Supporting statement B

Request for OMB Approval of a Data Collection Formative Tools for Addressing HIV Prevention Preferences among Adolescent Men Who Have Sex with Men (AMSM) OMB # 0920-1154 Expires 1/31/2020 Supporting Statement Part B October 19, 2017 Supported by: Division of Adolescent and School Health Centers for Disease Control and Prevention (DASH) Richard Dunville, MPH CDC/OID/NCHHSTP, Research Officer (404) 769-3290 dgo2@cdc.gov

Section B: Collections of Information Employing Statistical Methods

Table of Contents

1. Respondent Universe and Sampling Methods

2. Procedures for the Collection of Information

3. Methods to Maximize Response Rates and Deal with No Response

4. Tests of Procedures or Methods to be Undertaken

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

B1. Respondent Universe and Sampling Methods

Respondent Universe

This formative research study will enroll adolescents at high risk for HIV, living across the United States using social media and other websites. We will recruit individuals through paid ads on Facebook, Twitter, SnapChat, Kik, Tumblr, Google, and Instagram. Targeted ads will use the social media app and websites’ filtering abilities to show ads only to those who are most likely to be eligible; ads may be limited by factors such as age, gender, sexual orientation, education.

Eligible participants are male teenagers (13‑18) who are attracted to or sexually active with males, or who identify as a sexual minority (i.e., not straight). Also eligible participants are Transgender youth ages 13‑24 of any sex at birth.

Sample Size

As this request is to allow for the fielding of a pilot study only, the target sample size is a maximum of 3500 participants.

Sample sizes for each component of the soft launch for the pilot study are as follows:

• Gay/Bisexual Male Teens – A maximum of 250 participants or 4 weeks in the field, whichever comes first.

• Trans Adolescents ages 13‑24 – A maximum of 250 participants or 4 weeks in the field, whichever comes first.

Sample sizes for each component of the full launch for the pilot study are as follows:

• Gay/Bisexual Male Teens – A maximum of 1500 participants or 12 months in the field, whichever comes first.

• Trans Adolescents ages 13‑24 – A maximum of 1500 participants or 12 months in the field, whichever comes first.

Sampling Method

The sample will be a non‑probability based purposive sample. Respondents will be recruited via social media and other websites, including Facebook, Twitter, Kik, Tumblr, Instagram, Google, and SnapChat. Individuals meeting the age and gender criteria who visit one of the aforementioned social media apps or websites will be eligible to view the ads (Attachment 4). Ads will be restricted or targeted based on the profile of the viewer, using tools made available by the social media app and website advertisement vendors.

Potential respondents who click on an ad will be routed to the survey landing page which will explain the purpose of the study and include assent/consent language. Respondents will assent or consent by clicking on Continue from the survey landing page, where they will be taken to the web survey screener.

Sampling Plan

A non‑probability sample will be utilized for this survey, in order to collect data from young individuals at high risk for HIV infection across the United States. A review of the literature and market information, conducted by Socially Authentic, identified the following six social media sites for study recruitment:

• Facebook

• Twitter

• Kik

• SnapChat

• Instagram

• Tumblr

Additionally, Google Ads will be used to recruit respondents who use the internet but may not be active on the social media sites listed above.

B2. Procedures for the Collection of Information

For the study:

• Individuals meeting the age and gender criteria and who visit one of the social media or other websites will be eligible to view the sample ads (Attachment 4).

• Interested respondents who click on an ad will be routed to the pilot survey landing page which will explain the purpose of the study and include assent/consent language (Attachment 2).

• To determine eligibility of interested respondents, the web survey includes a brief screener to assess eligibility as well as determine skip patterns for the questionnaire (Attachments 1a‑b).

  • Eligible study participants must be residents of the United States and meet one of the following two criteria:

    • Teen males ages 13‑18 who are attracted to or sexually active with males, or identifies as a sexual minority (i.e., not straight).

    • Trans youth ages 13‑24, as defined by self‑identification as Transgender or Genderqueer or as having a different current gender from sex at birth.

• Eligible participants will then complete the full pilot Web Survey (Attachment 1c).

Data Management

• All personally identifying information (i.e., e‑mail addresses and/or phone numbers collected for token of appreciation delivery) will be maintained in separate databases that are fully divorced from the survey response data.

• No PII will be delivered to CDC or used in future research or analysis.

• Interview data will be organized in databases stored on secure local servers at NORC and will be backed‑up regularly.

• Electronic equipment and files will be kept password‑protected.

• Electronic devices will be kept locked when not in use.

• Individual records will be kept secure, accessible only to the study team.

