Population Council Research that makes a difference

The evaluation involved both quantitative and qualitative components. The quantitative portion of the evaluation focused on comprehension and willingness to participate.

The first objective was to determine among the recruitment population whether the addition of the video: (1) improved comprehension of the aims, procedures, risks, and benefits of the Phase 3 trial; (2) increased willingness to participate in the trial; and (3) increased the number of women who come for screening for the trial when compared to use of the study booklet alone.

The second objective was to assess the level of comprehension regarding aims, risks, and benefits among women enrolled in the Phase 3 trial after they had gone through the full informed consent process. The comprehensive informed consent process included the information session, viewing the video (at information session or screening), group review of the informed consent form, and a one-on-one discussion of comprehension questions at which the informed consent form was signed.

The quantitative evaluation was implemented in 2005 at the Soshanguve and Gugulethu study sites. Two hundred women at each site were interviewed before and after information sessions; 150 women per site were interviewed at their enrollment visit. Interviews were conducted by field workers employed by the Community Agency for Social Enquiry, a social science research organization based in Johannesburg. Final data analysis is underway.

The qualitative component of the evaluation used in-depth interviews and focus group discussions with study participants at various stages in their trial participation and with study staff. Focus groups were conducted with study participants and their willing male partners, both in single gender and mixed gender groups. The interviews and focus group discussions were conducted by local field workers at each of the three study sites.

Researchers conducted more than 100 interviews with participants, partners, and study staff. Preliminary findings indicate that the desire to know one’s HIV status and to receive quality care were primary motivations for joining the trial, and that partners, social networks, and staff played key roles in participants’ decisions to join and remain in a clinical trial. While most women disclosed trial participation to their partners, there was variation in how and when this information was disclosed, and how it was received by their social networks. Many volunteers articulated a sense of empowerment gained by their participation in the trial, which they suggested served to improve communication about HIV risk reduction (e.g., condom use) with their sexual partners.

In-depth interviews with counselors, nurses, and recruiters conducted at the end of the trial highlighted the importance for staff training and high-quality materials. Study staff stressed the importance of their role in ensuring that women understood their rights within the trial. While many of the staff members stated that the informed consent process and materials were comprehensive, they often felt pressured for time because many volunteers lacked fundamental health and clinical research knowledge. Several recommended additional community programs to foster a sense of health literacy prior to the start of a clinical trial. Final data analysis is underway.

This evaluation builds on previous efforts to develop, test, and adapt the informed consent forms and processes to ensure that women are truly informed and participate voluntarily. The findings of this evaluation will provide valuable information that can be applied to future clinical trials.

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


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