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Randomized Controlled Trial of a Safer Sex Intervention for High-Risk Adolescent Girls
Lydia A. Shrier, MD, MPH;
Rose Ancheta, MPH;
Elizabeth Goodman, MD;
Victoria M. Chiou, BA;
Michelle R. Lyden, RN, PNP;
S. Jean Emans, MD
Arch Pediatr Adolesc Med. 2001;155:73-79.
ABSTRACT
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Objective To determine the effect of an individualized safer sex intervention
on condom use and recurrent sexually transmitted disease (STD) among female
adolescents diagnosed as having an STD.
Design Randomized controlled trial.
Setting Urban children's hospital adolescent clinic and inpatient service.
Participants One hundred twenty-three adolescents with cervicitis or pelvic inflammatory
disease.
Intervention Participants completed a questionnaire and then were randomized to receive
standard STD education or to watch a videotape and have an individualized
intervention session. Follow-up questionnaires were completed at 1, 3, 6,
and 12 months. Intervention participants met with an educator at 1, 3, and
6 months to discuss interim sexual history and review the intervention.
Main Outcome Measures Change in self-reported condom use and recurrence of STD. Other self-reported
behaviors, sexual risk knowledge, attitudes toward condoms, and condom use
negotiation skills were also assessed.
Results At 1 month, compared with control participants, intervention participants
had increased sexual risk knowledge and more positive attitudes toward condoms
and tended to use condoms more with a nonmain partner. At 6 months, fewer
intervention participants than controls had sex with a nonmain sexual partner
in the previous 6 months. At 12 months, intervention participants were less
likely to have a current main partner and had a lower rate of recurrent STD
than controls, but these differences were not significant.
Conclusions This individualized safer sex intervention may improve condom use and
decrease the number of partners among adolescent girls who have had an STD.
Studies with larger samples are needed to determine definitive intervention
effects on recurrent STD in this high-risk population.
INTRODUCTION
SEXUALLY TRANSMITTED diseases (STDs) are a major cause of morbidity
among adolescent girls. Approximately two thirds of persons who acquire an
STD each year are younger than 25 years,1 with
minority female adolescents disproportionately affected.2
Adolescent girls who have had an STD are at particularly high risk for recurrent
STD.3, 4, 5 As many
as 54% of girls younger than 15 years develop a second infection with Chlamydia trachomatis 1 to 6 years after initial chlamydial
infection.3
A safer sex intervention for adolescents must capture their attention,
impart information, and promote attitudinal and behavior changes in one brief,
intensive session. Booster sessions may be important in sustaining behavior
change.6 Effective STD interventions recognize
gender-specific issues,7, 8, 9, 10, 11, 12, 13
address developmental factors, are pilot tested, and are based on behavior
change theory.12
Social Cognitive Theory postulates that a person's behavior is uniquely
determined by reciprocal interactions among environmental influences, behavior,
and personal factors, including self-efficacy (the confidence in one's ability
to perform the behavior).13 Interventions that
apply Social Cognitive Theory include (1) information to increase awareness
and knowledge of the consequences of behavior, (2) social and self-regulative
skills development to translate the knowledge into preventive action, (3)
opportunities for guided practice and corrective feedback in applying the
skills, and (4) suggested changes in social norms and supports for desired
behavior change.14
Drawing in part on Social Cognitive Theory, the Transtheoretical Model
of Behavior Change provides a practical approach to individual-level interventions.15 The Transtheoretical Model suggests personalized
counseling and recognizes the dynamic nature of change, which is postulated
to occur through the stages of precontemplation, contemplation, determination,
action, and maintenance.16, 17
Studies17, 18, 19, 20
indicate that this model can be adapted for sexual risk behaviors, such as
condom nonuse. The technique of motivational interviewing uses the principles
of individual responsibility, internal attribution, and cognitive dissonance
to move an individual from one stage of behavior change to the next21 and is applicable to counseling for young people.22
Social Cognitive Theory, the Transtheoretical Model of Behavior Change,
and motivational interviewing provide the conceptual framework for the present
randomized controlled trial of a safer sex intervention individualized for
female adolescents who have had an STD, with a 12-month follow-up.
PARTICIPANTS AND METHODS
PARTICIPANTS
Study participants were younger than 24 years and presented to a hospital-based
adolescent clinic for treatment of cervicitis (by positive endocervical test
results for gonorrhea or chlamydia) or were admitted to the affiliated pediatric
hospital for management of pelvic inflammatory disease (PID). The opportunistic
study intervention was designed to be administered at the time of STD treatment,
when the participant was most likely to be considering her diagnosis and associated
risk behaviors. Patients who were treated for an STD before laboratory confirmation
were excluded from study participation. Patients who were pregnant at the
treatment visit were also excluded. Finally, patients who had been exposed
to the intervention through their participation in the pilot study23 were excluded. Between July 6, 1996, and July 7,
1998, 330 patients had cervicitis or PID, 239 of whom met the eligibility
criteria. Of 91 patients excluded from the study, 39 had received treatment
for cervicitis before laboratory diagnosis, 18 were pregnant, and 34 had participated
in the pilot study (Figure 1). Of
239 eligible patients, 123 consented and were randomized to receive the intervention
or standard education; 64 participants had PID and 59 had cervicitis. For
82 patients, a research assistant was not available to approach them for study
participation at the time of treatment. Thirty-one patients refused study
participation because of time constraints, concerns about confidentiality,
or disinterest, and for 3 patients, the medical provider did not think that
study participation was appropriate because of complicating medical or psychological
issues.
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Figure 1. Study enrollment. Asterisk indicates
inclusion of a booster session; PID, pelvic inflammatory disease.
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Participants were randomized to receive safer sex education according
to either the study intervention (n = 60) or standard care (n = 63), stratified
by presenting diagnosis (cervicitis or PID) using 2 separate random numbers
lists. Three participants with cervicitis who were enrolled and randomized
did not receive the intervention or return for any follow-up visits. There
were no differences between the intervention and standard care groups in presenting
diagnosis, demographic characteristics, or baseline scale scores or behaviors.
Of 123 participants, 81 (66%) returned for the 1-month follow-up visit, 72
(59%) for the 3-month visit, 90 (73%) for the 6-month visit, and 64 (52%)
for the 12-month visit. Only 14 patients (11%) did not return for any follow-up
visits; 40 (33%) attended all 4 follow-up visits. There were no differences
in follow-up rates between the intervention and control groups. There were
no differences in demographic variables or baseline condom use between participants
who followed up and those who did not. The study was approved by the Committee
on Clinical Investigation (institutional review board) of Children's Hospital,
Boston, Mass.
METHODS
Measures
After a sociodemographic interview, participants completed a self-administered,
62-item questionnaire that used items from previously validated surveys. Questions
about age of first sexual intercourse, number of sexual partners (lifetime
and past 3 months), use of alcohol or other drugs before sexual intercourse
(ever and the last time), and condom use with last sexual intercourse were
adapted from the Youth Risk Behavior Survey.24
Using a scale developed by Redding et al,25
the adolescents were asked if they had a main partner currently and if they
had another, nonmain partner in the past 6 months; consistent condom use stage
of change was measured with 5 items for each type of partner. This scale required
skipping questions as directed and used a scoring algorithm to determine stage
of change. As part of this scale, frequency of condom use (5-point response
scale, from "every time" to "never") with a main partner and with another
partner was assessed. Both condom use frequency variables were dichotomized
to determine inconsistent condom use ( "not every time" or "every time") for
each type of partner. Participants were asked to report history of previous
STDs or PID and types of sexual intercourse (vaginal, oral, and anal). A 15-item
true-false sexual risk knowledge scale targeted facts emphasized in the intervention
(scored 0-15). Attitudes about condoms were measured by summing agree-disagree
responses to 10 statements.26 A 6-item condom
use negotiation self-efficacy scale measured how often the participant felt
able to ask a partner to use a condom without fear of anger, rejection, or
misunderstanding using a 5-point Likert-type response scale (scored 6-30).
For each scale, if at least 80% of items had responses, the mean value of
the obtained responses was substituted for the missing responses.
Standard Education
For participants randomized to the standard care condition, STD education
was provided at the discretion of the treating clinician. This education included
a discussion of STD transmission and the importance of consistent condom use.
Participants were offered free condoms at the conclusion of the visit.
Intervention
The intervention began with a 7-minute videotape adapted from Time Out: The Truth About AIDS, HIV, and You,27
in which popular entertainers and sports figures discussed and dramatized
condom names, buying condoms, and negotiating condom use and 2 female adolescents
demonstrated condom use to their peers. Condom use was portrayed as normative
behavior.
