HIV Incidence and Participation Retention in Pune, India (NCT00028119) | Clinical Trial Compass
CompletedNot Applicable
HIV Incidence and Participation Retention in Pune, India
India1,070 participantsStarted 2002-08
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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.
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 relationsh…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.