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Effectiveness of the Diaphragm for HIV Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00121459
Recruitment Status : Withdrawn (PI left and no data or information is available.)
First Posted : July 21, 2005
Last Update Posted : March 4, 2015
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Ibis Reproductive Health
Medical Research Council, South Africa
Women's Health Global Imperative
UZ-UCSF Collaborative Research Programme
Perinatal HIV Research Unit of the University of the Witswatersrand
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE July 12, 2005
First Posted Date  ICMJE July 21, 2005
Last Update Posted Date March 4, 2015
Study Start Date  ICMJE September 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
HIV incidence
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
  • STI incidence (CT, NG, syphilis, trichomoniasis, HSV2)
  • acceptability
  • feasibility and sustainability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of the Diaphragm for HIV Prevention
Official Title  ICMJE The Latex Diaphragm to Prevent HIV Acquisition Among Women: A Female-Controlled, Physical Barrier of the Cervix
Brief Summary The purpose of this trial is to determine whether using the diaphragm and a lubricant get can reduce women's risk of acquiring an HIV infection.
Detailed Description This multi-site randomized, controlled trial will measure the effectiveness of the diaphragm in preventing heterosexual acquisition of HIV infection among women. This Phase III study is powered to detect effectiveness (biological efficacy combined with adherence) of 33 percent. Women in South Africa and Zimbabwe (N=4,500) at risk of contracting HIV will be invited to participate and will be followed for up to 24 months, with a total study duration of 4 years. All women will receive safer-sex counseling, free male condoms and diagnosis and treatment of sexually transmitted infections (STIs). Half of the participants will be randomly selected to receive an Ortho All-Flex latex diaphragm and Replens lubricant gel. We will assess whether women using diaphragms and lubricant gel have lower rates of HIV or STI infection than do their non-diaphragm and gel counterparts. Additionally, we will investigate the long-term acceptability of the diaphragm in this study population.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Infection
Intervention  ICMJE Device: Ortho All-Flex diaphragm and Replens lubricant gel
Study Arms  ICMJE 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  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 3, 2015)
0
Original Enrollment  ICMJE
 (submitted: July 19, 2005)
5000
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 49 years old
  • Sexually active (coital frequency at least four times per month on average)
  • HIV negative based on testing within two weeks prior to enrollment
  • Chlamydia trachomatis and Neisseria gonorrhoeae negative based on testing within 30 days prior to enrollment or if positive, completes treatment before enrollment
  • Have a healthy cervix, as assessed by naked-eye speculum exam at enrollment
  • Planning to live in the study area for the next 24 months
  • Willing to be randomly assigned either to use or not use a latex diaphragm with lubricant gel during participation in the study, and to follow the protocol, including being tested for HIV and STIs
  • Willing and able to give informed consent

Exclusion Criteria:

  • Known sensitivity or allergy to latex
  • History of TSS (as suggested by current labeling for diaphragm use)
  • Currently pregnant, or desiring to become pregnant in the next two years
  • No cervix (total hysterectomy)
  • Refuses treatment for diagnosed or suspected current STI and/or reproductive tract infection requiring treatment at enrollment
  • Within six weeks of any pelvic surgery or last pregnancy outcome at the time of screening and enrollment
  • Presence of clinically apparent lesion(s) with epithelial disruption at enrollment (may enroll after lesion(s) has healed, if otherwise eligible)
  • Injected illicit drugs in the 12 months prior to screening and enrollment
  • Blood transfusion or received blood products in 3 months prior to screening and enrollment
  • Unable or unwilling to insert the diaphragm correctly
  • Participation in any other clinical trial (including those of a vaginal product or barrier contraceptive). Verification by comparing participant lists to other concurrently running research studies may be conducted if necessary.
  • Unable to speak English, Zulu, Shona, or Sotho
  • Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol, such as a major psychiatric disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa,   Zimbabwe
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00121459
Other Study ID Numbers  ICMJE H6070-22217-03
21082
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Bill and Melinda Gates Foundation
  • Ibis Reproductive Health
  • Medical Research Council, South Africa
  • Women's Health Global Imperative
  • UZ-UCSF Collaborative Research Programme
  • Perinatal HIV Research Unit of the University of the Witswatersrand
Investigators  ICMJE
Principal Investigator: Nancy Padian, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP