Developing a Dyadic Intervention for STI/HIV Prevention in Youth
Phase: NA
Conditions: Exposure to Sexually Transmissible Disorder (Event)
Sponsor: Johns Hopkins University

 
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Date: March 17, 2021  
Principal Investigator: Maria Trent, MD, MPH 
Application Number: IRB00148707 
 
 
 
 
 
 
 
Study Protocol 
 
OFFICIAL TITLE: Developing a Dyadic (Partner-Based) Intervention for Sexually Transmitted 
Infections (STI)/HIV Prevention in Youth 
NCT03275168 
Date of Document: March 17, 2021 
Date of Upload: January 7, 2022 
 
 

 
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JHM IRB - eForm A – Protocol 
 
 
 
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1. 
Abstract 
 
Adolescents and young adults less than 25 years of age continue to have the highest rates of sexually 
transmitted infections [STIs] in the United States. While public health control programs have shown 
some success the disparities for this population remain. For this reason additional supports to increase 
engagement in care and reduction in acquisition of STIs as a part of establishing a healthy sexuality 
are needed. STI prevention work with adolescents has primarily targeted individual level factors and 
fails to address higher level factors such as peer, media, and relationship influences that may influence 
sexual decision-making and behavior. Partner notification and treatment is a key strategy for disease 
control within the population to improve the health and well-being of the individuals affected by the 
disease process and has previously been explored among adults for STI/HIV prevention work but has 
yet to be explored in adolescents and young adults. In our prior research, we demonstrated that 
adolescent girls with complicated sexually transmitted infections are highly likely to notify their 
partners for treatment (88-92%), but that only those who experience brief behavioral interventions 
are 3 times more likely to be successful in arranging for partner treatment than girls receiving standard 
of care. There has been a failure to use our knowledge about the structure and function of romantic 
relationships occurring during critical developmental learning periods, to engage youth for individual 
and dyadic behavior change. Partner interventions for STI prevention have significant promise for 
harnessing the power of relationship dynamics to enhance sexual decision-making, communication, 
and subsequent health behaviors. In the EXPERIENCE study, we propose to pilot an intervention 
designed to change STI outcomes by understanding partners and the learning environment related to 
sex. If successful, this pilot will support adoption of an alternative cost conscious, but effective 
strategy for engaging young men involved in sexual relationships affected by an STI diagnosis for 
both individual and relationship behavior change. Proving that heterosexual adolescents and young 
adults can consistently and safely engage their partners in a supportive outpatient setting that 
integrates treatment with evidence-based STI/HIV prevention interventions delivered by gender 
matched professional dyads. 
 
During this COVID-19 pandemic, urban centers have been hard hit, but there has been little 
discussion regarding the impacts of sexual behavior and relationship interactions on the spread of 
COVID-19 within the community. The Women’s BioHealth cohort presents a vulnerable group of 
adolescent and young adults (AYA) who may be able to provide insights on how COVID-19 stay 
at home orders have impacted sexual behaviors and overall risk for STIs. COVID-19 stay at home 
orders may complicate the social situations for some AYA in the greater Baltimore Metropolitan 
Area given the known disparities in health, poverty, housing, and violence. We would like to 
conduct follow-up outreach calls to the Tech2Check participants to include questions about 
impacts of COVID-19 stay at home orders on sexual risk-taking behaviors, access and unmet need 
for sexual and reproductive health (SRH) services. We include assessments of social support, 
perceived safety, and resources to evaluate the impact of those factors on SRH risks. We also 
determine need for re-engagement in care and willingness/ability to use telemedicine services to 
fulfill unmet health needs.  
 

 
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2. 
Objectives 
 
1. To demonstrate the feasibility of the dyadic intervention for young urban dyads with a recent STI 
diagnosis as evidenced by recruitment and short-term retention [6 weeks].  
2. To demonstrate acceptability of a dyadic intervention for STI/HIV prevention for urban young 
dyads with a recent STI diagnosis as evidenced by appointment attendance, visit completion, and 
satisfaction by those who complete the intervention.  
3. To demonstrate the preliminary effectiveness of the intervention for increasing mutual sexual 
negotiation self-efficacy and self-reported communal coping at the end of the intervention visit and 
condom consistency at 6 weeks compared with dyads who receive individual interventions in a 
primary care setting to better operationalize the notion of transformational motivation in AYA dyads 
in the context of sexual relationships. 
4.   To improve our understanding of urban adolescent and young adult relationships in which a STI 
diagnosis has occurred and the extent to which partner dynamics and social context influence sexual 
health among urban partner-dyads affected by a STI diagnosis using in-depth interviews.  
The focus of this pilot will be on completion of EXPERIENCE study visits, delivery of the 
intervention, patient satisfaction with the experience, and learning more about relationships and 
sexual health among young dyads that will inform any future iterations of the dyadic intervention.    
 
To evaluate the impact of the COVID-19 stay-at home orders on TECH-N participants’ SRH 
behaviors and risk for STI. 
 
