Population Council Research that makes a difference

One particular aspect of acceptability involves the amount of lubrication that a microbicide might provide. Because most potential products currently being tested are formulated as gels, Council researchers are conducting a study to better understand women's and men's perceptions of type, amount, and significance of vaginal lubrication and people's preferences related to lubrication during sex. Results of this qualitative research were published in "Cultural norms and behavior regarding vaginal lubrication during sex: Implications for the acceptability of vaginal microbicides for the prevention of HIV/STIs" (PDF).

Because even a highly efficacious microbicide will not be effective if it is not used, acceptability research is a critical component of the product-development process. While research has been undertaken to explore the hypothetical acceptability of microbicides once they become available, it is necessary to develop an understanding of people’s experiences with actual microbicide products.

The Population Council is completing analysis for a qualitative research study that was conducted in conjunction with the Phase 3 Carraguard efficacy trial among women and their partners who participated in the Phase 3 trial.

The study explores the ways in which sociocultural values—such as sexual norms and practices, partner relationships, reproductive intentions, the importance of covert use—and product characteristics affect adherence to and the feasibility and acceptability of a microbicide. The research also aims to determine how relationships between study staff (as health care providers) and trial participants may have an impact on participants’ perceptions, experiences, and use of a microbicide. Additional objectives of the research are identifying the issues that may affect future microbicide use from the point of view of service providers, improving data collection instruments and educational materials related to behavioral aspects of microbicide trials, and informing messages for product introduction.

At each of the three Carraguard Phase 3 trial sites, in-depth interviews and focus group discussions were conducted with a sample of women who participated in the Carraguard trial. Male partners also participated in focus group discussions to gauge their perceptions about microbicides in the context of actual use. In-depth interviews were conducted with study nurses and counselors to explore their perceptions about talking to women about their sexual behavior and practices; understanding of issues that trial participants may find difficult to raise with study staff and why; and perceptions of challenges participants faced with regard to study product compliance.

While participants found the product attributes and the applicator highly acceptable, use was determined by factors independent of the gels themselves. Most women reported that they are expected to be sexually available to their partners, regardless of their own desires and needs, and rarely initiate sex. This had a tremendous impact on use of the product during the clinical trial. Participants were most likely to use the gels when their partners found it pleasurable, the gels were readily available, and the women could predict that sex was going to occur.

Results of the study will provide valuable insight from actual microbicide users and their partners that can help to inform future product development.

A randomized, placebo-controlled trial to assess the safety and acceptability of use of Carraguard vaginal gel by heterosexual couples in Thailand (abstract) 
Kilmarx,Peter H.; Blanchard,Kelly; Chaikummao,Supaporn; Friedland,Barbara A.; Srivirojana,Nucharee; Connolly,Cathy; Witwatwongwana,Paisit; Supawitkul,Somsak; Mock,Philip A.; Chaowanachan,Thanyanan; Tappero,Jordan W.
Sexually Transmitted Diseases 35(3): 226-232
Publication date: 2008


Consentement éclairé dans les essais de prévention du VIH: Points saillants d'un atelier international [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF) 
Publication date: 2008


Consentimento informado nos ensaios de prevenção do HIV: Pontos altos dum workshop internacional [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF) 
Publication date: 2008


Consentimiento informado en ensayos de prevención del VIH: Aspectos destacados de un taller internacional [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF) 
Publication date: 2008


Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials (abstract) 
van de Wijgert,Janneke; Kilmarx,Peter H.; Jones,Heidi E.; Karon,John M.; Chaikummao,Supaporn
Contraception 77(2): 122-129
Publication date: 2008


Efficacy of Carraguard for prevention of HIV infection in women in South Africa: A randomised, double-blind, placebo-controlled trial (abstract) 
Skoler-Karpoff,Stephanie; Ramjee,Gita; Ahmed,Khatija; Altini,Lydia; Gehret,Marlena; Friedland,Barbara A.; Govender,Sumentheran N.; de Kock,Alana; Cassim,Nazira; Palanee,Thesla; Dozier,Gregory; Maguire,Robin A.; Lahteenmaki,Pekka
Lancet 372(9654): 1977-1987
Publication date: 2008


