HIV Prevention trials by NARI in Pune

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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)

Information provided by: National Institute of Allergy and Infectious Diseases

(NIAID)

Purpose

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.

Condition

HIV Infections

HIV Seronegativity

MedlinePlus related topics: AIDS

Study Type: Observational

Study Design: Natural History

Official Title: HPTN HIV Incidence and Participant Retention

Protocol, Pune, India

Further Study Details:

Expected Total Enrollment: 1070

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).

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 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 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.

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.

Location and Contact Information

India

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

Recruiting

Sanjay Mehendale 91 20 7121342 sanjaymehendale@y...

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: August 2004

Record first received: December 13, 2001

ClinicalTrials.gov Identifier: NCT00028119

Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on 2005-01-19