Hypothesis 1:  AYA with a greater number of psychosocial risk factors across housing, food 
insecurity, income, and social support will have greater engagement in sexual risk-taking behaviors 
(e.g. non-condom use, non-use of contraception) during the COVID-19 stay at home order. 
Hypothesis 2: AYA with reduced SRH risk-taking behaviors during the COVID-19 stay at home 
orders are more likely to engage in increased SRH risk-taking behaviors once the order has been 
lifted.  
 
 
 
3. 
Background  
Our team has conducted prior research that serves as a backdrop for dyadic research with adolescent 
and young adults and a strategy to reach males for treatment and preventive services. Our Gender-
Based Differences Study utilized secondary data analysis from the Adolescent Health Study, a 
population-based telephone survey study in which urban adolescents from a high STI-prevalent 
community were queried about their sexual experience, fertility-related knowledge, beliefs related to 
timing of childbearing, and risk assessment of future fertility problems. Regression analyses indicated 
that female adolescents were more likely than male adolescents to identify chlamydia and pelvic 
inflammatory disease as causes of fertility problems. The most disturbing finding was that 72% of 
adolescent girls perceived significant risk for future fertility problems and almost 60% thought they 
had little or no control over it. We surmised that additional health education and motivation would be 
needed to increase adolescent participation in asymptomatic STI screening programs and the greatest 
challenge would be how to involve male adolescents given that fewer male adolescents understand 
the link between female fertility and common STI-related conditions despite their high value for 
partner fertility. 
 
The Young Women’s Health study (was a randomized controlled trial (RCT) funded by the Robert 
Wood Johnson Foundation that tested the effectiveness of a brief video intervention grounded in the 
health belief model to improve self-care behaviors associated with PID. The study was conducted at 

 
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two institutions with clinic and emergency department sites in Baltimore, Maryland covering census 
tracts most affected by STIs. The major finding from this work was that it demonstrated that the group 
viewing the video intervention prior to discharge [which included the treatment tag line “…. if he 
loves you, he’ll do it right?” was significantly more likely to engage in secondary prevention through 
partner notification for treatment compared to the standard of care control group. Although there were 
no differences in the rates of partner notification, girls in the intervention arm were 3 times more 
likely to facilitate partner treatment. This work suggests that one of the most powerful elements of 
intervention after an STI is partner engagement.  
 
Male Sexual and Reproductive Health Needs  
Dr. Gaydos has conducted extensive research with young men demonstrating the impact of STIs on 
young men and has been intrinsically involved in 1) guiding diagnostic testing, screening, and 
prevention approaches for STIs 2) pushing the field by using internet ordered-self-testing and 3) 
evaluating new diagnostic tests for STIs to further improve public health outcomes for men.  Dr. Trent 
conducted secondary analyses of data from the Adolescent Health study, a household study of urban 
adolescents 15-19 years in high STI prevalent communities in California, which demonstrated the 
high value of future fertility to youth across gender, but significant gender-based differences in STI 
knowledge as it related to infertility prevention. We identified the need at that time to involve male 
adolescents in STI prevention efforts given the high value they place on fertility preservation. 
 
In a series of projects lead by our team, the evidence for investment in and guidance for male sexual 
and reproductive health (SRH) services has been established. As an example, an analysis of data from 
the National Survey on Family Growth demonstrated that adolescent males were significantly less 
likely than female youth to receive SRH counseling from their health providers In a more recent cross-
sectional study of 16-35 year old males, 346 participants’ willingness to talk about 11 SRH topics 
with their healthcare provider and their preferred approach (provider- or self-initiated) was examined.  
Almost all participants (84%–98%) were willing to talk about all SRH topics and the top three were 
STI risk (98%); testicular cancer (98%); and HPV vaccine (97%). The majority preferred that the 
health provider initiated discussions, demonstrating the potential openness to clinic-based 
conversations by health providers as a proactive strategy for prevention with males experiencing STI 
exposure and/or diagnosis.  An earlier analysis demonstrated that this work could be performed in 
clinical settings primarily geared towards women.  This suggests that seeking care in a non-gendered 
adolescent-centered practice as employed in our design may be equally or more conducive male 
engagement. Finally, a sexual health curriculum for SRH was developed for use in a Baltimore youth 
employment and training program in 2008–2010 involving 197, mostly African American males aged 
16–24 years. Ninety-eight participants received three one-hour curriculum sessions on consecutive 
days; 99 served as controls. In analyses adjusting for baseline characteristics, intervention participants 
3 months later were more likely than control males to report increases in knowledge of STIs and 
health care use (odds ratio, 1.6 for each), frequency of condom use (1.8), use of lubricant with 
condoms (23.6), communication with a provider about STIs (12.3) and STD testing (16.6). We will 
use the specific experiences in implementation of a male SRH intervention to incorporate and 
effectively engage the male partner as a part of the STI treatment visit.  
 