Efficacy of Carraguard-based microbicides in vivo despite variable in vitro activity (abstract) (PDF) 
Turville,Stuart G.; Aravantinou,Meropi; Miller,Todd; Kenney,Jessica; Teitelbaum,Aaron; Hu,Lieyu; Chudolij,Anne; Zydowsky,Thomas M.; Piatak Jr.,Michael; Bess Jr.,Julian W.; Lifson,Jeffrey D.; Blanchard,James; Gettie,Agegnehu; Robbiani,Melissa
PLoS ONE 3(9): e3162-
Publication date: 2008


Idhini fahamishi katika majaribio ya kikliniki ya ukingaji wa virusi vya ukimwi [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF) 
Publication date: 2008


Imvume unolwazi ocwaningweni lokuvimbela igciwane lesandulela ngculaza [Informed consent in HIV prevention trials: Highlights from an international workshop] (PDF) 
Publication date: 2008


Informed consent in HIV prevention trials: Highlights from an international workshop (PDF) 
Publication date: 2008


Microbicide product development (abstract) 
Maguire,Robin A.
Current Opinion in HIV and AIDS 3(5): 554-557
Publication date: 2008


Microbicides: Chemistry, structure, and strategy (abstract) 
Zydowsky,Thomas M.
Current Opinion in HIV and AIDS 3(5): 548-553
Publication date: 2008


No increase in cervicovaginal proinflammatory cytokines after Carraguard use in a placebo-controlledrandomized clinical trial (abstract) 
Bollen,Liesbeth J.M.; Blanchard,Kelly; Kilmarx,Peter H.; Chaikummao,Supaporn; Connolly,Cathy; Wasinrapee,Punneporn; Srivirojana,Nucharee; Achalapong,Jullapong; Tappero,Jordan W.; McNicholl,Janet M.
Journal of Acquired Immune Deficiency Syndromes 47(2): 253-257
Publication date: 2008


Carrageenan/MIV-150 (PC-815), a combination microbicide (abstract) (HTML) 
Fernandez-Romero,Jose A.; Thorn,Mitchell; Turville,Stuart G.; Titchen,Kanani; Sudol,Kristin M.; Li,Jifan; Miller,Todd; Robbiani,Melissa; Maguire,Robin A.; Buckheit Jr.,Robert W.; Hartman,Tracy L.; Phillips,David M.
Sexually Transmitted Diseases 34(1): 9-14
Publication date: 2007


Acceptability of Carraguard, a candidate microbicide and methyl cellulose placebo vaginal gels among HIV-positive women and men in Durban, South Africa (abstract) (PDF) 
Ramjee,Gita; Morar,Neetha S.; Braunstein,Sarah; Friedland,Barbara A.; Jones,Heidi E.; van de Wijgert,Janneke
AIDS Research and Therapy 4(20)
Publication date: 2007


Carraguard vaginal gel safety in HIV-positive women and men in South Africa (abstract) 
van de Wijgert,Janneke; Braunstein,Sarah; Morar,Neetha S.; Jones,Heidi E.; Madurai,Lorna; Evans Strickfaden,Tammy T.; Moodley,Manivasan; Aboobaker,Jamila; Ndlovu,Gugulethu; Ferguson,Taja M.; Friedland,Barbara A.; Hart,Clyde E.; Ramjee,Gita
Journal of Acquired Immune Deficiency Syndromes 46(5): 538-546
Publication date: 2007


Day of dialogue--Insights and evidence from product introduction: Lessons for microbicides (PDF) 
Brady,Martha; McGrory,C.Elizabeth
Publication date: 2007


Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials (abstract) 
Wallace,Andrea R.; Teitelbaum,Aaron; Wan,Livia; Mulima,Maria Gloria; Guichard,Laura; Skoler,Stephanie; Vilakazi,Hlengiwe; Mapula,Fridda S.; Rossier,Jasmine; Govender,Sumentheran N.; Lahteenmaki,Pekka; Maguire,Robin A.; Phillips,David M.
Contraception 76(1): 53-56
Publication date: 2007


Effect of a single vaginal administration of levonorgestrel in Carraguard® gel on the ovulatory process: A potential candidate for 'dual protection' emergency contraception (abstract) 
Brache,Vivian; Croxatto,Horacio B.; Sitruk-Ware,Regine; Maguire,Robin A.; Montero,Juan Carlos; Kumar,Narender; Salvatierra,Ana Maria; Tejada,Ana-Sofia; Cochon,Leila; Forcelledo,Maria Luisa; Lahteenmaki,Pekka; Alvarez,Francisco; Faundes,Anibal
Contraception 76(2): 111-116
Publication date: 2007


