Effectiveness of the Diaphragm for HIV Prevention

University of California San Francisco (UCSF)

Status and phase

Withdrawn

Phase 3

Conditions

HIV Infection

Treatments

Device: Ortho All-Flex diaphragm and Replens lubricant gel

Study type

Interventional

Funder types

Other

Identifiers

NCT00121459

H6070-22217-03

21082

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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