The Perceived Risks for Sexually Transmitted Diseases (PRSTD) Study showed the importance of 
measuring risk perception in a partner specific manner, a second cohort was recruited and followed 
prospectively for three years to determine 1) age-related patterns of sexual behavior and STD 
acquisition among adolescents and young adults, 2) how an adolescents’ relative power in a sexual 
relationship affects condom behavior, 3) the accuracy of adolescents’ partner-specific PRSTD, and 
the concordance of childbearing plans among adolescent heterosexual dyads. Data was collected from 
392 sexually experienced 14 - 19 year old males and females who were seeking care at either the 
Baltimore City Health Department STD clinic or the Johns Hopkins Adolescent Medicine Clinic.  

 
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Most recent main sex partners of a random selection of participants at baseline were recruited into the 
study resulting in data on 132 adolescent heterosexual dyads.  This dyadic data has led to significant 
contributions to the literature, leading to a greater understanding of the poor agreement between 
adolescents’ perception of their partner having other sex partners and partner-reported behavior, such 
that adolescents who presume that they are in a mutually monogamous relationship often 
underestimate their own sexually transmitted disease risk. Findings from the second cohort motivated 
recruitment of a third prospective cohort, which collected daily electronic diaries to examine how 
changes in intimacy and perceived partner concurrency impact STD risk perception, sexual behaviors, 
and STD acquisition over time within adolescent dating relationships. Data from this cohort has 
shown significant variability in adolescents’ STI-associated feelings, perceptions, and behaviors 
within their sexual relationships and that this variability predicts behavior.  Further findings 
demonstrate that adolescent relationships last for a long duration despite concurrency within the 
relationship. It is on this premise that we further build our case for intervention designed to reduce 
and improve the quality of the relationship with this vulnerable population of youth. 
 
4. 
Study Procedures 
 
Overview of Study Design 
 
 
 
Setting: This research study will be conducted in Baltimore, Maryland. Maryland currently ranks 12th 
in the nation for incident infections with Neisseria gonorrhea (GC) and Chlamydia (CT) among its 
citizens and there are disproportionate rates of infection among individuals residing in Baltimore. The 
Maryland Department of Health and Mental Hygiene has determined that every county is a Chlamydia 
hotspot and county maps demonstrate that among hotspots, the city of Baltimore is the most densely 
affected. Although there are extremely low rates of youth non-insurance, the utilization of primary 
care providers for routine health maintenance drops off considerably. The Adolescent and Young 
Adult Clinic at Johns Hopkins established a Title X reproductive health clinic to serve the youth of 
Baltimore to aid in resolving the reproductive health access issues facing urban youth. The clinic sees 
over 200 unduplicated positive STI cases and partner referrals annually. Patients may also be referred 
for treatment through the Johns Hopkins Wellness Center, the Johns Hopkins Pediatrics Emergency 
Department, and/or the Baltimore City Health Department clinical sites. 
 
Participants and Recruitment: 
Fifty dyads will be recruited from Johns Hopkins primary and affiliated institutions in the greater 
Baltimore metropolitan area.  Index participants engaged in heterosexual relationships will be asked 
to recruit their main partner for enrollment in the dyadic intervention pilot. The index participant and 
their partner will contact study staff to be scheduled for a research visit together. Our target is to have 
complete data on 40 dyads so we set sample size at 50 in order to account for attrition.  However, we 
will stop recruiting when we reach 40 participants.   
 
Enrollment, Consent, Randomization, and Treatment: Recruiters will be available via phone 
during office and some evening hours for the Title X clinical setting. Providers for study contact will 
refer patients. Patients who agree to be contacted will be approached by a recruiter in person-or via 
phone and if eligible, the dyad will be scheduled for written informed consent and intervention 
procedures. At enrollment, the research staff will perform a detailed review of the EXPERIENCE 
 
50 Male or Female 
patients who self-
recruited 
main sexual 
partner 
 
 
Baseline 
Informed Consent 
Enrollment 
Randomization 
 
Individual 
gender-matched 
intervention merging 
key components of  
Focus on the Future  
and  
Sister-to-Sister 
 
 
EXPERIENCE 
 gender-mixed 
intervention 

 
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study with informed consent.  While the index patient and their partner are required to present together 
for study enrollment, they will each be consented separately.  Participants will have the option to 
separately consent for 1) completing both the ACASI and dyadic intervention and 2) additionally 
completing an in-depth interview. All study protocol study forms will be faxed to the project director 
at the time of enrollment and online questionnaire/ interview will be automatically uploaded to a 
secure server for warehousing in a central database. After enrollment, participants will be assigned to 
the control (1) versus intervention (2) using a computer generated randomization assignment.  
Envelopes based on dyadic study group number will be available to the research staff at the time of 
enrollment to adhere to the randomization sequence.  
 
Participants, Recruitment, Enrollment, and Consent for an In-Depth Interview Only: 
Index participants that are screened and eligible for the EXPERIENCE study intervention, but cannot 
recruit a partner or are not interested in the dyadic intervention will be asked to participate in a one-
time in depth interview about AYA sexual health. Consent for the in depth interview only will be a 
separate form. We expect to enroll up to 40 participants for the in depth interview. 
 
 
STI Testing/Notification of Positive cases 
All participants will be offered bacterial STI Testing through the Johns Hopkins Title X program and 
will be notified and treated for positive results by a team clinician who will assist with arranging 
treatment.  Three attempts will be made to reach the patient using their preferred contact number.  
Patients who fail to respond after three attempts via phone and/or MyChart will be sent the standard 
certified letter indicating that they have laboratory results that require their attention. No detailed 
results will be sent via mail. Documentation of attempts to reach patient will be placed in the electronic 
medical record to facilitate follow-up by medical providers during future visits. Patients who contact 
the team at any later date while the study is active will be referred for care. By law, the Johns Hopkins 
Hospital laboratory and the research team have an obligation to report positive cases of Neisseria 
gonorrhoeae and Chlamydia trachomatis to the Baltimore City Health Department (BCHD). Faxed 
reports will be sent to the health department. 
 
Remuneration 
Index patients and partners who complete treatment and the intervention will receive $50 
remuneration for the EXPERIENCE pilot visit, $50 for the 6-8 week telephone or in-person follow-
up interview, and $50 for participation in optional the in-depth interview.  Bus tokens will be provided 
participants  with transportation issues. 
 
Participants who agree to participate for the 2 COVID-19 calls will receive a total of $50. After each 
completed call, a $25 gift card will be sent via mail. 
 
 
Figure 1: The EXPERIENCE Study Recruitment Algorithm 
 

 
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Figure .2: Overview of Study Procedures 
 
 
 
 
 
 
 
 
Intervention 
EXPERIENCE Intervention 
The EXPERIENCE intervention is designed to utilize the STI partner treatment visit to engage young 
males and their female partners in treatment and risk reduction interventions.  Integral to the 
EXPERIENCE intervention is use of two effective behavioral interventions designed to reduce 
STI/HIV risk behaviors. We will use the Focus on the Future [FOF] for male and Sister-to-Sister 
[STS] for female participants. Both have 20-minute one-on-one sessions with a gender-matched 
health educator to guide the patient through skills-based risk reduction counseling. These 
interventions have been evaluated with African American males and females residing in communities 
with high STI rates and were found to increase condom use, reduce unprotected intercourse, and 
reduce new STIs among participants and are considered effective interventions for clinical 
implementation by the Centers for Disease Control and Prevention. The novel part of this intervention 
is that sexual partners will come together at the end of the individual sessions for a joint debriefing 
session that includes viewing of the condom negotiation videos and role-playing communication for 
condom use. At the end of the session with the EXPERIENCE health educators, the patient will be 
able to state/demonstrate: 1) understanding of the definition of STIs 2) how to prevent future STI 
episodes; 3) proper use of male and female condoms, 4) use of effective communication and condom 
negotiation strategies with their partner. Low-resource patients in our practice have been receptive to 
health educator support and our preliminary studies indicate that improved communication between 
an adolescent and her partner occurs with the support of a professional who can educate and motivate 
adolescents with an STI, and provide expertise on STI management. We will record a subsample 
(N=20) of intervention sessions for quality assurance purposes.  We will use video/audio recording 
of dyadic intervention sessions to ensure intervention delivery is consistent with the protocol and to 
identify content themes to bolster our understanding of relationship dynamics and the potential of 
communal coping.    
 
Index Participant
Yes to Participation 
in Dyadic 
Intervention
Recruits Partner and 
Participates in Dyadic 
Intervention
No to Participation in  
Dyadic Intervention 
or Unable to Recruit a 
Partner
Ask Participant If 
She/He Will 
Complete In Depth 
Interview Only
Recruitment Screener  
--> Eligible
Exit 
Exit 
Weekly SRH text msgs 
Enrollment
STS +FOF 
+ Joint De-
STS +FOF 
Weekly general health text 
Baseline 
6 weeks 
Optional 60-
minute in-depth 
interview 

 
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We will provide text message boosters related to care-seeking behavior, condom use, and condom 
access, over the six weeks of the study. Messages will be standardized and delivered via an 
automated one-way system.  These messages have well tested in the field with urban adolescents 
and young adults. No protected health information is disclosed as a part of this communication, but 
youth will be encouraged to provide an extra layer of protection on existing cell phone security to 
allow for an additional degree of privacy related to message content. We will send a welcome 
message right after enrollment “welcome to the EXPERIENCE study”, followed by one text every 
week, including: “don’t’ forget to try out your new communication skills”, “Did you practice the 
Experience role play?  Text the # of times you practiced together”, “Condoms prevent STDs. Stop 
by the clinic if you need some”, “Condoms can improve pleasure, if you need some stop by the 
clinic”, and “Want to up your game, practice your condom technique”. In week six, we will send 
“Thanks for trying EXPERIENCE, we’ll call you soon for feedback”.   
 
We will use SMS services through TextNow for communicating with participants in both arms of the 
study. TextNow is one of the fastest growing technology companies in North America and has created 
an all IP, cloud-based mobile phone carrier and mobile messaging and application service that has 
more than 8 million monthly active users.  It is the hybridization of Wi-Fi with cellular for texting 
and calling and can be enabled for use on a phone, tablet, or computer that makes this platform optimal 
for our pilot study. Further, TextNow has strict policies to protect the user to prevent unauthorized 
disclosure of information and physical, electronic, and procedural safeguards are in place according 
to industry standard procedures and security procedures. Research staff will be responsible for 
monitoring and using the online account to send standardized text-message boosters to participants 
in the study. Since a telephone number is created with each account, the telephone number will be 
recognizable to participants as EXPERIENCE communication. Finally, all participants will be 
encouraged to use standard safety mechanisms such as a pin or password to lock access to their cell 
phones by others. 
 
Control Group 
Participant dyads in the control group will also receive the 20-minute Focus on the Future [FOF] for 
male and Sister-to-Sister [STS] for female participants one-on-one sessions with a gender-matched 
health educator to guide the patient through skills-based risk reduction counseling. As noted above, 
these interventions have been evaluated with African American males and females residing in 
communities with high STI rates and were found to increase condom use, reduce unprotected 
intercourse, and reduce new STIs among participants and are considered effective interventions for 
clinical implementation by the Centers for Disease Control and Prevention.   While they will check 
out of the intervention together and be given information to set up next steps, they will NOT 
engage in the facilitated dyadic group process that includes viewing the condom negotiation 
video, role-playing, and group debrief with the health educators.  Participants in the control arm 
will also receive positive health-related attention-control text messages focused on general health 
(healthy eating, exercise, spending time with family and friends, healthy sleep).   No text messages 
related to relationships or condom use will be sent.  As with the intervention group, we will send 
“Thanks for trying EXPERIENCE, we’ll call you soon for feedback” in 6 weeks.  None of texts will 
request a response. 
 
COVID-19 Procedures 
Due to the COVID-19 pandemic, the remainder of participants will be recruited and enrolled virtually. 
We will be utilizing social media for recruitment and zoom to complete the enrollment visit. 
Recruiters will screen potential recruits over the phone and if eligible, set up a zoom meeting for 
enrollment. Participants will be consented with the oral consent script. The recruiters will read the 
baseline ACASI to the participants and record their answers. There will be separate zoom meeting 
for the individual gender-matched intervention and if the participants are randomized to the 

 
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intervention group, they will join after for the joint-debrief session. The exit survey through Qualtrics 
will be read to the participants afterwards by the recruiters and record their answers.  
 
Gift cards will be mailed to the participants after the enrollment visit has been completed. 
 
The 6-8 follow-up survey will remain the same and be completed over the phone with the participant.  
 
 
In-depth Interviews 
For a subset of participants, we will conduct separate in-depth, semi-structured, face-to-face and/or 
via telephone interviews. Participants for the interview will either be 1) enrolled in the EXPERIENCE 
study intervention and agree to the additional and optional in depth interview or 2) agree to participate 
in an in depth interview only and not enrolled in the intervention. The interview will explore the social 
context, specifically social support; relationship qualities, modeling, and communication; and 
communal coping, that informs AYA partner-dyad’s sexual health individually and at the partner 
level. For those participants that are enrolled in the intervention: the interview will occur 6-8 weeks 
after the dyad has completed the intervention. For those participants agreeing to an in depth interview 
only: the interview will be scheduled after written consent is completed. Participants will also be 
asked to complete a brief demographic questionnaire. We anticipate 40 individual interviews, but will 
continue sampling until we reach data saturation. The interviews for female and male partners will be 
conducted separately as to avoid any bias or influence of partner presence in given responses. An in-
depth interview guide has been developed for the individual interviews. The semi-structured 
interview guide focuses on obtaining AYA perceptions of how social context informs sexual health. 
The concepts of sexual health that will be explored will include sexual experiences, partnering 
decisions, sexual communication, and prevention of STIs. The development of the interview guide 
will be an iterative process, which will allow additional questions to be added to the interview guide 
as necessary. Using the interview guide, the interviewer will ask open-ended questions and seek 
clarification or elaborations as necessary. All sessions will be audio-recorded and the interviewer will 
take written notes during and after each interview. During the interview, the interviewee will be asked 
to refer to themselves, partner(s), and/or other individuals only by an initial to protect confidentiality 
on recorded audio. Participants who complete the in-depth interview will receive $50 in remuneration.   
 
COVID-19 Survey 
We will conduct outreach regarding COVID-19 via phone. Questions will include basic information 
about living conditions, sexual behavior, relationship status, and SRH behaviors and healthcare needs 
since the stay-at-home order [March 16, 2019 (school closings)] through the present.  We will 
interview individuals at baseline and three months from their designated call to determine if there is 
any change in behavior or circumstance [attached]. 
 
 
 
 
Quality Control 
 
1. Treatment Fidelity: Drs. Trent and Dr. Marcell [with technical assistance [TA] for specific 
interventions] will train and supervise research staff to ensure protocol execution with dyads.  
2. Recruitment Screener: Includes collection of basic demographic data and the outcome of 
recruitment effort so that we can keep an accurate account of referral patients who are ineligible 
and/or refuse to participate in the intervention. We include a standard question about (intimate partner 
violence) IPV in the screener to determine if this is a reason for refusal and/or influence the 
communication/behavior in the relationship over time. Participants who screen positively, will be 
provided with information and resources about IPV in the individual visit and referrals placed to the 
primary health provider for additional services.   

