CONRAD (organization)

Last updated
CONRAD
Formation1986;38 years ago (1986) [1]
TypeNonprofit organization
PurposePromote reproductive health and HIV prevention
Headquarters Norfolk, Virginia
Scientific and Executive Director
Gustavo Doncel, M.D., Ph.D
Parent organization
Eastern Virginia Medical School
Website www.conrad.org

CONRAD is a non-profit scientific research organization that works to improve global and reproductive health, particularly in women in developing countries. CONRAD was established in 1986 under a cooperative agreement between Eastern Virginia Medical School (EVMS) and the United States Agency for International Development (USAID). CONRAD’s products are developed primarily for women in low-resource settings, in that they are designed to be safe, affordable and user-friendly. [2] CONRAD is led by Scientific and Executive Director Gustavo F. Doncel, M.D., Ph.D. [3] Primary funding for CONRAD comes from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID), with additional funding from The Bill & Melinda Gates Foundation and the National Institutes of Health (NIH). [4] [5] [6]

Contents

Work method

CONRAD works by conducting pre-clinical development and clinical trials.

Major projects

Microbicides and HIV prevention

Using the antiretroviral tenofovir (TFV), donated by Gilead Sciences, [7] CONRAD developed a gel for use in the genital tract. Tenofovir gel was tested in a double-blinded, placebo-controlled Phase II study conducted by the Centre for AIDS Research Programme in South Africa (CAPRISA). Study participants were required to insert their assigned gel before and after sex, using a pre-filled applicator, not to exceed two doses in a 24-hour period - also called the BAT 24 regimen. In the overall study population, tenofovir gel reduced HIV-1 incidence by 39% and herpes simplex virus-2 (HSV-2) infections by 51%. CAPRISA 004. [8] Two subsequent trials tested the gel in larger populations in order to provide more evidence for regulatory approval: VOICE, [9] sponsored by the MTN, studied daily use of the gel, and FACTS 001, [10] sponsored by CONRAD and conducted by the Wits Reproductive Health and HIV Institute in South Africa, replicated the CAPRISA 004 study in a larger population of women and called for the BAT24 regimen. Unfortunately, neither study showed effectiveness in reducing HIV infections in the overall study population due to low adherence, although a trend toward effectiveness was seen in sub-group analyses of high adherers.

Contraception

CONRAD conducted studies leading to the regulatory approval of several contraceptive devices. CONRAD supported PATH Program for Appropriate Technology in Health in the development of a new female condom known as the Woman's Condom and collaborated with the California Family Health Council (CFHC) on a study comparing the performance of the Woman's Condom and the FC2 Female Condom. [11] Other contraceptive devices include Lea’s Shield barrier device, [12] and the FemCap barrier device. [13] CONRAD was a collaborator in PATH's SILCS diaphragm research, and conducted the pivotal study that showed the SILCS was as effective in preventing pregnancy as a standard diaphragm. [14] The SILCS is currently marketed as the Caya diaphragm in Europe and has received market clearance for distribution by the FDA. [15] [16]

Multipurpose prevention technologies

A movement by researchers and funders toward combining contraception with HIV and STI prevention has resulted in the development of new products called MPTs [17] or, multipurpose prevention technologies. Working with researchers at Northwestern University, CONRAD developed a vaginal ring that contains tenofovir and levonorgestrel (LNG), a contraceptive. The TFV/LNG ring is lightweight and flexible, and is designed to be inserted in the vagina close to the cervix, and active for up to 3 months. [18]

Maternal and neonatal health

Maternal and neonatal mortality and morbidity rates remain high worldwide, and interventions are needed to help prevent and treat causes such as undiagnosed pregnancy complications, preterm birth, and micronutrient deficiencies. [19] In collaboration with other clinical researchers at EVMS, CONRAD is working on pilot studies to investigate innovative diagnostic and therapeutic options to improve maternal and neonatal health outcomes. [20]

Biomarkers

Biomarkers are biochemical substances that can be used to measure the progress of disease or the effects of treatment. In the area of vaginal product research, biomarkers could give early information about the safety and likely efficacy of both contraceptive and microbicide products, facilitating triage of less promising candidates. CONRAD is developing new biomarkers of cervicovaginal inflammation, in order to more effectively discriminate the safety and efficacy of vaginal reproductive health candidates. [21]