Engaging advocates from concept to results: Summary report of the Advocates' Consultation on HIV Prevention Trials: Carraguard and VOICE Studies, Johannesburg, South Africa, 18-19 October 2007 (PDF) 
Meeting report
Publication date: 2007


Pharmacokinetic study to compare the absorption and tolerability of two doses of levonorgestrel following single vaginal administration of levonorgestrel in Carraguard® gel: A new formulation for 'dual protection' contraception (abstract) 
Sitruk-Ware,Regine; Brache,Vivian; Maguire,Robin A.; Croxatto,Horacio B.; Kumar,Narender; Kumar,Sushma; Montero,Juan Carlos; Salvatierra,Ana Maria; Phillips,David M.; Faundes,Anibal
Contraception 75(6): 454-460
Publication date: 2007


Tests suggest new microbicide will have improved efficacy (PDF) 
Population Briefs 13(2)
Publication date: 2007


Acceptability of Carraguard vaginal gel use among Thai couples (abstract) 
Whitehead,Sara J.; Kilmarx,Peter H.; Blanchard,Kelly; Manopaiboon,Chomnad; Chaikummao,Supaporn; Friedland,Barbara A.; Achalapong,Jullapong; Wankrairoj,Mayuree; Mock,Philip A.; Thanprasertsuk,Sombat; Tappero,Jordan W.
AIDS 20(17): 2141-2148
Publication date: 2006


Challenges in microbicide trial design and implementation (PDF) 
van de Wijgert,Janneke; Jones,Heidi E.
Studies in Family Planning 37(2): 123-129
Publication date: 2006


Challenges to microbicide introduction in South Africa (abstract) 
Orner,Phyllis; Harries,Jane; Cooper,Diane; Moodley,Jennifer; Hoffman,Margaret; Becker,Julie; McGrory,C.Elizabeth; Dabash,Rasha; Bracken,Hillary J.
Social Science and Medicine 63(4): 968-978
Publication date: 2006


Informed Consent in HIV Prevention Trials: Report of an International Workshop (PDF) 
McGrory,C.Elizabeth; Friedland,Barbara A.; Woodsong,Cynthia; MacQueen,Kathleen M.
Publication date: 2006


Our current microbicide trials: Lessons learned and to be learned (PDF) 
Skoler,Stephanie; Peterson,Leigh; Cates,Ward
The Microbicide Quarterly 4(1): 1-6
Publication date: 2006


Phase 3 study of the efficacy and safety of the microbicide Carraguard in preventing HIV seroconversion in women (Population Council Protocol 322): Summary (PDF) 
Population Council
Publication date: 2006


Phase 3 study of the efficacy and safety of the microbicide Carraguard in preventing HIV seroconversion in women: Protocol synopsis (PDF) 
Population Council
Publication date: 2006


Safety and acceptability of the candidate microbicide Carraguard in Thai women: Findings from a Phase II clinical trial (abstract) 
Kilmarx,Peter H.; van de Wijgert,Janneke; Chaikummao,Supaporn; Jones,Heidi E.; Limpakarnjanarat,Kanchit; Friedland,Barbara A.; Karon,John M.; Manopaiboon,Chomnad; Srivirojana,Nucharee; Yanpaisarn,Somboonsak; Supawitkul,Somsak; Young,Nancy L.; Mock,Philip A.; Blanchard,Kelly; Mastro,Timothy D.
Journal of Acquired Immune Deficiency Syndromes 43(3): 327-334
Publication date: 2006


Slamming the door on unwanted guests: Why preemptive strikes at the mucosa may be the best strategy against HIV (abstract) 
Trapp,Susanna; Turville,Stuart G.; Robbiani,Melissa
Journal of Leukocyte Biology 80(5): 1076-1083
Publication date: 2006


Microbicides: Developing and testing a gel to prevent HIV transmission (PDF) 
Population Council Annual Report 2004
Publication date: 2005


Microbicides: Developing and testing a gel to prevent HIV transmission [Arabic] (PDF) 
Population Council Annual Report 2004
Publication date: 2005


Phase III microbicide trial methodology: Opinions of experienced expanded safety trial participants in South Africa (abstract) 
van de Wijgert,Janneke; Jones,Heidi E.; Pistorius,Annalie; de Kock,Alana; Sebola,Mohlatlego H.; Friedland,Barbara A.; Hoosen,Anwar; Coetzee,Nicol
Journal of Social Aspects of HIV/AIDS 2(3): 311-319
Publication date: 2005