 
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3. Surveys: We have developed a survey to collect sexual and reproductive health history, perceived 
barriers to treatment, and self-efficacy data to be administered online during the study visit. This 
interview will be modified for this study, but will include: demographics, reproductive and sexual 
history (# partners, partner status (main versus casual), relationship status, coital frequency, prior 
STIs, condom use consistency, contraceptive use preferences for partner notification (e.g. female 
partner notification, case worker notification, email, text message), emotional response to diagnosis, 
access to medical care, access to technology (phone, internet, text), social provisions scale, and the 
short-form survey instrument (SF-12) as a measure of health-related quality of life, Fertility 
Knowledge and Awareness Scale, clinical symptoms, sensation seeking scale, relationship qualities 
scale and intimate disclosure scales to measure relationship quality and dyad communication, 
childbearing motivation, and communal coping.  We will also query patients at the end of the 
intervention to determine their level of confidence for negotiating with their partner and their 
satisfaction with the experience. It is important to test these measures with participants and the timing 
of completion.  
 
Participants will be contacted in 6-8 weeks for a brief (~30 min) telephone (or in-person) follow-up 
interview to assess sexual risk-taking behaviors, relationship status, social support, and satisfaction 
with the intervention experience.  
 
5. 
Inclusion/Exclusion Criteria 
Inclusion Criteria: The index patient must be 16-25 years, engage in male-female [heterosexual] 
intercourse, permanently reside in the Greater Baltimore Metropolitan Area (includes surrounding 
counties, i.e. Baltimore County, Anne Arundel, Howard County), willing to recruit their main sexual 
partner for the study, are willing to participate in a single individual session with a health educator 
followed by a joint debriefing session together with both health educators. The partner must be 16-
30 years, engage in male-female [heterosexual] intercourse, , permanently reside in the Greater 
Baltimore Metropolitan Area (includes surrounding counties, i.e. Baltimore County, Anne Arundel, 
Howard County), willing to recruit their main sexual partner for the study, are willing to participate 
in a single individual session with a health educator followed by a joint debriefing session together 
with both health educators. 
 
Exclusion Criteria: Index participants and partners who are unable to communicate with staff or 
participate in study procedures due to cognitive, mental, or language difficulties, will not be eligible 
for recruitment into the study. Dyads will also be excluded if in same-sex main partnership or a 
member of the dyad is currently enrolled in another sexual behavior study, the patient/partner is 
currently pregnant, one or both partners has a known concurrent HIV infection, one or more partners 
has a pending incarceration, there is more than five years age difference between the two partners, 
or there is evidence of intimate partner violence [IPV] in the relationship.  Couples who are married, 
engaged or in a committed relationship greater than two years will be excluded. Individuals who 
screen positive for IPV will be referred to local resources for assistance.   The Title X Clinic has 
adopted the RADAR screening approach with identified social work services in place for registered 
clinic patients who need further assessment and assistance.  
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used.  N/A 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are changed. 
N/A 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  N/A 
 
7. 
Study Statistics 

 
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a. Primary outcome variable. The primary outcome variable for this pilot study is feasibility of 
recruitment.  Recruitment feasibility will be defined as the number of dyads completing the 
intervention out of number of eligible dyads.  The feasibility of short-term retention will be 
calculated as the proportion of enrolled participants, who complete a follow-up interview at 6 
weeks.   
b. Secondary outcome variables. The secondary outcome variable for this pilot study is acceptability, 
measured as participant satisfaction with their intervention experience.  Participant satisfaction 
will be measured using a brief survey asking participants to rate their experience and qualitative 
feedback documented. 
c. Statistical plan including sample size justification and interim data analysis. 
We will enroll a total of 50 adolescent dyads. While the choice of 50 dyads is inherently arbitrary, 
it is the number we feel we can realistically enroll within our limited time of this pilot study. 
While we won’t have power to detect statistically significant differences, we will be able to 
examine correlations, which will be informative for future research proposals.  To address each 
aim, we will evaluate our outcomes, feasibility and acceptability, against benchmarks from 
previous studies.  To address aim 1, we will compare observed recruitment rates from the 
proposed pilot study to expected recruitment rates.  Expected recruitment rates will be determined 
from previous studies that recruited adolescents with an STI diagnosis.  Prior studies recruiting 
from the Adolescent Medicine Clinic have achieved recruitment rates ranging from 48to 91%.  To 
address aim 2, we will use a similar approach, comparing satisfaction scores to an a priori 
benchmark of patient satisfaction.  Based on previous work, average patient satisfaction greater 
than 80% would be necessary to conclude that the intervention is acceptable.  
 