Adherence

Adherence to a study product is essential for the reliable evaluation of its efficacy and safety in a clinical trial. When adherence is poor, a potentially effective drug can be erroneously judged to be ineffective. Pre-exposure prophylaxis (PrEP) trials which tested daily use of an oral antiretroviral in women and several vaginal gel trials for HIV prevention have been challenged by poor adherence. [22] There is a clear need for cost-saving and efficient trial designs to test safety and efficacy. [23] CONRAD, AVAC and the Forum for Collaborative HIV Research joined forces to convene a workshop in June 2014 to explore the potential of alternative trial designs for microbicides that can help address the issue of poor adherence. [24]

Related Research Articles

<span class="mw-page-title-main">Diaphragm (birth control)</span> Cervical barrier type of birth control

The diaphragm is a barrier method of birth control. It is moderately effective, with a one-year failure rate of around 12% with typical use. It is placed over the cervix with spermicide before sex and left in place for at least six hours after sex. Fitting by a healthcare provider is generally required.

<span class="mw-page-title-main">Nonoxynol-9</span> Chemical compound

Nonoxynol-9, sometimes abbreviated as N-9, is an organic compound that is used as a surfactant. It is a member of the nonoxynol family of nonionic surfactants. N-9 and related compounds are ingredients in various cleaning and cosmetic products. It is widely used in contraceptives for its spermicidal properties.

Spermicide is a contraceptive substance that destroys sperm, inserted vaginally prior to intercourse to prevent pregnancy. As a contraceptive, spermicide may be used alone. However, the pregnancy rate experienced by couples using only spermicide is higher than that of couples using other methods. Usually, spermicides are combined with contraceptive barrier methods such as diaphragms, condoms, cervical caps, and sponges. Combined methods are believed to result in lower pregnancy rates than either method alone.

<span class="mw-page-title-main">Microbicides for sexually transmitted infections</span> Pharmacologic agents and chemical substances

Microbicides for sexually transmitted infections are pharmacologic agents and chemical substances that are capable of killing or destroying certain microorganisms that commonly cause sexually transmitted infection.

FHI 360 is a nonprofit human development organization based in North Carolina. FHI 360 operates in more than 70 countries and all U.S. states and territories. Established in 1971, the organization manages projects relating to family planning and reproductive health. In 1986 the organization began a worldwide response to HIV/AIDS. FHI 360's research and programs also address malaria, tuberculosis, and other infectious and chronic diseases and international agencies, governments, foundations, research institutions, and individual donors.

<span class="mw-page-title-main">Pre-exposure prophylaxis for HIV prevention</span> HIV prevention strategy using preventative medication for HIV-negative individuals

Pre-exposure prophylaxis for HIV prevention, commonly known as PrEP, is a form of medication used to prevent HIV infection, the cause of HIV/AIDS.

iPrEx

iPrEx was a phase III clinical trial to determine whether the antiretroviral medication emtricitabine/tenofovir could safely and effectively prevent HIV acquisition through sex in men who have sex with men and transgender women. iPrEx was the first human study of an HIV prevention strategy known as pre-exposure prophylaxis, or PrEP.

CAPRISA 004 is the name of a clinical trial conducted by CAPRISA. This particular study was the first to show that a topical gel could reduce a person's risk of contracting HIV. The gel used in the study contained a microbicide.

Zeda Fran Rosenberg is an American microbiologist and epidemiologist, active in HIV biology and prevention. She is the chief executive officer of the International Partnership for Microbicides (IPM). IPM was founded by Rosenberg in 2002 and is a nonprofit organization dedicated to developing microbicides and other innovative HIV prevention products and making them available for women in developing countries.

A rectal microbicide is a microbicide for rectal use. Most commonly such a product would be a topical gel inserted into the anus so that it make act as protection against the contract of a sexually transmitted infection during anal sex.

PRO 2000 is an experimental vaginal microbicide which has been proposed as a preventive medicine for reducing the risk of contracting HIV. It has never been recommended as an effective medicine to be used for any purpose. Some clinical trials have shown that under some conditions it may provide some protection against HIV.

A vaginal microbicide is a microbicide for vaginal use, generally as protection against the contraction of a sexually transmitted infection during vaginal sexual intercourse. Vaginal microbicides are topical gels or creams inserted into the vagina.

The Microbicide Trials Network was a United States government-funded research organization working in the field of microbicides for sexually transmitted diseases. The MTN focused on research into microbicides which would prevent HIV infection. The MTN was a member of HANC. After its closure, partner organization HIV Prevention Trials Network took control of its projects.

