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Patterns and Predictors of Adherence to Diaphragm Use in a Phase III Trial in Sub-Saharan Africa: A Trajectory Analysis

van der Straten, Ariane PhD*†; Shiboski, Stephen PhD; Montgomery, Elizabeth T MHS*; Moore, Jie PhD§; De Bruyn, Guy MBChB; Ramjee, Gita PhD; Chidanyika, Agnes MBA#; Kacanek, Deborah PhD**; Padian, Nancy PhD*and the MIRA Team

JAIDS Journal of Acquired Immune Deficiency Syndromes: April 2009 - Volume 50 - Issue 4 - p 419-426
doi: 10.1097/QAI.0b013e3181958511
Epidemiology and Social Science

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.

From the *RTI international, Women's Global Health Imperative, San Francisco, CA; †Department of Medicine, Center for AIDS Prevention Studies, ‡Department of Epidemiology and Biostatistics, and §Department of Obstetrics and Gynecology, University of California San Francisco, San Francisco, CA; ∥Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa; ¶Medical Research Council, HIV Prevention Research Unit, Durban, South Africa; #University of Zimbabwe-University of California San Francisco, Collaborative Research Program, University of Zimbabwe, Harare, Zimbabwe; and **Ibis Reproductive Health, Cambridge, MA.

Received for publication June 10, 2008; accepted November 17, 2008.

Supported by a grant from the Bill and Melinda Gates Foundation (#21082).

Parts of the data and preliminary findings were presented at the meeting “Adherence and Its Measurement in Microbicide Clinical Trials”, sponsored by the Alliance for Microbicide Development and Family Health International, December 18-19, 2007, Washington, DC.

RTI International is a trade name of Research Triangle Institute.

Correspondence to: Ariane van der Straten, PhD, RTI International, 114 Sansome Street, Suite 500, San Francisco, CA 94104 (e-mail: ariane@rti.org).

© 2009 Lippincott Williams & Wilkins, Inc.