Preferences and practices related to vaginal lubrication: Implications for microbicide acceptability and clinical testing (abstract) 
Braunstein,Sarah; van de Wijgert,Janneke
Journal of Women's Health 14(5): 424-433
Publication date: 2005


Assay for establishing whether microbicide applicators have been exposed to the vagina (abstract) 
Wallace,Andrea R.; Thorn,Mitchell; Maguire,Robin A.; Sudol,Kristin M.; Phillips,David M.
Sexually Transmitted Diseases 31(8): 465-468
Publication date: 2004


Carraguard may block HIV by adhering to cells (PDF) 
Population Briefs 10(1)
Publication date: 2004


Lubricants containing N-9 may enhance rectal transmission of HIV and other STIs (abstract) 
Phillips,David M.; Sudol,Kristin M.; Taylor,Clark L.; Guichard,Laura; Elsen,Robert; Maguire,Robin A.
Contraception 70(2): 107-110
Publication date: 2004


Microbicide trials for preventing HIV/AIDS in South Africa: Phase II trial participants' experiences and psychological needs (abstract) 
Pistorius,Annalie; van de Wijgert,Janneke; Sebola,Mohlatlego H.; Friedland,Barbara A.; Nagel,Evelyn; Bokaba,Cathleen; Hoosen,Anwar
Journal of Social Aspects of HIV/AIDS 1(2): 78-86
Publication date: 2004


Paving the Path: Preparing for Microbicide Introduction-Report of a Qualitative Study in South Africa (PDF) 
Becker,Julie; Dabash,Rasha; McGrory,C.Elizabeth; Cooper,Diane; Harries,Jane; Hoffman,Margaret; Moodley,Jennifer; Orner,Phyllis; Bracken,Hillary J.
Publication date: 2004


Relative safety of sexual lubricants for rectal intercourse (abstract) (PDF) 
Sudol,Kristin M.; Phillips,David M.
Sexually Transmitted Diseases 31(6): 346-349
Publication date: 2004


Testing Carraguard: What you need to know (PDF) 
Clacherty,Glynis; Friedland,Barbara A.; de Kock,Alana; Marumo,Mabitso
Publication date: 2004


Carrageenan formulation prevents macrophage trafficking from vagina: Implications for microbicide development (abstract) (PDF) 
Perotti,Maria-Elisa; Pirovano,Alessia; Phillips,David M.
Biology of Reproduction 69(3): 933-939
Publication date: 2003


Cultural norms and behavior regarding vaginal lubrication during sex: Implications for the acceptability of vaginal microbicides for the prevention of HIV/STIs (PDF) 
Braunstein,Sarah; van de Wijgert,Janneke
Robert H. Ebert Program on Critical Issues in Reproductive Health Publication Series
Publication date: 2003


Female condoms and microbicides 
Esu-Williams,Eka; Blanchard,Kelly; Essex,Max; Mboup,Souleymane; Kanki,Phyllis J.; Marlink,Richard G.; Tlou,Sheila D.
from AIDS in Africa, pp. 506-513
Publication date: 2002


Informed consent: From good intentions to sound practices--A report of a seminar (PDF) 
Wood,Susan Y.; Friedland,Barbara A.; McGrory,C.Elizabeth
Robert H. Ebert Program on Critical Issues in Reproductive Health Publication Series
Publication date: 2002


Microbicides to prevent heterosexual transmission of HIV: Ten years down the road (HTML) 
van de Wijgert,Janneke; Coggins,Christiana
Bulletin of Experimental Treatments for AIDS 15(2): 23-28
Publication date: 2002


Motivations for and barriers to study participation (PDF) 
Population Briefs 8(1)
Publication date: 2002


Non-HIV STIs and the epidemiology of success 
Blanchard,Kelly; Elias,Christopher J.
from The Science of Microbicides: Accelerating Development, report of the Science Working Group of the Microbicide Initiative, pp. 47-51
Publication date: 2002


Nonoxynol-9 rapidly exfoliates rectal epithelium (PDF) 
Population Briefs, Spring 2002 (HIV/AIDS edition)
Publication date: 2002