<span class="mw-page-title-main">Quarraisha Abdool Karim</span>

Quarraisha Abdool Karim is an infectious diseases epidemiologist and co-founder and Associate Scientific Director of CAPRISA. She is a Professor in Clinical Epidemiology, Columbia University, New York and Pro-Vice Chancellor for African Health, University of KwaZulu-Natal, South Africa.

<span class="mw-page-title-main">Salim Abdool Karim</span> South African medical researcher

Salim S. Abdool Karim, MBChB, MMed, MS(Epi), FFPHM, FFPath (Virol), DipData, PhD, DSc(hc), FRS is a South African public health physician, epidemiologist and virologist who has played a leading role in the AIDS and COVID-19 pandemic. His scientific contributions have impacted the landscape of HIV prevention and treatment, saving thousands of lives.

HPTN 083 is a 2016 clinical trial which compares cabotegravir injections with oral use of Emtricitabine/tenofovir as pre-exposure prophylaxis ("PrEP") for prevention of HIV/AIDS.

Multipurpose prevention technologies (MPTs) are a class of products designed to address at least two health issues simultaneously, often focusing on sexual and reproductive health which includes contraception, human immunodeficiency virus (HIV) prevention, other sexually transmitted infection (STI) preventions, such as genital infection by human simplex virus (HSV) infection and human papillomavirus (HPV) infection. For example, MPTs can combine contraception and HIV prevention, contraception and other STI prevention, or the prevention of multiple STIs. Since the simultaneous use of multiple products with a single indication against each specific sexual and reproductive health issue is inconvenient, this method may affect adherence. As a result, the goal of developing a MPT as an all-in-one product is to combat this issue.

<span class="mw-page-title-main">Dapivirine Ring</span> Antiretroviral vaginal ring

Dapivirine (DPV) Ring is an antiretroviral vaginal ring pioneered by the International Partnership for Microbicides (IPM) pending for regulatory review. It is designed as a long-acting form of HIV prevention for at-risk women, particularly in developing nations such as sub-Saharan Africa. IPM has rights to both the medication and the medical device. A total of four rings with different drug diffusion systems and polymer composition have been developed by IPM. The latest design, Ring-004, is a silicone polymer matrix-type system capable of delivering DPV intravaginally in a sustained manner.

Sharon Louise Hillier is an American microbiologist. She is the Richard Sweet Endowed Chair in Reproductive Infectious Disease and vice chair of the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh Medical Center (UPMC) and Magee-Women's Research Institute.

<span class="mw-page-title-main">Jeanne Marrazzo</span> American microbiologist

Jeanne Marisa Marrazzo is an American physician-scientist and infectious diseases specialist. She was the director of the University of Alabama School of Medicine Division of Infectious Diseases and focused on prevention of HIV infection using biomedical interventions. Marrazzo is a fellow of the American College of Physicians and Infectious Disease Society of America. On August 2, 2023 Lawrence A. Tabak, acting director for the National Institutes of Health (NIH), named Jeanne M. Marrazzo as director of NIH’s National Institute of Allergy and Infectious Diseases.