The female health educators were trained by the principal investigator
(L.A.S.) in the theoretical underpinnings of the intervention and motivational
interviewing techniques. The educators used a standardized intervention manual
developed for this study that outlined key points to cover, activities to
perform, and motivation strategies to employ.
The educational session began with a self-assessment exercise. Participants
were asked to mark on the Wheel of Change (Figure 2) the phrase that best represented where they were in thinking
about changing their sexual risk behavior.
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Figure 2. The Wheel of Change was used by
participants to self-assess stage of change regarding their sexual risk behavior.18
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While conveying the same basic information to each participant, the
educator individualized the session based on assessment of the participant's
stage of change. The intervention recognized that adolescents with an STD
were most likely to be in an early stage for change of high-risk sexual behavior.
For participants in the precontemplation stage, the emphasis was on imparting
information and feedback about unsafe sex. For those in the contemplation
or determination stage, the discussion included creating a list of pros and
cons of condom use and role-playing condom use negotiation.
The educator offered the participant the following list of topics and
asked her to guide the order and emphasis of the intervention: consequences
of unprotected sex, risk perception, preventing pregnancy, preventing STDs,
condoms, spermicide, obtaining condoms, secondary abstinence, and talking
about sex. The educator (1) reviewed the videotape; (2) discussed STD transmission
using a pelvic model; (3) asked the participant to practice correct condom
use on a penis model; (4) discussed secondary abstinence; (5) demonstrated
use of the female condom; and (6) provided written materials about safer sex,
condoms, and spermicide and a gift of a condom key chain. Approximately 30
minutes were required to cover the intervention topics.
All participants were asked to return for follow-up visits 1, 3, 6,
and 12 months after enrollment to complete the questionnaire again. They were
offered $10 at each follow-up visit. Intervention participants had a booster
session with an educator at 1, 3, and 6 months to indicate their current stage
on the Wheel of Change, discuss interim sexual history, and review the content
of the intervention. These participants were offered condoms, written materials,
and the opportunity to view the videotape again.
Data Analysis
Changes from baseline to each follow-up visit for the scale scores and
condom use frequency variables were calculated and differences between treatment
groups were determined using the Mann-Whitney U test.
For the dichotomous risk variables—condom nonuse with last sexual intercourse,
inconsistent condom use with main partner and with another partner, having
a main partner, and having another partner—change in the risk behavior
was categorized as follows:
- Risk (behavior present) at baseline, no risk (behavior not present)
at follow-up
- No risk at baseline, no risk at follow-up
- Risk at baseline, risk at follow-up
- No risk at baseline, risk at follow-up
Differences between treatment groups in change in risk from baseline
to each follow-up visit were analyzed using the  2 test. Difference
between treatment groups in the proportion of participants reporting recurrent
STD at the 12-month visit was determined using the 2 test.
For the intervention group, differences in Wheel of Change stage between baseline
and each follow-up visit were determined using the Wilcoxon signed rank test.
All analyses were conducted using SPSS for Windows, version 10.0 (SPSS Inc,
Chicago, Ill).
RESULTS
There were no significant differences between the intervention and standard
education groups in baseline sociodemographic characteristics or sexual history
(Table 1). The median age of participants
was 17.2 years, and the median last grade completed was 11th. Participants
were of diverse race and ethnicity. Sexual risk behaviors were prevalent.
Sixty-two percent of participants reported having only vaginal intercourse;
25% had vaginal and oral intercourse; 3% had vaginal, anal, and oral intercourse;
and 2% had only oral intercourse (both of these participants had culture-positive
cervicitis); 8% did not respond to the item (data not shown).
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Table 1. Baseline Characteristics of Female Adolescents With STDs*
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At baseline, less than half of the participants reported using a condom
with last sexual intercourse (Table 2).
Of 93 participants reporting a main partner in the past 6 months, only 26
(28%) used condoms consistently with this partner. Consistent condom use with
another, nonmain partner was more frequently reported. Baseline median knowledge,
attitudes, and negotiation scale scores were high. The cervicitis group had
higher baseline knowledge (P = .03) and negotiation
(P = .008) scores than the PID group. On the stage
of change scale, 73% of respondents did not follow the instructions to skip
questions and thus the scale could not be scored. On the Wheel of Change,
49 intervention participants (82%) marked their stage of change for safer
sex behavior. As expected, most were in a pre-action stage: of those who completed
the Wheel of Change, 11 (23%) indicated contemplation; 27 (56%), determination;
3 (4%), action; and 8 (17%), maintenance.
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Table 2. Condom Use, Partnering, and Scale Scores at Baseline and Follow-up
Visits*
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Results are presented for the 1-, 6-, and 12-month follow-up visits
(Table 2). There were no differences
between treatment groups in change in any of the study variables at the 3-month
visit. At 1 month, compared with controls, intervention participants had greater
increases in STD risk knowledge (P = .02) and positive
attitudes toward condoms (P = .007) and were somewhat
more likely to report more frequent (P = .08) and
more consistent (P = .09) condom use with a nonmain
partner. For the change in knowledge score, the group x diagnosis interaction
was not significant. At 6 months, compared with controls, fewer intervention
participants reported increasing their risk of having sex with a nonmain sexual
partner in the previous 6 months (P = .01), and there
was a tendency for fewer intervention participants to report increased risk
of condom nonuse with last sexual intercourse (P
= .09). As at 1 month, at 6 months, intervention participants had greater
increases in positive attitudes toward condoms than did controls (P = .007). At 12 months, intervention participants tended to have decreased
risk of having a main sexual partner (P = .07) compared
with controls. At the 12-month follow-up visit, 17% of intervention participants
reported having an STD since enrolling in the study compared with 32% of participants
receiving standard education (P = .17) (data not
shown).
Because it was part of the intervention, the Wheel of Change was administered
to intervention participants only. Compared with their baseline self-assessment,
intervention participants had positive movement in self-stage on the Wheel
of Change at each follow-up visit. By the 12-month visit, most participants
who completed the Wheel of Change indicated that they were in the action (38%)
or maintenance (25%) stage (Wilcoxon signed rank test comparing 12-month visit
with baseline, P = .04).
COMMENT
In this randomized controlled trial, we sought to determine whether
a theory-based safer sex intervention individualized to participants' stage
of change would reduce sexual risk behaviors and recurrent STD in a high-risk
sample of adolescent girls diagnosed as having an STD. The opportunistic intervention
was designed to be conducted at the time of STD treatment. Three booster sessions
were included at intervals typical for clinical return visits and consistent
with movement in stage of change. A 1-year follow-up visit provided a long-term
assessment period not frequently reported in intervention trials in adolescents.28
The small sample size and modest follow-up rate require that we consider
the data with caution. However, the results suggest that the intervention
was related to improvement in cognitive and behavioral factors. We found that
at 1 month the intervention was associated with higher sexual risk knowledge
and better condom use attitudes. The data also suggest an increase in the
frequency of condom use with a nonmain partner among intervention participants,
but the difference from controls did not reach statistical significance. Because
only 28 adolescents (35%) who followed up at 1 month reported a nonmain partner
in the previous 6 months, the study had limited power (35%) to detect a significant
difference in condom use between groups. Baseline condom use frequency was
higher with a nonmain partner than a main partner, which might indicate further
progression along the stages of change and explain the tendency toward improvement
in condom use seen for a nonmain partner only. Other studies20, 29
have found differences in condom use frequency with main vs other sexual partners.
Recognition of the nature of the partner relationship and its impact on safer
sex behaviors is an aspect of intervention development that requires further
investigation.30 In their efforts to encourage
condom use and other safer sex behaviors in adolescents, health care providers
need to inquire about main vs other sexual partners and determine with their
patients factors that might enhance or hinder condom use with specific partners.
The number of sexual partners may be the most important risk factor
for STD.31 Six months after enrollment, we
found that intervention participants were much less likely than controls to
report having a nonmain sexual partner in the previous 6 months. Twelve months
after enrollment, intervention participants tended to be less likely than
controls to report a current main partner. Because abstinence is the most
effective safer sex behavior, an intervention effect of decreasing the likelihood
of having a sexual partner is noteworthy.
