discordant couples for a proposed HPTN trial, as well as a timely assessment of the HIV incidence rate in these exposed partners. This study will provide essential experience and a preliminary base for the enrollment of discordant couples into future HPTN clinical trials. Taken together with the need for current estimates of HIV incidence in the cohort and community populations and the need for data to ensure high retention rates, this protocol is important for the HPTN generally and for HPTU in Pune in particular.
Potential study participants will undergo eligibility screening, including administration of a questionnaire, physical examination, and HIV antibody testing. Once participants are enrolled in the study, the requirements will include follow-up every 3 months for 17.5 months, phlebotomy, physical exams, and questionnaires. At every follow-up visit, a short questionnaire will be administered to all participants to assess their continued understanding about the nature, duration, benefits and risks of being in the study and to assure their voluntary participation in the study. Participants seen in follow-up also will have a physical examination, be evaluated and treated for any STDs, receive additional counseling, and be offered retesting for HIV infection. In addition, participants also will be invited to participate in additional assessment issues addressing retention using a series of focus groups, key informant interviews, and individual qualitative and quantitative assessments. Participants in this protocol may also be eligible to enroll into 1 of 2 proposed ancillary laboratory substudies (HPTN 034A and 034B).
- Conditions
- HIV Infections, HIV Seronegativity
- Keywords
- Clinical Trials, Sexual Partners, Risk Factors, Incidence, HIV Seronegativity, India, Patient Compliance, Preventive Health Services
- Medical subject headings
- HIV Infections, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | HIV-uninfected non-sex worker women | |
| Cohort 2 | HIV-discordant heterosexual couples attending STD clinics |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2001 (estimated)
- Study startAug 2002
- Primary completionAug 2005
- Study completionAug 2005
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.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,070 participants
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Robert Bollinger, Principal investigator, Johns Hopkins UniversitySanjay Mehendale, Principal investigator, NARI Pune CRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028119
- Sponsor's protocol ID
- HPTN 034
- Other IDs
- U01AI046749, HPTN 034B substudy, HPTN 034A substudy
- Status last verified
- Aug 2022
- First submitted
- 13 Dec 2001
- Last updated
- 26 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPTN HIV Incidence and Participant Retention Protocol, Pune, India
- ClinicalTrials.gov ID
- NCT00028119
- Acronym / sponsor ID
- HPTN 034
- Conditions
- HIV Infections, HIV Seronegativity
- Keywords
- Clinical Trials, Sexual Partners, Risk Factors, Incidence, HIV Seronegativity, India, Patient Compliance, Preventive Health Services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,070 participants
- Lead sponsor
- HIV Prevention Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Aug 2002
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 14 Dec 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 ensure that the HIV Prevention Trials Unit (HPTU) in Pune will be able to enroll and retain participants for 2 upcoming HPTN clinical trials. Specifically, this study seeks to find the rate of HIV infection and follow-up among a group of high-risk, HIV-negative non-sexworker women in Pune, as well as among HIV-discordant couples (couples where 1 partner is HIV-infected and the other is not).
Phase III studies of HIV prevention require the participation of a large number of people at high risk for HIV infection. It is also important that these participants continue and follow through with the study through the extended period of follow-up. A measurement of HIV incidence and retention rate among high-risk women and HIV-discordant couples is necessary for upcoming HPTN trials. Taken together with the need for estimates of HIV incidence and the need for data to ensure high retention rates, this protocol is important for the HPTN generally and for HPTU in Pune in particular.
Detailed description
Previous prevention-trial planning efforts have indicated that Phase III studies of HIV prevention interventions will require the participation of large numbers of persons at high risk for HIV infection. In addition to accruing large numbers of participants, research centers conducting Phase III HIV prevention studies must retain participants in extended periods of follow-up in order to accurately reflect the impact of the intervention in the target population. A current measurement of HIV incidence, the risk factors associated with HIV infection, and the retention rate of newly enrolled high-risk women is necessary for an upcoming HPTN trial. In addition, HPTN requires an assessment of its ability to enroll and retain HIV-discordant couples for a proposed HPTN trial, as well as a timely assessment of the HIV incidence rate in these exposed partners. This study will provide essential experience and a preliminary base for the enrollment of discordant couples into future HPTN clinical trials. Taken together with the need for current estimates of HIV incidence in the cohort and community populations and the need for data to ensure high retention rates, this protocol is important for the HPTN generally and for HPTU in Pune in particular.
Potential study participants will undergo eligibility screening, including administration of a questionnaire, physical examination, and HIV antibody testing. Once participants are enrolled in the study, the requirements will include follow-up every 3 months for 17.5 months, phlebotomy, physical exams, and questionnaires. At every follow-up visit, a short questionnaire will be administered to all participants to assess their continued understanding about the nature, duration, benefits and risks of being in the study and to assure their voluntary participation in the study. Participants seen in follow-up also will have a physical examination, be evaluated and treated for any STDs, receive additional counseling, and be offered retesting for HIV infection. In addition, participants also will be invited to participate in additional assessment issues addressing retention using a series of focus groups, key informant interviews, and individual qualitative and quantitative assessments. Participants in this protocol may also be eligible to enroll into 1 of 2 proposed ancillary laboratory substudies (HPTN 034A and 034B).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –HIV-uninfected non-sex worker women |
| Cohort 2 | – | –HIV-discordant heterosexual couples attending STD clinics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-uninfected non-sex worker women and HIV-discordant heterosexual couples attending STD clinics in Pune, India
Key inclusion criteria (28 listed)
- At least 18 years old.
- Able and willing to provide written informed consent for HIV testing and to take part in this study.
- Willing to receive their HIV test results.
- HIV-negative.
- Available for at least 17.5 months of study follow-up.
Key exclusion criteria (5 listed)
- Are HIV-uninfected women who report a history of prior commercial sex work. However, HIV-infected female commercial sex workers can be enrolled in the HIV-discordant partners study with their HIV-uninfected male sexual partner.
- Have mental problems that would interfere with study participation.
- Have any other condition that, in the opinion of the investigator, would interfere with the study.
- Are an HIV-discordant couple that reports a history of domestic violence.
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 26 Aug 2022.
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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.
Robert Bollinger principal investigator
Johns Hopkins University
Sanjay Mehendale principal investigator
NARI Pune CRS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HIV Seronegativity, run by HIV Prevention Trials Network 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 28 inclusion and 5 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 26 Aug 2022. 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 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 26 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.