Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone
Phase: PHASE4
Conditions: Gender Dysphoria, Adolescent
Sponsor: University of Colorado, Denver

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w 
COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax:  303-724-0990 
 
 
 
Protocol #: 22-1037 
Project Title: Counseling among gender diverse adolescents who use depot 
medroxyprogesterone 
 
 
 
 
 
Principal Investigator:  Nancy Fang, MD 
Co-Investigators: Ryan O’Connell, MS; Elizabeth Kvach, MD 
Version Date: 16-SEP 2022 
 
 
 
 
 
  
 
I. 
Hypotheses and Specific Aims:  
Recommendations regarding contraceptive counseling and reproductive health differ amongst 
transgender and gender diverse (TGD) youth compared to cis-gender youth. TGD youth face 
unique health disparities including increased risk of sexually transmitted infections, sexual abuse 
and violence, and unwanted pregnancies. TGD youth also face inequities within the healthcare 
system including lack of access to providers and delay or avoidance of care.  Both patients and 
providers also have misconceptions around pregnancy risk in transgender individuals assigned 
female at birth (AFAB) who are sexually active with people assigned male at birth. Limited existing 
literature demonstrates the need for contraceptive counseling that moves beyond cis- and 
heteronormative assumptions that start with pregnancy prevention and addresses concerns at the 
intersection of gender identity. 
 
Our qualitative study will focus on creating best practices regarding equitable contraceptive 
counseling for TGD youth. We will recruit transgender youth who are AFAB, and currently or 
interested in using depo medroxyprogesterone (DMPA). Through focus groups (FG) and semi-
structured interviews, we hope to gain the perspectives of and experiences of TGD youth with self- 
and clinic- administered DMPA. We hope the results of this study can guide providers in creating 
best practices and more equitable contraceptive counseling for TGD youth. 
 
With this exploratory study, we aim to  
1. Understand the perspectives of, and experiences with previous contraceptive education 
and counseling among transmasculine youth and young adults; 
2. Understand what drives interest in, and initiation or discontinuation of DMPA among 
transmasculine youth and young adults; 
3. Understand why transmasculine youth and young adults choose in office or self- 
administrated DMPA; 
4. Explore the acceptability and satisfaction of office or self-administered DMPA; 
5. Identify the unique patient-centered communication considerations when counseling and 
prescribing contraceptives at the intersection of gender identity in transmasculine youth 
and young adults 
 
 
II. Background and Significance:  
 
The Society of Family Planning, American Academy of Pediatrics, the World Professional 
Association of Transgender Health (WPATH), the American Society of Reproductive Medicine 
(ASRM), and the Endocrine Society have all recommended counseling on contraception and 
reproductive health specific to transgender and gender diverse (TGD) youth. 1,2 TGD youth face 
disparities related to sexual health such as increased risk of STIs, HIV, sexual abuse and violence, 
unintended and unwanted pregnancies, and are less informed about their sexual health when 
compared their cisgender counterparts. 1,3,4 Further, underlying structural inequities, such as 

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discrimination within health care settings, and difficulty finding health systems and providers who 
offer gender affirming care have resulted in unmet healthcare needs, delay or avoidance of care, 
and persistent disparities for TGD youth, particularly within sexual health. 5,6This is particularly 
illuminated by a national survey showing 71% of national OBGYN providers stated they were 
uncomfortable caring for TGD patients assigned female-at-birth, 7and 50% of TGD people report 
having to teach their clinicians about their own health care needs, including reproductive health 
concerns.  
 
