AIDS and behavior
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Randomized Controlled Trial
Acceptability and use of the diaphragm and Replens lubricant gel for HIV prevention in Southern Africa.
The acceptability and use of the diaphragm and lubricant gel were assessed as part of a large randomized controlled trial to determine the effectiveness of the methods in women's HIV acquisition. 2,452 intervention-arm women were enrolled at five Southern African clinics and followed quarterly for 12-24 months. Acceptability and use data were collected by face-to-face interviews at Month 3 and Exit. ⋯ At Exit, consistent disclosure of use (AOR 1.97, 95% CI: 1.10-3.55); an overall high diaphragm rating (AOR 1.84, 95% CI: 1.45-2.34) and perception of partner approval (AOR 1.75, 95% CI: 1.35-2.26) were the most significant acceptability factors independently associated with consistent use. Despite being female-initiated, disclosure of use to male partners and his perceived approval of the products were factors significantly associated with their consistent use.
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Randomized Controlled Trial
The use of the diaphragm instead of condoms in a phase III diaphragm trial.
The MIRA trial assessed whether providing diaphragm, lubricant gel, and condoms (intervention) compared with condoms alone (control) could reduce HIV incidence among 5,039 Southern African women. Compared with the control group, the cumulative proportion of last sex acts protected by any method was higher in the intervention group (OR = 1.33; 95% CI 1.18, 1.49); however, only 36.3% of last sex acts were protected by both a male condom and a diaphragm, whereas 36.6% were protected by a diaphragm only. Product substitution (ever deciding to use a diaphragm instead of a condom in the previous 3 months) was reported at every visit by 22.4%, at some visits by 60.7%, and at none of the visits by 16.8% of these women. Women at greater risk for infection through their own or their partner's behavior or who believed the diaphragm protected against HIV were more likely to report product substitution at every visit.