| Project SAFE (Sexual Awareness for Everyone) |
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Science and Success, Second Edition: Sex Education and Other Programs that Work to Prevent Teen Pregnancy, HIV and Sexually Transmitted Infections Full Study Report [HTML] [PDF] Program Components
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Evaluation MethodologyProject SAFE:
Project SAFE-2:
Evaluation Findings
Evaluators’ comments: Despite substantial observed ethnic differences in attitudes, behaviors, and re-infection rates, the cognitive-behavioral intervention used in Project SAFE resulted in similar, proportionate reductions in the rate of re-infection among both ethnic groups, comparing study women with control women. This accomplishment is encouraging, in light of the disproportionate burden of sexually transmitted disease borne by low-income minority populations in the United States. Program DescriptionThis gender specific and culture specific behavioral intervention is based on cognitive behavioral theories, including the Health Belief Model, self-efficacy theory, diffusion theory, and decision-making models. It conforms to the stages of the AIDS Risk Reduction Model. The intervention consists of three multi-component sessions, each lasting three to four hours. Participants (ranging from three to 12 in a group) and a female facilitator (of the same race or ethnicity as participants) meet once a week for three consecutive weeks. Contents of the culture specific interventions are the same, although emphases and cultural cues vary. Highly trained facilitators provide information and also actively involve participants in lively and open discussions and games as well as in watching videos, modeling behaviors, and participating in role plays. Facilitators encourage participants to identify realistic risk-reduction strategies within the context of their own life and values. Discussion covers abstinence, mutual monogamy, correct and consistent condom use, full compliance with STI treatment protocols, and reducing the number of one’s sex partners. In addition, participants are also encouraged to continue with optional support groups in meeting in five once-a-month sessions.[42,43] In addition to the multi-component sessions, participants receive screening and treatment for STIs along with routine follow-up appointments at six, 12, 18, and 24 months after the baseline screening as well as encouragement to come in for screening whenever symptoms of STIs arise.[42,43] Evaluation MethodologyProject SAFE: Participants were recruited from public health clinics in San Antonio, Texas. They were Latinas and African American women who had a non-viral STI, such as chlamydia, gonorrhea, syphilis, or trichomoniasis. All participants spoke English. After giving informed consent, participants were interviewed and received baseline examination, screening for STIs, treatment where necessary, and counseling. At this point, participants were randomly divided into treatment and control conditions. Controls received standard STI counseling, lasting about 15 minutes, provided by nurse clinicians and conforming to guidelines issued by the Centers for Disease Control & Prevention. Participants, whether treatment or control, also received follow-up appointments for six and 12 months later and encouragement to come in if and when they experienced STI symptoms or feared re-infection. Participants received $25.00 for their initial visit and for their six-month visit; they received $50.00 for the 12-month visit.[42] Seventy-one percent of participants were younger than age 24; the mean age of intervention group was 21.8 years and that of the control group was 21.3 years. Monthly income for the intervention group was a mean of $243.00 while that of the control group was $267.00. Women’s mean educational attainment was 10.8 years in both groups. Seventy percent of participants were Mexican American (70 percent of intervention group and 68 percent of control group); the rest of the women were African American (30 and 32 percent, respectively). At baseline, 28 percent of women in the intervention group and 33 percent of the control group were pregnant. There were no significant differences at baseline between intervention and control group participants in the proportion infected with various STIs. Among the intervention group, 21 percent were infected with gonorrhea, 67 percent with chlamydia, 26 percent with trichomoniasis, and six percent with syphilis. Among the control group, 21 percent were infected with gonorrhea, 71 percent with chlamydia, 21 percent with trichomoniasis, and six percent with syphilis.[42] After stratification according to race/ethnicity, a total of 424 Mexican American and 193 African American women were randomly assigned to study (n=313) or control (n=304) conditions. Rates of participation among the study group were 90 percent for the first session, 82 percent for at least two sessions, and 75 percent for all three sessions. Enrollment began in January 1993 and ended in July 1994. Six- and 12-month retention rates were 82 percent at six months (84 percent of study group; 80 percent of controls; total=508); and 89 percent at 12 months (91 percent of study group; 87 percent of controls; total=549). Twenty-six women with six-month visits were lost to follow-up at 12 months, while 67 women who missed the six-month screening returned at 12 months. Repeat screening for chlamydia and gonorrhea were also performed at a total of 260 problem visits. The analysis included 509 women at six months, 545 at 12 months, and 549 for the total study period. Behavioral analysis included results for 477 women who attended both follow-up visits. Rates of loss at follow-up did not differ significantly between study and control groups for any subgroup analysis.[42] Project SAFE-2: The evaluation protocol was nearly the same as in the first Project SAFE except that there were two treatment conditions (with and without optional support group meetings). All Mexican American and African American women diagnosed with gonorrhea, chlamydia, syphilis, or trichomoniasis in public health clinics were referred to the study for potential participation. Eligible English speaking women of reproductive age (15 to 45 years old) were offered enrollment.[43] Fourteen-year-old women were enrolled only at the specific request of the Health Department or their guardians and with special IRB permission. Researchers unexpectedly enrolled a much higher proportion of alcoholics and drug addicts in this study than in the previous study. Substance users were not excluded unless they were under age 18, used hard drugs, and had dropped out of middle or high school. Women with only two of these three risk factors were still allowed to enroll. Young teens, ages 14 and 15, who had been sexually abused were allowed to participate but were excluded from analysis. Fifty-three enrolled women were later declared ineligible because of: protocol violations (n=5); severe mental illness (n=2); criminal activity in the clinic (n=1); being sexually abused 14- to 15-year-olds (n=16); or 14- to 17-year-old dropout users of hard drugs (n=29).[43] A total of 585 Mexican American and 190 African American women were randomly assigned to enhanced intervention (Project Safe-2; n=262; with follow-up for a full two years), standard intervention (Project SAFE; n=237; with follow-up for one year), or a control group (n=276). All participants received follow-up appointments for six, 12, 18, and 24 months later and were encouraged to come in if and when they experienced STI symptoms or feared re-infection. Participants received $25.00 for their initial and their six-month visits; they received $15.00 for the 18-month visit and $50.00 for each of the two annual visits (12 and 24 months).[43] Enrollment began in March 1996 and ended in June 1998. Of 1,271 potentially eligible women 33 percent declined to participate. Intervention show rates (before the six-month visit) were 96 percent for at least one session, 92 percent for at least two sessions, and 86 percent for all three sessions. Among women assigned to the enhanced intervention, 63 percent chose not to attend the optional support groups; however, 37 percent attended at least one session prior to their six-month visit and 26 percent attended two or more sessions. Twelve-month and 24-month retention rates (based on 775 eligible women) were both 91 percent (n=709 and 707, respectively). No group differences in retention rates were detected although, within the enhanced intervention group, women who attended support groups had higher retention rates than those who did not attend (96 versus 84 percent, P=0.004). Support-group non-attendees subsequently lost to follow-up (compared to non-attendees who were retained in the program) were more likely to have had more than one partner at baseline (P≤0.06) and to have had syphilis (P≤0.001).[43] Low levels of income and education characterized the study participants; 53 percent were under age 20 and 85 percent under age 25. Less than 10 percent were married and over 60 percent had more than one partner in the previous year. Most importantly and despite random assignment, one or both intervention groups had a higher percentage of women who were under age 20, were in high substance risk categories, and/or had multiple additional screenings for gonorrhea and/or chlamydia. Support group attendees, compared to non-attendees, had less education (10.1 versus 10.7 years; P≤0.02), were more likely to be young (62 versus 50 percent; P=0.056), and were likely to report three or more partners in the previous three (13 versus five percent; P≤0.03) and six month periods (27 versus 13 percent; P=0.007).[43] Project SAFE Outcomes:
Long-Term Impact
Project SAFE-2 Outcomes:
Long-Term Impact
Note: Analysis of the effects of support group attendance indicated that both attendees and non-attendees were less likely than controls to be infected with gonorrhea or chlamydia (45 and 37 percent less likely; P≤0.004, 0.01, respectively). In year two, attendees were 42 percent less likely than controls to be infected (P≤0.05) whereas differences between non-attendees and controls did not reach statistical significance.[43] Note on Project SAFE: When the evaluators looked at racial/ethnic differences in regard to risk and protective behaviors of women in the intervention and control groups, they found that the intervention was equally effective with both groups (OR=0.58 and 0.54, respectively). African American women reported more douching after sex, less mutual monogamy, and more rapid partner turnover. However, Mexican American women appeared slightly more likely to have sex with an untreated partner. There were no other differences in sexual behaviors likely to lead to STIs. A consistent pattern emerged in which most sexual risk behaviors were less common in intervention group participants than in control participants, regardless of their race/ethnicity.[42,44] For More Information or to Order, Contact
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