Epidemiological Study of HIV in the South African National Defense Force

December 13, 2019 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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)

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.

...

Study Overview

Status

Terminated

Conditions

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

Enrollment (Actual)

8676

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Eastern Cape, South Africa
        • Umatata Sickbay
      • Free State, South Africa
        • Area Military Health Unit Free State Poli-clinic
      • Kwazulu-Natal, South Africa
        • Mtubatuba SIckbay
      • Western Cape, South Africa
        • 2 Military Hospital
    • Limpopo
      • Phalaborwa, Limpopo, South Africa
        • Phalaborwa Sickbay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Michael A Polis, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 14, 2004

Study Completion

November 7, 2012

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

November 7, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 999904096
  • 04-I-N096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe