Program

Nov 06, 2012

OVERVIEW

Project SAFE is a culture- and gender-specific, behavioral intervention for African-American and Latina women at high risk for sexually transmitted infections (STIs). The small-group intervention is organized around three objectives: recognition of personal susceptibility to STI, commitment to behavior change, and acquisition of STI risk-reduction skills. The intervention is adapted from the AIDS Risk Reduction Model. An experimental evaluation of Project SAFE among high-risk, low-income African American and Latina women revealed positive program impacts on STI, on number of past-year sexual partners, and numbers of unprotected sexual acts in the prior three months.  A similar evaluation of Project SAFE and Project SAFE 2 revealed similar positive impacts of both interventions.

DESCRIPTION OF PROGRAM

Target population: African American and Latina women at risk for sexually transmitted infections.
Project SAFE is a behavioral-cognitive intervention that consists of three, weekly, small-group, multi-component sessions, each lasting between three and four hours.  The program, which is led by trained facilitators of the same race/ethnicity and gender as the program participants, involves open discussion, videos, behavior modeling, and role playing.  Project SAFE 2 includes five optional monthly support groups following the Project SAFE intervention that focus on HIV/AIDs risk; emotional, physical, and sexual risk; gender roles; and love, trust and intimacy.  Project SAFE and Project SAFE 2 are culture- and gender-specific programs geared towards minority women.

The program is organized around three components: recognition of personal susceptibility to STI, commitment to behavior change, and acquisition of STI risk reduction skills.  The first component (recognition of risk) involves developing an awareness of minorities’ increased risk for STI; addressing myths about STIs, STI risk, and the selection of sex partners; and improving understanding of personal STI risk. The second component (commitment to change) involves providing the women with information about STIs and STI treatment and well as STI preventive strategies (including condom use, abstinence, mutual monogamy, and reduction in numbers of sexual partners) as well as by developing realistic relationship goals and decision-making skills. The final component (acquisition of skills) focuses on building communication and negotiation skills within the context of sexual relationships, encouraging communication around condom use, identifying triggers to unsafe sex, setting realistic goals, and sharing information within the group.

EVALUATIONS OF PROGRAM

Shain, R. N., Piper, J. M., Newton, E. R., Perdue, S. T., Ramos, R., Champion, J. D.,  & Guerra, F. A. (1999). A randomized, controlled trial of a behavioral intervention to prevent sexually transmitted disease among minority women. The New England Journal of Medicine, 340(2), 93-110.

Evaluated population: The evaluated population included 617 women (424 Mexican-American and 193 African American women) recruited from public health clinics in San Antonio, Texas in 1993 and 1994. All participants were positive for non-viral STIs (Chlamydia, gonorrhea, syphilis, or trichomoniasis) at enrollment to ensure their high-risk status. The women ranged in age from 14 to 45 years, although the majority (71 percent) were younger than 24.  All of the women could speak English, and most of the women had low education and low income levels.

Approach: Women were tested for infections, treated, consented into the study, and administered a knowledge-based test.  The women were then provided with a standard individual 15-minute counseling session with a nurse clinician, which was tailored to the participant’s sexual history and her responses to the knowledge test. At the end of the initial visit, participants were stratified by race/ethnicity and randomized to the treatment group (n=313) or the control group (n= 304).  Women in the control group received only the standard counseling, but were invited to receive Project SAFE after the evaluation was completed.  Women in the treatment group were provided with three weekly 3-4 hour small-group Project SAFE sessions; they received $25 for their participation in the first session and $15 for their participation in each of the second and third sessions.  The treatment group women were also provided with meals and inexpensive gifts that promoted bonding among members of the small-group sessions. Participants were interviewed at baseline and again at 6- and 12-months; they were also tested for chlamydial and gonorrheal infection.  STI tests were also performed at any “problem” visits to the clinic that occurred in the interim time periods.

The primary outcome of interest was infection with Chlamydia or gonorrhea; the secondary outcomes included multiple sex partners and unprotected sex.

Results: Women in the treatment group were less likely that those in the control group to test positive for Chlamydia or gonorrhea at the 6-month-follow-up (that is, they were less likely to be infected with Chlamydia or gonorrhea between baseline and the 6-month follow-up) and at the 12-month follow-up (they were less likely to be infected between the 6- and 12-month follow-up). It follows, then, that participants in the treatment group were also less likely than those in the control group to test positive for Chlamydia or gonorrhea between the baseline and the 12-month follow-up.  The women in the treatment group were also less likely to have multiple instances of infection over the evaluation period.  At the 12-month follow-up, participants in the treatment group also had fewer sex partners in the prior 12 months and had fewer instances of unprotected sexual acts in the prior 3 months.

