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HIV InfectionPhase 3NCT00121459

Effectiveness of the Diaphragm for HIV Prevention

A Phase 3 study testing Ortho All-Flex diaphragm and Replens lubricant gel in people with HIV Infection, run by University of California, San Francisco at 3 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
HIV Infection
What is being tested?
Ortho All-Flex diaphragm and Replens lubricant gel
Type of treatment
Medical device
How many people
0 participants
Where
3 sitesin 2 countries
Study dates
Sep 2003to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

South Africa2 sites

  • Medical Research Council of South Africa

    Durban, KwaZulu-Natal

  • Perinatal HIV Research Unit

    Soweto, Gauteng

Other trials in South Africa

Zimbabwe1 site

  • UZ-UCSF

    Harare

Other trials in Zimbabwe

About this study

Official title: The Latex Diaphragm to Prevent HIV Acquisition Among Women: A Female-Controlled, Physical Barrier of the Cervix

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.

Read the 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.

Conditions
HIV Infection
Being tested
Ortho All-Flex diaphragm and Replens lubricant gel
Keywords
Diaphragm, HIV prevention, Southern/South Africa, Zimbabwe, female-controlled methods, Replens, STI prevention, HIV Seronegativity
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ortho All-Flex diaphragm and Replens lubricant gelDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV incidence

Secondary outcomes (3)

  1. STI incidence (CT, NG, syphilis, trichomoniasis, HSV2)

  2. acceptability

  3. feasibility and sustainability

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2005 (estimated)
  2. Study startSep 2003

Why it stopped: PI left and no data or information is available.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121459
Sponsor's protocol ID
H6070-22217-03
Other IDs
21082
Status last verified
Mar 2015
First submitted
12 Jul 2005
Last updated
4 Mar 2015
Results posted
No

Publications

  • Teasdale CA, Abrams EJ, Chiasson MA, Justman J, Blanchard K, Jones HE. Incidence of sexually transmitted infections during pregnancy. PLoS One. 2018 May 24;13(5):e0197696. doi: 10.1371/journal.pone.0197696. eCollection 2018.

    PubMed 29795625

  • Abbai NS, Wand H, Ramjee G. Biological factors that place women at risk for HIV: evidence from a large-scale clinical trial in Durban. BMC Womens Health. 2016 Mar 19;16:19. doi: 10.1186/s12905-016-0295-5.

    PubMed 26992693

  • Abbai NS, Wand H, Ramjee G. Socio-demographic and behavioural characteristics associated with HSV-2 sero-prevalence in high risk women in KwaZulu-Natal. BMC Res Notes. 2015 May 5;8:185. doi: 10.1186/s13104-015-1093-0.

    PubMed 25940115

  • Naidoo S, Wand H, Abbai NS, Ramjee G. High prevalence and incidence of sexually transmitted infections among women living in Kwazulu-Natal, South Africa. AIDS Res Ther. 2014 Sep 15;11:31. doi: 10.1186/1742-6405-11-31. eCollection 2014.

    PubMed 25243015

  • Ramjee G, Wand H. Geographical clustering of high risk sexual behaviors in "hot-spots" for HIV and sexually transmitted infections in Kwazulu-Natal, South Africa. AIDS Behav. 2014 Feb;18(2):317-22. doi: 10.1007/s10461-013-0578-x.

    PubMed 23934268

  • Wand H, Ramjee G. The relationship between age of coital debut and HIV seroprevalence among women in Durban, South Africa: a cohort study. BMJ Open. 2012 Jan 5;2(1):e000285. doi: 10.1136/bmjopen-2011-000285. Print 2012.

    PubMed 22223838

  • Blanchard K, Bostrom A, Montgomery E, van der Straten A, Lince N, de Bruyn G, Grossman D, Chipato T, Ramjee G, Padian N. Contraception use and effectiveness among women in a trial of the diaphragm for HIV prevention. Contraception. 2011 Jun;83(6):556-63. doi: 10.1016/j.contraception.2010.10.018. Epub 2011 Jan 26.

    PubMed 21570554

  • de Bruyn G, Shiboski S, van der Straten A, Blanchard K, Chipato T, Ramjee G, Montgomery E, Padian N; MIRA Team. The effect of the vaginal diaphragm and lubricant gel on acquisition of HSV-2. Sex Transm Infect. 2011 Jun;87(4):301-5. doi: 10.1136/sti.2010.047142. Epub 2011 Mar 29.

    PubMed 21447515

  • van der Straten A, Cheng H, Minnis AM. Change in condom and other barrier method use during and after an HIV prevention trial in Zimbabwe. J Int AIDS Soc. 2010 Oct 19;13:39. doi: 10.1186/1758-2652-13-39.

    PubMed 20955629

  • Sawaya GF, Chirenje MZ, Magure MT, Tuveson JL, Ma Y, Shiboski SC, Da Costa MM, Palefsky JM, Moscicki AB, Mutasa RM, Chipato T, Smith-McCune KK. Effect of diaphragm and lubricant gel provision on human papillomavirus infection among women provided with condoms: a randomized controlled trial. Obstet Gynecol. 2008 Nov;112(5):990-7. doi: 10.1097/AOG.0b013e318189a8a4.

    PubMed 18978097

  • Ramjee G, van der Straten A, Chipato T, de Bruyn G, Blanchard K, Shiboski S, Cheng H, Montgomery E, Padian N; MIRA team. The diaphragm and lubricant gel for prevention of cervical sexually transmitted infections: results of a randomized controlled trial. PLoS One. 2008;3(10):e3488. doi: 10.1371/journal.pone.0003488. Epub 2008 Oct 22.

    PubMed 18941533

  • Padian NS, van der Straten A, Ramjee G, Chipato T, de Bruyn G, Blanchard K, Shiboski S, Montgomery ET, Fancher H, Cheng H, Rosenblum M, van der Laan M, Jewell N, McIntyre J; MIRA Team. Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial. Lancet. 2007 Jul 21;370(9583):251-261. doi: 10.1016/S0140-6736(07)60950-7.

    PubMed 17631387

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ortho All-Flex diaphragm and Replens lubricant gel in people with HIV Infection, run by University of California, San Francisco at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Africa, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV incidence. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00121459, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.

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