References

  1. ↑ "International Conference On Aids India Presents Lifetime Achievement Award". CONRAD. 20 October 2005. Archived from the original on 25 July 2011. Retrieved 28 March 2011.
  2. ↑ "Microbicides: Providing HIV Prevention Options for Women". USAID.gov. U.S. Agency for International Development. Archived from the original on 2015-05-10. Retrieved 2015-04-14.
  3. ↑ "Gustavo F. Doncel, M.D., Ph.D: CONRAD". www.conrad.org. Archived from the original on 2017-07-11. Retrieved 2015-04-14.
  4. ↑ "HIV/AIDS - NIH: National Institute of Allergy and Infectious Diseases". www.niaid.nih.gov.
  5. ↑ "Partnerships and Projects". www.usaid.gov. 2018-02-08. Archived from the original on 2018-12-19. Retrieved 2015-04-14.
  6. ↑ "OPP1114939". Bill & Melinda Gates Foundation.
  7. ↑ Keller, Daniel M. (July 21, 2010). "Tenofovir Vaginal Gel First Microbicide to Prevent HIV, HSV Infections". Medscape .
  8. ↑ "Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV". ClinicalTrials.gov. 23 March 2010. Retrieved 28 March 2011.
  9. ↑ Marrazzo, Jeanne M.; Ramjee, Gita; Richardson, Barbra A.; Gomez, Kailazarid; Mgodi, Nyaradzo; Nair, Gonasagrie; Palanee, Thesla; Nakabiito, Clemensia; van der Straten, Ariane; Noguchi, Lisa; Hendrix, Craig W.; Dai, James Y.; Ganesh, Shayhana; Mkhize, Baningi; Taljaard, Marthinette; Parikh, Urvi M.; Piper, Jeanna; Mâsse, Benoît; Grossman, Cynthia; Rooney, James; Schwartz, Jill L.; Watts, Heather; Marzinke, Mark A.; Hillier, Sharon L.; McGowan, Ian M.; Chirenje, Z. Mike (5 February 2015). "Tenofovir-Based Preexposure Prophylaxis for HIV Infection among African Women". New England Journal of Medicine. 372 (6): 509–518. doi:10.1056/NEJMoa1402269. PMC   4341965 . PMID   25651245.
  10. ↑ "Disappointing result for tenofovir-gel microbicide shows that young women still lack HIV prevention methods they can use". aidsmap.com.
  11. ↑ Schwartz, Jill L.; Barnhart, Kurt; Creinin, Mitch D.; Poindexter, Alfred; Wheeless, Angie; Kilbourne-Brook, Maggie; Mauck, Christine K.; Weiner, Debra H.; Callahan, Marianne M. (2008). "Comparative crossover study of the PATH Woman's Condom and the FC Female Condom®". Contraception. 78 (6): 465–473. doi:10.1016/j.contraception.2008.07.020. PMID   19014792.
  12. ↑ "Lea's Shield: a study of the safety and efficacy of a new vaginal barrier contraceptive used with and without spermicide. - PubFacts.com". www.pubfacts.com.
  13. ↑ Allen, Jane E. (April 28, 2003). "New fit for U.S. birth control". Los Angeles Times . Retrieved 2015-04-14.
  14. ↑ Schwartz, Jill L.; Weiner, Debra H.; Jou Lai, Jaim; Frezieres, Ron G.; Creinin, Mitchell D.; Archer, David F.; Bradley, Lynn; Barnhart, Kurt T.; Poindexter, Alfred; Kilbourne-Brook, Maggie; Callahan, Marianne M.; Mauck, Christine K. (2015). "Contraceptive Efficacy, Safety, Fit, and Acceptability of a Single-Size Diaphragm Developed with End-User Input". Obstetrics and Gynecology. 125 (4): 895–903. doi:10.1097/AOG.0000000000000721. PMID   25751199. S2CID   205466445.
  15. ↑ "SILCS Diaphragm Design History" (PDF). Program for Appropriate Technology in Health . Retrieved 28 March 2011.
  16. ↑ "Regulatory clearance opens the way for new single-size contraceptive diaphragm in the US". medicalxpress.com.
  17. ↑ "Multipurpose Prevention Technologies (MPTs)". CAMI Health. Archived from the original on 2015-02-21. Retrieved 2015-04-03.
  18. ↑ "New HIV Prevention Technologies on the Horizon". TheBodyPRO.com.
  19. ↑ "Maternal and newborn health".
  20. ↑ "Obstetrics & Gynecology Research - Eastern Virginia Medical School (EVMS), Norfolk, Hampton Roads". www.evms.edu.
  21. ↑ Jacot, Terry A.; Nelson, Ashley; Thurman, Andrea; Kashuba, Angela D. M.; Archer, David F.; Doncel, Gustavo F. (9 December 2014). "Development of a Composite Measure of Product Adherence, Protocol Compliance, and Semen Exposure Using DNA and Protein Biomarkers for Topical HIV Prevention Studies". PLOS ONE. 9 (12): e114368. Bibcode:2014PLoSO...9k4368J. doi: 10.1371/journal.pone.0114368 . PMC   4260853 . PMID   25489736.
  22. ↑ "FHI 360: Final Results Of FEM-PrEP HIV-Prevention Study Indicate Great Attention To Adherence Will Be Required In PrEP Programs" (Press release). FHI 360. July 11, 2012. Retrieved 2015-04-14– via PR Newswire.
  23. ↑ Woodsong, C; MacQueen, K; Amico, KR; Friedland, B; Gafos, M; Mansoor, L; Tolley, E; McCormack, S (2013). "Microbicide clinical trial adherence: insights for introduction". J Int AIDS Soc. 16 (1): 18505. doi:10.7448/ias.16.1.18505. PMC   3619032 . PMID   23561044.
  24. ↑ Hauschild, Ben. "AVAC/CONRAD/FORUM Workshop on Alternative Trial Designs for Microbicides - Forum for Collaborative Research". www.hivforum.org.

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