Acceptability and feasibility of Micralax applicators and of methyl cellulose gel placebo for large-scale clinical trials of vaginal microbicides (abstract) (PDF) 
Coetzee,Nicol; Blanchard,Kelly; Ellertson,Charlotte; Hoosen,Anwar; Friedland,Barbara A.
AIDS 15(14): 1837-1842
Publication date: 2001


Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: Where have we been? Where are we going? (abstract) 
Elias,Christopher J.; Coggins,Christiana
Journal of Women's Health and Gender-Based Medicine 10(2): 163-173
Publication date: 2001


Phase 1 trial of the topical microbicide BufferGel: Safety results from four international sites (abstract) 
van de Wijgert,Janneke; Fullem,Andrew; Kelly,Clifton A.; Mehendale,Sajay; Rugpao,Sungwal; Kumwenda,Newton; Chirenje,Zvavahera M.; Joshi,Mita; Taha,Taha; Padian,Nancy F.; Bollinger,Robert; Nelson,Kenrad
Journal of Acquired Immune Deficiency Syndromes 26(1): 21-27
Publication date: 2001


Recommendations for the clinical development of topical microbicides: An update (abstract) (PDF) 
Mauck,Christine; Rosenberg,Zeda; Van Damme,Lut; van Dam,C.Johannes
AIDS 15(7): 857-868
Publication date: 2001


The case for microbicides: A global priority. Second edition (PDF) 
Attawell,Kathy
Publication date: 2001


U.S. women's attitudes toward a potential microbicide 
Poster presentation at the Fourteenth Meeting of the International Society of Sexually Transmitted Diseases Research, Berlin, June
Friedland,Barbara A.; McGrory,C.Elizabeth
Publication date: 2001


Women's willingness to participate in microbicide trials in northern Thailand (abstract) 
Kanokwan,Tharawan; Manopaiboon,Chomnad; Ellertson,Charlotte; Limpakarnjanarat,Kanchit; Chaikummao,Supaporn; Kilmarx,Peter H.; Blanchard,Kelly; Coggins,Christiana; Mastro,Timothy D.; Elias,Christopher J.
Journal of Acquired Immune Deficiency Syndromes 28(2): 180-186
Publication date: 2001


Men's attitudes toward vaginal product use: Farmers and taxi drivers in Mexico 
Coggins,Christiana; Madrigal,Mauricio Ramos; Llamas,Alicia
Publication date: 2000


Men's attitudes towards a potential vaginal microbicide in Zimbabwe, Mexico and the USA (abstract) 
Coggins,Christiana; Blanchard,Kelly; Friedland,Barbara A.
Reproductive Health Matters 8(15): 132-141
Publication date: 2000


Preliminary safety and acceptability of a carrageenan gel for possible use as a vaginal microbicide (abstract) 
Coggins,Christiana; Blanchard,Kelly; Alvarez,Francisco; Brache,Vivian; Weisberg,Edith; Kilmarx,Peter H.; Lacarra,Maria; Massai,Rebeca; Mishell,Daniel R.,Jr.; Salvatierra,Ana Maria; Witwatwongwana,Paisit; Elias,Christopher J.; Ellertson,Charlotte
Sexually Transmitted Infections 76(6): 480-483
Publication date: 2000


Informing Research on HIV Prevention: A Consultation (PDF) 
Fonn,Sharon; McGrory,C.Elizabeth
Publication date: 1999


Pushing the frontiers of science-the Population Council's Microbicide Basic Science Network on vaginal microbicide research (abstract) 
Johansson,Elof D.B.; Maguire,Robin A.; Phillips,David M.
International Journal of Gynecology and Obstetrics 67(suppl 2): 117-124
Publication date: 1999


A study of women's preferences regarding the formulation of over-the-counter vaginal spermicides (PDF) 
Coggins,Christiana; Elias,Christopher J.; Atisook,Ronachai; Bassett,Mary T.; Ettiegne-Traore,Virginie; Ghys,Peter D.; Jenkins-Woelk,Laura; Thongkrajai,Earmporn; VanDevanter,Nancy L.
Robert H. Ebert Program on Critical Issues in Reproductive Health Publication Series
Publication date: 1998


Practical and ethical dilemmas in the clinical testing of microbicides: A report on a symposium 
Heise,Lori L.; McGrory,C.Elizabeth; Wood,Susan Y.
Publication date: 1998


The development of microbicides: A new method of HIV prevention for women (PDF) 
Elias,Christopher J.; Heise,Lori L.
Programs Division Working Paper (no. 6)
Publication date: 1993