Possessing baseline competency in care that is both gender-affirming and recognizes the unique 
needs of TGD patients can play an influential role in creating opportunities for equitable health care 
experiences and sexual health outcomes of TGD youth. Transgender and gender diverse youth 
who were assigned female-at-birth (AFAB) should receive counseling regarding contraceptive 
options when seeking hormone replacement therapy or gonadotropin releasing hormone for 
menstrual suppression, pregnancy prevention, or both.8 However, there is minimal literature on 
counseling regarding the specific use of hormonal contraception in TGD youth, most focusing on 
fertility preservation and pregnancy prevention.9 While these topics are important to address, 
reasons for hormonal contraceptive use also includes menstrual suppression. Menstrual periods 
may be associated with significant anxiety, worsened dysphoria, and social barriers to menstrual 
hygiene such as concerns of personal safety while using public restrooms.10,11 Both patients and 
providers also have misconceptions around pregnancy risk in transgender AFAB individuals who 
are sexually active with people assigned male at birth.8 Obtaining contraception can be difficult 
without invasive and potentially traumatic examinations.12Further, services for adolescents are 
constrained by issues of consent, assent, and parental support of their child’s transitional or 
reproductive decisions.13 This literature, though limited, demonstrates the need for contraceptive 
counseling that moves beyond cis- and heteronormative assumptions that start with pregnancy 
prevention and addresses concerns at the intersection of gender identity. 
 
Patient-centered contraceptive counseling (PCCC) is essential in achieving equitable sexual and 
reproductive health and is a prominent aspect in the Quality in Family Planning Guidelines.14 PCCC 
is measure of patient centeredness and language that evaluates how a patient feels they were 
respected as a person, were able to say what mattered most to them, if their preferences about 
contraceptive choice were taken seriously, and whether they were given enough information to 
make the best decision about their preferred methods. Despite the broader documented 
importance of patient-centered counseling, best practices for working with TGD youth within a 
patient-centered framework does not exist.15 PCCC offers a framework to better understand the 
unique experiences and needs concerning contraceptive counseling in TGD youth despite its cis-
normative and heteronormative underpinnings. Application of this framework to gender expansive 
populations also offers opportunity to assure PCCC can be more equitably framed for all 
populations. 
 
Given the persistent disparities in sexual and reproductive health within TGD youth, it is crucial to 
investigate the unique views, experiences, beliefs, attitudes, language preferences, and desires 
about communication regarding contraceptive use— particularly at the intersection of gender 
identity. For this project, we respond to the call in the literature to center voices of TGD youth, 15 
address direct patient experiences,16 and move beyond previous work which has primarily 
investigated this topic through surveys and secondary data sources. Within this qualitative study 
we will use the underlying principles of PCCC to interview TGD adolescents and young adults 
about perspectives of and experiences with self- and clinic- administered DMPA. We hope the 
results of this study can guide providers in creating best practices and more equitable 
contraceptive counseling for TGD youth. 
 
 
II. 
Preliminary Studies/Progress Report:   
 

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Limited data exists on contraceptive counseling of TGD youth. It a study of 231 TGD 
adolescents, 58% reported current use of contraception. The most reported method 
was DMPA at 35%. Although this study showed that DMPA was most reported, it did 
not measure the perspectives or experiences with TGD youth during contraceptive 
counseling. Previous studies show that TGD individuals may have their gender 
dysphoria worsened by repeatedly taking medication that is associated with cisgender 
women. 17 Additionally, TGD individuals may prefer contraception that does not 
require a pelvic exam and are more likely to choose a contraceptive method which 
suppresses menstruation. 17 Use of DMPA does not require a pelvic exam and 
studies have shown it suppresses ovulation. This makes DMPA a potential preferred 
method of contraception for TGD youth. DMPA can be prescribed as an intramuscular 
(IM) injection or as a subcutaneous (SC) injection. The CDC adopted the WHO 
recommendation for self-administered DMPA-SC in 2021. 18 Compared to the DMPA-
IM dose, DMPA-SC has been proven to be associated with fewer side effects while 
still providing equal efficacy. 19 DMPA-SC has not approved for self-administration 
use by the FDA. Self-administration of DMPA-SC has been proven to result in longer 
continuation rates and higher satisfaction.   
 
IV. Research Methods 
 
A. Outcome Measure(s):   
1. Understand the perspectives of, and experiences with previous contraceptive education 
and counseling among transmasculine youth and young adults; 
2. Understand what drives interest in, and initiation or discontinuation of DMPA among 
transmasculine youth and young adults; 
3. Understand why transmasculine youth and young adults choose in office or self- 
administrated DMPA; 
4. Explore the acceptability and satisfaction of office or self-administered DMPA; 
5. Identify the unique patient-centered communication considerations when counseling and 
prescribing contraceptives at the intersection of gender identity in transmasculine youth 
and young adults 
 
 
B. Description of Population to be Enrolled:   
 
We will recruit up to 40 transmasculine adolescent and young adult participants from two clinic 
sites that provide care for gender-diverse patients in the Denver metro area. Clinic sites include: (1) 
a centralized pediatric gender services clinic in a university-based medical center; and (2) a 
decentralized safety-net hospital system that sees gender diverse patients in an integrated primary 
care clinic setting and/or at school-based health centers. Among our clinic sites, approximately 100 
out of 800 gender diverse patients have used DMPA-IM within the last year. Self-administered 
DMPA-SC is not currently offered at either of these clinic sites. 
 