The web survey will be administered using Voxco, a computer‑aided interviewing platform that meets all project security standards. Voxco has some safeguards in place to help ensure that individuals do not participate in the study more than once. Voxco will ask participants for their email address or telephone number at the end of the survey in order to send the respondent their token of appreciation. Should duplicates be identified, the respondent will be reminded of the token of appreciation they already received and their response data will be marked as a duplicate. Email and phone numbers will be maintained by NORC in a separate database from the survey data; CDC will not have access to this information. The email and phone numbers will be destroyed at the conclusion of the study, thus preserving participants’ privacy.

B3. Methods to Maximize Response Rates and Deal with Nonresponse

Study participation is voluntary, and study leads will make every effort to maximize the rate of response. The following procedures will be used to maximize cooperation and achieve the desired participation rates:

A token of appreciation with a value of $10 will be offered to participants who complete the web survey. Respondents will be given the option of one of the following gifts: Month of Spotify; Five song downloads; One digital movie; Month of Netflix, Hulu, or YouTubeRed; Two drinks from Starbucks or Dunkin Donuts; One Uber/Lyft ride; One sandwich.

NORC will provide a toll‑free telephone number for the NORC project team and a toll‑free telephone number for the NORC IRB hotline should participants have any questions about the study or their rights as study participants as well as contact information for CDC Info and AIDS.gov should they have questions or concerns about HIV or wish to locate HIV‑related or other services.

All participants will be routed to CDC web resources for LGBT youth at the end of the survey, where they may find additional information to answer questions or seek help. Any participant who reports nonconsensual sex will be provided with the child welfare website: https://www.childwelfare.gov/aboutus/find‑help/.

Main challenges to the success of the project include willingness of participants to share personal information on sexual behavior. Proposed solutions are to ensure confidentiality for all respondents, as described on the Consent and Landing Page, and to utilize accurate, unbiased language throughout the survey to avoid insinuating a value judgment for any behaviors.

B4. Test of Procedures or Methods to be Undertaken

The study team previously conducted usability testing and cognitive interviews with eight survey‑eligible participants in Chicago, IL. The study team provided an overview of the study and explained the rationale, followed by a review of the informed consent and screener questions with each individual participant. The participants then completed the survey using a tablet, smartphone, or laptop, while a survey methodologist probed the individual’s understanding of, interpretation of, and comfort with each item. The youth provided feedback on their comprehension of the informed consent, the acceptability of the subject matter, and questionnaire content. Revisions were made to the questionnaire based on this feedback. The group did not find the informed consent or questionnaire process burdensome.

The pilot study is intended to:

• Evaluate potential to recruit sufficient sample of eligible youth in areas disproportionately affected by HIV/AIDS

• Calculate an average cost per respondent

• Assess success of individual ads and recruitment venues

• Inform development of tools and guidance for a variety of public health practitioner audiences that will support the implementation of feasible and scalable public health strategies to increase HIV prevention among Black and Latino AMSM and Transgender youth, via survey responses on:

  • Knowledge of HIV risk behavior and attitudes toward HIV vulnerability, and racial‑ethnic and other demographic differences in knowledge and attitudes

  • Sexual identity and demographic differences in these areas

  • Risk and protective factors, such as mental health resiliency, and demographic differences in these areas

  • Access to sex education and other HIV prevention activities in school and community settings

  • Knowledge of and attitudes toward PrEP and other biobehavioral prevention interventions

  • Role of parental involvement in HIV prevention and testing

B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Role	Name	Telephone Number	Email
Data collection and/or analysis	NORC
	Stuart Michaels	773‑256‑6236	michaels‑stuart@norc.org
	Sabrina Bauroth	312‑325‑2569	bauroth‑sabrina@norc.org
	Mike Stern	312‑357‑3891	stern‑michael@norc.org
	Melissa Heim Viox	404‑240‑8412	heimviox‑melissa@norc.org
	Ipek Bilgen	312‑357‑3874	bilgen‑ipek@norc.org
	Erin Fordyce	312‑357‑7011	fordyce‑erin@norc.org
	TFI
	Sean Cahill	617‑927‑6016	scahill@fenwayhealth.org
	Kerith Conron	617‑927‑6369	conron@law.ucla.edu
	Sophia Geffen	857‑313‑6670	sgeffen@fenwayhealth.org
	Holly Fontenot	617‑552‑1846	holly.fontenot@bc.edu
	Timothy Wang	617‑927‑6112	twang@fenwayhealth.org
	CDC
	Richard Dunville	404‑769‑3290	dgo2@cdc.gov
	Chris Harper	404‑718‑8330	xgj4@cdc.gov
	Michelle Johns	404‑718‑8858	yrm9@cdc.gov
Research Advisors	Leandro Mena	NA*	lmena@umc.edu
	Patrick Wilson	NA	pw2219@cumc.columbia.edu
	Eszter Hargittai	NA	hargittai@gmail.com
	Brian Mustanski	NA	brian@northwestern.edu
	Sari Reisner	NA	sreisner@fenwayhealth.org

^*Not Available (NA)

7