Change in condom and other barrier method use during and after an HIV prevention trial in Zimbabwe

Abstract

Background: We examined the use of male condoms and the diaphragm following completion of a clinical trial of the diaphragm's HIV prevention effectiveness. In the trial, called Methods for Improving Reproductive Health in Africa (MIRA), women were randomized to a diaphragm group (diaphragm, gel and condoms) or a condom-only control group. At trial exit, all women were offered the diaphragm and condoms.

Methods: Our sample consisted of 801 Zimbabwean MIRA participants who completed one post-trial visit (median lapse: nine months; range two to 20 months). We assessed condom, diaphragm and any barrier method use at last sex act at enrolment, final MIRA and post-trial visits. We used multivariable random effects logistic regression to examine changes in method use between these three time points.

Results and discussion: In the condom group, condom use decreased from 86% at the final trial visit to 67% post trial (AOR = 0.20; 95% CI: 0.12 to 0.33). In the diaphragm group, condom use was 61% at the final trial visit, and did not decrease significantly post trial (AOR = 0.77; 95% CI: 0.55 to 1.09), while diaphragm use decreased from 79% to 50% post trial (AOR = 0.18; 95% CI: 0.12 to 0.28). Condom use significantly decreased between the enrolment and post-trial visits in both groups. Use of any barrier method was similar in both groups: it significantly decreased between the final trial and the post-trial visits, but did not change between enrolment and the post-trial visits.

Conclusions: High condom use levels achieved during the trial were not sustained post trial in the condom group. Post-trial diaphragm use remained relatively high in the diaphragm group (given its unknown effectiveness), but was very low in the condom group. Introducing "new" methods for HIV prevention may require time and user skills before they get adopted. Our findings underscore the potential benefit of providing a mix of methods to women as it may encourage more protected acts.

Trial registration: ClinicalTrials.gov NCT00121459.

Figures

Figure 1

Study sample flow chart. *This includes women who remained HIV seronegative throughout the duration of the trial, and excludes those (n = 31) who had no MIRA follow-up data.

Figure 2

Group averages in method(s) used at last sex, by MIRA visits and post-trial visit. Figure 2a. Male condom use at last sex by visit type and MIRA diaphragm and condom groups; n = 801 Figure 2b. Diaphragm use at last sex by visit type in MIRA diaphragm group; n = 381 Figure 2c. Barrier method(s) use at last sex act (male condom, female condom, diaphragm) by visit type and MIRA diaphragm and condom groups; n = 801

Figure 3

Last sex act by barrier method used and by visit type. Figure 3a. Last sex act by barrier method used and by visit type among diaphragm group participants; n = 381 Figure 3b. Last sex act by barrier method used and by visit type among condom group participants; n = 420