For the in-depth interviews, audiotapes and notes from the sessions will be transcribed verbatim 
and uploaded to NVivo 11, a qualitative data analysis software package. We will use constant 
comparative method of grounded theory to analyze the qualitative data. Using a 3-stage analytic 
coding strategy, the transcripts will be examined for salient categories (codes) through constant 
comparison between text within a single interview, within dyads, and between interviews. Axial 
coding will be completed to identify relationships between the codes. Finally, through selective 
coding the core category will be identified and a theory will be developed that integrates and 
explains relationships between axial codes. To ensure validity and qualitative rigor, we will use 
the following three strategies: audit trail with external review, deviant case analysis, and peer 
debriefing. Additionally, to ensure reliability in coding, two coders will independently code each 
transcript and through regular meetings will compare and discuss application of the codebook to 
each transcript until they reach consensus.  
 
COVID-19 Outreach Study 
Descriptive and bivariate analyses will be performed to determine the general impact of COVID-
19 risk on AYA in the sample and to evaluate the covariates such as change in living situation, 
cohabitation, stress, access to SRH services and COVID-fears on SRH behaviors.  
Bivariate analyses generating p 0.1will be evaluated using logistic regression models, 
accounting for potential confounders or effect modifiers.  
 
  
 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency.  
 
There are no significant medical risks involved in this study. Sexual history interviews and 
collection of vaginal and urine specimens are a part of routine care. While the study will attempt 
to preserve patient confidentiality, there is potential for breaches of confidentiality, but miniscule 

 
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given the limited number of personnel with access to participant information. Disclosures by the 
partner to others are an ongoing risk dictated by public health practice given the CDC 
recommendations for partner notification and treatment.  Non-enrolled patients will be given the 
option to notify partners anonymously for treatment and study participation using standard issue 
notification cards commonly employed through the health department.   Finally, while the 
EXPERIENCE intervention focuses on positive communication and condom negotiation; dyad 
strife may develop during the context of the joint session. While health educator will be trained 
in basic conflict resolution; there are staff onsite to provide both mental health [social work; 
mental health counselors, psychologists] and seasoned security staff available to intervene as 
needed. We have previously followed AYA and their partners as a part of clinical practice and in 
research trials [clinic and community-based] without complaints of undue exposure, 
confidentiality breach, or adverse event such as physical or emotional harm to a patient, family 
member, and/or sexual partners who have presented for STI treatment. There have also been no 
complaints by patient, parents/guardians about AYA participation in the sexual health research 
studies. Further, this project was presented to the community advisory board (CAB) for the Harriet 
Lane Clinical Program (Home of the Adolescent Young Adult Practice) [Meeting December 18, 
2014] and community youth and parents found the project highly relevant and were 
overwhelmingly support or this research strategy. Input on youth engagement and retention from 
CAB members has been incorporated alongside preliminary data and research expertise to 
optimize our approach and to minimize risk. 
 
There are no additional risks associated with these telephone calls as this is in line with the work 
that we are currently doing in this study. 
 
 
b. Steps taken to minimize the risks. 
 
Human subject approval has been granted for beta testing of this research protocol by the 
Johns Hopkins institutional review (IRB00083609).  As previously noted, all participants will 
provide informed consent and will be informed that their participation in the study will have no 
effect on subsequent medical care. All patient data will be kept confidential and secure.  Individual 
patient data shared during health education sessions and clinical visits [sexual history data, lab 
results, clinical findings] will not be disclosed to the partner in accordance with HIPAA 
regulations, however, the patient will be encouraged to notify partners regarding behavioral risks 
that impact their partner per standard of care and public health practice. The research team on this 
project has training and experience in the protection of human research participants and the 
treatment of protected health information as evidence by completion of their institutional 
compliance courses that are reviewed every 3 years per Johns Hopkins Medicine faculty and staff 
requirements. New staff without prior training must complete human subjects training through 
the Johns Hopkins Committee on Clinical Investigation courses as a part of orientation training 
and as a condition of their employment. 
 
Maryland state law permits an adolescent under 18 years old to consent to research when receiving 
reproductive care and most adolescents being seen in ambulatory sites at Johns Hopkins seek care 
unaccompanied by a parent, we will not require parental consent for participation in this study.  
The Johns Hopkins Institutional Review Board has approved this approach for the TECH-N, 
YWHS, PRSTD and other research studies described in the preliminary data section without 
experiencing adverse outcomes. Due to the longitudinal approach involved in this study and our 
data showing that they discuss sexual and reproductive health issues with  mothers  we  encourage  
adolescents  to  keep  parents  informed  about  their  general participation in the study.  For the 

 
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purposes of this research, we are only recruiting patients 16 years or older given the range of 
patients seeking care and the primary age of consent in the state of Maryland.   
 