Shain, R. N., Piper, J. M., Holden, A. E. C., Champion, J. D., Perdue, S. T., Korte, J. E.,  & Guerra, F. A. (2004). Prevention of gonorrhea and Chlamydia through behavioral intervention: Results of a two-year controlled randomized trial in minority women. Sexually Transmitted Diseases, 31(7), 401-408.

Evaluated population: The evaluated population consisted of 775 minority women (585 Mexican-American and 190 African-American women) ages 14 to 43, who were recruited from public clinics in Texas.  All women enrolled tested positive for a non-viral STIs (Chlamydia, gonorrhea, syphilis, or trichomoniasis). More than one-half (53 percent) were younger than 20, and the majority (91 percent) were younger than 30. Most of the women had low education and income levels. All women were English-speaking.

Due to an unanticipated high number of substance users enrolled in the evaluation (and the lack of focus on this population), the evaluators excluded from the evaluation the very-high risk group of women who were under 18, had dropped out of high school, and were using hard drugs.  The same was true for young women (ages 14 and 15) who had been sexually abused.

Approach: Participants were enrolled in the study within one month of their non-viral sexually transmitted infection.  Participants were consented and treated (if they remained untreated, had not completed treatment, had untreated partners, or had engaged in unprotected sex since treatment).  Participants were then provided with a standard 15-minute counseling session emphasizing topics such as treatment seeking and adherence, mutual monogamy, selective partnerships, and consistent condom use. At the end of this visit, participants were randomized to the control group (n=276) or to one of two treatment groups: the traditional Project SAFE group (n=237) or an enhanced Project SAFE 2 group (n=262).

Women in the control group received only the standard counseling, but were invited to receive Project SAFE after the evaluation was completed.  Women in the Project SAFE and Project SAFE 2 treatment groups participated in three, weekly small-group sessions, each lasting approximately 3 hours. The groups were held separately for each ethnic group and were conducted by a race/ethnicity-matched female facilitator. Additionally, women in the Project SAFE 2 treatment group were given the option of attending five monthly 90-minute support group meetings. Participants were provided with a $25 incentive for their participation in the first session and $15 for their participation in each of the second and third sessions.  The women were also provided with meals and inexpensive gifts that promoted bonding among members of the small-group sessions. Participants in the Project SAFE 2 group were also provided with $5 for each support group they attended.

Participants were interviewed at baseline and again at 6-, 12-, 18-, and 24-months post-baseline. STI screening was provided at the 6-, 12-, and 24-month follow-ups (and was optional at 18-months). The primary outcome was infection with Chlamydia or gonorrhea; the secondary outcomes included sexual risk behaviors.

Results: At both the 12- and 24-month follow-up, women in the Project SAFE treatment group and those in the enhanced Project SAFE 2 treatment group were less likely than those in the control group to test positive for Chlamydia and gonorrhea infection.  The women in these treatment groups were also less likely to have repeat infections over the course of the 24-month evaluation period. Additionally, women in the two treatment groups were also less likely to have multiple past-year sex partners (and they also had fewer cumulative numbers of partners each of the two years and over the evaluation period) and less likely to have unprotected sex with an untreated or incompletely treated sex partner.

Due to the high number of substance users in the sample, the evaluators ran analyses by substance use level (low, moderate, and high) and found that the treatments only had positive impacts on STI compared with the control for those in the “low” substance use category.
SOURCES FOR MORE INFORMATION

References:

Shain, R. N., Piper, J. M., Holden, A. E. C., Champion, J. D., Perdue, S. T., Korte, J. E.,  & Guerra, F. A. (2004). Prevention of gonorrhea and Chlamydia through behavioral intervention: Results of a two-year controlled randomized trial in minority women. Sexually Transmitted Diseases, 31(7), 401-408.

Shain, R. N., Piper, J. M., Newton, E. R., Perdue, S. T., Ramos, R., Champion, J. D., & Guerra, F. A. (1999). A randomized, controlled trial of a behavioral intervention to prevent sexually transmitted disease among minority women. The New England Journal of Medicine, 340(2), 93-110.

Shain, R. N., Ramos, R., Perdue, S. T., & Newton, E. R. (2002). Project SAFE: An Intervention to prevent STIs among minority women. Los Altos: Sociometrics.

Program information and curriculum materials available at:  http://www.socio.com/hap10.php

KEYWORDS: Adolescents (12-17); Young Adults (18-24); Females Only; Black/African American; Hispanic/Latino; Urban; Clinic/Provider-based; Manual is Available; Skills Training; STD/HIV/AIDs; Sexual Activity Use; Condom Use and Contraception

Program information last updated on 11/6/12.