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.

Consistent use of a combination product versus a single product in a safety trial of the diaphragm and microbicide in Harare, Zimbabwe.

BACKGROUND: We examined the use and acceptability of a combination product (diaphragm and gel) compared to a single product (gel) during a 6-month safety trial in Zimbabwe. STUDY DESIGN: Women were randomized to the use of a diaphragm with gel or the use of gel alone, in addition to male condoms. Ever use and use of study product on the last act of sexual intercourse were assessed monthly by Audio Computer-Assisted Self-Interviewing. Acceptability, correct use and consistent use (use at every sexual act during the previous 3 months) were measured on the last visit by face-to-face interview. Predictors of consistent use were examined using multivariate logistic regression analyses. RESULTS: In this sample of 117 sexually active, monogamous, contracepting women, rates of consistent use were similar in both groups (59.7% for combination method vs. 56.4% for gel alone). Product acceptability was high, but was not independently associated with consistent use. Independent predictors of consistent use included age [adjusted odds ratio (AOR)=1.08; 95% confidence interval (95% CI)=1.01-1.16], consistent condom use (AOR=3.85; 95% CI=1.54-9.63) and having a partner who approves of product use (AOR=2.66; 95% CI=1.10-6.39). CONCLUSIONS: Despite high reported acceptability and few problems with the products, the participants reported only moderate product adherence levels. Consistent use of condoms and consistent use of products were strongly associated. If observed in other studies, this may bias the estimation of product effectiveness in future trials of female-controlled methods.

Patterns and predictors of adherence to diaphragm use in a phase III trial in sub-Saharan Africa: a trajectory analysis.

BACKGROUND: We examined diaphragm adherence among 2429 women randomized to the intervention arm (diaphragm + gel + condoms) in Methods for Improving Reproductive Health in Africa, a phase III trial of the diaphragm for HIV prevention in Zimbabwe and South Africa. METHODS: Women were followed for a median of 7 quarterly visits (range: 1-8 quarterly visits) during which diaphragm adherence was assessed. We conducted trajectory analyses to identify behavioral groups associated with specific diaphragm adherence patterns. Multivariate multinomial logistic regression was used to identify baseline characteristics associated with higher probability of being in a particular trajectory group. RESULTS: Diaphragm uptake was very high (3.1% never used diaphragms). However, diaphragm adherence was reported at only 49% of visits. Women were clustered into 4 diaphragm adherence groups based on their highest estimated group membership probability: low adherers (31.0%), decreasing adherers (28.9%), increasing adherers (9.3%), and high adherers (30.8%). Women classified as high adherers (as compared with low adherers) were more likely to be older [adjusted odds ratio (AOR) = 1.09, 95% confidence interval (CI): 1.07 to 1.11] and to report baseline condom adherence (AOR = 2.00, 95% CI: 1.47 to 2.71). They were less likely to have high-risk behavior (AOR = 0.51; 95% CI: 0.37 to 0.71) and to have high-risk partners (AOR = 0.58; 95% CI: 0.43 to 0.78). They were most likely to be from the Zimbabwe site (AOR = 2.82; 95% CI: 1.89 to 4.20) and least likely to be from the Johannesburg site (AOR = 0.51; 95% CI: 0.37 to 0.77). CONCLUSION: This analytic approach could help to identify high compliers for enrollment in future HIV prevention trials or the types of participants who may need intensive adherence counseling during follow-up.