Clinical trial NCT00028119: HIV Incidence and Participation Retention in Pune, India
Official title: HPTN HIV Incidence and Participant Retention Protocol, Pune, India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
HIV Seronegativity
Keywords: Clinical Trials
Sexual Partners
Risk Factors
Incidence
HIV Seronegativity
India
Patient Compliance
Preventive Health Services
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2001-12-14
Enrollment: 1070
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-uninfected non-sex worker women and HIV-discordant heterosexual couples attending STD clinics in Pune, India

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.

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).

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pune
country: India
facility: National AIDS Research Institute
Study officials:
affiliation: Johns Hopkins University
name: Robert Bollinger
role: PRINCIPAL_INVESTIGATOR
affiliation: NARI Pune CRS
name: Sanjay Mehendale
role: PRINCIPAL_INVESTIGATOR
References: