Safer Sex Intervention Program

The intervals for the booster sessions were chosen based on:

1. Typical intervals for return to clinical care (e.g., STI re-screening recommendations at the time of the original study, contraceptive checks, etc.)
2. Intervals over which movement from one stage of change to the next might be expected, according to the Transtheoretical Model of Behavior Change
3. Intervals over which sexual behavior and its consequences might occur with sufficient frequency to assess intervention effects

Sites will have to balance these considerations if they need to alter the follow-up schedule owing to practical concerns. (2-14-2011)

The original study did not evaluate the efficacy of administering the booster sessions by means other than in person, in the clinic. Critical elements of the booster sessions include that:

1. They be administered in privacy with an assurance of confidentiality for what is discussed
2. They are one on one with an SSI educator
3. They can allow for offering a viewing of the video and condoms

These elements may be more difficult, but not impossible to ensure outside of the clinic setting. However, it may be difficult to schedule the booster sessions without the option of alternative settings. Videoconference is a possibility if consideration is given to the elements listed above. Telephone-administered booster sessions would not be an appropriate adaption. (8-16-2011)

While I think that peers could be taught to follow the intervention manual, I designed the intervention to be administered by an adult. Viewed at the outset of the intervention, the video helps to normalize teens discussing and using condoms through a clip of two teen girls.

The intervention was designed for female patients seen for STI treatment in the Division of Adolescent/Young Adult Medicine at Boston Children’s Hospital or admitted to the hospital for management of pelvic inflammatory disease (PID). As such, the reading level, language, and expectations for ability to engage in the intervention activities were for teenagers and young adults (the youngest participant in the randomized controlled trial was 13 years of age and all participants had had sexual intercourse). I would recommend reviewing the materials carefully and considering developmentally appropriate modifications if the intervention is to be used with middle school children.

In the original study, I hypothesized that the diagnosis of cervicitis or PID presented a “teachable moment,” such that the young women would be more receptive to an intervention to reduce their sexual risk behaviors than they would be if the material was presented during a routine health care visit or at another random time. Further, requiring an STI diagnosis for inclusion in the study made it likely that the participants were engaging in current or recent sexual risk behavior (part of the theoretical basis for the intervention is predicated on the adolescents engaging a behavior that needs to change to reduce risk). However, the intervention can be effective if delivered to women without an STI diagnosis. A replication was conducted in Columbus, Ohio, with young women at risk for, but not necessarily diagnosed, with STI. I would not advise using the intervention in its original form for youth who have never had sexual intercourse.

Young women presenting for STI testing and perhaps also those presenting for pregnancy testing (who do not desire pregnancy and are, in fact, not pregnant) are thinking about the consequences of their sexual behavior and therefore may be motivated for behavior change. (2-14-2011)

It is not out of the question to identify high-risk adolescents in settings outside of a clinic or hospital, such as an alternative school. However, there would need to be a way to screen for students for whom SSI would be appropriate, ensure privacy and confidentiality, and arrange access to sexual and other health services. Consideration would need to be given to how to prevent participants from being identified by other members of the school community as at-risk and how to manage requests to participate from low-risk students. (8-16-2011)

In the original study, I excluded pregnant patients because their intentions to use condoms may differ from non-pregnant patients. I would think including teens who were post-partum would be fine.

We did not discontinue participation for participants who became pregnant during the study. In the original study, our outcomes of interest pertained to STI prevention and acquisition, issues relevant to both pregnant and non-pregnant women. If your only outcome of interest is pregnancy, then you could argue that there is no point in continuing the study for pregnancy participants as you would be using study resources for someone who has already had the outcome. However, you could argue that the participant should continue in the study as you will be measuring secondary STI-related outcomes and because the participant could still benefit from the sessions. Your evaluation can take into account the occurrence and timing of the pregnancy for those participants affected. (4-6-2012)

Yes. In the original study, all of the health educators were female nurses or public health students.

The original study offered the intervention only to female adolescents and young adults who had been diagnosed with a sexually transmitted infection and therefore were presumed to not be engaging in safer sex behaviors consistently. It is important to choose an appropriate (i.e., similar) target population to minimize the likelihood that many of the young women will be engaging in safer sex behaviors already and therefore not be appropriate participants for SSI. Additionally, stage determination is through assessment by the educator as well as by the participant. A young woman may indicate on the Wheel of Change that she is beyond the Contemplation stage, but the educator may determine otherwise during their discussion. (9-21-2011)

The video was designed to introduce the topic of the intervention, using peers and story-telling to communicate facts about the consequences of unprotected sex and about using condoms, promote safer sex peer norms, and model condom use negotiation and behavior. The original video also served as an icebreaker, providing the material in an engaging and humorous manner. The video can be replaced with one better suited to your particular population, but it should be brief, include peers, demonstrate correct condom use, and preferably use humor or otherwise be entertaining. (9-21-2011)

I have provided some wording on a waiver of parental permission below. Sites can feel free to use or adapt the wording for their Institutional Review Board (IRB) proposals but should discuss with me any intention to use in future grant applications or publications. I frequently use similar wording in my proposals and papers. I have also shared some guidance from the Boston Children's Hospital's IRB on this matter — they have been a national leader on human subjects' concerns in research in children.

My language: We will not be obtaining written consent from the parent or legal guardian of recruited youth under the age of 18 years. This is in accordance with the federal regulations governing research (45 CFR 46), Section 116(d).¹ These regulations allow a waiver of the parental permission requirement for informed consent when (a) the research involves no more than minimal risk, (b) the waiver would not adversely affect the rights and welfare of the participants, (c) the research could not practicably be carried out without a waiver, and (d) whenever appropriate, the participants will be provided with additional pertinent information after participation. Our proposed study meets all four of these criteria. Importantly, with regard to criterion (c), this significant and needed research could not be practicably conducted without a waiver of parental consent because we would not be able to ensure confidentiality around the adolescents' sexual activity and substance use if parental consent were required for adolescents ages 15 to 17 years. Lack of a waiver of parental consent would hinder recruitment, particularly of youth engaging in high-risk behaviors, and more importantly, have the potential to severely limit the generalizability of the findings. As stated in the Position Paper of the Society for Adolescent Medicine on Guidelines for Adolescent Health Research,² “low response rates and sampling bias may be considered evidence of impracticability.”

In addition, the report and recommendations for research involving children of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research3 recognizes that parental permission is not a reasonable requirement when the research examines issues related to conditions for which adolescents may legally receive care without parental consent, such as reproductive health care. All states afford adolescents the right to consent to their own care around STIs, which is a right that is also protected by federal law. (2-14-11)

Boston Children's Hospital Committee on Clinical Investigation (CCI)

In accordance with DHHS regulations, the waiver of parental informed consent with reliance solely on the child/adolescent’s consent is permitted in two situations. The first situation is when research meets the criteria listed which includes the research (i) involves no more than minimal risk to the subjects; (ii) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (iii) the research could not practicably be carried out without the waiver or alteration; and (iv) whenever appropriate, the subjects will be provided with additional pertinent information after participation. A second criteria which is not limited to minimal risk research is when it is unreasonable to obtain the parent’s permission (e.g., the research involves health care issues subject to confidentiality specific to an adolescent subject). This situation is common in areas of adolescent research that involve sexually transmitted diseases, birth control, high-risk behaviors and AIDS prevention. Parental permission is to be obtained whenever reasonable. However, in situations in which the investigator considers it unreasonable, the CCI is to carefully consider the investigator’s request and determine whether the waiver falls within the guidelines established by the Society of Adolescent Medicine and federal regulations. An additional waiver form is available as part of the protocol application should a waiver of parental permission be requested for this purpose. If the CCI determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement for protecting the subjects (e.g., neglected or abused children), it may waive the consent requirements, provided an appropriate mechanism is substituted to protect the children who will participate as subjects in the research, and provided that the waiver is not inconsistent with federal, state, or local law.

1. Protection of Human Subjects. (Accessed Feb. 2, 2025, at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html.)
2. Santelli JS, Smith Rogers A, Rosenfeld WD, et al. Guidelines for adolescent health research. A position paper of the Society for Adolescent Medicine. Journal of Adolescent Health 2003;33:396-409.
3. The National Commission for the Protection Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Research Involving Children. Washington, DC: US Government Printing Office; 1977. Report No.: DHEW Pub. No. (OS) 77-0004.