NCT00341887

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. ...

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,676

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
6.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2012

Completed
Last Updated

December 16, 2019

Status Verified

November 7, 2012

First QC Date

June 19, 2006

Last Update Submit

December 13, 2019

Conditions

HIV

Keywords

ScreeningAIDSAntiretroviralsMilitaryForce readiness

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Phalaborwa Sickbay

Phalaborwa, Limpopo, South Africa

Location

Umatata Sickbay

Eastern Cape, South Africa

Location

Area Military Health Unit Free State Poli-clinic

Free State, South Africa

Location

Mtubatuba Sickbay

Kwazulu-Natal, South Africa

Location

2 Military Hospital

Western Cape, South Africa

Location

Related Publications (3)

  • Rabkin M, El-Sadr W, Katzenstein DA, Mukherjee J, Masur H, Mugyenyi P, Munderi P, Darbyshire J. Antiretroviral treatment in resource-poor settings: clinical research priorities. Lancet. 2002 Nov 9;360(9344):1503-5. doi: 10.1016/S0140-6736(02)11478-4. No abstract available.

    PMID: 12433534BACKGROUND

  • Grosskurth H, Gray R, Hayes R, Mabey D, Wawer M. Control of sexually transmitted diseases for HIV-1 prevention: understanding the implications of the Mwanza and Rakai trials. Lancet. 2000 Jun 3;355(9219):1981-7. doi: 10.1016/S0140-6736(00)02336-9.

    PMID: 10859054BACKGROUND

  • Mellors JW, Munoz A, Giorgi JV, Margolick JB, Tassoni CJ, Gupta P, Kingsley LA, Todd JA, Saah AJ, Detels R, Phair JP, Rinaldo CR Jr. Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med. 1997 Jun 15;126(12):946-54. doi: 10.7326/0003-4819-126-12-199706150-00003.

    PMID: 9182471BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Michael A Polis, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

January 14, 2004

Study Completion

November 7, 2012

Last Updated

December 16, 2019

Record last verified: 2012-11-07

Locations

ZA(5)