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Trial record 1 of 2 for:    9182471 [PUBMED-IDS]
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Epidemiological Study of HIV in the South African National Defense Force

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ClinicalTrials.gov Identifier: NCT00341887
Recruitment Status : Terminated
First Posted : June 21, 2006
Last Update Posted : October 10, 2019
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date June 19, 2006
First Posted Date June 21, 2006
Last Update Posted Date October 10, 2019
Study Start Date January 14, 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00341887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiological Study of HIV in the South African National Defense Force
Official Title PHIDISA I: A Prospective, Observational Cohort Study of HIV Infection (Both Treated and Untreated) and Risk-Related Co-Infections in the South African National Defence Force (SANDF)
Brief Summary

This project, called PHIDISA I, will screen uniformed personnel of the South African National Defense Force (SANDF) and their registered family members for HIV, hepatitis B and C, gonorrhea, syphilis, and chlamydia to determine the incidence and prevalence of these sexually transmitted diseases. It will identify people who may be eligible to participate in clinical trials for preventing or treating HIV disease and will provide information that will be helpful in developing policy and better care for people affected with HIV and other diseases.

This project is part of the South Africa-U.S. PHIDISA Programme-a collaboration between the South African Military Health Service (SAMHS) of the SANDF, the U.S. Department of Defense, and the U.S. National Institutes of Health-to help prevent HIV transmission among South African military and civilian employees and their families.

Uniformed SANDF personnel or their family members who are eligible for health services from the SAMHS may enroll in the study. Participants visit the clinic every 6 months for up to 5 years for the following tests and procedures:

  • Fill out a demographic information questionnaire
  • Fill out a HIV risk assessment questionnaire
  • Fill out a quality of life questionnaire
  • Blood test
  • Urine test
  • Review of test results and counseling session with a doctor or nurse

Patients who test positive for HIV have a physical examination and additional blood draws.

...

Detailed Description

The South Africa - U.S. PHIDISA Project is a cooperative HIV/AIDS treatment research initiative established in 2003 for a likely duration of at least five years. It is an extension of the Masibambisane Programme, which is a cooperative initiative to help prevent the transmission of HIV/AIDS among South African military and civilian employees and their families. The PHIDISA Project is a collaboration between the South African Military Health Service of the South African National Defence Force (SANDF), the U.S. Department of Defence and the National Institutes of Health of the United States.

The PHIDISA Project has conducted clinical and operational research in HIV/AIDS in military and military-associated civilian populations. Scientists engaged in the research have been from South Africa, the United States and Australia and represent military and civilian medical, research and academic institutions. The project has established clinical research infrastructure within the SANDF and a network of its clinics, sick bays and hospitals. This has established important biomedical and public health research capacity that can be used in the future to address health issues of critical importance for military force preparedness.

An Executive Committee that includes South African and U.S. members manages the PHIDISA Project. An independent External Advisory Committee advises the project.

As a result of this project, information will be generated to assist SANDF in its future decisions about how best to manage the HIV/AIDS epidemic in military settings to assure SANDF combat readiness and to expand the wealth of knowledge regarding the best way to treat HIV infections. As a project complimentary to the Masibambisane Programme it also is anticipated that the PHIDISA Project will also contribute to the success of HIV transmission prevention activities in the military. The results of the PHIDISA Project also may contribute to HIV/AIDS clinical management, and related policy decisions, in the South African civilian sector.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition HIV
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 4, 2018)
8676
Original Enrollment
 (submitted: June 19, 2006)
50000
Study Completion Date November 7, 2012
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:

Uniformed SANDF personnel or family members 14 years of age or older of SANDF personnel who are registered as eligible for health services from the SAMHS.

Able to provide written informed consent.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries South Africa
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00341887
Other Study ID Numbers 999904096
04-I-N096
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Not Provided
Investigators
Principal Investigator: Michael A Polis, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date November 7, 2012