Funding Source and Project Period: NICHD, R01; 2004 - 2009

Collaborating Institutions and Key Personnel:

HIV Center:
Principal Investigator: Joanne Mantell, Ph.D.
Co-Principal Investigators: Susie Hoffman, Dr.P.H.; Theresa Exner, Ph.D.
Co-Investigators: Zena Stein, M.B., B.Ch.;

Reproductive Health Research Unit Wits Health Consortium, South Africa:
Co-Investigators: Jennifer Smit, B.Pharm., Ph.D.; Mags Beksinska, M.Sc.;
Helen Rees, M.B., B.Chir.
Intervention Supervisor: Zonke Mabude, R.N., M.S.
Coordinator of Intervention and Field Operations: Nomsa Queen Cebekhulu, B.A.

Project Overview

(from abstract submitted to NICHD)

Women's unequal position in sexual negotiations highlights the need for methods – such as the female condom – that they can initiate. In South Africa, the female condom has been endorsed as a pregnancy and disease prevention method, and demand has been growing since the launch of a government-sponsored introductory strategy. The female condom has the potential to enhance women's bargaining power within their relationships, but its successful use also depends on male partner cooperation. Few interventions for women to learn female condom negotiation skills have been developed and evaluated, especially in settings such as South Africa, where unequal gender relations pose a special challenge. The proposed study will develop and test a two-session, culture-specific, group-based female condom negotiation and insertion skills intervention on a South African university campus. Our Specific Aims are to (1) develop, implement, and test the effectiveness in a randomized controlled trial of a brief cognitive-behavioral intervention versus a standard information-only intervention on short- and long-term use of the female condom, total number of male and female condom-unprotected occasions, and female condom attitudes among South African female university students; (2) identify the individual, contextual, and method-related determinants of female condom initiation, maintenance, and discontinuation; (3) explore the context of the introduction and use of the female condom for both women and their male partners using qualitative methods, and (4) explore men's attitudes about the female condom and men's role in female condom use. In the Preparatory Research Phase, formative qualitative work (ethnographic mapping on campus and 20 focus groups, N=200) and a campus-wide representative cross-sectional survey of 1,000 students is being conducted to understand the social context and characterize the target population, formulate appropriate intervention messages, and serve as a recruitment source for the Phase II trial. The Trial Phase will test the effectiveness of a cognitive-behavioral skills intervention against an information-only control condition on short- and long-term use and discontinuation of the female condom among 280 women. Participants will be assessed prior to and immediately post-intervention, and at three and six months thereafter. In-depth interviews with 70 female trial participants and 70 of their male partners will augment data provided by women participants to increase understanding of the contextual factors that influence initial adoption, long-term use and discontinuation of the female condom. If successful, this brief intervention should be widely replicable in other similar settings.

Publications related to this project (as of 2/23/10)

Mantell JE, Needham, SL, Smit, JA, Hoffman, S, Cebekhulu, Q, Adams-Skinner, J, Exner, TM, Mabude, Z, Beksinska, M, Stein ZA, Milford, C. Gender norms in South Africa: Implications for HIV and pregnancy prevention among Black and Indian women students at a South African university. Culture, Health, and Sexuality 2009; 11 (2): 139-157. PMCID: PMC2782559; NIHMS#126916.