Female-Initiated HIV Prevention Technology  TUAC1
Type:
Oral abstract session Back
Venue: Bayside Auditorium A
Time: 11:00 - 12:30, Tuesday, 24.07.2007
Code: TUAC1
Co-Chairs: Roberta Black, United States
Kenneth Hugh Mayer, United States
Click here to see a webcast of this session on kaisernetwork.org

    Presentations in this session:
11:00
TUAC101
Abstract
Powerpoint (1.87 MB)		Factors contributing to diaphragm size change among enrolled women at the Durban site in a phase III HIV prevention clinical trial
Presented by Sharlene Mandalyn Govender, South Africa
Govender S.M.1, Mtungwa L.N.1, Manarsingh F.1, Naidoo V.1, Ramjee G.1
1Medical Research Council, HIV Prevention Research Unit, Durban, South Africa

11:15
TUAC102
Abstract		Diaphragm and gel adherence in a safety trial in Harare, Zimbabwe
Presented by Ariane van der Straten, United States
van der Straten A.1, Wu J.1, Moore J.1, Napierala S.2, Hammond N.3, Padian N.1
1University of California San Francisco, OBGYN, San Francisco, United States, 2University of California San Francisco, OBGYN, Harare, Zimbabwe, 3University of Zimbabwe, OBGYN, Harare, Zimbabwe

11:30
TUAC103
Abstract
Powerpoint (156 KB)		Genital tract abnormalities among female sex workers who douche with lemon/lime juice in northern Nigeria
Presented by Atiene Sagay, Nigeria
Sagay A.1, Imade G.1, Egah D.2, Onwuliri V.3, Adisa J.4, Grigg M.5, Musa J.1, Thacher T.6, Potts M.7, Short R.5
1University of Jos/Jos University Teaching Hospital, Jos, Dept of Obstetrics and Gynaecology, Jos, Nigeria, 2University of Jos/Jos University Teaching Hospital, Jos, Dept of Medical Microbiology, Jos, Nigeria, 3University of Jos, Dept of Biochemistry, Jos, Nigeria, 4Jos University Teaching Hospital, Dept of Histopathology, Jos, Nigeria, 5University of Melbourne, Faculty of Medicine, Melbourne, Australia, 6Jos University Teaching Hospital, Dept of Family Medicine, Jos, Nigeria, 7University of California, School of Public Health, Berkeley, California, United States

11:45
TUAC104
Abstract
Powerpoint (1.47 MB)		Achieving a 95% cohort retention rate in a phase III trial of the diaphragm and gel in Southern Africa
Presented by Constancia Watadzaushe
Chidanyika A.C.1, Montgomery E.2, Gappoo S.3, Pato S.4, Lam M.2, Lince N.5, van der Straten A.2, Padian N.2, Watadzaushe C.1
1UZ-UCSF Collaborative Programme in Women's Health, Harare, Zimbabwe, 2University of California, San Francisco, United States, 3Medical Research Council, Durban, South Africa, 4Perinatal HIV Research Unit, Johannesburg, South Africa, 5Ibis Reproductive Health, Johannesburg, South Africa

12:00
TUAC105
Abstract
Powerpoint (2.55 MB)		Female-controlled HIV prevention methods in Zimbabwe: how “involved” are the primary male partners?
Presented by Elizabeth Montgomery, United States
Montgomery E.1, Chidanyika A.2, Mtetwa S.2, Purchia E.1, Chipato T.2, Padian N.1, van der Straten A.1, the MIRA study team (Zimbabwe)
1University of California, San Francisco, Women's Global Health Imperative, San Francisco, CA, United States, 2University of Zimbabwe, University of California, San Francisco Collaborative Programme, Harare, Zimbabwe

12:15
TUAC1LB
Abstract
Powerpoint (211 KB)		SPL7013 Gel (VivaGel(TM)), a topical microbicide in development for prevention of HIV and genital herpes, shown to be well tolerated and comparable with placebo after seven days administration in healthy males.
Presented by Jeremy Paull
Paull J.1, Chen M.2, Millwood I.3, Wand H.3, Poynten M.3, Law M.3, Kaldor J.3, Wesselingh S.4, Price C.1, Heery G.1, Clark L.1, Fairley C.2, Funded with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Contract No. HHSN266200500042C
1Starpharma Pty Ltd, Melbourne, Australia, 2Melbourne Sexual Health Centre and School of Population Health, University of Melbourne, Melbourne, Australia, 3National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia, 4Burnet Institute, Melbourne, Australia


Audio files:
  1. audio file - high quality (mp3 format, 44.1 MB)
  2. audio file - low quality (mp3 format, 22 MB)

Rapporteur report

Track C: Biomedical Prevention report by Iona Millwood

Female-Initiated HIV Prevention Technology

 

Three presentations focussed on components of the MIRA study, a phase III randomised controlled trial of diaphragm+lubricant gel for HIV prevention among women in South Africa and Zimbabwe. The full study results will be presented as a late breaker in session WESS3, and have just been published (Padian et al, Lancet July 21, 370:251).

            Govender presented data on factors influencing diaphragm size changes among 1515 women enrolled at the Durban site. The most common size fitted for was 70 mm. During the study 289 women (38%) underwent re-fitting, with size changes required due to changes relating to pregnancy, discomfort, weight changes, or other factors, and 62% did not require re-fitting. There were few cases initiated by male partner complaints.

            Retention in the MIRA study was high at >90% in each study arm over the 12-24 months of participation, as presented by Constancia Watadzaushe. The study maintained detailed locator information, to enable visit reminders and outreach visits for hard to reach participants. Extended clinic site opening times, with transport, childcare and other facilities were provided, as were a series of small gifts and incremental re-imbursement during follow up.

            A substudy on male involvement at the Harare site, was presented by Liz Montgomery. Although a high degree of partner support (95%) was reported, with discussion and interest from partners, this did not translate into men visiting the study clinic when invited (4%).

            Adherence in the DMS study, a 3-arm study of diaphragm+6% CS gel, diaphragm+placebo gel, or 6% CS gel, conducted in Zimbabwe, was presented by Ariane van der Straten. Adherence overall was similar between those using gel only or gel+diaphragm, although somewhat higher at monthly visit in gel only users. Condom use was strongly associated with adherence, and partner approval was also important.

            These presentations and discussion highlighted the importance of evaluating retention, adherence, and acceptability, including partner acceptability, critical factors in the success of biomedical prevention intervention trials, and the value of sharing experiences across trials.

            A cross sectional study of genital tract abnormalities among female sex workers in Nigeria, compared those who douche with lemon or lime juice (N=81) with those who don’t report douching (N=293), presented by Atiene Sagay. There was no difference in colposcopy findings, however, cytology of pap smears identified a higher prevalence of squamous lesions among lemon/lime users (OR 2.13, 95% CI 1.03-4.40, P=0.025), with further research into this warranted. The importance of involving sex workers in research into lemon and lime douching practices was discussed.

            As a late breaker abstract, Jeremy Paull presented the results from a Phase I male tolerance study of 3% SPL7013 Gel conducted in Australia. Although under development for prevention of male to female transmission of HIV and HSV, male exposure will occur during safety and efficacy trials in sexually active women, and the study found SPL703 Gel to be well tolerated when applied by healthy men for 7 days.


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