ATN 168: HAPPY

Study Summary:

The ATN 168 study, HIV and Pregnancy Protection for Youth (HAPPY), will examine the values and preferences for a long-acting, multi-purpose prevention product that would prevent HIV and pregnancy in cisgender women, transgender men, and nonbinary people with child-bearing potential. Long-acting products may have an advantage over other products, particularly in young people, because they are convenient, discreet, and do not require daily use to be effective. This new prevention product is in the early stages of development and incorporating end-user preferences will help ensure that the developed multi-purpose prevention product is acceptable to young people. Increased acceptability may mean that the product will be more likely used in the future. The ATN 168 study includes three steps, that all build on one another. The information gather in Step 1 will inform the DCE survey, which will be piloted in Step 2 and refined in Step 3.

What is the study trying to discover?

The HAPPY study is trying to learn about young people’s thoughts and opinions about the features that would be important for a HIV and pregnancy prevention product to have. This information will help inform the development of the new combined product for HIV and pregnancy prevention.

Why is this study important?

Few studies to date in the U.S. have evaluated end-user preferences for a multi-purpose prevention product, particularly among adolescents and young adults, and in transgender and gender diverse individuals. Data from this study will help inform the development of a new multi-purpose product that could be used for both HIV and pregnancy prevention and could also have menstrual suppression benefits.

Who is this study for?   

The ATN 168 study is for cisgender women, transgender men, and gender diverse individuals assigned female at birth aged 15-24 years.

What happens during the study?

There are three steps in the ATN 168 study: Step 1, In-depth interview; Step 2, Pilot Discrete Choice Experiment (DCE) survey; and Step 3, DCE Survey. Participants will also complete a brief sociodemographic survey in each of the steps. Study participation requires a single study visit lasting between 1.5 hours and 4 hours depending on the study step. The visit may be split over more than one day, if needed.

Step 1

  • 50 individuals with child-bearing potential age 15-24 years
  • Participant self-complete a short survey
  • Complete an in-depth interview with an interviewer

Step 2

  • 10-15 individuals with child-bearing potential age 15-24 years
  • Participant self-complete a pilot DCE survey
  • Participant discusses their survey responses with an interviewer and the interviewer completes the interview summary sheet

Step 3

  • 440 individuals with child-bearing potential age 15-24 years
  • Administer DCE survey that includes questions on socio-demographics and sexual behavior

Study Details:

Protocol Status:

Undergoing IRB review. Step 1 is expected to open for enrollment in November of 2023.

Study Purpose: 

To examine the values and preferences for a long-acting, multi-purpose prevention product that would prevent HIV and pregnancy in cisgender women, transgender men, and nonbinary people with child-bearing potential.

Study Design:

ATN 168 is a cross-sectional (i.e., at a single time point) survey to elicit multipurpose prevention product preferences.

Study Population:

Study participants will be adolescents and young cisgender women, transgender men, and nonbinary people with child-bearing potential aged 15-24 years, inclusive.

Sample Size:

Up to 505 individuals will be enrolled in the study across all three steps.

Study Duration:

The ATN 168 study will take 18 months to complete, including 3 months for regulatory submissions, 12 months of data collection, and 3 months for close out.

Study Intervention:

ATN 168 does not involve an intervention. Depending on the study step, participants will complete the following:

  • Step 1: Brief sociodemographic (“short”) survey and in-person interview (approximately 4 hours); or
  • Step 2: Completion of the pilot DCE survey that also includes the “short” survey and discussion of survey responses (approximately 2.5 hours); or
  • Step 3: Completion of the DCE survey that also includes questions on sociodemographics, and sexual and risk behaviors (approximately 1.5 hour).

Study Objectives:

To assess the values and preferences for a novel, systemic, injectable multi-purpose prevention product for pregnancy and HIV prevention in adolescents and young adult cisgender women and transgender and gender diverse individuals assigned female at birth.

In development

Participating Site Consortiums

Step 1

Baylor College of Medicine

Johns Hopkins University

University of South Florida

Step 2

Baylor College of Medicine

Children’s Hospital Los Angeles

University of Illinois Chicago

The Fenway Institute

Johns Hopkins University

St. Jude Children’s Research Hospital

Tulane University

University of South Florida

Protocol Co-Chairs

Sinead Delany-Moretlwe
sdelany@wrhi.ac.za

Mark Marzinke
mmarzin1@jhmi.edu

Study Manager

Nancy Liu
nancyliu@westat.com