Intervention Description
Intervention Package Information
Evaluation Study and Results
References and Contact Information

Intervention Description

Target Population
Heterosexual women in family planning clinics

Goal of Intervention
Reduce unsafe sexual encounters (unprotected vaginal or anal sex occasions)

Theoretic Basis

• AIDS Risk Reduction Model
• Social Learning Theory

Intervention Duration
Eight 2-hour sessions delivered over 8 weeks, followed by a 2-hour booster session delivered about 7 months after completion of the intervention

Intervention Setting
Planned Parenthood Clinic

Deliverer
Two female facilitators, with at least one matching the ethnic background of the majority of participants

Delivery Methods

• Demonstrations
• Exercises
• Goal setting
• Group discussions
• Lectures
• Printed materials
• Role plays
• Video

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Intervention Package Information

An intervention package is not available at this time. Contact Dr. Anke A. Ehrhardt, HIV Center for Clinical and Behavioral Studies, 1051 Riverside Drive, New York State Psychiatric Institute Unit 15, New York, NY 10032, e-mail: ehrharda@child.cpmc.columbia.edu, for details on intervention materials.

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Evaluation Study and Results

The original evaluation study was conducted in Brooklyn, New York between 1994 and 1997. The study sample included 360 women, 82% of whom had a high-school education.

Key Intervention Effects

• Reduced unprotected vaginal/anal sex occasions
• Increased safer sex or no unprotected vaginal/anal sex

Study Sample

• 73% African American; 17% Hispanic; 10% White; 0.3% Asian
• 100% Female
• Mean age of 22 years

Recruitment Settings
Planned Parenthood clinic

Eligibility Criteria
Participants were considered eligible if they were between 18 and 30 years of age, spoke fluent English, and were heterosexually active within the past year. Women who received a blood transfusion between 1980 and 1985, reported injection drug use during the past year, were HIV-positive, or were pregnant or trying to become pregnant were excluded.

Assignment Method
Participants were randomly assigned to 1 of 3 groups: 8-session intervention (n = 112), 4-session intervention (n=128), and an assessment-only control (n = 120).

Comparison Group
Women assigned to the control group received only the baseline, 1-, 6-, and 12-month assessments.

Relevant Outcomes Measured and Follow-up Time

• Sexual risk behaviors during the previous 3 months (including total number of unprotected vaginal and/or anal sex occasions and the proportion of male or female condom-protected vaginal or anal sex occasions) were measured 1-, 6- and 12-months post-intervention.
• Follow-ups occurred at 1, 6, and 12 months after the 8 small group sessions. The 12-month follow-up translates to approximately 5-months after the booster session.

Participant Retention

• 8-Session FIO Intervention:
  92% retained at 1 month
  89% retained at 6 months
  98% retained at 12 months
• 4-Session FIO Intervention:
  94% retained at 1 month
  95% retained at 6 months
  96% retained at 12 months
• Assessment-only Control: 
  90% retained at 1 month
  87% retained at 6 months
  96% retained at 12 months

Significant Findings

• At 5 months post-booster, women in the 8-Session FIO intervention group reported significantly fewer unprotected vaginal or anal intercourse occasions (p<.001) and a greater proportion of condom-protected occasions than women in the control group.
• Among women engaging in unprotected sex at baseline, those assigned to the 8-session intervention were twice as likely to report decreased unprotected sex (OR=2.08, 95% C.I.=1.06, 4.10, p = .03) and reported significantly fewer unprotected vaginal or anal intercourse occasions (p<.001).

Considerations

• Significant effects for the 8-session intervention were reported at the 12-month follow-up, which occurred approximately 5 months after completion of the booster session.
• The 4-session intervention, which covered comparable content to the 8-session intervention, was not found to significantly reduce sex risk behaviors at either the 6- or 12-month follow-ups.

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References and Contact Information

• Ehrhardt, A. A., Exner, T. M., Hoffman, S., et al. (2002). A gender-specific HIV/STD risk reduction intervention for women in a health care setting: Short- and long-term results of a randomized clinical trial. AIDS Care, 14, 147-161.
• Miller, S., Exner, T. M., Williams, S. P., & Ehrhardt, A. A. (2000). A gender-specific intervention for at-risk women in the USA. AIDS Care, 12, 603-612.
• Ehrhardt, A. A., Exner, T. M., Hoffman S., Silberman, I., Yingling, S., Adams-Skinner, J., & Smart-Smith, L. (2002). HIV/STD risk and sexual strategies among women family planning clients in New York: Project FIO. AIDS and Behavior, 6, 1-13.
• Hoffman, S., Koslofsky, S., Exner, T. M., Yingling, S., & Ehrhardt, A. A. (2000). At risk or not? Susceptibility perceptions of women using family planning services in an AIDS epicenter. AIDS and Behavior, 4, 389-398.
• Exner, T. M., Hoffman, S., Parikh, K., Leu, C., & Ehrhardt, A. A. (2002). HIV counseling and testing: Women’s experiences and the perceived role of testing as a preventive strategy. Perspectives on Sexual and Reproductive Health, 34, 76-83.
• Hoffman, S., Exner, T. M., Leu, C., Ehrhardt, A. A., & Stein, Z. (2003). Female-condom use in a gender-specific family planning clinic trial. American Journal of Public Health, 93, 1897-1903.
• Melendez, R. M., Hoffman, S., Exner, T., Leu, C. & Ehrhardt, A. A. (2003). Intimate partner violence and safer sex negotiation: Effects of a gender-specific intervention. Archives of Sexual Behavior, 32, 499-511.
• Exner, T. M., Hoffman, S., Dworkin, S. L., & Ehrhardt, A. A. (2003). Beyond the male condom: The evolution of gender-specific HIV interventions for women. Annual Review of Sex Research, 14, 114-136.

Researcher: Dr. Anke A. Ehrhardt, HIV Center for Clinical and Behavioral Studies, 1051 Riverside Drive, New York State Psychiatric Institute Unit 15, New York, NY 10032. e-mail: ehrharda@child.cpmc.columbia.edu

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