Effectiveness of the Diaphragm for HIV Prevention

NCT00121459 | Withdrawn Phase 3

• 2 other identifiers: H6070-22217-0321082
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

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.

Conditions

HIV Infection

Keywords

Diaphragm; HIV prevention; Southern/South Africa, Zimbabwe; female-controlled methods; Replens; STI prevention; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• HIV incidence

Secondary Outcomes (3)

• STI incidence (CT, NG, syphilis, trichomoniasis, HSV2)

• acceptability

• feasibility and sustainability

Interventions

Ortho All-Flex diaphragm and Replens lubricant gel DEVICE

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Bill and Melinda Gates Foundation: collaborator
• Ibis Reproductive Health: collaborator
• Medical Research Council, South Africa: collaborator
• Women's Health Global Imperative: collaborator
• UZ-UCSF Collaborative Research Programme: collaborator
• Perinatal HIV Research Unit of the University of the Witswatersrand: collaborator

Study Sites (3)

Perinatal HIV Research Unit

Soweto, Gauteng, South Africa

Location

Medical Research Council of South Africa

Durban, KwaZulu-Natal, South Africa

Location

UZ-UCSF

Harare, Zimbabwe

Location

Related Publications (12)

• 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.

  PMID: 29795625 DERIVED

• 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.

  PMID: 26992693 DERIVED

• 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.

  PMID: 25940115 DERIVED

• 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.

  PMID: 25243015 DERIVED

• 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.

  PMID: 23934268 DERIVED

• 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.

  PMID: 22223838 DERIVED

• 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.

  PMID: 21570554 DERIVED

• 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.

  PMID: 21447515 DERIVED

• 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.

  PMID: 20955629 DERIVED

• 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.

  PMID: 18978097 DERIVED

• 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.

  PMID: 18941533 DERIVED

• 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.

  PMID: 17631387 DERIVED

Related Links

• Ibis Reproductive Health web site
• Cervical Barrier Advancement Society web site
• Women's Global Health Imperative
• University of Zimbabwe, UCSF
• Medical Research Council
• Perinatal HIV Research Unit of South Africa

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nancy Padian, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2005
• First Posted: July 21, 2005
• Study Start: September 1, 2003
• Last Updated: March 4, 2015

Record last verified: 2015-03

Locations

ZI (1); ZA (2)