Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial

Padian, Nancy; Straten, Ariane van der; Ramjee, Gita; Chipato, Tsungai; Bruyn, Guy de; Blanchard, Kelly; Shiboski, Stephen; Montgomery, Elizabeth T.; Fancher, Heidi; Cheng, Helen; Rosenblum, Michael; Laan, Mark van der; Jewell, Nicholas P.; McIntyre, James

doi:10.1016/s0140-6736(07)60950-7

Cited by 302 publications

(286 citation statements)

References 36 publications

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“…2,3 Trials for the prevention of HIV-1 infection have been heavily focused on developing biomedical interventions under female control. [4][5][6] Typically these trials recruit sexually active, non-pregnant women of childbearing age and, since the teratogenic effects of the products they test are seldom known, the women are required to use an effective birth control method. Furthermore, if a trial participant falls pregnant, she is usually taken off the product under study, a practice that reduces the trial's statistical power and its ability to demonstrate the product's efficacy.…”

Section: Introductionmentioning

confidence: 99%

Population-level impact of hormonal contraception on incidence of HIV infection and pregnancy in women in Durban, South Africa

Ramjee¹,

Wand²

2012

Bull World Health Org

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Section: Introductionmentioning

confidence: 99%

Population-level impact of hormonal contraception on incidence of HIV infection and pregnancy in women in Durban, South Africa

Ramjee¹,

Wand²

2012

Bull World Health Org

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“…This study was conducted concurrently with the MIRA trial 18 , between May and September 2006; a total of 93 young women aged 16-21 years were approached and prescreened by outreach workers in schools, youth centres, sports clubs, youth-friendly clinics, and market places in the city of Chitungwiza, near Harare. Fifty-one (55%) young women came to the study site and were re-screened for eligibility.…”

Section: Study Design and Participantsmentioning

confidence: 99%

“…[13][14][15][16] This effort continues, despite disappointing results from a recently completed trial of the diaphragm used with a lubricant gel, the MIRA trial, which was unable to demonstrate a protective effect of the intervention against HIV or cervical STIs, over and above that of male condoms. [17][18][19] Nevertheless, it is still biologically plausible that the diaphragm or other CB can provide partial protection from cervical infections, and function as a reusable delivery mechanism for, or enhance the effectiveness of, a microbicidal gel. 20 Indeed, as CB retain gel close to the cervix, they may potentially prolong the duration of action of a microbicide in situ, by slowing the rapid leakage of gel to the lower vagina and the introitus during sexual intercourse.…”

mentioning

confidence: 99%

Feasibility and potential acceptability of three cervical barriers among vulnerable young women in Zimbabwe

Straten

Sahin-Hodoglugil²,

Clouse³

et al. 2010

j fam plann reprod health care

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Background We explored the potential acceptability of three cervical barriers (CB) (Ortho All-Flex ® diaphragm, SILCS ® diaphragm, FemCap TM cervical cap) among sexually experienced Zimbabwean young women.Methods Forty-five young women (aged 16-21 years) received an individual CB educational session. Participants were then randomly assigned to one of the three CBs in a 1:1:1 ratio, and practised insertion and removal of their device at the clinic. Next, participants were interviewed on their practice experiences, and their post-practice attitudes towards CB.Results All 45 young women were willing and able to insert their assigned device. The majority reported "easy" insertion and removal and 93% "liked" the device they tried. All showed interest in participating in future CB studies: when asked which device they would like to try 13 IntroductionYoung women are the most vulnerable population for heterosexual acquisition of HIV. 1 Adolescents are more susceptible than adult women, likely because an immature genital tract increases their susceptibility to physical trauma and sexually transmitted infections (STIs). 2 Furthermore, gender inequalities in sexual relationships often leave young women unable to negotiate condom use. [3][4][5] In Zimbabwe, 25% of females aged 15-24 years are infected with HIV compared to 11% of males in that age group. 6 Additionally, with 40% of Zimbabwean women aged 15-49 years being non-current users of modern family planning methods, there remains a significant unmet need for contraception, particularly among young sexually active women (63% non-current users among 15-19-yearolds), as indicated by estimates that up to 60 000-80 000 illegal and unsafe abortions occur each year. 6,7 Male condoms are the only currently available method known to provide dual protection by preventing pregnancy in the future, over half (58%) chose SILCS, regardless of the device they had tried. The majority felt comfortable touching their genitals to insert/remove the CB and most participants favoured methods' attributes associated with female-control and non-interference with sex. Over half the participants said they would prefer to use a CB continuously compared to episodic use. Two-thirds of them expressed interest in CB for dual protection. ConclusionThe concept of CB, and initial insertion experience, were well accepted in this selected, small group of Zimbabwean young women. Evaluating CB in larger studies seems feasible in this population. and STIs including HIV; although not proven in clinical trials, female condoms are believed to provide similar protection. 8,9 While female condoms are woman-initiated, they still require male partner co-operation, as they are noticeable during sex. Cervical barriers (CB), including the diaphragm, are also woman-initiated methods, and act by protecting the cervix from exposure to ejaculate. The diaphragm is one of the oldest contraceptives, although it has lost much of its popularity with the advent of hormonal contraceptives. 10 CB might be of interest to...

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“…Des microbicides ont donné lieu à des essais mais aucun n'a encore démontré son efficacité. Selon une étude récente, l'utilisation du diaphragme comme moyen de prévention ne serait pas efficace [19], ni le traitement de HSV2 (herpes simplex virus) par l'aciclovir chez les femmes co-infectées par HSV2 et VIH [20]. Le vaccin [21], la prophylaxie pré-exposition et la prophylaxie post-exposition sont encore à l'étude.…”

Section: Resultsunclassified

La circoncision

Legeai

Auvert

2008

Med Sci (Paris)

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Circoncision et épidémie de VIH en Afrique sub-saharienne : un lien ?De 1986 -année de la première publication -à nos jours, le lien entre la circoncision, qui consiste en l'ablation de la majeure partie du prépuce, et l'infection à VIH a été étudié d'un point de vue épidémiologique à l'aide d'études observationnelles, écologiques et expérimen-tales, ainsi que d'un point de vue biologique. Les études observationnellesLes études épidémiologiques observationnelles, qu'elles soient transversales, cas-témoins ou prospectives, menées pour la plupart en Afrique sub-saharienne, ont montré qu'il existait à l'échelle individuelle une association entre le fait d'être non-circoncis et le risque d'être infecté par le VIH. Selon une méta-analyse portant sur 15 études observationnelles, le risque d'infection par le

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Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial

Abstract: SummaryBackground-Female-controlled methods of HIV prevention are urgently needed. We assessed the effect of provision of latex diaphragm, lubricant gel, and condoms (intervention), compared with condoms alone (control) on HIV seroincidence in women in South Africa and Zimbabwe.

Cited by 302 publications

References 36 publications

Population-level impact of hormonal contraception on incidence of HIV infection and pregnancy in women in Durban, South Africa

Population-level impact of hormonal contraception on incidence of HIV infection and pregnancy in women in Durban, South Africa

Feasibility and potential acceptability of three cervical barriers among vulnerable young women in Zimbabwe

La circoncision

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