Effectiveness of the Diaphragm for HIV Prevention

This study has been withdrawn prior to enrollment.
(PI left and no data or information is available.)
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Ibis Reproductive Health
Medical Research Council, South Africa
Women's Health Global Imperative
UZ-UCSF Collaborative Programme on Women's Health
Perinatal HIV Research Unit of the University of the Witswatersrand
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00121459
First received: July 12, 2005
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
HIV Infection
Device: Ortho All-Flex diaphragm and Replens lubricant gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Latex Diaphragm to Prevent HIV Acquisition Among Women: A Female-Controlled, Physical Barrier of the Cervix

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • HIV incidence

Secondary Outcome Measures:
  • STI incidence (CT, NG, syphilis, trichomoniasis, HSV2)
  • acceptability
  • feasibility and sustainability

Estimated Enrollment: 5000
Study Start Date: September 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121459

Locations
South Africa
Perinatal HIV Research Unit
Soweto, Gauteng, South Africa
Medical Research Council of South Africa
Durban, KwaZulu Natal, South Africa
Zimbabwe
UZ-UCSF
Harare, Zimbabwe
Sponsors and Collaborators
University of California, San Francisco
Bill and Melinda Gates Foundation
Ibis Reproductive Health
Medical Research Council, South Africa
Women's Health Global Imperative
UZ-UCSF Collaborative Programme on Women's Health
Perinatal HIV Research Unit of the University of the Witswatersrand
Investigators
Principal Investigator: Nancy Padian, PhD University of California, San Francisco
  More Information

Additional Information:
No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00121459     History of Changes
Other Study ID Numbers: H6070-22217-03, 21082
Study First Received: July 12, 2005
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board
South Africa: Medicines Control Council

Keywords provided by University of California, San Francisco:
Diaphragm
HIV prevention
Southern/South Africa, Zimbabwe
female-controlled methods
Replens
STI prevention
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 01, 2014