Women of childbearing age living in high HIV/STD prevalence inner-city neighborhoods often face the dual challenge of pregnancy and disease prevention. Family planning (FP) clinics are a natural venue for reaching these women as they are important sites for care; unfortunately, pregnancy and disease prevention counseling and services are often poorly integrated. This project seeks to 1) test the efficacy of an individualized, clinic-based, provider-delivered intervention designed to increase adoption and maintenance of dual protection (DP) - i.e., methods that provide concurrent protection from both HIV/STDs and unintended pregnancy; and 2) examine the determinants of DP. Prior to the intervention trial, formative evaluation will elicit information on provider and client behaviors, experiences, values, and attitudes that will be used to tailor the intervention and assessment. In the intervention trial, a cohort of 500 low-income, primarily minority, HIV-seronegative, non-pregnant women will be recruited from the Community Healthcare Network's (CHN) Crown Heights Clinic and be randomized based on day of clinic visit to immediately receive (1) Standard of Care, which consists of HIV pretest and method selection counseling; or (2) Risk and Decision-making (RAD) counseling, which likewise provides pretest counseling but uses a semi-structured, individualized approach rooted in decision-making theory to help clients simultaneously address both disease and pregnancy prevention goals. Women will be assessed at baseline, immediately post-counseling, and six and 12 months later. Tests for pregnancy and STDs will be conducted at each time point as well. At the 6-month visit, all women who receive standard of care at baseline will again receive standard of care. Among women who receive RAD at baseline, half will be randomized to again receive RAD counseling at the 6-month follow-up; the rest will receive standard of care. Primary analyses will evaluate intervention impact on safer sex behavior, incident pregnancy/STDs, and client HIV/STD risk perception. At 6-month follow-up we will examine the effect of a single session of RAD vs. Standard of care; at the 12-month follow-up, we will examine the effectiveness of one versus two sessions of RAD against standard of care. Interview data also will be used to evaluate the determinants of DP and mediators of intervention efficacy; analyses will examine the role of confounding and mediating variables using generalized estimating equations.
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