HIV Incidence and Participation Retention in Pune, India

NCT00028119 | Completed

• 4 other identifiers: HPTN 034U01AI046749HPTN 034B substudyHPTN 034A substudy
• Study Type: observational
• Target: 1,070
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; HIV Seronegativity

Keywords

Clinical Trials; Sexual Partners; Risk Factors; Incidence; HIV Seronegativity; India; Patient Compliance; Preventive Health Services

Study Arms (2)

Cohort 1

HIV-uninfected non-sex worker women

Cohort 2

HIV-discordant heterosexual couples attending STD clinics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-uninfected non-sex worker women and HIV-discordant heterosexual couples attending STD clinics in Pune, India

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HIV Prevention Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

National AIDS Research Institute

Pune, 411 026, India

Location

MeSH Terms

Conditions

HIV Infections; Patient Compliance

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Robert Bollinger

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Sanjay Mehendale

  NARI Pune CRS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2001
• First Posted: December 14, 2001
• Study Start: August 1, 2002
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

IN (1)