There are several limitations to this study. The sample was drawn largely
from an urban pediatric hospital's general adolescent clinic and might not
be representative of other adolescent populations. However, the baseline sexual
history and behaviors in this sample are consistent with frequencies reported
by other studies with adolescent clinic,32
urban youth,33, 34 and school-based35 samples. The sample size was small, limiting the
power to detect an intervention effect, and the low participation rate threatens
the external validity of our results. It is possible that the adolescents
who declined participation differed on the sexual risk cognitive and behavioral
measures from those who enrolled in the study. The attrition rate was moderate,
but it is unlikely that the results were biased by attrition because there
were no differences in baseline characteristics between participants who followed
up and those who did not. However, we cannot exclude the possibility that
treatment group differences may have been smaller if more participants had
completed the follow-up visits. The unavailability of a research assistant
to approach 82 eligible adolescents might have introduced bias.
Improvements in the cognitive and behavioral outcomes were not seen
consistently over the follow-up visits, which may be a function of the small
numbers of participants returning at each visit. None of the analyses revealed
significant improvements in the control group over the intervention group,
suggesting that the reported findings are unlikely to result from chance.
Self-reported measures of STD risk behaviors were used, the validity of which
is open to question.36, 37 The
sexual risk knowledge, condom use attitudes, and condom use negotiation scale
scores were skewed, likely resulting in a ceiling effect on score changes.
The significant improvement in scores on the knowledge and attitudes scales
for intervention participants is notable in light of the high baseline scores.
Results of the condom use stage of change scale could not be evaluated in
this study owing to the participants' inability to correctly follow the skip
pattern. Since this study concluded, a version of this scale has been developed
that does not include a skip pattern,20 which
might be easier for adolescents to complete. Results on the Wheel of Change
support the assumption that at baseline most adolescents who received the
study intervention were in a pre-action stage of change for safer sex. Adolescents
who received the intervention showed forward movement in their stage of change
as measured by this instrument. Further study of the progression through stages
for adolescent girls with STDs receiving standard safer sex education is needed
to determine whether this movement was due to intervention effect. Validation
of the Wheel of Change will be important because it might prove to be a useful
tool to measure stage of behavior change in research and clinical practice.
Despite progress toward meeting the Healthy People
2000 objectives for the reduction of STDs, adolescents consistently
show slower decline in STD rates than adults.38
Rates of the behaviors targeted by the STD/HIV (human immunodeficiency virus)
risk reduction objectives have been found to have increased in the general
adolescent population38 or declined only in
subgroups of adolescents, such as male high school students.35
To effectively reduce STD rates, theory-based educational interventions to
promote healthy sexual behaviors must target groups of adolescents not being
reached by current efforts. Individualized, theory-based safer sex education
administered at the time of STD treatment can be an effective intervention
with adolescent girls. The results of this randomized controlled trial suggest
that sexual risk knowledge and condom use attitudes might be improved in the
short term and that sexual risk behaviors might be reduced in the long term.
More research with larger sample sizes is needed to further evaluate the effect
of this targeted intervention on STD recurrence in this high-risk population.
AUTHOR INFORMATION
Accepted for publication September 11, 2000.
This study was supported by the Children's Hospital Aerosmith Endowment
Fund, Boston, Mass; the Harvard Pilgrim Health Care Foundation, Boston; project
MCJ-MA259195 of the Maternal-Child Health Bureau (Title V, Social Security
Act), Health Resources and Services Administration, US Department of Health
and Human Resources, Rockville, Md; the Alfred E. Frechette Postdoctoral Fellowship
in Public Health (1998-1999) from the Massachusetts Health Research Institute,
Boston (Dr Shrier); and Mentored Patient-Oriented Research Career Development
Award 1 K23 MH01845-01 from the National Institute of Mental Health, National
Institutes of Health, Bethesda, Md (Dr Shrier).
Presented in part at the annual meeting of the Society for Adolescent
Medicine, Los Angeles, Calif, March 18, 1999.
We gratefully acknowledge Lynn Basilio, MPH, Kate Berrien, MPH, Lisa
Kelly, BS, Laura Robertson, BA, and Elizabeth Yellen, BA, for their assistance
in entering data and conducting the intervention educational sessions and
study follow-up visits. We are indebted to the young women who participated
in this study and shared their private lives with us.
From the Division of Adolescent/Young Adult Medicine, Children's Hospital,
Harvard Medical School, Boston, Mass.
Corresponding author and reprints: Lydia A. Shrier, MD, MPH, Division
of Adolescent/Young Adult Medicine, Children's Hospital, 300 Longwood Ave,
Boston, MA 02115 (e-mail: shrier{at}a1.tch.harvard.edu).
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