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Home > "H" Clinical Trials Conditions > HIV Incidence and Participation Retention in Pune, India  HIV Incidence and Participation Retention in Pune, India
HIV Incidence and Participation Retention in Pune, India
For Condition: HIV Infections,HIV Seronegativity
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 1200
Location and Contact Information:
Overall Study Official:
RobertBollinger, Principal Investigator,
National AIDS Research Institute *Recruiting*
Pune, , 411 026
India
Recruiting Sanjay Mehendale 91 20 7121342
Additional Information:
Study ID Numbers: HPTN 034; HPTN 034A substudy,HPTN 034B substudy
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028119
Other Hiv Infections Studies:
1. Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo)
2. A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59
3. HIV-1 Vaccine Test in Uninfected Adult Volunteers
4. Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
5. Studies of HIV-1 Infection in Newly Infected Individuals in Southern Africa
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HIV Incidence and Participation Retention in Pune, India
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