While minors can consent to confidential counseling and treatment in the state of Maryland 
related to sexually transmitted infections, we will set the age of recruitment to 16 years (the age 
of consent to sexual activity in the state of Maryland) as there is no close in age exemption in 
the state of Maryland.  Further, the research team will comply with Maryland law and notify 
local or state authorities related to the mandated reporting of suspected abuse or neglect of a 
child or dependent adult for disclosures that occur in the course of communication with enrolled 
participants during counseling sessions.  Additional language will be added to the consent form 
to ensure that potential participants are aware of this obligation set forth in Maryland law for 
their protection and a separate sign-off for this provision will be added to the consent form using 
a change in research addendum to ensure that participants understand the requirement and 
supports available to them should a report be made in the context of disclosures to research 
staff.  All research staff will complete the required institutional human subjects training and 
additional study-specific training on this topic for effective communication with key contacts to 
facilitate notifications and referrals to mobilize support services for optimal outcomes. 
http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/rep
orting_obligations.html 
 
 
Only members of our clinical care and evaluation team will have access to the patient chart and 
data extraction forms to document STI results.  Involved personnel will be trained and committed 
to confidentiality and protection of patient rights and have received formal training through the 
institution. Additional training on delivery of the interventions and group debriefing will be 
provided to staff. No identifying patient data will be included in any of the presentations or 
publications that may be generated as a consequence of this study.   Our analytic database will 
not contain any patient identifiers, as all participants will be assigned unique identifiers. Due to 
cost constraints, the study cannot have a dedicated data manager.  The principal investigator will 
not access the database except download the collected data for use by contracted data analyst 
through the Institutional Center for Translational Research (ICTR) for interim analyses required 
to generate reports for data safety monitoring committee. 
 
There is no added risk with the COVID-19 Survey. However, as with our other contacts with 
participants, they can be referred to the institutional resources for follow-up for health concerns 
raised during the call. The Adolescent Health/Young Adult Clinic has access to a range of 
additional services including social work and the Johns Hopkins Healthy Community 
Connections program which offers a range of support services including job placement, ride-
share services, legal referral, and food pantry. Research staff who have additional questions 
related to where patients can receive services will contact core outreach staff, community health 
nursing staff, or the principal investigator for advice and support to facilitate referral. All 
referrals will be documented in the research record.  
 
 
Data Safety Monitoring Plan: The study will employ a data safety-monitoring plan consistent 
with NIH guidelines. The research team will meet regularly to communicate about ethical issues 
related to the study. As a small randomized pilot trial, a data-safety and monitoring committee 
[DSMC] will be created. DSMC members will not have any formal association with the study and 
will be selected based on their expertise in AYA clinical interventions, SRH service delivery, and 
biostatistics. The following faculty members have been identified to serve in this role:  Dr. Cynthia 
Rand (Professor of Pediatrics, Johns Hopkins Medicine), Dr. Sharon Ghazarian (Centers for 

 
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Disease Control and Prevention/Johns Hopkins Medicine), Dr. Peter Rowe (Professor of 
Pediatric, Johns Hopkins Medicine, and Dr. Lydia Shirer, MD, MPH (Adolescent Medicine, 
Harvard Medical School) The DSMC will develop a charter to govern DSMC activities and 
develop a communication plan with the research team. Annual data reports will be submitted to 
the DSMC for review prior to the annual continuing IRB review as a part of ongoing study and 
subject monitoring. Online tracking of patient data will be managed via the clinical research 
monitoring system (CRMS) and Biostatistical consultation and support will be obtained through 
the Johns Hopkins Biostatistics Center in conjunction with the Johns Hopkins Institute for Clinical 
and Translational Research. Dr. Trent has budgeted for and will submit a consultation request 
upon grant approval. Dr. Trent has effectively utilized this service for prior research. Use of this 
service for data analytic support will also allow for the study to remain single blinded to the 
principal investigator. 
 
c. Plan for reporting unanticipated problems or study deviations.  
Any unanticipated problems or adverse events will be reported to the IRB immediately. 
Deviations from the original study protocol will be requested through a change in research request. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality.  
 
There are no anticipated legal risks associated with study participation. We have been following 
girls in the community for many years and in their homes without consequence as we have put 
safeguards in place to protect confidentiality as outlined above. 
 
e. Financial risks to the participants.  
 
There are no anticipated financial risks to participations that are unaccounted for in the support 
and remuneration plan. 
 
 
9. 
Benefits 
 
There are no direct benefits to participants in this study. The proposed research is the first to measure 
the feasibility and acceptability of an intervention designed to change [STI] outcomes by 
understanding partners and the learning environment related to sex. If successful, this study will 
support adoption of an alternative cost conscious, but effective strategy for engaging dyads in their 
sexual health.  Additionally, data gathered from the in-depth interviews will serve to inform any future 
iterations or interventions involving dyads. Partners may also receive free STI/HIV testing through 
the Title X program and treated accordingly, that they may not have sought without the infrastructure 
of the study. 
 
10. 
Payment and Remuneration 
 
Study incentives are: $50 for the intervention visit and $50 for the follow-up interview for each 
participant, both patient and partner.  Those participants who elect to complete the in-depth interview 
will receive $50.   
 
Participants who agree to participate for the 2 COVID-19 calls will receive a total of $50. After each 
completed call, a $25 gift card will be sent via mail. 
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify who 
will pay for them. 

 
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There are no anticipated costs to participants that are unaccounted for in the support and remuneration 
plan for the study and/or usual care