Inclusion criteria includes participants with fluency in English, between ages 15-21, currently 
receiving care at one of the clinic sites, assigned female-at-birth, identify as transgender or gender 
diverse (we use these terms for ease of communication in this proposal, with recognition that 
patients may have a range of terms and identities to describe themselves), and currently using or 
are interested in using DMPA. We limit our participants to English-speaking to make focus group 
discussion more feasible given the small sample size. Young adults up to age 21 are still seen in 
the pediatric clinic. For participants under 18 years of age, we will obtain a waiver of parental 
consent from the IRB. This is available because reproductive services are confidential for all 
adolescents in the state of Colorado. The University of Colorado IRB recognizes that requiring 
consent for studies which involve the same risks as routine contraceptive care is biased against 
adolescent participation. Furthermore, we anticipate that a large proportion (>50%) of the potential 
participants will arrive at the clinic without a parent or guardian. Hence, a requirement of parental 

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consent for participation is apt to differentially exclude participants, thereby biasing the findings by 
including only those that are supported by and can discuss contraceptive choices and sexual 
health with their parent/guardian and may further exclude the perspectives an already marginalized 
population. 
 
 
 
C. Study Design and Research Methods   
 
After the participant has been consented, research staff will collect clinical and demographic 
information from each participant. 
 
We will collect data for this phenomenological study using focus groups and semi-structured 
interviews to explore the perspectives and experiences of transmasculine adolescents and young 
adults using DMPA and contraceptive counseling. Phenomenology, like much of qualitative inquiry, 
privileges the voices of participants, allowing for in-depth exploration into the significance, 
structure, and meaning they ascribe to their lived experiences. While they are many approaches to 
qualitative inquiry, hermeneutic phenomenology excels at situation persons back into the context of 
their unique lives and aligns with tenants of PCCC which aims to center individual experiences, 
intersecting identities, structural injustices, and experiences within sexual and reproductive health 
care.20 
 
We will use purposive sampling to recruit (up to 30) participants, specifically with criterion and 
chain-referral strategies21 to participate in focus groups and interviews. While the final number will 
depend on the adequate depth of responses to create experientially rich accounts, we are limited 
by the feasibility of funding for compensation and availability of participants. Purposeful sampling 
with a criterion strategy is appropriate because (1) it aligns with tenets of phenomenology where 
selected individuals represent those who have experienced the central phenomenon under study; 
and (2) because TGD adolescents and young adults who are interested in or using DMPA 
represent a relatively small proportion of the population. We will employ a chain referral strategy by 
collaborating with providers who will help identify and help distribute study information through 
virtual and/or direct communication such as emails, clinic newsletter, and use of a flyer while youth 
are in the clinic for appointments. Study recruitment material will have information about the 
project, and contact information for the study team (email, phone). Members of the study team may 
also be in the clinics during appointment hours to speak directly with interested participants, or 
answer questions about the study. We will collect contact information including a reliable preferred 
method of contact (telephone number and/or e-mail address). A member of the study team will 
offer each participant a date for an online focus group or ask about availability for interviews via an 
online platform. 
 
We will collect data for this study through focus groups with participants who are already using 
clinic-administered intramuscular (IM) and participants who are initiating DMPA (IM or SC). At the 
end of the FG, all participants will be offered the opportunity to switch to self-administration of 
subcutaneous (SC) DMPA. If they elect initiate self-administered DMPA-SC, a trained member of 
our research staff will follow-up with self-injection instructions and a care kit (2 doses of DMPA-SC, 
a sharps container, alcohol swabs, and a calendar with the next injections). Participants will be 
asked to participate in a semi-structured interview after 2 self-administered injections. Semi-
structured interviews will be conducted with participants who initiate self-administered DMPA-SC or 
change from in-clinic administration of DMPA-IM to self-administration of DMPA-SC during the 
study period. In this study, self-administration may also include administration by another individual 
outside of the clinic setting (e.g. parent/guardian).  
 
Focus Groups  
 

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Focus groups and individual interviews will be led by a member of the trans-masculine young adult 
community who will be trained on interviews and focus group procedures. Guides will be developed 
from a collaboration between experts in gender affirming care (N. Nokoff), qualitative community-
based research and transgender health (R. O’Connell), community advocate (L. Dunbar) and 
family planning (N. Fang). Before finalization, we will conduct two short interviews with (community 
partners, youth, providers) to review interview guide and make recommendations with a member of 
the research team. 
Focus groups are used for generating information on collective views and follow the tenets 
phenomenology to help highlight the meanings that lie behind those views. Focus groups capitalize 
on communication between participants, and explicitly use group interaction to generate a rich 
understanding of participants' experiences. For youth, and anyone who may be reluctant to be 
interviewed on their own, FG are useful in creating group process that generating conversation that 
may not come up in 1-1 interviews, and help to examine not just what participant think, but how and 
why and often allow for communication that resembles more day-to-conversation rather than 
response to direct questions. We will conduct online focus groups, which can provide adolescents 
a more permissive and less intimidating environment to share their experiences.22 An online 
platform is also preferable given the continued COVID-19 pandemic and encourages limited in-
person interaction. Focus group guides will be structured with primary questions about 
perspectives of, and experiences with DMPA. Questions will include experiences around 
contraceptive counseling, language and communication about contraceptive use, their reasons for 
initiation and choice of contraception and administration, Focus groups will be conducted with 
participants who are continuing DMPA-IM and initiating DMPA (either IM or SC). Focus groups will 
be composed of 4-6 participants and a facilitator. All focus groups will be conducted over an online 
platform (Zoom). 
 
Interviews 
For those participants who participated in the FGs and who switch to self-administration, 
we will ask them to also participate in a semi-structured interview after 2 injections. For those 
initiating DMPA during the study period and choose the SC formulation, they will participate in an 
individual interview after 2 injections. Interviews will focus on experience of home administration, 
side effects, satisfaction, and acceptability.  Study participants will be compensated $50 ($100 
total) for participating per focus group or individual interviews. 
 
 

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Optional Study Procedures.  
At-home administration of DMPA-SC 
 
Both DMPA-IM and DMPA-SC are FDA-approved for use in humans and therefore do not have an 
IND or IDE.  Both drugs are FDA-approved for administration by a health care provider.  DMPA-SC 
is not FDA-approved for self-administration by patients, however the 2021 update to the CDC 
Selected Practice Recommendations advises that DMPA-SC be made available for self-
administration.18    Self-administration of DMPA-SC in this research study should be considered 
exempt from IND requirements under Category #1 - Lawfully Marketed Drugs (21 CFR 312.2(b)(1)) 
or Biologics, because a) it is lawfully marketed in the United States; b) the research is not intended 
to be reported to the FDA in support of a new indication for use nor intended to be used to support 
any other significant change in labeling for the drug; c) the research is not intended to support a 
significant change in advertising for the drug; d) the research does not involve a route of 
administration, dosage level, use in a patient population, or other factor that significantly increases 
the risk (or decreases the acceptability of the risks) associated with the use of the drug; and e) the 
research is conducted in compliance with the marketing limitations described in 21 CFR §312.7.  In 
particular, as outlined above, extensive data exists documenting that self-administration of DMPA-
SC is associated with similar or lower rates of adverse effects compared to health care provider-
administration of DMPA. 
 
Each participant will be given the opportunity to initiate or switch to a 6 month trial of at-home 
administration of DMPA-SC (104 mg). For those interested in initiating or switching to this method, 
we will provide a 6 month supply for at-clinic pick-up or ship to their preferred location. We will also 
offer a telehealth visit for teaching, video, and written instructions on how to administer the 
medication. DMPA-SC is currently not offered at the clinical sites we are recruiting from. However, 
our clinical staff have been prescribing and shipping DMPA-SC to adolescents through another 
clinical site (BC4U) within the same hospital system. Additionally, both recruitment sites offer self-
administration of other medications, including subcutaneous testosterone, as part of clinical 
practice.  
 
 
   
  
D. Description, Risks and Justification of Procedures and Data Collection Tools: 
 
 
Risk of loss of privacy and/or confidentiality: There is a risk that people who are not on the 
research team may see the research information. All research documentation will be stores in a 
locked cabinet behind two locked doors that only the research staff will have access to. All 
electronic information will be stored in REDCap. We will complete all necessary steps to protect all 
information, but confidentiality cannot be guaranteed.  
 
Risk of DMPA use: The most common adverse reactions experienced with DMPA are changes in 
menstrual periods, weight gain, nausea, stomach cramping or pain, bloating dizziness, headache, 
tiredness, drowsiness, irritability, breast tenderness, decrease in breast size, acne, hair loss, 
decreased sex drive, hot flashes, joint pain, or injection site reactions.  
 
Risk of Pregnancy: There is a rare risk, 4% chance that DMPA injection could fail, leading to an 
unintended pregnancy. DMPA has a failure rate of over one year of use. All participants will be 
counseled on this potential risk of pregnancy23.  
 
Injection site reactions: There is an increased risk of injection site reactions with self-administered 
DMPA-SC. Injection site reactions are typically mild to moderate and resolve without sequalae.  
 
 
    

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E. Potential Scientific Problems:   
We anticipate some limitations in our qualitative study, given that the population may not want to 
engage in additional research activities beyond their gender-affirming medical care. Participants 
may be not representative of greater community of transgender and transmasculine adolescents 
since we are restricting participants to those who present to well-known gender-affirming care 
centers and providers, as well as restricting participants to English speakers only. Lastly, TGD 
youth may discontinue DMPA for a variety of reasons, including menses suppression secondary to 
testosterone or no longer engaging in penile/vaginal intercourse. Therefore, satisfaction and 
acceptability of DMPA-SC should be framed in the context of aligning with the goals of the 
participants rather than continuation rates or rates of unintended pregnancy. 
 
Data Collection Tools: As each subject completes the study, we will enter all data into REDCap, 
which is a password-protected database that will allow us to de-identify subject-specific data. The 
only personnel that will have access to this data will be the PI, co-investigator, and any trained 
research staff on the protocol. All study-related documents including the informed consent forms 
will be stored in a locked cabinet in a locked room. The only people who will have access to the 
documents will be the PI, co-investigator, and any trained research staff on the protocol.   
 
 
F. Data Analysis Plan:   
 
All focus groups and interviews will be audio-recorded and transcribed into NVivo for coding and 
analysis. We will provide descriptive statistics for demographic information and code interviews 
accordingly to isolate any demographic difference in experience which may suggest future 
research questions. Data analysis of focus groups and interviews will be ongoing and iterative, 
allowing the team to make any changes to interview questions reflecting changes or emerging 
themes that may appear as data collection progresses. Thematic analysis in phenomenological 
research seeks to uncover the essential components of a particular experience. We will use three 
steps to isolate themes: (1) holistic, (2) selective, and (3) detailed. In the holistic approach the goal 
is to find one phrase that can capture the “fundamental or main significance of the text as whole.”17 
In the selective approach, the goal is to find a number of specific phrases that stand out that seem 
to be thematic of the experience. In the detailed approach, a line-by-line analysis occurs with the 
goal of asking what each sentence or group of sentences might reveal about an experience. During 
this process we will begin to link themes together that have common characteristics and patterns 
and develop a codebook while ensuring concepts stay close as possible to participants’ own words. 
We will also examine themes across focus groups and interviews.  
 
 
 
G. Summarize Knowledge to be Gained:   
 
We need a better understanding of the contraceptive practices among gender diverse patient 
populations. We plan to build upon this study to explore acceptability and satisfaction with different 
contraceptive methods for those desiring menses suppression and/or pregnancy prevention.  We 
also aim to develop counseling aids with the goal of improving care provision for gender diverse 
adolescents. 
 
 
 H. References: 
 
 
 
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