Pune: NARI is currently recruiting HIV patients for clinical trial

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HIV Incidence and Participation Retention in Pune, India

This study is currently recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases

(NIAID)

Purpose

The overall goal is to make sure that the HIV Prevention Trials Unit

(HPTU) in Pune is at its best for the start, enrollment, and

retention of participants for 2 upcoming HPTN clinical trials.

Specifically, this study wants 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.

Condition

HIV Infections

HIV Seronegativity

Study Type: Observational

Study Design: Natural History

Official Title: HPTN HIV Incidence and Participant Retention

Protocol, Pune, India

Further Study Details:

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 1

year, 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).

Eligibility

Ages Eligible for Study: 18 Years and above , Genders Eligible for

Study: Both Accepts Healthy Volunteers

Criteria

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 12 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 12 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 12 months of study follow-up.

Each couple has stated intention to continue their relationship for

at least 12 months.

Each partner is willing and able to attend each scheduled follow-up

study visit.

Exclusion Criteria

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.

Expected Total Enrollment: 1200

Location and Contact Information

India: National AIDS Research Institute, Pune, 411 026, India;

Recruiting

Sanjay Mehendale 91 20 7121342 sanjaymehendale@...

Study chairs or principal investigators

Bollinger, Principal Investigator

Sanjay Mehendale, Principal Investigator

More Information

Study ID Numbers HPTN 034; HPTN 034B substudy; HPTN 034A substudy

Record last reviewed March 2003

NLM Identifier NCT00028119

http://clinicaltrials.gov/ct/gui/show/NCT00028119?order=1